A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Randomized, Double-Blind, Phase 2 Study Of Erlotinib With Or Without SU011248 In The Treatment Of Metastatic Non-Small Cell Lung Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00265317

Acronym

SUN1058

Enrollment

162

Registered

2005-12-14

Start date

2006-06-30

Completion date

2012-01-31

Last updated

2013-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Keywords

Non-small cell lung cancer, sunitinib, erlotinib, Phase 2

Brief summary

This study will test whether treatment with erlotinib plus SU011248 is better than erlotinib alone in patients with advanced/metastatic lung cancer who have received previous treatment with a platinum-based regimen

Interventions

DRUGerlotinib

erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity

DRUGsunitinib

Sunitinib 37.5 mg daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity

DRUGplacebo

Placebo daily by oral capsule in a continuous regimen plus erlotinib 150 mg daily by tablets in a continuous regimen, until progression or unacceptable toxicity

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients with locally advanced/metastatic non-small cell lung cancer * Prior treatment with no more than 2 chemotherapy regimens including a platinum-based regimen

Exclusion criteria

* Prior treatment with any receptor tyrosine kinase inhibitors, Vascular endothelial growth factor (VEGF) inhibitors or other angiogenic inhibitors * History of or known brain metastases

Design outcomes

Primary

Measure	Time frame	Description
Progression-Free Survival (PFS)	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to \[≥\]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.

Secondary

Measure	Time frame	Description
Plasma Concentration of Soluble VEGFR-3 at Baseline	Baseline (Cycle 1, Day 1)	—
Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts	Baseline (Day 1, Cycle 1)	A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.
EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)	The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.
Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)	Randomization up until Month 17	Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes \[min\]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP \>150 mmHg/diastolic BP \>100 mmHg at any timepoint postbaseline.
Number of Participants With BP Greater Than 200/110 mmHg	Randomization up until Month 17	Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes \[min\]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP \>150 mmHg/diastolic BP \>100 mmHg at any timepoint postbaseline.
Plasma Concentration of VEGF-C at Baseline	Baseline (Cycle 1, Day 1)	—
Plasma Concentration of Soluble KIT (sKIT) at Baseline	Baseline (Cycle 1, Day 1)	—
Percentage of Participants With Objective Response	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.
Time to Tumor Progression (TTP)	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.
Duration of Response (DR)	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.
Overall Survival (OS)	From randomization until death (up to Month 17)	OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.
Percentage of Participants Surviving at 1 Year	From randomization until death (up until Month 17)	Percentage of participants alive at 1 year after date of first administration of study medication.
Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib	Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose	AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib
AUC(0-24) of Sunitinib	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose	AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib
AUC(0-24) of SU-012662 (Metabolite of Sunitinib)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose	AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)
AUC(0-24) of Total Drug (Sunitinib + SU-012662)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose	AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)
Maximum Observed Plasma Concentration (Cmax) of Erlotinib	Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose	—
Cmax of Sunitinib	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	—
Cmax of SU-012662 (Metabolite of Sunitinib)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	—
Cmax of Total Drug (Sunitinib + SU-012662)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	—
Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib	Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)	AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC\[0-t\]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC\[t-inf\])
AUC(0-inf) for Sunitinib	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)	AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)
AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)	AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)
AUC(0-inf) for Total Drug (Sunitinib + SU-012662)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)	AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)
Plasma Decay Half-life (t1/2) of Erlotinib	Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Plasma Decay Half-life (t1/2) of Sunitinib	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.
Erlotinib Clearance at Steady State After Oral Administration (CL/F)	Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose	—
Sunitinib Clearance at Steady State After Oral Administration (CL/F)	Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	—
Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib	Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose	—
Tmax for Sunitinib	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	—
Tmax for SU-012662 (Metabolite of Sunitinib)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	—
Tmax for Total Drug (Sunitinib + SU-012662)	Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose	—
Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)	Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)	Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)	Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)	Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)	Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)	Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.
Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff	Baseline	Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.
Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)	Baseline	Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.
Percentage of Participants With EGFR Gene Copy Number Increase	Baseline	The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.
PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.
Percentage of Participants With EGFR Gene Amplification	Baseline	The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
PFS in Subgroups That Were Defined by EGFR Gene Amplification	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
Percentage of Participants With EGFR Gene Mutation	Baseline	Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.
PFS in Subgroups That Were Defined by EGFR Gene Mutation	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations	Baseline	Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.
PFS in Subgroups That Were Defined by KRAS Gene Mutation	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Baseline	Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.
PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	From randomization until death (up to Month 17)	OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.
Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Baseline	Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.
Number of Participants on Anti-hypertensive Medications	Randomization to Day 28 of Cycle 18	Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.
PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.
Percentage of Participants by Tumor VEGFR Mutation	Baseline	Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
Plasma Concentration of Soluble VEGFR-2 at Baseline	Baseline (Cycle 1, Day 1)	—
Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	Baseline	Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.
PFS in Subgroups That Were Defined by RNA Expression Profile	From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)	PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.
Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1	EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.

Other

Measure	Time frame	Description
VEGFR-2 Ratio to Baseline at Each Timepoint	Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)	Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)
VEGFR-3 Ratio to Baseline at Each Timepoint	Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)	Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)
sKIT Ratio to Baseline at Each Timepoint	Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)	Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)
VEGF-C Ratio to Baseline at Each Timepoint	Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)	Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)

Countries

Canada, Hungary, Italy, Netherlands, Poland, Romania, Spain, United States

Participant flow

Participants by arm

Arm	Count
Sunitinib + Erlotinib (Original Lead-In) Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).	13
Sunitinib + Erlotinib (Amended Lead-in) Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)	17
Sunitinib + Erlotinib Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.	65
Erlotinib + Placebo Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.	67
Total	162

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002	FG003
Lead-In	Adverse Event	2	1	0	0
Lead-In	Death	3	5	0	0
Lead-In	Objective progression or relapse	6	11	0	0
Lead-In	Withdrawal/other than adverse event	1	0	0	0
Phase 2	Adverse Event	0	0	7	5
Phase 2	Death	0	0	12	15
Phase 2	Global deterioration of health status	0	0	3	0
Phase 2	Lost to Follow-up	0	0	0	1
Phase 2	Objective progression or relapse	0	0	37	38
Phase 2	Other	0	0	1	1
Phase 2	Protocol Violation	0	0	1	4
Phase 2	Study terminated by sponsor	0	0	1	0
Phase 2	Withdrawal/other than adverse event	0	0	2	1

Baseline characteristics

Characteristic	Sunitinib + Erlotinib (Original Lead-In)	Sunitinib + Erlotinib (Amended Lead-in)	Sunitinib + Erlotinib	Erlotinib + Placebo	Total
Age, Customized Greater than or equal to 65 years	6 participants	7 participants	17 participants	24 participants	54 participants
Age, Customized Less than 65 years	7 participants	10 participants	47 participants	43 participants	107 participants
Age, Customized Unknown or Not Collected	0 participants	0 participants	1 participants	0 participants	1 participants
Sex/Gender, Customized Female	6 participants	6 participants	25 participants	22 participants	59 participants
Sex/Gender, Customized Male	7 participants	11 participants	39 participants	45 participants	102 participants
Sex/Gender, Customized Unknown or Not Collected	0 participants	0 participants	1 participants	0 participants	1 participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —
other Total, other adverse events	13 / 13	15 / 17	60 / 64	61 / 64
serious Total, serious adverse events	5 / 13	7 / 17	29 / 64	28 / 64

Outcome results

Primary

Progression-Free Survival (PFS)

PFS=time from randomization date to date of first documentation of progressive disease (PD; defined as greater than or equal to \[≥\]20% increase in sum of longest dimensions of target lesions taking as a reference smallest sum of longest dimensions recorded since first dose or appearance of ≥1 new lesions) or death on-study due to any cause, whichever occurred first based on third party independent imaging review laboratory assessment. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02. Used 7.02 days as it equals 365 days per year divided by 52 weeks per year.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: Full Analysis Set (FA):all participants in randomized phase randomized with study medication assignment designated according to initial randomization, regardless of whether participants actually received study medication or received different medication from what they were randomized.

Arm	Measure	Value (MEDIAN)
Sunitinib + Erlotinib	Progression-Free Survival (PFS)	12.3 Weeks
Erlotinib + Placebo	Progression-Free Survival (PFS)	8.5 Weeks

Comparison: Sample size for randomized portion of study determined based on these assumptions: median PFS (erlotinib)=10 weeks, accrual time=12 months. With 6 months follow-up, study was powered to detect a difference in PFS of 5 weeks. 1-sided log rank test comparing the 2 treatment groups with 115 events of PD or death among a target sample size of 126 participants (63 per group) achieved 80% power at a 10% significance level to detect a 50% improvement in PFS from 10 to 15 weeks.p-value: 0.320680% CI: [0.575, 1.404]Log Rank

Secondary

Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of erlotinib

Time frame: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Amended Lead-in Cohort Arm A: participants received sunitinib QD for 28 days each cycle (27 days in Cycle 1) and erlotinib QD for 28 days each cycle (7 days in Cycle 1)

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib	Cycle 1, Day 1	12.96 micrograms (mcg)*hour(hr)/milliliter (mL	Standard Deviation 4
Sunitinib + Erlotinib	Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib	Cycle 1, Day 22	11.87 micrograms (mcg)*hour(hr)/milliliter (mL	Standard Deviation 4.35

Secondary

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib

AUC (0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for erlotinib. It is obtained from AUC from time zero (pre-dose) to last quantifiable concentration(AUC\[0-t\]) plus AUC from time last quantifiable concentration extrapolated infinite time (AUC\[t-inf\])

Time frame: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose; predose on Days 22 and 23 (Cycle 1)

Population: Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, AUC(0-inf) could not be accurately estimated.

Secondary

AUC(0-24) of SU-012662 (Metabolite of Sunitinib)

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of SU-012662 (metabolite of sunitinib)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	AUC(0-24) of SU-012662 (Metabolite of Sunitinib)	Cycle 1, Day 1	50.06 ng*hr/mL	Standard Deviation 22.76
Sunitinib + Erlotinib	AUC(0-24) of SU-012662 (Metabolite of Sunitinib)	Cycle 1, Day 15	99.57 ng*hr/mL	Standard Deviation 39.48

Secondary

AUC(0-24) of Sunitinib

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of sunitinib

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Amended Lead-In Cohort Arm B: participants received sunitinib for 28 days each cycle (13 days in Cycle 1) and erlotinib QD for 28 days each cycle (26 days in Cycle 1).

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	AUC(0-24) of Sunitinib	Cycle 1, Day 1	372.76 nanograms (ng)*hr/mL	Standard Deviation 105.21
Sunitinib + Erlotinib	AUC(0-24) of Sunitinib	Cycle 1, Day 15	231.61 nanograms (ng)*hr/mL	Standard Deviation 69.42

Secondary

AUC(0-24) of Total Drug (Sunitinib + SU-012662)

AUC0-24=Area under the plasma concentration versus time curve from time zero (pre-dose) to 24 hours (0-24) of total drug (sunitinib + SU-012662)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	AUC(0-24) of Total Drug (Sunitinib + SU-012662)	Cycle 1, Day 1	422.93 ng*hr/mL	Standard Deviation 123.29
Sunitinib + Erlotinib	AUC(0-24) of Total Drug (Sunitinib + SU-012662)	Cycle 1, Day 15	331.45 ng*hr/mL	Standard Deviation 88.67

Secondary

AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)

AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for SU-012662 (metabolite of sunitinib). It is obtained from AUC(0-t) plus AUC(t-inf)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)

Population: Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.

Secondary

AUC(0-inf) for Sunitinib

AUC (0 - inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for sunitinib. It is obtained from AUC(0-t) plus AUC(t-inf)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)

Population: Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.

Secondary

AUC(0-inf) for Total Drug (Sunitinib + SU-012662)

AUC(0-inf) = Area under the plasma concentration versus time curve (AUC) from time zero (pre-dose) to extrapolated infinite time (0-inf) for total drug (sunitinib + SU-012662). It is obtained from AUC(0-t) plus AUC(t-inf)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose; predose on Days 15, 16, and 17 (Cycle 1)

Population: Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, AUC(0-inf) could not be accurately estimated.

Secondary

Cmax of SU-012662 (Metabolite of Sunitinib)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Cmax of SU-012662 (Metabolite of Sunitinib)	Cycle 1, Day 1	3.09 ng/mL	Standard Deviation 1.33
Sunitinib + Erlotinib	Cmax of SU-012662 (Metabolite of Sunitinib)	Cycle 1, Day 15	6.83 ng/mL	Standard Deviation 4.22

Secondary

Cmax of Sunitinib

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Cmax of Sunitinib	Cycle 1, Day 1	21.61 ng/mL	Standard Deviation 6.76
Sunitinib + Erlotinib	Cmax of Sunitinib	Cycle 1, Day 15	13.59 ng/mL	Standard Deviation 5.88

Secondary

Cmax of Total Drug (Sunitinib + SU-012662)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Cmax of Total Drug (Sunitinib + SU-012662)	Cycle 1, Day 1	24.51 ng/mL	Standard Deviation 7.72
Sunitinib + Erlotinib	Cmax of Total Drug (Sunitinib + SU-012662)	Cycle 1, Day 15	20.09 ng/mL	Standard Deviation 7.8

Secondary

Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts

A blood sample (6 mL) was collected before on-study treatment and was used to isolate DNA. These samples were not anonymized. Correlation was investigated by the percentage of participants with anemia (based on hemoglobin count), neutropenia (based on neutrophil count) and thrombocytopenia (based on platelet count) endpoints and genetic variation as measured by c-KIT, FLT-3, and c-FMS was to be analyzed.

Time frame: Baseline (Day 1, Cycle 1)

Population: Blood samples were collected; however, because of the small sample size that resulted in a lack of power for statistical testing, no formal statistical analyses were performed.

Secondary

Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Time frame: predose Day 15 (Cycle1); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Population: Number of participants analyzed (N)=participants with observations above LLOQ in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 1, Day 15 (n=6)	1.14 mcg/mL	Standard Deviation 0.92
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 2, Day 1 (n=45)	1.46 mcg/mL	Standard Deviation 0.9
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 3, Day 1 (n=44)	1.07 mcg/mL	Standard Deviation 0.76
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 4, Day 1 (n=20)	0.99 mcg/mL	Standard Deviation 0.71
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 5, Day 1 (n=16)	0.98 mcg/mL	Standard Deviation 0.99
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 6, Day 1 (n=12)	1.09 mcg/mL	Standard Deviation 0.85
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 7, Day 1 (n=8)	1.08 mcg/mL	Standard Deviation 1.13
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 8, Day 1 (n=3)	0.80 mcg/mL	Standard Deviation 0.36
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 9, Day 1 (n=6)	0.94 mcg/mL	Standard Deviation 0.8
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 10, Day 1 (n=4)	1.71 mcg/mL	Standard Deviation 1.73
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 11, Day 1 (n=3)	0.53 mcg/mL	Standard Deviation 0.57
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 12, Day 1 (n=4)	1.31 mcg/mL	Standard Deviation 1.34
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 13, Day 1 (n=3)	0.75 mcg/mL	Standard Deviation 0.43

Secondary

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Time frame: predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 1, Day 15 (n=7)	18.08 ng/mL	Standard Deviation 6.14
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 2, Day 1 (n=44)	21.02 ng/mL	Standard Deviation 8.75
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 3, Day 1 (n=43)	19.26 ng/mL	Standard Deviation 11.67
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 4, Day 1 (n=19)	16.41 ng/mL	Standard Deviation 7.74
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 5, Day 1 (n=16)	15.26 ng/mL	Standard Deviation 4.97
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 6, Day 1 (n=13)	15.05 ng/mL	Standard Deviation 4.95
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 7, Day 1 (n=8)	15.99 ng/mL	Standard Deviation 5.03
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 8, Day 1 (n=4)	12.80 ng/mL	Standard Deviation 3.94
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 9, Day 1 (n=6)	14.00 ng/mL	Standard Deviation 5.59
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 10, Day 1 (n=4)	16.44 ng/mL	Standard Deviation 10.57
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 11, Day 1 (n=3)	11.98 ng/mL	Standard Deviation 3.31
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 12, Day 1 (n=3)	11.26 ng/mL	Standard Deviation 2.08
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 13, Day 1 (n=3)	15.60 ng/mL	Standard Deviation 9.96

Secondary

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of SU-012662 prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Time frame: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 2, Day 1 (n=44)	21.02 ng/mL	Standard Deviation 8.75
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 3, Day 1 (n=43)	19.26 ng/mL	Standard Deviation 11.67
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 4, Day 1 (n=28)	15.74 ng/mL	Standard Deviation 7.88
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 5, Day 1 (n=22)	15.38 ng/mL	Standard Deviation 6.05
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 6, Day 1 (n=19)	15.04 ng/mL	Standard Deviation 6.18
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 7, Day 1 (n=15)	17.13 ng/mL	Standard Deviation 9.34
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 8, Day 1 (n=8)	12.50 ng/mL	Standard Deviation 3.76
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 9, Day 1 (n=9)	12.24 ng/mL	Standard Deviation 5.19
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 10, Day 1 (n=6)	14.29 ng/mL	Standard Deviation 8.84
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 11, Day 1 (n=6)	19.35 ng/mL	Standard Deviation 21.6
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 12, Day 1 (n=4)	11.58 ng/mL	Standard Deviation 1.82
Sunitinib + Erlotinib	Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 13, Day 1 (n=3)	15.60 ng/mL	Standard Deviation 9.96

Secondary

Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original Cohort predose on Day 15 (Cycle 1, Time Zero) and Day 1 (Cycle 3), in the Amended Lead-In Cohort (Arms A and B) predose on Day 1 (Cycle 3) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Time frame: predose Day 15 (Cycle 1) and Day 1 (Cycle 3); predose Day 1 (Cycle 3); predose Day 1 (Cycles 1-18)

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 1, Day 15 (n=7)	18.80 ng/mL	Standard Deviation 4.27
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 2, Day 1 (n=44)	22.94 ng/mL	Standard Deviation 11.34
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 3, Day 1 (n=43)	21.48 ng/mL	Standard Deviation 9.62
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 4, Day 1 (n=19)	20.58 ng/mL	Standard Deviation 13.96
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 5, Day 1 (n=16)	17.26 ng/mL	Standard Deviation 9.79
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 6, Day 1 (n=13)	20.16 ng/mL	Standard Deviation 8.78
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 7, Day 1 (n=8)	21.97 ng/mL	Standard Deviation 10.21
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 8, Day 1 (n=4)	13.56 ng/mL	Standard Deviation 6.31
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 9, Day 1 (n=6)	15.17 ng/mL	Standard Deviation 7.71
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 10, Day 1 (n=4)	15.61 ng/mL	Standard Deviation 6.45
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 11, Day 1 (n=3)	15.24 ng/mL	Standard Deviation 6.65
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 12, Day 1 (n=3)	11.99 ng/mL	Standard Deviation 5.54
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 13, Day 1 (n=3)	19.79 ng/mL	Standard Deviation 13.47

Secondary

Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of sunitinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Time frame: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 2, Day 1 (n=44)	22.94 ng/mL	Standard Deviation 11.34
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 3, Day 1 (n=43)	21.48 ng/mL	Standard Deviation 9.62
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 4, Day 1 (n=28)	19.93 ng/mL	Standard Deviation 12.74
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 5, Day 1 (n=22)	18.58 ng/mL	Standard Deviation 10.47
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 6, Day 1 (n=19)	22.07 ng/mL	Standard Deviation 13.32
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 7, Day 1 (n=15)	24.85 ng/mL	Standard Deviation 12.12
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 8, Day 1 (n=8)	18.44 ng/mL	Standard Deviation 7.35
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 9, Day 1 (n=9)	14.81 ng/mL	Standard Deviation 7.56
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 10, Day 1 (n=6)	17.17 ng/mL	Standard Deviation 6.1
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 11, Day 1 (n=6)	21.42 ng/mL	Standard Deviation 19.1
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 12, Day 1 (n=4)	11.67 ng/mL	Standard Deviation 4.57
Sunitinib + Erlotinib	Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 13, Day 1 (n=3)	19.79 ng/mL	Standard Deviation 13.47

Secondary

Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Ctrough = plasma concentration of erlotinib prior to study drug administration. Dose correction was made to the initial intended dose in Cycle 1. Assessed in the Original and Amended Lead-In (Arms A and B) Cohorts predose on Day 1 (Cycles 3-13) and in the Randomized Cohort (Sunitinib + Erlotinib treatment group only) predose on Day 1 of Cycles 1-18.

Time frame: predose Day 1 (Cycles 3-13); predose Day 1 (Cycles 1-18)

Population: Number of participants analyzed (N)=participants with observations above lower limit of quantification (LLOQ) in Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), Randomized Cohort (Sunitinib + Erlotinib treatment group only); n=number of participants with observations above LLOQ for specified cycle

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 2, Day 1 (n=45)	1.46 mcg/mL	Standard Deviation 0.9
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 3, Day 1 (n=44)	1.07 mcg/mL	Standard Deviation 0.76
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 4, Day 1 (n=31)	1.11 mcg/mL	Standard Deviation 0.85
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 5, Day 1 (n=22)	1.00 mcg/mL	Standard Deviation 0.93
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 6, Day 1 (n=18)	1.00 mcg/mL	Standard Deviation 0.8
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 7, Day 1 (n=15)	1.16 mcg/mL	Standard Deviation 1.3
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 8, Day 1 (n=8)	0.57 mcg/mL	Standard Deviation 0.34
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 9, Day 1 (n=10)	0.90 mcg/mL	Standard Deviation 0.68
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 10, Day 1 (n=6)	1.52 mcg/mL	Standard Deviation 1.48
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 11, Day 1 (n=6)	1.94 mcg/mL	Standard Deviation 3.67
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 12, Day 1 (n=5)	1.21 mcg/mL	Standard Deviation 1.18
Sunitinib + Erlotinib	Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)	Cycle 13, Day 1 (n=3)	0.75 mcg/mL	Standard Deviation 0.43

Secondary

Duration of Response (DR)

DR was defined as time from first documentation of objective tumor response (CR or PR) that was subsequently confirmed to the first documentation of PD or death on-study due to any cause, whichever occurred first. DR was calculated as (first date of PD or death minus first date of CR or PR that was subsequently confirmed plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA subset of participants with a confirmed objective response were to be analyzed. As only 3 and 2 responses were observed, duration of response was not analyzed.

Secondary

EORTC-QLQ-C30 Lung Cancer Module (LC13) Score

The EORTC-QLQ-C30 LC13 is a self-administered questionnaire assessing specific lung cancer disease related symptoms (dyspnea, coughing, hemoptysis, sore mouth, dysphagia, peripheral neuropathy, alopecia, pain in the chest, arm/shoulder or other parts of the body). Recall period: past week; response range: not at all (1) to very much (4). Scale score range: 0 to 100. Higher symptom score = greater degree of symptoms.

Time frame: Baseline (Cycle 1 [Day 1]) to Cycle 18 (Day 1)

Population: PRO Analysis Set; n is number of participants with an assessment at the specific time point

Arm	Measure	Group	Value (MEAN)
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C7, D1) (n=7, 10)	33.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C9, D1) (n=4, 3)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C8, D1) (n=4, 6)	24.98 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C3, D1) (n=27, 32)	2.47 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C9, D1) (n=4, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C2, D1) (n=41, 46)	31.70 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C10, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C4, D1) (n=19, 22)	1.75 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C11, D1) (n=3, 3)	22.20 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C5, D1) (n=12, 18)	22.21 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C12, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C5, D1) (n=14, 18)	2.38 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C13, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C3, D1) (n=27, 32)	32.09 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C6, D1) (n=9, 14)	3.70 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C15, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C10, D1) (n=3, 4)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C7, D1) (n=7, 10)	4.76 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C4, D1) (n=19, 22)	29.81 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C8, D1) (n=4, 6)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C1, D1) (n=49, 54)	12.92 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C3, D1) (n=26, 32)	24.77 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C2, D1) (n=41, 46)	4.87 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C1, D1) (n=49, 54)	6.12 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C3, D1) (n=27, 32)	7.40 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C5, D1) (n=14, 18)	38.08 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C4, D1) (n=19, 22)	10.52 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C2, D1) (n=41, 46)	19.50 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C5, D1) (n=14, 18)	16.66 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C11, D1) (n=3, 3)	18.50 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C6, D1) (n=9, 14)	14.80 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C3, D1) (n=27, 32)	16.04 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C7, D1) (n=7, 10)	14.27 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C6, D1) (n=9, 14)	33.31 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C8, D1) (n=4, 6)	8.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C4, D1) (n=19, 22)	12.27 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C9, D1) (n=4, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C6, D1) (n=8, 14)	18.04 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C10, D1) (n=3, 4)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C5, D1) (n=14, 18)	23.79 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C11, D1) (n=3, 3)	33.30 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C7, D1) (n=7, 10)	33.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C12, D1) (n=3, 4)	33.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C6, D1) (n=9, 14)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C13, D1) (n=3, 3)	33.30 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C12, D1) (n=3, 4)	14.80 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C14, D1) (n=2, 3)	33.35 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C7, D1) (n=7, 10)	4.76 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C1, D1) (n=49, 53)	19.72 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C8, D1) (n=4, 7)	24.98 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C2, D1) (n=41, 46)	11.38 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C8, D1) (n=4, 6)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C3, D1) (n=27, 32)	8.64 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C2, D1) (n=38, 46)	25.71 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C4, D1) (n=18, 22)	11.11 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C10, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C5, D1) (n=14, 18)	16.66 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C9, D1) (n=4, 4)	24.98 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C6, D1) (n=9, 14)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C13, D1) (n=3, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C7, D1) (n=7, 10)	19.03 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C13, D1) (n=3, 3)	7.40 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C8, D1) (n=4, 6)	8.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C14, D1) (n=2, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C9, D1) (n=4, 3)	8.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C10, D1) (n=3, 4)	22.20 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C10, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C1, D1) (n=49, 54)	6.80 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C11, D1) (n=3, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C7, D1) (n=6, 10)	14.80 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C12, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C2, D1) (n=41, 46)	13.00 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C13, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C11, D1) (n=3, 3)	22.20 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C3, D1) (n=26, 32)	7.68 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C4, D1) (n=19, 22)	7.01 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C1, D1) (n=49, 54)	21.08 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C12, D1) (n=3, 4)	22.20 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C2, D1) (n=41, 46)	10.56 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C5, D1) (n=14, 18)	11.91 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C3, D1) (n=27, 32)	14.81 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C15, D1) (n=1, 2)	22.20 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C4, D1) (n=19, 22)	12.27 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C6, D1) (n=9, 14)	3.70 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C5, D1) (n=14, 18)	19.04 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C13, D1) (n=3, 3)	22.20 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C6, D1) (n=9, 14)	14.80 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C7, D1) (n=7, 10)	4.76 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C7, D1) (n=7, 10)	23.80 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C4, D1) (n=18, 22)	27.16 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C8, D1) (n=4, 6)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C8, D1) (n=4, 6)	8.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C9, D1) (n=4, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C10, D1) (n=3, 4)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C9, D1) (n=4, 3)	8.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C11, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C12, D1) (n=3, 4)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C10, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C13, D1) (n=3, 3)	22.20 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C15, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C11, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C15, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C12, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C13, D1) (n=3, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C1, D1) (n=48, 51)	26.38 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C8, D1) (n=4, 6)	8.33 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C2, D1) (n=40, 43)	14.17 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C14, D1) (n=2, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C3, D1) (n=26, 31)	16.67 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C4, D1) (n=18, 20)	14.81 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C1, D1) (n=49, 54)	18.37 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C5, D1) (n=13, 18)	35.90 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C6, D1) (n=9, 14)	18.51 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C2, D1) (n=41, 46)	14.63 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C7, D1) (n=6, 10)	16.67 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C8, D1) (n=4, 6)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C3, D1) (n=27, 32)	16.04 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C9, D1) (n=4, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C1, D1) (n=48, 53)	21.05 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C10, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C4, D1) (n=19, 22)	22.81 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C11, D1) (n=3, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C1, D1) (n=49, 54)	2.04 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C12, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C5, D1) (n=14, 18)	26.18 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C13, D1) (n=3, 3)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C1, D1) (n=49, 53)	36.72 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C6, D1) (n=9, 14)	18.51 score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C2, D1) (n=41, 46)	6.50 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C14, D1) (n=2, 3)	25.90 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C1, D1) (n=48, 53)	25.56 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C2, D1) (n=38, 46)	26.08 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C3, D1) (n=26, 32)	26.03 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C4, D1) (n=18, 22)	23.73 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C5, D1) (n=12, 18)	32.71 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C6, D1) (n=8, 14)	21.41 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C7, D1) (n=6, 10)	29.99 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C8, D1) (n=4, 6)	22.22 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C9, D1) (n=4, 3)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C10, D1) (n=3, 4)	33.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C11, D1) (n=3, 3)	29.60 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C12, D1) (n=3, 4)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C15, D1) (n=1, 2)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C17, D1) (n=1, 2)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C18, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C1, D1) (n=49, 53)	37.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C2, D1) (n=41, 46)	31.87 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C3, D1) (n=27, 32)	30.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C4, D1) (n=19, 22)	15.14 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C5, D1) (n=14, 18)	29.62 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C6, D1) (n=9, 14)	26.17 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C7, D1) (n=7, 10)	16.67 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C8, D1) (n=4, 7)	28.56 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C9, D1) (n=4, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C10, D1) (n=3, 4)	25.00 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C11, D1) (n=3, 3)	33.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C12, D1) (n=3, 4)	41.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C13, D1) (n=3, 3)	33.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C14, D1) (n=2, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C17, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Coughing Symptom (C18, D1) (n=1, 2)	33.35 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C1, D1) (n=49, 54)	6.17 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C2, D1) (n=41, 46)	4.34 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C3, D1) (n=27, 32)	5.21 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C4, D1) (n=19, 22)	1.51 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C5, D1) (n=14, 18)	5.56 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C6, D1) (n=9, 14)	2.38 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C7, D1) (n=7, 10)	NA score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Haemoptysis Symptom (C8, D1) (n=4, 6)	5.55 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C1, D1) (n=49, 54)	1.23 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C2, D1) (n=41, 46)	7.97 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C3, D1) (n=27, 32)	6.25 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C4, D1) (n=19, 22)	7.58 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C5, D1) (n=14, 18)	12.96 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C6, D1) (n=9, 14)	2.38 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C7, D1) (n=7, 10)	6.67 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C8, D1) (n=4, 6)	5.55 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C10, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C13, D1) (n=3, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Sore Mouth Symptom (C14, D1) (n=2, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C1, D1) (n=49, 54)	6.17 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C2, D1) (n=41, 46)	10.14 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C3, D1) (n=26, 32)	14.58 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C4, D1) (n=19, 22)	12.12 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C5, D1) (n=14, 18)	11.11 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C6, D1) (n=9, 14)	7.14 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C7, D1) (n=7, 10)	10.00 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C8, D1) (n=4, 6)	NA score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C9, D1) (n=4, 3)	NA score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C10, D1) (n=3, 4)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C11, D1) (n=3, 3)	NA score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C12, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dysphagia Symptom (C14, D1) (n=2, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C1, D1) (n=49, 54)	17.28 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C2, D1) (n=41, 46)	20.28 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C3, D1) (n=27, 32)	34.37 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C4, D1) (n=19, 22)	25.75 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C5, D1) (n=14, 18)	22.22 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C6, D1) (n=9, 14)	23.81 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C7, D1) (n=7, 10)	23.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C8, D1) (n=4, 6)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C9, D1) (n=4, 3)	33.30 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C10, D1) (n=3, 4)	33.30 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C11, D1) (n=3, 3)	44.43 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C12, D1) (n=3, 4)	41.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C13, D1) (n=3, 3)	44.43 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C14, D1) (n=2, 3)	44.43 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C17, D1) (n=1, 2)	33.30 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Peripheral Neuropathy Symptom (C18, D1) (n=1, 2)	33.30 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C1, D1) (n=49, 54)	12.96 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C2, D1) (n=41, 46)	5.79 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C3, D1) (n=27, 32)	5.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C4, D1) (n=19, 22)	13.63 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C5, D1) (n=14, 18)	22.22 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C6, D1) (n=9, 14)	19.04 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C7, D1) (n=7, 10)	16.67 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C8, D1) (n=4, 6)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C9, D1) (n=4, 3)	22.23 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C10, D1) (n=3, 4)	25.00 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C11, D1) (n=3, 3)	NA score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C12, D1) (n=3, 4)	25.00 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C13, D1) (n=3, 3)	33.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Alopecia Symptom (C14, D1) (n=2, 3)	33.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C1, D1) (n=49, 53)	15.09 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C2, D1) (n=41, 46)	14.48 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C3, D1) (n=27, 32)	18.75 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C4, D1) (n=18, 22)	10.60 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C5, D1) (n=14, 18)	20.37 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C6, D1) (n=9, 14)	11.90 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C7, D1) (n=7, 10)	16.66 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C8, D1) (n=4, 6)	5.55 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C9, D1) (n=4, 3)	NA score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C10, D1) (n=3, 4)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C11, D1) (n=3, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C12, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C14, D1) (n=2, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Chest Symptom (C17, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C1, D1) (n=49, 54)	11.72 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C2, D1) (n=41, 46)	16.66 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C3, D1) (n=27, 32)	17.71 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C4, D1) (n=19, 22)	21.21 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C5, D1) (n=14, 18)	25.92 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C6, D1) (n=9, 14)	26.19 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C7, D1) (n=7, 10)	23.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C8, D1) (n=4, 6)	5.55 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C9, D1) (n=4, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C10, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C11, D1) (n=3, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C12, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C14, D1) (n=2, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C17, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Arm or Shoulder (C18, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C1, D1) (n=48, 51)	35.29 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C2, D1) (n=40, 43)	28.68 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C3, D1) (n=26, 31)	29.03 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C4, D1) (n=18, 20)	20.00 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C5, D1) (n=13, 18)	31.48 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C6, D1) (n=9, 14)	21.43 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C7, D1) (n=6, 10)	33.34 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C8, D1) (n=4, 6)	27.77 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C9, D1) (n=4, 3)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C10, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C11, D1) (n=3, 3)	11.10 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C12, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Pain in Other Parts of Body (C14, D1) (n=2, 3)	NA score on a scale
Erlotinib + Placebo	EORTC-QLQ-C30 Lung Cancer Module (LC13) Score	Dyspnea Symptom (C16, D1) (n=1, 2)	22.20 score on a scale

Secondary

Erlotinib Clearance at Steady State After Oral Administration (CL/F)

Time frame: Day 15 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Number of participants with calculable data in Original Lead-In; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 24 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm A.

Arm	Measure	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Erlotinib Clearance at Steady State After Oral Administration (CL/F)	5.52 Liters (L)/hr	Standard Deviation 3.65

Secondary

Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score

EORTC QLQ-C30: self-administered questionnaire assessing global health status/quality of life (QoL), functional domains (physical, role, cognitive, emotional, and social), symptom scales/items (fatigue, pain, nausea and vomiting, dyspnea, insomnia, loss of appetite, constipation, and diarrhea), and financial difficulties. Recall period: past week; response range: not at all (1) to very much (4); global/QoL range: very poor (1) to excellent (7). Scale score range: 0 to 100. Higher functional/global QoL score = better functioning and higher symptom score = greater degree of symptoms.

Time frame: Baseline (Cycle [C] 1, Day [D] 1) to Cycle 18, Day 1

Population: Patient-Reported Outcome (PRO) Analysis Set: participants from the FA Set who had at least 1 EORTC QLQ-C30 or EORTC QLQ Lung cancer (QLQ-LC13) module questionnaire assessment while on treatment; n is number of participants with an assessment at the specified time point.

Arm	Measure	Group	Value (MEAN)
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C2, D1) (n=41, 46)	62.60 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C13, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C15, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C1, D1) (n=49, 54)	7.49 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C2, D1) (n=41, 46)	16.26 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C3, D1) (n=28, 32)	16.67 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C4, D1) (n=19, 22)	13.16 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C5, D1) (n=14, 18)	16.66 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C6, D1) (n=9, 14)	9.26 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C7, D1) (n=7, 10)	16.67 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C8, D1) (n=4, 7)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C9, D1) (n=4, 5)	4.18 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C10, D1) (n=3, 4)	11.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C11, D1) (n=3, 4)	16.67 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C12, D1) (n=3, 4)	5.57 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C1, D1) (n=49, 54)	25.85 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C2, D1) (n=41, 46)	19.51 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C3, D1) (n=28, 32)	19.05 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C4, D1) (n=19, 22)	16.67 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C8, D1) (n=4, 7)	93.35 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C5, D1) (n=14, 18)	21.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C6, D1) (n=9, 14)	12.98 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C7, D1) (n=7, 10)	19.06 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C8, D1) (n=4, 7)	12.5 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C9, D1) (n=4, 5)	95.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C10, D1) (n=3, 4)	93.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C11, D1) (n=3, 4)	93.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C12, D1) (n=3, 4)	97.77 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C13, D1) (n=3, 3)	95.57 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C14, D1) (n=2, 3)	93.35 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C15, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C16, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C17, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C9, D1) (n=4, 5)	8.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C10, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C11, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C12, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C13, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C1, D1) (n=49, 54)	26.51 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C2, D1) (n=41, 46)	30.07 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C3, D1) (n=28, 32)	26.18 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C4, D1) (n=19, 22)	36.83 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C5, D1) (n=14, 18)	30.94 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C6, D1) (n=9, 14)	25.91 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C7, D1) (n=7, 10)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C8, D1) (n=4, 7)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C9, D1) (n=4, 5)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C10, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C11, D1) (n=3, 4)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C12, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C13, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C15, D1) (n=1, 2)	33.30 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C1, D1) (n=49, 53)	66.49 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C3, D1) (n=27, 32)	61.73 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C4, D1) (n=19, 22)	66.67 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C5, D1) (n=14, 18)	69.05 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C6, D1) (n=8, 14)	80.20 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C7, D1) (n=7, 10)	71.41 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C8, D1) (n=4, 7)	89.60 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C18, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C9, D1) (n=4, 5)	79.18 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C10, D1) (n=3, 4)	88.90 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C11, D1) (n=3, 4)	86.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C12, D1) (n=3, 4)	88.90 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C13, D1) (n=3, 3)	80.57 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C14, D1) (n=2, 3)	75.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C15, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C17, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C1, D1) (n=49, 53)	80.95 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C18, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C2, D1) (n=41, 46)	67.89 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C3, D1) (n=28, 32)	72.63 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C4, D1) (n=19, 22)	68.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C5, D1) (n=14, 17)	69.06 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C6, D1) (n=9, 14)	83.34 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C7, D1) (n=7,10)	85.71 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C8, D1) (n=4, 7)	91.68 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C9, D1) (n=4, 5)	91.68 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C10, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C11, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C12, D1) (n=3, 4)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C13, D1) (n=3, 3)	88.90 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C14, D1) (n=2, 3)	83.35 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C15, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C16, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C17, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C18, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C1, D1) (n=49, 54)	85.03 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C2, D1) (n=41, 46)	86.99 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C3, D1) (n=27, 32)	87.04 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C4, D1) (n=19, 22)	89.47 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C5, D1) (n=14, 18)	82.14 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C6, D1) (n=8, 14)	85.40 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C7, D1) (n=7, 10)	85.71 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C8, D1) (n=4, 7)	91.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C9, D1) (n=4, 5)	91.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C1, D1) (n=49, 54)	79.32 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C10, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C11, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C12, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C13, D1) (n=3, 3)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C14, D1) (n=2, 3)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C15, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C16, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C17, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C18, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C2, D1) (n=41, 46)	77.24 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C1, D1) (n=49, 53)	74.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C2, D1) (n=41, 46)	77.85 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C3, D1) (n=27, 32)	76.86 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C4, D1) (n=19, 22)	82.46 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C5, D1) (n=14, 18)	79.18 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C6, D1) (n=8, 14)	78.13 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C7, D1) (n=7, 10)	79.77 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C8, D1) (n=4, 7)	87.50 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C9, D1) (n=4, 5)	91.68 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C10, D1) (n=3, 4)	97.23 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C11, D1) (n=3, 4)	97.23 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C12, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C13, D1) (n=3, 3)	86.13 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C14, D1) (n=2, 3)	83.35 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C3, D1) (n=28, 32)	73.58 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C15, D1) (n=1, 2)	91.70 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C16, D1) (n=1, 2)	91.70 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C17, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C18, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C4, D1) (n=19, 22)	71.58 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C5, D1) (n=14, 18)	75.72 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C6, D1) (n=9, 14)	85.92 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C1, D1) (n=49, 53)	80.95 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C2, D1) (n=41, 46)	80.09 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C3, D1) (n=27, 32)	79.01 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C4, D1) (n=19, 22)	81.58 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C5, D1) (n=14, 18)	76.19 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C6, D1) (n=8, 14)	89.58 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C7, D1) (n=7, 10)	90.47 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C8, D1) (n=4, 7)	91.68 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C9, D1) (n=4, 5)	91.68 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C10, D1) (n=3, 4)	88.90 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C11, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C12, D1) (n=3, 4)	94.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C13, D1) (n=3, 3)	88.90 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C14, D1) (n=2, 3)	83.35 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C15, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C16, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C17, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C18, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C1, D1) (n=49, 53)	32.64 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C2, D1) (n=41, 46)	37.93 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C3, D1) (n=28, 32)	40.07 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C4, D1) (n=19, 22)	36.25 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C7, D1) (n=7, 10)	80.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C5, D1) (n=14, 18)	31.73 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C6, D1) (n=9, 14)	21.59 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C7, D1) (n=7, 10)	25.40 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C8, D1) (n=4, 7)	8.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C9, D1) (n=4, 5)	13.88 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C10, D1) (n=3, 4)	7.40 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C11, D1) (n=3, 4)	25.90 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C12, D1) (n=3, 4)	14.80 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C1, D1) (n=49, 54)	29.24 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C2, D1) (n=41, 46)	22.76 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C3, D1) (n=28, 32)	29.75 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C4, D1) (n=19, 22)	14.03 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C5, D1) (n=14, 18)	19.04 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C6, D1) (n=9, 14)	11.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C7, D1) (n=7, 10)	14.29 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C8, D1) (n=4, 7)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C9, D1) (n=4, 5)	24.98 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C10, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C11, D1) (n=3, 4)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C12, D1) (n=3, 4)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C13, D1) (n=3, 3)	22.20 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C14, D1) (n=2, 3)	33.30 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C15, D1) (n=1, 2)	33.30 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C16, D1) (n=1, 2)	33.30 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C1, D1) (n=49, 54)	23.12 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C2, D1) (n=41, 46)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C3, D1) (n=28, 32)	36.90 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C4, D1) (n=19, 22)	28.06 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C5, D1) (n=14, 18)	26.18 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C6, D1) (n=9, 14)	22.21 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C7, D1) (n=7, 10)	28.56 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C8, D1) (n=4, 7)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C9, D1) (n=4, 5)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C10, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C11, D1) (n=3, 4)	22.23 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C12, D1) (n=3, 4)	22.20 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C13, D1) (n=3, 3)	22.20 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C1, D1) (n=48, 54)	12.49 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C2, D1) (n=41, 46)	4.88 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C3, D1) (n=28, 32)	13.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C4, D1) (n=19, 22)	1.75 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C5, D1) (n=14, 18)	7.14 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C6, D1) (n=8, 13)	12.50 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C7, D1) (n=7, 10)	4.76 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C8, D1) (n=4, 7)	8.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C9, D1) (n=4, 5)	8.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C10, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C11, D1) (n=3, 4)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C12, D1) (n=3, 4)	11.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C13, D1) (n=3, 3)	11.10 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C14, D1) (n=2, 3)	16.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C15, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C1, D1) (n=49, 54)	6.80 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C2, D1) (n=41, 46)	38.21 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C3, D1) (n=27, 32)	37.03 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C4, D1) (n=19, 22)	38.59 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C5, D1) (n=14, 18)	30.94 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C6, D1) (n=8, 14)	24.99 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C7, D1) (n=7, 10)	42.86 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C8, D1) (n=4, 7)	33.30 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C9, D1) (n=4, 5)	33.30 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C10, D1) (n=3, 4)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C11, D1) (n=3, 4)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C12, D1) (n=3, 4)	66.67 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C13, D1) (n=3, 3)	33.30 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C14, D1) (n=2, 3)	50.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C15, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C16, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C17, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C18, D1) (n=1, 2)	NA score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C1, D1) (n=49, 53)	21.76 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C2, D1) (n=41, 45)	17.07 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C3, D1) (n=27, 32)	17.27 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C4, D1) (n=19, 22)	8.77 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C5, D1) (n=14, 18)	21.42 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C6, D1) (n=8, 14)	24.99 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C7, D1) (n=7, 10)	9.51 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C8, D1) (n=4, 7)	41.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C9, D1) (n=4, 5)	33.33 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C10, D1) (n=3, 4)	44.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C11, D1) (n=3, 4)	44.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C12, D1) (n=3, 4)	44.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C13, D1) (n=3, 3)	44.43 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C14, D1) (n=2, 3)	66.65 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C15, D1) (n=1, 2)	100.00 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C16, D1) (n=1, 2)	100 score on a scale
Sunitinib + Erlotinib	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C16, D1) (n=1, 2)	100.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C2, D1) (n=41, 46)	26.81 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C11, D1) (n=3, 4)	64.60 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C13, D1) (n=3, 3)	25.90 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C15, D1) (n=1, 2)	66.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C14, D1) (n=2, 3)	40.73 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C2, D1) (n=41, 46)	72.03 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C12, D1) (n=3, 4)	54.15 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C16, D1) (n=1, 2)	38.90 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C3, D1) (n=28, 32)	26.04 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C17, D1) (n=1, 2)	33.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C13, D1) (n=3, 3)	69.43 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C18, D1) (n=1, 2)	33.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C5, D1) (n=14, 18)	14.81 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C1, D1) (n=49, 54)	9.26 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C4, D1) (n=19, 22)	24.24 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C2, D1) (n=41, 46)	14.13 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C14, D1) (n=2, 3)	63.90 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C3, D1) (n=28, 32)	11.98 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C3, D1) (n=27, 32)	16.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C4, D1) (n=19, 22)	6.82 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C15, D1) (n=1, 2)	75.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C5, D1) (n=14, 18)	8.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C5, D1) (n=14, 18)	24.08 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C6, D1) (n=9, 14)	2.39 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C16, D1) (n=1, 2)	75.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C7, D1) (n=7, 10)	8.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C6, D1) (n=8, 14)	11.90 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C8, D1) (n=4, 7)	9.51 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C7, D1) (n=7, 10)	71.99 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C3, D1) (n=28, 32)	72.28 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C9, D1) (n=4, 5)	6.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C17, D1) (n=1, 2)	62.50 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C10, D1) (n=3, 4)	12.50 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C6, D1) (n=9, 14)	26.19 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C11, D1) (n=3, 4)	8.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C11, D1) (n=3, 4)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C12, D1) (n=3, 4)	NA score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C4, D1) (n=19, 22)	74.23 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Nausea/Vomiting (C17, D1) (n=1, 2)	8.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C7, D1) (n=7, 10)	30.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C1, D1) (n=49, 54)	30.25 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C5, D1) (n=14, 18)	68.89 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C2, D1) (n=41, 46)	31.52 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C7, D1) (n=7, 10)	6.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C3, D1) (n=28, 32)	28.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C18, D1) (n=1, 2)	83.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C8, D1) (n=4, 7)	14.29 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C4, D1) (n=19, 22)	28.80 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C1, D1) (n=49, 53)	80.19 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C5, D1) (n=14, 18)	33.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C4, D1) (n=19, 22)	24.25 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C6, D1) (n=9, 14)	25.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C2, D1) (n=41, 46)	77.53 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C7, D1) (n=7, 10)	23.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C9, D1) (n=4, 5)	20.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C8, D1) (n=4, 7)	19.04 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C8, D1) (n=4, 7)	74.29 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C3, D1) (n=27, 32)	81.26 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C9, D1) (n=4, 5)	73.32 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C8, D1) (n=4, 7)	14.29 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C10, D1) (n=3, 4)	70.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C4, D1) (n=19, 22)	75.75 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C11, D1) (n=3, 4)	71.68 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C10, D1) (n=3, 4)	25.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C12, D1) (n=3, 4)	71.68 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C5, D1) (n=14, 18)	75.93 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C13, D1) (n=3, 3)	73.30 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C6, D1) (n=9, 14)	75.24 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C14, D1) (n=2, 3)	68.90 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C16, D1) (n=1, 2)	33.30 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C15, D1) (n=1, 2)	NA score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C15, D1) (n=1, 2)	70.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C6, D1) (n=8, 14)	80.96 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C16, D1) (n=1, 2)	66.70 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C11, D1) (n=3, 4)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C17, D1) (n=1, 2)	70.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C7, D1) (n=7, 10)	85.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C9, D1) (n=4, 5)	20.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C9, D1) (n=4, 5)	6.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C10, D1) (n=3, 4)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C8, D1) (n=4, 7)	73.81 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C11, D1) (n=3, 4)	24.98 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C12, D1) (n=3, 4)	25.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C12, D1) (n=3, 4)	24.98 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C9, D1) (n=4, 5)	83.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C5, D1) (n=14, 18)	16.67 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C14, D1) (n=2, 3)	22.20 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C10, D1) (n=3, 4)	83.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C13, D1) (n=3, 3)	11.10 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C17, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C11, D1) (n=3, 4)	62.50 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Pain (C18, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C10, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C1, D1) (n=49, 54)	25.91 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C12, D1) (n=3, 4)	66.68 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C2, D1) (n=41, 46)	26.80 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C14, D1) (n=2, 3)	11.10 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C3, D1) (n=28, 32)	24.99 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C13, D1) (n=3, 3)	72.23 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C4, D1) (n=19, 22)	25.75 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C12, D1) (n=3, 4)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C5, D1) (n=14, 18)	29.62 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C14, D1) (n=2, 3)	72.20 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C6, D1) (n=9, 14)	23.79 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C17, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C7, D1) (n=7, 10)	19.98 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C15, D1) (n=1, 2)	91.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C8, D1) (n=4, 7)	23.81 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C11, D1) (n=3, 4)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C9, D1) (n=4, 5)	6.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C16, D1) (n=1, 2)	91.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C10, D1) (n=3, 4)	16.68 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C1, D1) (n=48, 54)	16.67 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C11, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C17, D1) (n=1, 2)	83.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C12, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C6, D1) (n=8, 14)	19.05 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Social Functioning (C18, D1) (n=1, 2)	91.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C14, D1) (n=2, 3)	22.20 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C2, D1) (n=41, 46)	13.77 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C1, D1) (n=49, 53)	33.11 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C12, D1) (n=3, 4)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C1, D1) (n=49, 53)	62.26 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C12, D1) (n=3, 4)	27.78 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C2, D1) (n=41, 46)	57.43 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C2, D1) (n=41, 46)	39.85 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C3, D1) (n=27, 32)	59.12 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C3, D1) (n=28, 32)	18.75 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C4, D1) (n=19, 22)	60.98 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C3, D1) (n=28, 32)	37.49 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C5, D1) (n=14, 18)	61.12 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C16, D1) (n=1, 2)	66.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C6, D1) (n=8, 14)	67.27 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C4, D1) (n=19, 22)	10.60 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C7, D1) (n=7, 10)	63.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C4, D1) (n=19, 22)	33.84 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C13, D1) (n=3, 3)	11.10 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C18, D1) (n=1, 2)	73.30 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C8, D1) (n=4, 7)	59.51 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C5, D1) (n=14, 18)	44.44 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C9, D1) (n=4, 5)	66.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C5, D1) (n=14, 18)	14.82 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C10, D1) (n=3, 4)	56.25 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C6, D1) (n=9, 14)	33.32 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C11, D1) (n=3, 4)	62.50 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C7, D1) (n=7, 10)	13.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C12, D1) (n=3, 4)	58.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C7, D1) (n=7, 10)	33.32 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C13, D1) (n=3, 3)	61.10 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C6, D1) (n=8, 13)	12.82 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C14, D1) (n=2, 3)	55.53 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C8, D1) (n=4, 7)	39.69 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C14, D1) (n=2, 3)	11.10 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C17, D1) (n=1, 2)	58.30 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C9, D1) (n=4, 5)	28.90 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C7, D1) (n=7, 10)	3.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C1, D1) (n=49, 53)	69.18 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C10, D1) (n=3, 4)	36.10 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C2, D1) (n=41, 46)	64.13 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C13, D1) (n=3, 3)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C3, D1) (n=28, 32)	64.07 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Fatigue (C11, D1) (n=3, 4)	30.55 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C4, D1) (n=19, 22)	67.43 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C8, D1) (n=4, 7)	NA score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C5, D1) (n=14, 17)	67.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C6, D1) (n=9, 14)	69.05 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C17, D1) (n=1, 2)	33.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C7, D1) (n=7,10)	73.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C9, D1) (n=4, 5)	13.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C8, D1) (n=4, 7)	69.04 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Dyspnea (C18, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C9, D1) (n=4, 5)	66.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C8, D1) (n=4, 7)	38.10 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C10, D1) (n=3, 4)	50.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C1, D1) (n=49, 54)	27.78 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C11, D1) (n=3, 4)	62.50 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C10, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C12, D1) (n=3, 4)	62.50 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C2, D1) (n=41, 46)	29.71 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C13, D1) (n=3, 3)	72.23 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C14, D1) (n=2, 3)	66.67 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C3, D1) (n=28, 32)	38.54 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C15, D1) (n=1, 2)	83.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Global Health Status/QoL (C18, D1) (n=1, 2)	66.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C11, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C16, D1) (n=1, 2)	66.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C4, D1) (n=19, 22)	25.76 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C17, D1) (n=1, 2)	58.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C16, D1) (n=1, 2)	NA score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Role Functioning (C18, D1) (n=1, 2)	66.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C5, D1) (n=14, 18)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C1, D1) (n=49, 54)	82.71 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C12, D1) (n=3, 4)	8.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C2, D1) (n=41, 46)	82.24 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C6, D1) (n=9, 14)	23.81 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C3, D1) (n=27, 32)	82.29 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C17, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C4, D1) (n=19, 22)	81.06 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C7, D1) (n=7, 10)	19.99 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C5, D1) (n=14, 18)	81.48 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C13, D1) (n=3, 3)	NA score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C6, D1) (n=8, 14)	84.53 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C8, D1) (n=4, 7)	38.09 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C7, D1) (n=7, 10)	89.99 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C9, D1) (n=4, 5)	26.66 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C8, D1) (n=4, 7)	71.43 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C9, D1) (n=4, 5)	33.32 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C9, D1) (n=4, 5)	83.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C14, D1) (n=2, 3)	NA score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C10, D1) (n=3, 4)	41.68 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C10, D1) (n=3, 4)	79.18 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C18, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C11, D1) (n=3, 4)	87.50 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Physical Functioning (C1, D1) (n=49, 54)	74.81 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C11, D1) (n=3, 4)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C12, D1) (n=3, 4)	79.15 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Constipation (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C13, D1) (n=3, 3)	83.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C12, D1) (n=3, 4)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C14, D1) (n=2, 3)	83.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C14, D1) (n=2, 3)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C15, D1) (n=1, 2)	100.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C13, D1) (n=3, 3)	22.20 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C16, D1) (n=1, 2)	91.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C1, D1) (n=49, 54)	2.47 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C17, D1) (n=1, 2)	83.35 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C14, D1) (n=2, 3)	44.47 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C1, D1) (n=49, 53)	13.84 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Cognitive Functioning (C18, D1) (n=1, 2)	100.00 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C15, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C1, D1) (n=49, 53)	71.23 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C2, D1) (n=41, 46)	21.01 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C2, D1) (n=41, 46)	71.37 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C16, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C3, D1) (n=27, 32)	67.98 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C10, D1) (n=3, 4)	33.33 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C4, D1) (n=19, 22)	71.21 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C17, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C5, D1) (n=14, 18)	71.30 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C3, D1) (n=27, 32)	17.69 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C6, D1) (n=8, 14)	79.76 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Insomnia (C18, D1) (n=1, 2)	16.65 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C7, D1) (n=7, 10)	70.82 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Financial Difficulties (C2, D1) (n=41, 45)	11.85 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C8, D1) (n=4, 7)	61.90 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Loss of Appetite (C1, D1) (n=49, 54)	20.99 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C9, D1) (n=4, 5)	78.34 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Diarrhea (C4, D1) (n=19, 22)	7.57 score on a scale
Erlotinib + Placebo	Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score	Emotional Functioning (C10, D1) (n=3, 4)	66.68 score on a scale

Secondary

Maximum Observed Plasma Concentration (Cmax) of Erlotinib

Time frame: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Amended Lead-In Cohort Arm A

Arm	Measure	Group	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Maximum Observed Plasma Concentration (Cmax) of Erlotinib	Cycle 1, Day 1	0.99 mcg/mL	Standard Deviation 0.48
Sunitinib + Erlotinib	Maximum Observed Plasma Concentration (Cmax) of Erlotinib	Cycle 1, Day 22	0.86 mcg/mL	Standard Deviation 0.37

Secondary

Number of Participants on Anti-hypertensive Medications

Number of participants with BP greater than 150/100 mmHg or 200/110 mmHg who were treated with anti-hypertensive medications.

Time frame: Randomization to Day 28 of Cycle 18

Population: Per Protocol Set; data were not analyzed

Secondary

Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)

Systolic/diastolic BP measured in triplicate (separated by approximately 2 minutes \[min\]) using validated electronic device (same device for all measurements), recorded to nearest mmHg. Dominant arm used (same one each time) with appropriate cuff size encircling at least 80% of arm. BP measured after 5 min rest and before invasive procedures, while seated in a chair with back supported, arms bared, supported at heart level. No smoking or caffeine use allowed during 30 min before measurement. Number of participants with systolic BP \>150 mmHg/diastolic BP \>100 mmHg at any timepoint postbaseline.

Time frame: Randomization up until Month 17

Population: Per-Protocol Set: all participants in the Phase 2 portion (randomized) who received at least 1 dose of study medication (either erlotinib or blinded medication) with treatment assignments designated according to actual study medication received

Arm	Measure	Value (NUMBER)
Sunitinib + Erlotinib	Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)	10 Participants
Erlotinib + Placebo	Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)	8 Participants

Secondary

Number of Participants With BP Greater Than 200/110 mmHg

Time frame: Randomization up until Month 17

Population: Per-Protocol Set

Arm	Measure	Value (NUMBER)
Sunitinib + Erlotinib	Number of Participants With BP Greater Than 200/110 mmHg	1 Participants
Erlotinib + Placebo	Number of Participants With BP Greater Than 200/110 mmHg	0 Participants

Secondary

OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by PDGFRB polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: Per Protocol Caucasian Population

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs34586048 Genotype: C/C	8.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/A	8.40 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/T	8.20 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: G/G	6.40 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/G	6.90 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/T	8.20 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: G/G	1.80 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/G	6.05 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/C	6.65 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: A/A	9.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/T	8.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/C	8.20 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: T/T	11.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/A	8.20 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/G	11.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: C/C	12.05 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/A	8.20 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/A	6.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: A/A	5.60 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864972 Genotype: G/G	6.65 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/T	6.35 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: T/T	6.40 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/G	9.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864972 Genotype: G/A	8.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: G/G	14.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/T	9.70 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/G	9.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864972 Genotype: A/A	11.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/A	5.40 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/C	8.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/T	6.40 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/G	6.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/A	14.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: T/T	7.25 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/A	6.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/A	14.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/G	11.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/G	6.65 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: G/G	11.60 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/T	8.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/G	6.90 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/A	8.00 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/A	8.20 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/C	7.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: A/A	8.40 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: A/A	5.70 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/G	7.55 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: C/C	NA Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/A	11.30 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/G	8.20 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: A/A	4.80 Months
Sunitinib + Erlotinib	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/C	12.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: A/A	4.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/C	9.60 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/A	6.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: A/A	5.60 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/C	5.90 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/T	7.60 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: T/T	NA Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/G	4.75 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/A	9.60 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: A/A	NA Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/A	5.90 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/T	6.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: T/T	NA Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/A	6.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/G	10.00 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: G/G	8.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/G	8.45 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/C	7.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: C/C	6.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864972 Genotype: G/G	11.50 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864972 Genotype: G/A	6.35 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864972 Genotype: A/A	7.90 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/G	7.00 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/A	5.90 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/T	5.40 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/C	14.95 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: C/C	6.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs34586048 Genotype: C/C	6.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/T	6.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/G	14.40 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: G/G	NA Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/C	11.50 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/T	6.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: T/T	7.90 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/G	6.70 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/A	6.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: A/A	8.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/T	14.35 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/G	7.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: G/G	4.70 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/G	6.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/A	6.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/T	7.20 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/A	5.90 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/A	12.95 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/G	6.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: G/G	4.80 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/G	5.40 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/A	13.40 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: A/A	NA Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/G	11.50 Months
Erlotinib + Placebo	OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/A	6.20 Months

Comparison: Locus: PDGFRB/rs2304060 Genotype: C/Cp-value: 0.856395% CI: [0.326, 3.847]Log Rank

Comparison: Locus: PDGFRB/rs2304060 Genotype: C/Ap-value: 0.737595% CI: [0.599, 2.064]Log Rank

Comparison: Locus: PDGFRB/rs234060 Genotype: A/Ap-value: 0.806695% CI: [0.375, 2.147]Log Rank

Comparison: Locus: PDGFRB/rs17656204 Genotype: C/Cp-value: 0.694595% CI: [0.449, 1.708]Log Rank

Comparison: Locus: PDGFRB/rs17656204 Genotype: C/Tp-value: 0.853695% CI: [0.536, 2.122]Log Rank

Comparison: Locus: PDGFRB/rs17656204 Genotype: T/Tp-value: 0.365795% CI: [0.283, 26.42]Log Rank

Comparison: Locus: PDGFRB/rs2304061 Genotype: G/Gp-value: 0.465795% CI: [0.424, 1.483]Log Rank

Comparison: Locus: PDGFRB/rs2304061 Genotype: G/Ap-value: 0.416895% CI: [0.641, 2.9]Log Rank

Comparison: Locus: PDGFRB/rs1077724 Genotype: A/Ap-value: 0.783695% CI: [0.456, 1.809]Log Rank

Comparison: Locus: PDGFRB/rs1077724 Genotype: A/Tp-value: 0.853195% CI: [0.472, 1.863]Log Rank

Comparison: Locus: PDGFRB/rs1077724 Genotype: T/Tp-value: 0.327295% CI: [0.412, 13.07]Log Rank

Comparison: Locus: PDGFRB/rs919751 Genotype: A/Ap-value: 0.96395% CI: [0.491, 1.972]Log Rank

Comparison: Locus: PDGFRB/rs919751 Genotype: A/Gp-value: 0.600395% CI: [0.567, 2.656]Log Rank

Comparison: Locus: PDGFRB/rs919751 Genotype: G/Gp-value: 0.670395% CI: [0.229, 2.58]Log Rank

Comparison: Locus: PDGFRB/rs2304058 Genotype: G/Gp-value: 0.8195% CI: [0.485, 2.525]Log Rank

Comparison: Locus: PDGFRB/rs2304058 Genotype: G/Cp-value: 0.833595% CI: [0.541, 2.141]Log Rank

Comparison: Locus: PDGFRB/rs2304058 Genotype: C/Cp-value: 0.59895% CI: [0.268, 2.141]Log Rank

Comparison: Locus: PDGFRB/rs1864972 Genotype: G/Gp-value: 0.928795% CI: [0.487, 2.199]Log Rank

Comparison: Locus: PDGFRB/rs1864972 Genotype: G/Ap-value: 0.884295% CI: [0.526, 2.106]Log Rank

Comparison: Locus: PDGFRB/rs1864972 Genotype: A/Ap-value: 0.850195% CI: [0.316, 4.028]Log Rank

Comparison: Locus: PDGFRB/rs3733678 Genotype: G/Gp-value: 0.411895% CI: [0.749, 2.017]Log Rank

Comparison: Locus: PDGFRB/rs3733678 Genotype: G/Ap-value: 0.129995% CI: [0.051, 1.596]Log Rank

Comparison: Locus: PDGFRB/rs246396 Genotype: T/Tp-value: 0.185995% CI: [0.399, 1.2]Log Rank

Comparison: Locus: PDGFRB/rs246396 Genotype: T/Cp-value: 0.009195% CI: [1.291, 10.44]Log Rank

Comparison: Locus: PDGFRB/rs34586048 Genotype: C/Cp-value: 0.870895% CI: [0.654, 1.652]Log Rank

Comparison: Locus: PDGFRB/rs11740355 Genotype: T/Tp-value: 0.988895% CI: [0.59, 1.681]Log Rank

Comparison: Locus: PDGFRB/rs11740355 Genotype: T/Gp-value: 0.970295% CI: [0.36, 2.891]Log Rank

Comparison: Locus: PDGFRB/rs740751 Genotype: C/Cp-value: 0.941995% CI: [0.466, 2.032]Log Rank

Comparison: Locus: PDGFRB/rs740751 Genotype: C/Tp-value: 0.767795% CI: [0.549, 2.252]Log Rank

Comparison: Locus: PDGFRB/rs740751 Genotype: T/Tp-value: 0.850195% CI: [0.316, 4.028]Log Rank

Comparison: Locus: PDGFRB/rs4705415 Genotype: G/Gp-value: 0.523395% CI: [0.322, 1.782]Log Rank

Comparison: Locus: PDGFRB/rs4705415 Genotype: G/Ap-value: 0.7595% CI: [0.549, 2.297]Log Rank

Comparison: Locus: PDGFRB/rs4705415 Genotype: A/Ap-value: 0.661495% CI: [0.483, 3.142]Log Rank

Comparison: Locus: PDGFRB/rs3776075 Genotype: T/Tp-value: 0.255295% CI: [0.652, 4.855]Log Rank

Comparison: Locus: PDGFRB/rs3776075 Genotype: T/Gp-value: 0.793195% CI: [0.577, 2.052]Log Rank

Comparison: Locus: PDGFRB/rs3776075 Genotype: G/Gp-value: 0.136595% CI: [0.152, 1.331]Log Rank

Comparison: Locus: PDGFRB/rs17708574 Genotype: G/Gp-value: 0.554495% CI: [0.504, 1.447]Log Rank

Comparison: Locus: PDGFRB/rs17708574 Genotype: G/Ap-value: 0.313295% CI: [0.59, 5.021]Log Rank

Comparison: Locus: PDGFRB/rs10063714 Genotype: T/Tp-value: 0.369895% CI: [0.755, 2.113]Log Rank

Comparison: Locus: PDGFRB/rs10063714 Genotype: T/Ap-value: 0.149595% CI: [0.119, 1.423]Log Rank

Comparison: Locus: PDGFRB/rs3776081 Genotype: A/Ap-value: 0.191195% CI: [0.781, 3.332]Log Rank

Comparison: Locus: PDGFRB/rs3776081 Genotype: A/Gp-value: 0.525995% CI: [0.384, 1.636]Log Rank

Comparison: Locus: PDGFRB/rs3776081 Genotype: G/Gp-value: 0.099695% CI: [0.082, 1.339]Log Rank

Comparison: Locus: PDGFRB/rs2007637 Genotype: G/Gp-value: 0.275595% CI: [0.45, 1.259]Log Rank

Comparison: Locus: PDGFRB/rs2007637 Genotype: G/Ap-value: 0.01295% CI: [1.253, 18.78]Log Rank

Comparison: Locus: PDGFRB/rs2302273 Genotype: G/Gp-value: 0.466395% CI: [0.661, 2.457]Log Rank

Comparison: Locus: PDGFRB/rs2302273 Genotype: G/Ap-value: 0.709795% CI: [0.406, 1.848]Log Rank

Comparison: Locus: PDGFRB/rs2302273 Genotype: A/Ap-value: 0.53495% CI: [0.117, 3.158]Log Rank

Secondary

Overall Survival (OS)

OS was defined as time from date of randomization to date of death due to any cause. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4. For participants still alive at the time of analysis, OS time was censored on last date that participants were known to be alive.

Time frame: From randomization until death (up to Month 17)

Population: FA Set

Arm	Measure	Value (MEDIAN)
Sunitinib + Erlotinib	Overall Survival (OS)	8.2 Months
Erlotinib + Placebo	Overall Survival (OS)	7.6 Months

p-value: 0.617195% CI: [0.705, 1.612]Log Rank

Secondary

Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

OS, defined as time from date of randomization to date of death due to any cause, in subgroups that were defined by VEGFR2 polymorphisms. OS was calculated as (date of death minus date of randomization plus 1) divided by 30.4.

Time frame: From randomization until death (up to Month 17)

Population: Per Protocol Caucasian Population

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: T/T	11.30 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/C	8.20 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/T	6.40 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: T/T	11.60 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/G	8.00 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/T	6.25 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: T/T	NA Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/T	6.40 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/A	8.00 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: A/A	NA Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/C	8.40 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/T	5.80 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: T/T	NA Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/C	6.40 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/T	9.30 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: T/T	6.30 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs35636987 Genotype: C/C	8.00 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/C	9.30 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/T	6.65 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/G	6.40 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/A	8.00 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: A/A	11.30 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/G	11.30 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/A	6.90 Months
Sunitinib + Erlotinib	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: A/A	9.30 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: T/T	9.60 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/C	7.60 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/C	6.20 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: A/A	9.55 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/T	5.30 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/T	5.80 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: T/T	16.50 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/G	8.40 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/G	5.50 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: T/T	10.00 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/T	7.60 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/A	4.90 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: T/T	NA Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs35636987 Genotype: C/C	6.80 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/T	10.00 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/A	4.40 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/A	4.70 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/C	13.40 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: A/A	NA Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: A/A	13.40 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/C	10.00 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/T	4.90 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/T	4.90 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/G	8.60 Months
Erlotinib + Placebo	Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: T/T	NA Months

Comparison: Locus: VEGFR2/rs1531289 Genotype: C/Cp-value: 0.948695% CI: [0.473, 2.014]Log Rank

Comparison: Locus: VEGFR2/rs1531289 Genotype: C/Tp-value: 0.908495% CI: [0.487, 1.897]Log Rank

Comparison: Locus: VEGFR2/rs1531289 Genotype: T/Tp-value: 0.200995% CI: [0.534, 15.48]Log Rank

Comparison: Locus: VEGFR2/rs2305845 Genotype: G/Gp-value: 0.786395% CI: [0.554, 2.175]Log Rank

Comparison: Locus: VEFR2/rs2305945 Genotype: G/Tp-value: 0.526795% CI: [0.633, 2.442]Log Rank

Comparison: Locus: VEGFR2/rs2305945 Genotype: T/Tp-value: 0.62495% CI: [0.049, 6.208]Log Rank

Comparison: Locus: VEFR/rs1870377 Genotype: T/Tp-value: 0.488295% CI: [0.66, 2.384]Log Rank

Comparison: Locus: VEGFR2/rs1870377 Genotype: T/Ap-value: 0.130795% CI: [0.29, 1.189]Log Rank

Comparison: Locus: VEGFR2/rs1870377 Genotype: A/Ap-value: 0.559695% CI: [0.139, 35.9]Log Rank

Comparison: Locus: VEGFR2/rs2305948 Genotype: C/Cp-value: 0.796695% CI: [0.628, 1.833]Log Rank

Comparison: Locus: VEGFR2/rs2305948 Genotype: C/Tp-value: 0.922495% CI: [0.366, 2.484]Log Rank

Comparison: Locus: VEGFR2/rs7692791 Genotype: C/Cp-value: 0.931795% CI: [0.363, 3.025]Log Rank

Comparison: Locus: VEGFR2/rs7692791 Genotype: C/Tp-value: 0.869695% CI: [0.546, 2.044]Log Rank

Comparison: Locus: VEGFR2/rs7692791 Genotype: T/Tp-value: 0.869495% CI: [0.453, 2.554]Log Rank

Comparison: Locus: VEGFR2/rs3563987 Genotype: C/Cp-value: 0.870895% CI: [0.654, 1.652]Log Rank

Comparison: Locus: VEGFR2/rs7667298 Genotype: C/Cp-value: 0.766795% CI: [0.442, 3.026]Log Rank

Comparison: Locus: VEGFR2/rs7667298 Genotype: C/Tp-value: 0.382295% CI: [0.401, 1.422]Log Rank

Comparison: Locus: VEGFR2/rs7667298 Genotype: T/Tp-value: 0.508995% CI: [0.498, 4.04]Log Rank

Comparison: Locus: VEGFR2/rs41408948 Genotype: G/Gp-value: 0.394495% CI: [0.691, 2.544]Log Rank

Comparison: Locus: VEGFR2/rs41408948 Genotype: G/Ap-value: 0.310395% CI: [0.339, 1.416]Log Rank

Comparison: Locus: VEGFR2/rs41408948 Genotype: A/Ap-value: 0.894295% CI: [0.089, 8.294]Log Rank

Comparison: Locus: VEGFR2/rs2071559 Genotype: G/Gp-value: 0.66595% CI: [0.466, 3.304]Log Rank

Comparison: Locus: VEGFR2/rs2071559 Genotype: G/Ap-value: 0.441595% CI: [0.412, 1.475]Log Rank

Comparison: Locus: VEGFR2/rs2071559 Genotype: A/Ap-value: 0.468295% CI: [0.523, 4.06]Log Rank

Secondary

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile

Includes colony-stimulating factor 1 receptor (CSF-1R), PDGFRalpha, PDGFRbeta, vascular endothelial growth factor (VEGF), VEGF C (VEGF-C), VEGF receptor 1 (VEGFR1), VEGF receptor 2 (VEGFR2), VEGF receptor 3 (VEGFR3), fibroblast growth factor (FGF), FLT-3, KIT (stem cell factor receptor), and RET (rearranged during transfection). Correlative analysis was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

Time frame: Baseline

Population: FA Set

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR2/High	45 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRalpha/Indeterminate	3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR2/Low	52 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF/Low	39 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR2/Indeterminate	3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRalpha/High	45 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR3/High	35 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF/Indeterminate	23 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR3/Low	55 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRbeta/High	45 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR3/Indeterminate	10 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF-C/High	52 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FGF/Detected	10 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	CSF-1R/Indeterminate	3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FGF/Not Detected	84 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF-C/Low	45 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FGF/Indeterminate	6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRbeta/Low	48 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FLT3/Detected	26 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF-C/Indeterminate	3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FLT3/Not Detected	71 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRalpha/Low	52 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FLT3/Indeterminate	3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR1/High	35 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	KIT/Detected	39 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRbeta/Indeterminate	6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	KIT/Not Detected	58 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR1/Low	48 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	KIT/Indeterminate	3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	CSF-1R/Low	52 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	RET/Detected	10 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR1/Indeterminate	16 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	RET/Not Detected	84 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF/High	39 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	RET/Indeterminate	6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	CSF-1R/High	45 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	RET/Indeterminate	11 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	CSF-1R/High	44 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	CSF-1R/Low	41 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	CSF-1R/Indeterminate	15 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRalpha/High	48 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRalpha/Low	41 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRalpha/Indeterminate	11 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRbeta/High	44 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRbeta/Low	44 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	PDGFRbeta/Indeterminate	11 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF/High	41 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF/Low	41 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF/Indeterminate	19 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF-C/High	41 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF-C/Low	52 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGF-C/Indeterminate	7 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR1/High	44 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR1/Low	33 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR1/Indeterminate	22 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR2/High	48 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR2/Low	41 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR2/Indeterminate	11 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR3/High	48 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR3/Low	30 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	VEGFR3/Indeterminate	22 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FGF/Detected	19 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FGF/Not Detected	67 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FGF/Indeterminate	15 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FLT3/Detected	19 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FLT3/Not Detected	78 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	FLT3/Indeterminate	4 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	KIT/Detected	30 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	KIT/Not Detected	67 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	KIT/Indeterminate	4 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	RET/Detected	30 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile	RET/Not Detected	59 Percentage of Participants

Secondary

Percentage of Participants by Tumor VEGFR Mutation

Percentage of participants with VEGFR mutations in DNA from tumor samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

Time frame: Baseline

Population: Full Analysis - All Population; data were not analyzed

Secondary

Percentage of Participants Surviving at 1 Year

Percentage of participants alive at 1 year after date of first administration of study medication.

Time frame: From randomization until death (up until Month 17)

Population: FA Set

Arm	Measure	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants Surviving at 1 Year	32 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants Surviving at 1 Year	42 Percentage of Participants

Comparison: Percentage of participants surviving at 1 year in the Sunitinib + Erlotinib Treatment Group, estimated using the Kaplan-Meier method95% CI: [19.7, 44.3]

Comparison: Percentage of participants surviving at 1 year in the Erlotinib + Placebo Treatment Group, estimated using the Kaplan-Meier method95% CI: [30.1, 54.2]

Secondary

Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)

Percentage of participants with EGFR Expression by IHC using a 10% cutoff; Reported as positive (positive values were defined as being greater than 10% of cells demonstrating membranous staining for EGFR), negative, or unmeasured. Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

Time frame: Baseline

Population: FA Set

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)	Positive	45 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)	Negative	29 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)	Unmeasured	26 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)	Positive	54 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)	Negative	18 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)	Unmeasured	28 Percentage of Participants

Secondary

Percentage of Participants With EGFR Gene Amplification

The percentage of participants with EGFR gene amplification (defined as greater than 15) was determined and reported as yes, no, or unmeasured. Correlative analysis of EGFR gene amplification was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

Time frame: Baseline

Population: FA Set

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Amplification	Yes	0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Amplification	No	48 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Amplification	Unmeasured	52 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Amplification	Yes	0 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Amplification	No	43 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Amplification	Unmeasured	57 Percentage of Participants

Secondary

Percentage of Participants With EGFR Gene Copy Number Increase

The number of copies corresponding to exon 19 of the EGFR gene was determined by real-time quantitative polymerase chain reaction (PCR). The percentage of participants with EGFR Gene Copy Number Increase (defined as greater than 4 copies) was determined using deoxyribonucleic acid (DNA) from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. Reported as yes, no or unmeasured.

Time frame: Baseline

Population: FA Set

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Copy Number Increase	Yes	0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Copy Number Increase	No	48 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Copy Number Increase	Unmeasured	52 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Copy Number Increase	Yes	1 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Copy Number Increase	No	42 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Copy Number Increase	Unmeasured	57 Percentage of Participants

Secondary

Percentage of Participants With EGFR Gene Mutation

Mutations in exons 18 through 21 of the EGFR gene were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with EGFR mutations categorized as mutated, wild type or indeterminate was reported.

Time frame: Baseline

Population: FA Set

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Mutation	Mutated	6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Mutation	Wild Type	32 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With EGFR Gene Mutation	Indeterminate	62 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Mutation	Mutated	1 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Mutation	Wild Type	28 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With EGFR Gene Mutation	Indeterminate	70 Percentage of Participants

Secondary

Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff

Percentage of participants with EGFR expression by IHC using a 0% cutoff; Reported as positive, negative, or unmeasured (where positive was greater than 0% of cells demonstrating membranous staining for EGFR). Correlative analysis of EGFR expression was conducted using tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable.

Time frame: Baseline

Population: FA Set

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff	Positive	35 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff	Negative	38 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff	Unmeasured	26 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff	Positive	36 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff	Negative	36 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff	Unmeasured	28 Percentage of Participants

Secondary

Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms

Blood samples were collected at baseline for multiplex RT analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline PDGFRB SNPs was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, A/T, A/G, T/C, T/G, G/C, C/A and G/A.

Time frame: Baseline

Population: Full Analysis - All Population

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304060 Genotype:C/C	21.3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304060 Genotype: C/A	52.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304060 Genotype: A/A	25.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs17656204 Genotype: C/C	48.5 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs17656204 Genotype: C/T	44.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs17656204 Genotype: T/T	7.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304061 Genotype: G/G	51.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304061 Genotype: G/A	44.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304061 Genotype: A/A	3.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs1077724 Genotype: A/A	43.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs1077724 Genotype: A/T	46.3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs1077724 Genotype: T/T	10.3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs919751 Genotype: A/A	46.3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs919751 Genotype: A/G	39.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs919751 Genotype: G/G	14.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304058 Genotype: G/G	25.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304058 Genotype: G/C	49.3 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2304058 Genotype: C/C	25.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs1864972 Genotype: G/G	41.2 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs1864972 Genotype: G/A	41.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs1864972 Genotype: A/A	16.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3733678 Genotype: G/G	80.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3733678 Genotype: G/A	19.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs246396 Genotype: T/T	70.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs246396 Genotype: T/C	27.2 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs246396 Genotype: C/C	2.2 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs34586048 Genotype: C/C	100 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs11740355 Genotype: T/T	80.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs11740355 Genotype: T/G	18.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs11740355 Genotype: G/G	0.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs740751 Genotype: C/C	41.2 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs740751 Genotype: C/T	41.2 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs740751 Genotype: T/T	17.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs4705415 Genotype: G/G	36.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs4705415 Genotype: G/A	44.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs4705415 Genotype: A/A	19.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3776075 Genotype: T/T	22.8 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3776075 Genotype: T/G	56.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3776075 Genotype: G/G	20.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs17708574 Genotype: G/G	79.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs17708574 Genotype: G/A	17.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs17708574 Genotype: A/A	2.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs10063714 Genotype: T/T	76.5 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs10063714 Genotype: T/A	22.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs10063714 Genotype: A/A	1.5 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3776081 Genotype: A/A	39.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3776081 Genotype: A/G	47.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs3776081 Genotype: G/G	14.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2007637 Genotype: G/G	79.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2007637 Genotype: G/A	19.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2007637 Genotype: A/A	1.5 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2302273 Genotype: G/G	56.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2302273 Genotype: G/A	38.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms	Locus: PDGFRB / rs2302273 Genotype: A/A	6.0 Percentage of Participants

Secondary

Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms

Blood samples were collected at baseline for multiplex reverse transcription (RT) analysis of genes expressing proteins that are targets of sunitinib or involved in angiogenesis or tumor growth to determine expression levels. Percentage of participants with germline VEGFR2 single nucleotide polymorphisms (SNPs) was reported for the following genotype frequencies: homozygous C alleles (C/C), T alleles (T/T), G alleles (G/G), or A alleles (A/A), and the following heterozygous genotypes C/T, G/T, T/A, and G/A.

Time frame: Baseline

Population: Full Analysis - All Population: all participants from lead-in period and Phase 2 (randomized phase)

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs1531289; Genotype: C/C	44.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs1531289; Genotype: C/T	45.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs1531289; Genotype: T/T	9.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2305945; Genotype: G/G	44.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2305945; Genotype: G/T	47.1 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2305945; Genotype: T/T	8.8 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus VEGFR2 / rs1870377; Genotype: T/T	53.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus VEGFR2 / rs1870377; Genotype: T/A	39.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus VEGFR2 / rs1870377; Genotype: A/A	6.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2305948; Genotype: C/C	81.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2305948; Genotype: C/T	17.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2305948; Genotype: T/T	0.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs7692791; Genotype: C/C	19.9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs7692791; Genotype: C/T	50.7 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs7692791; Genotype: T/T	29.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs35636987; Genotype: C/C	100 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs7667298; Genotype: C/C	27.2 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs7667298; Genotype: C/T	50.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs7667298; Genotype: T/T	22.8 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs41408948; Genotype: G/A	57.4 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs41408948; Genotype: A/A	36.0 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs41408948; Genotype: G/G	6.6 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2071559; Genotype: G/G	26.5 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2071559; Genotype: G/A	47.8 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms	Locus: VEGFR2 / rs2071559; Genotype: A/A	25.7 Percentage of Participants

Secondary

Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations

Mutations in exons 2-3 of the KRAS gene (including codons 12, 13, and 61) were analyzed by high-performance liquid chromatography using DNA from tumor biopsy samples collected at the time of initial diagnosis (preferred) or at the time of most recent recurrence/progression, although any time was acceptable. The percentage of participants with KRAS mutations categorized as mutated, wild type or indeterminate was reported.

Time frame: Baseline

Population: FA Set

Arm	Measure	Group	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations	Mutated	9 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations	Wild Type	34 Percentage of Participants
Sunitinib + Erlotinib	Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations	Indeterminate	57 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations	Mutated	6 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations	Wild Type	28 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations	Indeterminate	66 Percentage of Participants

Secondary

Percentage of Participants With Objective Response

Objective Response Rate (ORR)=participants with confirmed complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST,Version 1.0) based on third party independent imaging review laboratory assessment. A CR was defined as the disappearance of all target lesions that persisted on repeat imaging study at least 4 weeks after initial documentation of response. A PR was defined as a ≥30% decrease in sum of longest dimensions of target lesions taking as a reference the baseline sum longest dimensions.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Value (NUMBER)
Sunitinib + Erlotinib	Percentage of Participants With Objective Response	4.62 Percentage of Participants
Erlotinib + Placebo	Percentage of Participants With Objective Response	2.99 Percentage of Participants

Comparison: 95% confidence interval (CI) calculated based on f-distributionp-value: 0.625195% CI: [0.267, 8.954]Cochran-Mantel-Haenszel

Secondary

PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)

PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 0% cutoff where positive was greater than 0% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)	Positive	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)	Negative	8.1 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)	Unmeasured	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)	Positive	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)	Negative	8.5 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)	Unmeasured	8.4 Weeks

Comparison: Positive EGFR Expressionp-value: 0.224795% CI: [0.351, 1.591]Log Rank

Comparison: Negative EGFR Expressionp-value: 0.679795% CI: [0.581, 2.414]Log Rank

Comparison: Unmeasured EGFR Expressionp-value: 0.169395% CI: [0.245, 1.627]Log Rank

Secondary

PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)

PFS defined as time in weeks from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in the following subgroups: positive, negative, or unmeasured EGFR expression. EGFR expression was analyzed using a 10% cutoff where positive was greater than 10% of cells demonstrating membranous staining for EGFR. PFS calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)	Positive	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)	Negative	8.1 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)	Unmeasured	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)	Positive	10.4 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)	Negative	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)	Unmeasured	8.4 Weeks

Comparison: Positive EGFR Expressionp-value: 0.322395% CI: [0.458, 1.628]Log Rank

Comparison: Negative EGFR Expressionp-value: 0.460895% CI: [0.362, 2.474]Log Rank

Comparison: Unmeasured EGFR Expressionp-value: 0.169395% CI: [0.245, 1.627]Log Rank

Secondary

PFS in Subgroups That Were Defined by EGFR Gene Amplification

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene amplification (defined as greater than 15) and reported as no or unmeasured. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Amplification	No	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Amplification	Unmeasured	12.0 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Amplification	No	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Amplification	Unmeasured	8.1 Weeks

Comparison: No EGFR Gene Amplificationp-value: 0.583995% CI: [0.557, 2.085]Log Rank

Comparison: Unmeasured EGFR Gene Amplificationp-value: 0.152995% CI: [0.38, 1.344]Log Rank

Secondary

PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase

PFS, defined as time from date of randomization to the date of the first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene copy number increase (reported as yes, no, or unmeasured). The number of copies corresponding to exon 19 of the EGFR gene was determined and an increase was defined as greater than 4 copies. PFS was calculated as (first event date minus randomization date plus 1)/7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase	Yes	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase	No	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase	Unmeasured	12.0 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase	Yes	NA Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase	No	8.8 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase	Unmeasured	8.1 Weeks

Comparison: No EGFR Gene Copy Number Increasep-value: 0.552695% CI: [0.542, 2.031]Log Rank

Comparison: Unmeasured EGFR Gene Copy Number Increasep-value: 0.152995% CI: [0.38, 1.344]Log Rank

Secondary

PFS in Subgroups That Were Defined by EGFR Gene Mutation

PFS, defined as time from date of randomization to date of first documentation of PD or to death on-study due to any cause, whichever occurred first, in subgroups that were defined by EGFR gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Mutation	Indeterminate	12.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Mutation	Mutated	19.1 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by EGFR Gene Mutation	Wild Type	9.0 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Mutation	Wild Type	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Mutation	Mutated	NA Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by EGFR Gene Mutation	Indeterminate	8.1 Weeks

Comparison: Wild Type EGFR Gene Mutationp-value: 0.632495% CI: [0.516, 2.608]Log Rank

Comparison: Indeterminate EGFR Gene Mutationp-value: 0.241395% CI: [0.464, 1.424]Log Rank

Secondary

PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by PDGFRB polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: Per Protocol Caucasian Population

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs34586048 Genotype: C/C	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/G	19.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/T	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/G	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/G	16.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/C	16.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: G/G	7.80 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: G/G	19.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/C	20.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/A	7.80 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/T	8.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/G	19.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: T/T	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/C	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/G	19.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/C	9.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/A	8.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: A/A	10.90 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: A/A	19.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: C/C	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/T	16.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/T	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/G	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864975 Genotype: G/G	20.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: G/G	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/A	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/G	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864975 Genotype: G/A	8.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/A	9.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: A/A	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/T	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864975 Genotype: A/A	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/A	20.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/T	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/A	19.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/G	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/G	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/A	20.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: G/G	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: T/T	8.65 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/G	16.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/T	16.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/A	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: T/T	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: A/A	4.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/C	7.80 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/G	19.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/A	9.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/A	9.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: C/C	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: A/A	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/A	9.50 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: A/A	10.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/C	19.20 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: C/A	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304060 Genotype: A/A	7.90 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/C	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: C/T	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17656204 Genotype: T/T	NA Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/G	7.80 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: G/A	8.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304061 Genotype: A/A	NA Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/A	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: A/T	7.85 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1077724 Genotype: T/T	19.20 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/A	11.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: A/G	7.85 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs919751 Genotype: G/G	7.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/G	6.35 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: G/C	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2304058 Genotype: C/C	8.50 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864975 Genotype: G/G	7.85 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864975 Genotype: G/A	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs1864975 Genotype: A/A	8.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/A	NA Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/T	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: T/C	8.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs246396 Genotype: C/C	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs34586048 Genotype: C/C	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/T	8.50 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: T/G	7.40 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs11740355 Genotype: G/G	NA Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/C	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: C/T	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs740751 Genotype: T/T	8.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/G	11.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: G/A	7.90 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs4705415 Genotype: A/A	7.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/T	7.50 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: T/G	8.05 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776075 Genotype: G/G	10.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/G	8.05 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs17708574 Genotype: G/A	7.90 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/T	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs10063714 Genotype: T/A	19.20 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/A	7.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: A/G	8.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3776081 Genotype: G/G	10.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/G	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: G/A	12.80 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2007637 Genotype: A/A	52.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/G	10.15 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs2302273 Genotype: G/A	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms	Locus: PDGFRB/rs3733678 Genotype: G/G	8.00 Weeks

Comparison: Locus: PDGFRB/rs2304060 Genotype: C/Cp-value: 0.730195% CI: [0.304, 5.47]Log Rank

Comparison: PDGFRB/rs2304060 C/Ap-value: 0.501395% CI: [0.39, 1.592]Log Rank

Comparison: Locus: PDGFRB/rs2304060 Genotype: A/Ap-value: 0.36895% CI: [0.298, 1.578]Log Rank

Comparison: Locus: PDGFRB/rs17656204 Genotype: C/Cp-value: 0.380495% CI: [0.371, 1.467]Log Rank

Comparison: Locus: PDGFRB/rs17656204 Genotype: C/Tp-value: 0.150795% CI: [0.261, 1.247]Log Rank

Comparison: Locus PDGFRB/rs17656204 Genotype: T/Tp-value: 0.0772Log Rank

Comparison: Locus: PDGFRB/rs2304061 Genotype: G/Gp-value: 0.214995% CI: [0.339, 1.284]Log Rank

Comparison: Locus: PDGFRB/RS2304061 Genotype: G/Ap-value: 0.949195% CI: [0.466, 2.26]Log Rank

Comparison: Locus: PDGFRB/rs1077724 Genotype: A/Ap-value: 0.811495% CI: [0.447, 1.881]Log Rank

Comparison: Locus: PDGFRB/rs1077724 Genotype: A/Tp-value: 0.137995% CI: [0.273, 1.221]Log Rank

Comparison: Locus: PDGFRB/rs1077724 Genotype: T/Tp-value: 0.534195% CI: [0.256, 13.51]Log Rank

Comparison: Locus: PDGFRB/rs919751 Genotype: A/Ap-value: 0.856495% CI: [0.431, 2.014]Log Rank

Comparison: Locus: PDGFRB/rs919751 Genotype: A/Gp-value: 0.576695% CI: [0.355, 1.788]Log Rank

Comparison: Locus: PDGFRB/rs919751 Genotype: G/Gp-value: 0.204395% CI: [0.14, 1.557]Log Rank

Comparison: Locus: PDGFRB/rs2304058 Genotype: G/Gp-value: 0.162695% CI: [0.214, 1.317]Log Rank

Comparison: Locus: PDGFRB/rs2304058 Genotype: G/Cp-value: 0.96895% CI: [0.484, 2.006]Log Rank

Comparison: Locus: PDGFRB/rs2304058 Genotype: C/Cp-value: 0.358795% CI: [0.171, 1.92]Log Rank

Comparison: Locus: PDGFRB/rs1864972 Genotype: G/Gp-value: 0.463595% CI: [0.331, 1.662]Log Rank

Comparison: Locus: PDGFRB/rs1864972 Genotype: G/Ap-value: 0.983495% CI: [0.476, 2.069]Log Rank

Comparison: Locus: PDGFRB/rs1864972 Genotype: A/Ap-value: 0.176495% CI: [0.072, 1.725]Log Rank

Comparison: Locus: PDGFRB/rs3733678 Genotype: G/Gp-value: 0.201895% CI: [0.422, 1.209]Log Rank

Comparison: Locus: PDGFRB/rs3733678 Genotype: G/Ap-value: 0.459295% CI: [0.354, 9.673]Log Rank

Comparison: Locus: PDGFRB/rs246396 Genotype: T/Tp-value: 0.159395% CI: [0.373, 1.184]Log Rank

Comparison: Locus: PDGFRB/rs246396 Genotype: T/Cp-value: 0.589795% CI: [0.469, 3.755]Log Rank

Comparison: Locus: PDGFRB/rs34586048 Genotype: C/Cp-value: 0.368195% CI: [0.488, 1.309]Log Rank

Comparison: Locus: PDGFRB/rs11740355 Genotype: T/Tp-value: 0.323595% CI: [0.423, 1.336]Log Rank

Comparison: Locus: PDGFRB/rs11740355 Genotype: T/Gp-value: 0.746395% CI: [0.303, 2.355]Log Rank

Comparison: Locus: rs740751 Genotype: C/Cp-value: 0.417995% CI: [0.33, 1.593]Log Rank

Comparison: Locus: PDGFRB/rs740751 Genotype: C/Tp-value: 0.942395% CI: [0.462, 2.05]Log Rank

Comparison: Locus: PDGFRB/rs7407451 Genotype: T/Tp-value: 0.176495% CI: [0.072, 1.725]Log Rank

Comparison: Locus: PDGFRB/rs4705415 Genotype: G/Gp-value: 0.235295% CI: [0.201, 1.501]Log Rank

Comparison: Locus: PDGFRB/rs4705415 Genotype: G/Ap-value: 0.967495% CI: [0.485, 2.003]Log Rank

Comparison: Locus: PDGFRB/rs4705415 Genotype: A/Ap-value: 0.352495% CI: [0.235, 1.686]Log Rank

Comparison: Locus: PDGFRB/rs3776075 Genotype: T/Tp-value: 0.665295% CI: [0.308, 2.124]Log Rank

Comparison: Locus: PDGFRB/rs3776075 Genotype: T/Gp-value: 0.593195% CI: [0.436, 1.618]Log Rank

Comparison: Locus: PDGFRB/rs3776075 Genotype: G/Gp-value: 0.262595% CI: [0.125, 1.813]Log Rank

Comparison: Locus: PDGFRB/rs17708574 Genotype: G/Gp-value: 0.216895% CI: [0.4, 1.239]Log Rank

Comparison: Locus: PDGFRB/rs17708574 Genotype: G/Ap-value: 0.980295% CI: [0.353, 2.759]Log Rank

Comparison: Locus: PDGFRB/rs10063714 Genotype: T/Tp-value: 0.114595% CI: [0.378, 1.122]Log Rank

Comparison: Locus: PDGFRB/rs10063714 Genotype: T/Ap-value: 0.772595% CI: [0.36, 3.946]Log Rank

Comparison: Locus: PDGFRB/rs3776081 Genotype: A/Ap-value: 0.328695% CI: [0.321, 1.473]Log Rank

Comparison: Locus: PDGFRB/rs3776081 Genotype: A/Gp-value: 0.94895% CI: [0.47, 2.028]Log Rank

Comparison: Locus: PDGFRB/rs3776081 Genotype: G/Gp-value: 0.384495% CI: [0.125, 2.282]Log Rank

Comparison: Locus: PDGFRB/rs2007637 Genotype: G/Gp-value: 0.137395% CI: [0.381, 1.153]Log Rank

Comparison: Locus: PDGFRB/rs2007637 Genotype: G/Ap-value: 0.858695% CI: [0.339, 3.667]Log Rank

Comparison: Locus: PDGFRB/rs2302273 Genotype: G/Gp-value: 0.847895% CI: [0.47, 1.861]Log Rank

Comparison: Locus: PDGFRB/rs2302273 Genotype: G/Ap-value: 0.244595% CI: [0.287, 1.401]Log Rank

Comparison: Locus: PDGFRB/rs2302273 Genotype: A/Ap-value: 0.919195% CI: [0.072, 18.59]Log Rank

Secondary

PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by VEGFR2 polymorphisms. PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: Per Protocol Caucasian Population: all Caucasian participants in randomized phase who received at least 1 dose of study medication (either erlotinib or blinded medication), with treatment assignments designated according to actual study medication received

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: T/T	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/T	9.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/A	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: T/T	16.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/T	9.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs35636987 Genotype: C/C	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: A/A	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/C	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/T	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/T	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/C	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: T/T	9.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: T/T	20.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/G	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/T	12.30 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/A	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/G	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: A/A	13.45 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: T/T	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/G	9.50 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/T	8.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/A	17.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/C	12.00 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: A/A	8.10 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/C	9.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: A/A	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/C	8.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: C/T	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1531289 Genotype: T/T	13.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/G	12.30 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: G/T	7.80 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305945 Genotype: T/T	NA Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/T	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: T/A	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs1870377 Genotype: A/A	20.40 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/C	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: C/T	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2305948 Genotype: T/T	12.10 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/C	7.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: C/T	8.50 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7692791 Genotype: T/T	7.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs35636987 Genotype: C/C	8.00 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/C	8.05 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: C/T	7.80 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs7667298 Genotype: T/T	12.80 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/G	11.70 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: G/A	7.75 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs41408948 Genotype: A/A	13.60 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/G	12.80 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms	Locus: VEGFR2/rs2071559 Genotype: G/A	7.80 Weeks

Comparison: Locus: VEGFR2/rs1531289 Genotype: C/Cp-value: 0.742395% CI: [0.541, 2.36]Log Rank

Comparison: Locus: VEGFR2/rs1531289 Genotype: C/Tp-value: 0.15795% CI: [0.29, 1.236]Log Rank

Comparison: Locus: VEGFR2/rs1531289 Genotype: T/Tp-value: 0.795495% CI: [0.131, 4.819]Log Rank

Comparison: Locus: VEGFR2/rs2305945 Genotype: G/Gp-value: 0.62195% CI: [0.401, 1.732]Log Rank

Comparison: Locus: VEGFR2/rs2305945 Genotype: G/Tp-value: 0.526895% CI: [0.385, 1.64]Log Rank

Comparison: Locus: VEGFR2/rs1870377 Genotype: T/Tp-value: 0.975395% CI: [0.504, 2.027]Log Rank

Comparison: Locus: VEGFR2/rs1870377 Genotype: T/Ap-value: 0.014195% CI: [0.168, 0.85]Log Rank

Comparison: Locus: VEGFR2/rs1870377 Genotype: A/Ap-value: 0.559695% CI: [0.139, 35.9]Log Rank

Comparison: Locus: VEGFR2/rs2305948 Genotype: C/Cp-value: 0.278895% CI: [0.422, 1.288]Log Rank

Comparison: Locus: VEGFR2/rs2305948 Genotype: C/Tp-value: 0.897195% CI: [0.352, 3.286]Log Rank

Comparison: Locus: VEGFR2/rs7692791 Genotype: C/Cp-value: 0.655995% CI: [0.251, 2.388]Log Rank

Comparison: Locus: VEGFR2/rs7692791 Genotype: C/Tp-value: 0.856395% CI: [0.466, 1.889]Log Rank

Comparison: Locus: VEGFR2/rs7692791 Genotype: T/Tp-value: 0.66895% CI: [0.13, 1.12]Log Rank

Comparison: Locus: VEGFR2/rs35636987 Genotype: C/Cp-value: 0.368195% CI: [0.488, 1.309]Log Rank

Comparison: Locus: VEGFR2/rs7667298 Genotype: C/Cp-value: 0.75295% CI: [0.331, 2.237]Log Rank

Comparison: Locus: VEGFR2/rs7667298 Genotype: C/Tp-value: 0.083395% CI: [0.276, 1.098]Log Rank

Comparison: Locus: VEGFR2/rs7667298 Genotype: T/Tp-value: 0.477295% CI: [0.444, 5.506]Log Rank

Comparison: Locus: VEGFR2/rs41408948 Genotype: G/Gp-value: 0.923595% CI: [0.522, 2.048]Log Rank

Comparison: Locus: VEGFR2/rs41408948 Genotype: G/Ap-value: 0.084595% CI: [0.223, 1.126]Log Rank

Comparison: Locus: VEGFR2/rs41408948 Genotype: A/Ap-value: 0.549395% CI: [0.284, 10.47]Log Rank

Comparison: Locus: VEGFR2/rs2071559 Genotype: G/Gp-value: 0.52195% CI: [0.492, 3.987]Log Rank

Comparison: Locus: VEGFR2/rs2071559 Genotype: G/Ap-value: 0.085495% CI: [0.261, 1.108]Log Rank

Comparison: Locus: VEGFR2/rs2071559 Genotype: A/Ap-value: 0.919895% CI: [0.365, 2.489]Log Rank

Secondary

PFS in Subgroups That Were Defined by KRAS Gene Mutation

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by KRAS gene mutation (reported as mutated, wild type, or indeterminate). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by KRAS Gene Mutation	Mutated	20.1 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by KRAS Gene Mutation	Wild Type	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by KRAS Gene Mutation	Indeterminate	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by KRAS Gene Mutation	Mutated	7.5 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by KRAS Gene Mutation	Wild Type	12.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by KRAS Gene Mutation	Indeterminate	8.3 Weeks

Comparison: Mutated KRAS Gene Mutationp-value: 0.207795% CI: [0.079, 2.91]Log Rank

Comparison: Wild Type KRAS Gene Mutationp-value: 0.643995% CI: [0.534, 2.531]Log Rank

Comparison: Indeterminate KRAS Gene Mutationp-value: 0.266495% CI: [0.457, 1.489]Log Rank

Secondary

PFS in Subgroups That Were Defined by RNA Expression Profile

PFS, defined as time from date of randomization to date of first documentation of PD or death on-study due to any cause, whichever occurred first, in subgroups that were defined by RNA Gene expression (CSF-1R, PDGFRalpha, PDGFRbeta, VEGF, VEGF-C, VEGFR1, VEGFR2, VEGFR3, FGF, FLT-3, KIT, and RET). PFS was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	CSF-1R/High	19.1 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	CSF-1R/Low	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	CSF-1R/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRalpha/High	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRalpha/Low	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRalpha/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRbeta/High	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRbeta/Low	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRbeta/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF/High	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF/Low	19.1 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF-C/High	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF-C/Low	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF-C/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR1/High	12.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR1/Low	19.1 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR1/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR2/High	17.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR2/Low	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR2/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR3/High	NA Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR3/Low	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR3/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	KIT/Detected	19.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	KIT/Not Detected	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	KIT/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	RET/Detected	10.4 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	RET/Not Detected	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	RET/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	FGF/Detected	11.7 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	FGF/Not Detected	12.3 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	FGF/Indeterminate	9.5 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	FLT3/Detected	16.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	FLT3/Not Detected	17.0 Weeks
Sunitinib + Erlotinib	PFS in Subgroups That Were Defined by RNA Expression Profile	FLT3/Indeterminate	9.5 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	RET/Detected	10.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	CSF-1R/High	10.9 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR2/High	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	CSF-1R/Low	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	FLT3/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	CSF-1R/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR2/Low	8.8 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRalpha/High	52.0 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	RET/Not Detected	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRalpha/Low	7.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR2/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRalpha/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	FGF/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRbeta/High	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR3/High	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRbeta/Low	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	RET/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	PDGFRbeta/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR3/Low	8.8 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF/High	10.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR3/Indeterminate	8.0 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF/Low	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	FLT3/Not Detected	8.5 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	KIT/Detected	10.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF-C/High	12.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	FGF/Detected	7.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF-C/Low	8.5 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	KIT/Not Detected	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGF-C/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	FLT3/Detected	12.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR1/High	11.2 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	KIT/Indeterminate	8.1 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR1/Low	11.7 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	FGF/Not Detected	12.3 Weeks
Erlotinib + Placebo	PFS in Subgroups That Were Defined by RNA Expression Profile	VEGFR1/Indeterminate	8.1 Weeks

Comparison: High CSF-1R expressionp-value: 0.166795% CI: [0.159, 1.921]Log Rank

Comparison: Low CSF-1R expressionp-value: 0.768895% CI: [0.534, 3.944]Log Rank

Comparison: Indeterminate CSF-1R expressionp-value: 0.349895% CI: [0.503, 1.574]Log Rank

Comparison: High PDGFRalpha expressionp-value: 0.949795% CI: [0.79, 9.143]Log Rank

Comparison: Low PDGFRalpha expressionp-value: 0.040195% CI: [0.127, 1.173]Log Rank

Comparison: Indeterminate PDGFRalpha expressionp-value: 0.312895% CI: [0.487, 1.524]Log Rank

Comparison: High PDGFRbeta expressionp-value: 0.36595% CI: [0.273, 2.488]Log Rank

Comparison: Low PDGFRbeta expressionp-value: 0.610595% CI: [0.408, 3.48]Log Rank

Comparison: Indeterminate PDGFRbeta expressionp-value: 0.302795% CI: [0.488, 1.502]Log Rank

Comparison: High VEGF expressionp-value: 0.443695% CI: [0.262, 3.184]Log Rank

Comparison: Low VEGF expressionp-value: 0.458295% CI: [0.296, 3.062]Log Rank

Comparison: Indeterminate VEGF expressionp-value: 0.37295% CI: [0.536, 1.548]Log Rank

Comparison: High VEGF-C expressionp-value: 0.558695% CI: [0.35, 3.397]Log Rank

Comparison: Low VEGF-C expressionp-value: 0.365295% CI: [0.313, 2.266]Log Rank

Comparison: Indeterminate VEGF-C expressionp-value: 0.330195% CI: [0.493, 1.554]Log Rank

Comparison: High VEGFR1 expressionp-value: 0.560595% CI: [0.331, 3.636]Log Rank

Comparison: Low VEGFR1 expressionp-value: 0.213295% CI: [0.16, 2.236]Log Rank

Comparison: Indeterminate VEGFR1 expressionp-value: 0.360595% CI: [0.53, 1.537]Log Rank

Comparison: High VEGFR2 expressionp-value: 0.443895% CI: [0.304, 2.784]Log Rank

Comparison: Low VEGFR2 expressionp-value: 0.569995% CI: [0.403, 3.125]Log Rank

Comparison: Indeterminate VEGFR2 expressionp-value: 0.314795% CI: [0.489, 1.528]Log Rank

Comparison: High VEGFR3 expressionp-value: 0.501595% CI: [0.281, 3.581]Log Rank

Comparison: Low VEGFR3 expressionp-value: 0.488795% CI: [0.334, 3.025]Log Rank

Comparison: Indeterminate VEGFR3 expressionp-value: 0.243295% CI: [0.473, 1.414]Log Rank

Comparison: Detected FGF expressionp-value: 0.232195% CI: [0.048, 4.101]Log Rank

Comparison: No detected FGF expressionp-value: 0.714395% CI: [0.526, 3.292]Log Rank

Comparison: Indeterminate FGF expressionp-value: 0.281295% CI: [0.486, 1.465]Log Rank

Comparison: Detected FLT3 expressionp-value: 0.650495% CI: [0.248, 7.96]Log Rank

Comparison: No detected FLT3 expressionp-value: 0.326695% CI: [0.375, 1.876]Log Rank

Comparison: Indeterminate FLT3 expressionp-value: 0.359795% CI: [0.502, 1.598]Log Rank

Comparison: Detected KIT expressionp-value: 0.690795% CI: [0.419, 4.297]Log Rank

Comparison: Participants with no detected KIT expressionp-value: 0.19995% CI: [0.265, 1.731]Log Rank

Comparison: Indeterminate KIT expressionp-value: 0.359795% CI: [0.502, 1.598]Log Rank

Comparison: Detected RET expressionp-value: 0.375795% CI: [0.071, 6.765]Log Rank

Comparison: No detected RET expressionp-value: 0.372395% CI: [0.358, 2.13]Log Rank

Comparison: Indeterminate RET expressionp-value: 0.326395% CI: [0.501, 1.523]Log Rank

Secondary

Plasma Concentration of Soluble KIT (sKIT) at Baseline

Time frame: Baseline (Cycle 1, Day 1)

Population: FA Set

Arm	Measure	Value (MEDIAN)
Sunitinib + Erlotinib	Plasma Concentration of Soluble KIT (sKIT) at Baseline	49520 pg/mL
Erlotinib + Placebo	Plasma Concentration of Soluble KIT (sKIT) at Baseline	47242.50 pg/mL

p-value: 0.3945Wilcoxon Rank Sum Test

Secondary

Plasma Concentration of Soluble VEGFR-2 at Baseline

Time frame: Baseline (Cycle 1, Day 1)

Population: FA Set

Arm	Measure	Value (MEDIAN)
Sunitinib + Erlotinib	Plasma Concentration of Soluble VEGFR-2 at Baseline	10904.50 pg/mL
Erlotinib + Placebo	Plasma Concentration of Soluble VEGFR-2 at Baseline	10027 pg/mL

p-value: 0.5982Wilcoxon Rank Sum Test

Secondary

Plasma Concentration of Soluble VEGFR-3 at Baseline

Time frame: Baseline (Cycle 1, Day 1)

Population: FA Set

Arm	Measure	Value (MEDIAN)
Sunitinib + Erlotinib	Plasma Concentration of Soluble VEGFR-3 at Baseline	23190 pg/mL
Erlotinib + Placebo	Plasma Concentration of Soluble VEGFR-3 at Baseline	23350 pg/mL

p-value: 0.9807Wilcoxon Rank Sum Test

Secondary

Plasma Concentration of VEGF-C at Baseline

Time frame: Baseline (Cycle 1, Day 1)

Population: FA Set

Arm	Measure	Value (MEDIAN)
Sunitinib + Erlotinib	Plasma Concentration of VEGF-C at Baseline	474.15 picograms (pg)/mL
Erlotinib + Placebo	Plasma Concentration of VEGF-C at Baseline	502.10 picograms (pg)/mL

p-value: 0.3681Wilcoxon Rank Sum Test

Secondary

Plasma Decay Half-life (t1/2) of Erlotinib

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Amended Lead-In Cohort Arm A; Due to the long half-life of the drug and sample collection just up to 24 hours only, t1/2 could not be accurately estimated.

Secondary

Plasma Decay Half-life (t1/2) of Sunitinib

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Amended Lead-In Cohort Arm B; Due to the long half-life of the drug and sample collection just up to 48 hours only, t1/2 could not be accurately estimated.

Secondary

Sunitinib Clearance at Steady State After Oral Administration (CL/F)

Time frame: Day 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Number of participants with calculable data in Original Lead-In Cohort; after protocol amendment 3, the study design was modified (steady-state versus single dose), due to the long half-life of the drug, sample collection just up to 48 hours was not sufficient for the calculation of CL/F for Amended Lead-In Arm B.

Arm	Measure	Value (MEAN)	Dispersion
Sunitinib + Erlotinib	Sunitinib Clearance at Steady State After Oral Administration (CL/F)	63.28 L/hr	Standard Deviation 13.5

Secondary

Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib

Time frame: Days 1 and 22 (Cycle 1) at 0, 1, 2, 4, 6, 8, and 24 hours postdose

Population: Amended Lead-In Cohort Arm A

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib	Cycle 1, Day 1	2.00 Hours
Sunitinib + Erlotinib	Time to Reach Maximum Observed Plasma Concentration (Tmax) for Erlotinib	Cycle 1, Day 22	2.00 Hours

Secondary

Time to Tumor Progression (TTP)

TTP was defined as the time from date of randomization to first documentation of PD based on third party independent imaging review laboratory assessment. TTP was calculated as (first event date minus randomization date plus 1) divided by 7.02.

Time frame: From randomization to Weeks 8 and 12, then every 8 weeks until disease progression or death (up to Month 17)

Population: FA Set

Arm	Measure	Value (MEDIAN)
Sunitinib + Erlotinib	Time to Tumor Progression (TTP)	12.3 Weeks
Erlotinib + Placebo	Time to Tumor Progression (TTP)	10.1 Weeks

p-value: 0.373295% CI: [0.572, 1.485]Log Rank

Secondary

Tmax for SU-012662 (Metabolite of Sunitinib)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	Tmax for SU-012662 (Metabolite of Sunitinib)	Cycle 1, Day 1	4.00 Hours
Sunitinib + Erlotinib	Tmax for SU-012662 (Metabolite of Sunitinib)	Cycle 1, Day 15	4.00 Hours

Secondary

Tmax for Sunitinib

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	Tmax for Sunitinib	Cycle 1, Day 1	6.00 Hours
Sunitinib + Erlotinib	Tmax for Sunitinib	Cycle 1, Day 15	6.00 Hours

Secondary

Tmax for Total Drug (Sunitinib + SU-012662)

Time frame: Days 1 and 15 of Cycle 1 at 0, 1, 2, 4, 6, 8, 24 and 48 hours postdose

Population: Amended Lead-In Cohort Arm B

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	Tmax for Total Drug (Sunitinib + SU-012662)	Cycle 1, Day 1	6.00 Hours
Sunitinib + Erlotinib	Tmax for Total Drug (Sunitinib + SU-012662)	Cycle 1, Day 15	5.00 Hours

Other Pre-specified

sKIT Ratio to Baseline at Each Timepoint

Plasma sKIT concentration at each time point divided by sKIT concentration at baseline (ratio to baseline)

Time frame: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Population: FA Set; n equals number of participants with evaluable data at specified cycle

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	sKIT Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=43, 47)	0.76 Ratio
Sunitinib + Erlotinib	sKIT Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 36)	0.58 Ratio
Erlotinib + Placebo	sKIT Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=43, 47)	1.00 Ratio
Erlotinib + Placebo	sKIT Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 36)	0.95 Ratio

Comparison: sKIT Ratio to Baseline for Cycle 2, Day 1p-value: <0.0001Wilcoxon Rank Sum Test

Comparison: sKIT Ratio to Baseline for Cycle 3, Day 1p-value: <0.0001Wilcoxon Rank Sum Test

Other Pre-specified

VEGF-C Ratio to Baseline at Each Timepoint

Plasma VEGF-C concentration at each time point divided by VEGF-C concentration at baseline (ratio to baseline)

Time frame: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Population: FA Set; n equals number of participants with evaluable data at specified cycle

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	VEGF-C Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=41, 46)	0.86 Ratio
Sunitinib + Erlotinib	VEGF-C Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 35)	0.95 Ratio
Erlotinib + Placebo	VEGF-C Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=41, 46)	1.02 Ratio
Erlotinib + Placebo	VEGF-C Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 35)	0.95 Ratio

Comparison: VEGF-C Ratio to Baseline for Cycle 2, Day 1p-value: 0.2702Wilcoxon Rank Sum Test

Comparison: VEGF-C ratio to Baseline for Cycle 3, Day 1p-value: 0.7354Wilcoxon Rank Sum Test

Other Pre-specified

VEGFR-2 Ratio to Baseline at Each Timepoint

Plasma VEGFR-2 concentration at each time point divided by VEGFR-2 concentration at baseline (ratio to baseline)

Time frame: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Population: FA Set; n equals number of participants with evaluable data at specified cycle

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	VEGFR-2 Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=43, 46)	0.71 Ratio
Sunitinib + Erlotinib	VEGFR-2 Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 36)	0.67 Ratio
Erlotinib + Placebo	VEGFR-2 Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=43, 46)	0.98 Ratio
Erlotinib + Placebo	VEGFR-2 Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 36)	0.99 Ratio

Comparison: VEGFR-2 Ratio to Baseline for Cycle 2, Day 1p-value: <0.0001Wilcoxon Rank Sum Test

Comparison: VEGFR-2 Ratio to Baseline for Cycle 3, Day 1p-value: <0.0001Wilcoxon Rank Sum Test

Other Pre-specified

VEGFR-3 Ratio to Baseline at Each Timepoint

Plasma VEGFR-3 concentration at each time point divided by VEGFR-3 concentration at baseline (ratio to baseline)

Time frame: Baseline to Cycle 2 (Day 1) and Cycle 3 (Day 1)

Population: FA Set; n equals number of participants with evaluable data at specified cycle

Arm	Measure	Group	Value (MEDIAN)
Sunitinib + Erlotinib	VEGFR-3 Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=43, 47)	0.60 Ratio
Sunitinib + Erlotinib	VEGFR-3 Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 36)	0.57 Ratio
Erlotinib + Placebo	VEGFR-3 Ratio to Baseline at Each Timepoint	Cycle 3, Day 1 (n=36, 36)	0.92 Ratio
Erlotinib + Placebo	VEGFR-3 Ratio to Baseline at Each Timepoint	Cycle 2, Day 1 (n=43, 47)	0.98 Ratio

Comparison: VEGFR-3 Ratio to Baseline for Cycle 2, Day 1p-value: <0.0001Wilcoxon Rank Sum Test

Comparison: VEGFR-3 Ratio to Baseline for Cycle 3, Day 1p-value: <0.0001Wilcoxon Rank Sum Test

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

A Study In Patients With Non-Small Cell Lung Cancer Testing If Erlotinib Plus SU011248 (Sunitinib) Is Better Than Erlotinib Alone

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Other

Countries

Participant flow

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Progression-Free Survival (PFS)

Area Under the Curve From Time Zero to 24 Hours [AUC(0-24)] of Erlotinib

Area Under the Curve From Time Zero to Extrapolated Infinite Time (AUC0-inf) for Erlotinib

AUC(0-24) of SU-012662 (Metabolite of Sunitinib)

AUC(0-24) of Sunitinib

AUC(0-24) of Total Drug (Sunitinib + SU-012662)

AUC(0-inf) for SU-012662 (Metabolite of Sunitinib)

AUC(0-inf) for Sunitinib

AUC(0-inf) for Total Drug (Sunitinib + SU-012662)

Cmax of SU-012662 (Metabolite of Sunitinib)

Cmax of Sunitinib

Cmax of Total Drug (Sunitinib + SU-012662)

Correlation of Polymorphisms in Stem Cell Factor Receptor (c-Kit), FMS-like Tyrosine Kinase 3 Receptor (FLT-3), and c-FMS With Blood Counts

Dose-Corrected Ctrough for Erlotinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for SU-012662 (Metabolite of Sunitinib) on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for Sunitinib on Day 15 Cycle 1 (Original), Day 1 of Cycle 3 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Ctrough for Sunitinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Dose-Corrected Observed Plasma Trough Concentrations (Ctrough) for Erlotinib on Day 1 of Cycles 3-13 (Original and Amended, Arms A and B), and Day 1 of Cycles 1-18 (Randomized)

Duration of Response (DR)

EORTC-QLQ-C30 Lung Cancer Module (LC13) Score

Erlotinib Clearance at Steady State After Oral Administration (CL/F)

Health Related Quality of Life (HRQoL) and Lung Cancer Related Symptoms as Assessed With European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC-QLQ-C30) Score

Maximum Observed Plasma Concentration (Cmax) of Erlotinib

Number of Participants on Anti-hypertensive Medications

Number of Participants With Blood Pressure (BP) Greater Than 150/100 Millimeters of Mercury (mmHg)

Number of Participants With BP Greater Than 200/110 mmHg

OS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

Overall Survival (OS)

Overall Survival (OS) in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

Percentage of Participants by Ribonucleic Acid (RNA) Expression Profile

Percentage of Participants by Tumor VEGFR Mutation

Percentage of Participants Surviving at 1 Year

Percentage of Participants With EGFR Expression by IHC (Using 10% Cutoff)

Percentage of Participants With EGFR Gene Amplification

Percentage of Participants With EGFR Gene Copy Number Increase

Percentage of Participants With EGFR Gene Mutation

Percentage of Participants With Epidermal Growth Factor Receptor (EGFR) Expression by Immunohistochemistry (IHC) Using 0 Percent [%] Cutoff

Percentage of Participants With Germline Platelet-derived Growth Factor Receptor Beta (PDGFRB) Polymorphisms

Percentage of Participants With Germline Vascular Endothelial Growth Factor Receptor 2 (VEGFR2) Polymorphisms

Percentage of Participants With KRAS (V-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog) Gene Mutations

Percentage of Participants With Objective Response

PFS in Subgroups That Were Defined by EGFR Expression (Using 0% Cutoff)

PFS in Subgroups That Were Defined by EGFR Expression (Using 10% Cutoff)

PFS in Subgroups That Were Defined by EGFR Gene Amplification

PFS in Subgroups That Were Defined by EGFR Gene Copy Number Increase

PFS in Subgroups That Were Defined by EGFR Gene Mutation

PFS in Subgroups That Were Defined by Germline PDGFRB Polymorphisms

PFS in Subgroups That Were Defined by Germline VEGFR2 Polymorphisms

PFS in Subgroups That Were Defined by KRAS Gene Mutation

PFS in Subgroups That Were Defined by RNA Expression Profile

Plasma Concentration of Soluble KIT (sKIT) at Baseline

Plasma Concentration of Soluble VEGFR-2 at Baseline

Plasma Concentration of Soluble VEGFR-3 at Baseline

Plasma Concentration of VEGF-C at Baseline

Plasma Decay Half-life (t1/2) of Erlotinib

Plasma Decay Half-life (t1/2) of Sunitinib

Sunitinib Clearance at Steady State After Oral Administration (CL/F)