Non-Small Cell Lung Cancer
Conditions
Keywords
Tumors, Antibodies, Monoclonal, Stage IIIb Metastatic Non-Small Cell Lung Cancer, Stage IV Metastatic Non-Small Cell Lung Cancer
Brief summary
The purpose of this study is to determine the number of participants whose cancer shrinks or disappears after treatment on the study.
Detailed description
Participants with Stage IIIb or IV non-small cell lung cancer (NSCLC) who have not received previous chemotherapy will be stratified, based on disease histology (squamous versus \[vs.\] nonsquamous).
Interventions
DRUGGemcitabine
1000 milligrams per square meter (mg/m\^2) on Days 1 and 8 of each cycle \[First 6 cycles (18 weeks)\]
DRUGCisplatin
75 mg/m\^2 on Day 1 of each cycle \[First 6 cycles (18 weeks)\]
BIOLOGICALIMC-A12 (cixutumumab)
6 milligrams per kilogram (mg/kg) intravenous (IV) infusion, administered once per week (on Days 1, 8, and 15 of each cycle) \[First 6 cycles (18 weeks)\]
BIOLOGICALCetuximab
400 mg/m\^2 IV infusion, administered on Day 1 of Cycle 1, 250 mg/m\^2 once per week thereafter \[First 6 cycles (18 weeks)\]
DRUGCarboplatin
Area under the curve (AUC) = 5, Day 1 of each cycle \[First 6 cycles (18 weeks)\] \*Carboplatin will be replaced by Cisplatin
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Has histologically or cytologically confirmed, Stage IIIb - IV NSCLC * Has metastatic disease * Has a tumor measurable according to Response Evaluation Criteria in Solid Tumors (RECIST) * Has adequate hematologic function * Has adequate hepatic function * Has adequate renal function * Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation
Exclusion criteria
* Has uncontrolled brain metastases * Has leptomeningeal disease * Has received previous chemotherapy for NSCLC (participants who have received adjuvant chemotherapy are eligible if the last administration of the prior adjuvant regimen occurred at least 6 months prior to randomization) * Receiving any other investigational agent(s) * Has a history of treatment with other agents targeting the insulin-like growth factor (IGF) or the epidermal growth factor (EGF) receptor * Has a known allergy / history of hypersensitivity reaction to any of the treatment components * Has poorly controlled diabetes mellitus. Participants with a history of diabetes mellitus are allowed to participate, provided that their blood glucose is within normal range \[fasting glucose \<160 milligrams per deciliter (mg/dL) or below the upper limit of normal (ULN) and hemoglobin A1C≤ 7%\] and that they are on a stable dietary or therapeutic regimen for this condition * Has an uncontrolled intercurrent illness * Pregnant or lactating * Has a history of another primary cancer, with the exception of: a) curatively resected nonmelanomatous skin cancer; b) curatively treated cervical carcinoma in situ; or c) other primary solid tumor treated with curative intent and no known active disease present and no treatment administered during the last 3 years * Has superior vena cava syndrome contraindicating hydration * Has current clinically-relevant coronary artery disease (New York Heart Association III or IV) or uncontrolled congestive heart failure * Has any National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI-CTCAE) Version (v) 3.0 Grade ≥2 peripheral neuropathy * Has significant third space fluid retention, requiring repeated drainage
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | Randomization to measured progressive disease (PD) (up to 16.9 months) | ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated \* 100. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cmin of Cixutumumab for Cycle 3 | Week 7 (Cycle 3, Day 1) | — |
| Cmin of Cixutumumab for Cycle 5 | Week 13 (Cycle 5, Day 1) | — |
| Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity) | Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy | — |
| Maximum Concentration (Cmax) of Cixutumumab at Study Day 1 | Day 1 | — |
| Cmax of Cixutumumab for Cycle 1 | Week 1 (Cycle 1, Day 1) | — |
| Cmax of Cixutumumab for Cycle 3 | Week 7 (Cycle 3, Day 1) | — |
| Cmin of Cixutumumab for Cycle 1 | Week 1 (Cycle 1, Day 1) | — |
| Minimum Concentration (Cmin) of Cixutumumab at Study Day 1 | Day 1 | — |
| Overall Survival (OS) | Randomization to death due to any cause or censor (up to 30.4 months) | OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact. |
| Progression-Free Survival (PFS) | Randomization to PD or death due to any cause or censor (up to 16.9 months) | PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact. |
| Time To Progression (TTP) | Randomization to months until PD or censor (up to 16.9 months) | TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact. |
| Duration of Response | Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months) | The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression. |
| Number of Participants With Adverse Events (AEs) or Deaths | Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up | Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report. |
| Cmax of Cixutumumab Cycle 5 | Week 13 (Cycle 5, Day 1) | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gemcitabine/Carboplatin/Cetuximab (GCC) Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).
Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).
Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).
Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 4 |
| GCC Plus Cixutumumab Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).
Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).
Carboplatin: AUC = 5 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).
Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).
Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 6 |
| Gemcitabine/Cisplatin/Cetuximab (GCiC) Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).
Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).
Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycles).
Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 29 |
| GCiC Plus Cixutumumab Gemcitabine: 1000 mg/m\^2 on Days 1 and 8 of each 3-week cycle for a total of 6 cycles (18 weeks).
Cisplatin: 75 mg/m\^2 on Day 1 of each 3-week cycle for a total of 6 cycles (18 weeks).
Cetuximab: Initial dose of 400 mg/m\^2 on Day 1 of Cycle 1, and subsequent doses of 250 mg/m\^2 Q1W of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 500 mg/m\^2 Q2W in the subsequent cycles (2-week cycle).
Cixutumumab: 6 mg/kg IV infusion Q1W on Days 1, 8, and 15 of each 3-week cycle for a total of 6 cycles (18 weeks). Later administered at 10 mg/kg IV Q2W in the subsequent cycles (2-week cycles).
Treatment was continued until disease progression, unacceptable toxicity, withdrawal of consent or any other discontinuation criteria were met. | 25 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 2 | 2 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 1 | 3 |
Baseline characteristics
| Characteristic | Total | Gemcitabine/Carboplatin/Cetuximab (GCC) | GCC Plus Cixutumumab | Gemcitabine/Cisplatin/Cetuximab (GCiC) | GCiC Plus Cixutumumab |
|---|---|---|---|---|---|
| Age, Continuous | 62.00 years | 68.50 years | 54.50 years | 64.00 years | 60.00 years |
| Body Surface Area (BSA) | 1.88 square meters (m^2) STANDARD_DEVIATION 0.225 | 1.89 square meters (m^2) STANDARD_DEVIATION 0.186 | 1.98 square meters (m^2) STANDARD_DEVIATION 0.223 | 1.89 square meters (m^2) STANDARD_DEVIATION 0.214 | 1.84 square meters (m^2) STANDARD_DEVIATION 0.246 |
| Eastern Cooperative Oncology Status Performance Status (ECOG PS) Score 0 = Fully Active | 18 Participants | 0 Participants | 4 Participants | 5 Participants | 9 Participants |
| Eastern Cooperative Oncology Status Performance Status (ECOG PS) Score 1 = Ambulatory, Restricted Work Activity | 46 Participants | 4 Participants | 2 Participants | 24 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 63 Participants | 4 Participants | 6 Participants | 29 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Height | 169.99 centimeters (cm) STANDARD_DEVIATION 9.758 | 173.10 centimeters (cm) STANDARD_DEVIATION 3.982 | 176.78 centimeters (cm) STANDARD_DEVIATION 8.935 | 170.04 centimeters (cm) STANDARD_DEVIATION 9.356 | 167.79 centimeters (cm) STANDARD_DEVIATION 10.537 |
| Race/Ethnicity, Customized Black or African American | 6 Participants | 0 Participants | 0 Participants | 3 Participants | 3 Participants |
| Race/Ethnicity, Customized White | 58 Participants | 4 Participants | 6 Participants | 26 Participants | 22 Participants |
| Randomization Stratum Nonsquamous | 34 Participants | 2 Participants | 3 Participants | 15 Participants | 14 Participants |
| Randomization Stratum Squamous | 30 Participants | 2 Participants | 3 Participants | 14 Participants | 11 Participants |
| Region of Enrollment United States | 64 Participants | 4 Participants | 6 Participants | 29 Participants | 25 Participants |
| Sex: Female, Male Female | 27 Participants | 1 Participants | 2 Participants | 13 Participants | 11 Participants |
| Sex: Female, Male Male | 37 Participants | 3 Participants | 4 Participants | 16 Participants | 14 Participants |
| Weight | 75.27 kilograms (kg) STANDARD_DEVIATION 14.815 | 74.93 kilograms (kg) STANDARD_DEVIATION 13.814 | 80.43 kilograms (kg) STANDARD_DEVIATION 16.72 | 76.30 kilograms (kg) STANDARD_DEVIATION 13.908 | 72.90 kilograms (kg) STANDARD_DEVIATION 15.957 |
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 | 4 / 4 | 6 / 6 | 29 / 29 | 25 / 25 |
| serious Total, serious adverse events | 4 / 4 | 5 / 6 | 20 / 29 | 15 / 25 |
Outcome results
Primary
Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)]
ORR was defined as the percentage of participants achieving either CR or PR. Response was defined using Response Evaluation Criteria in Solid Tumors (RECIST), version (v) 1.0 criteria. CR was defined as the disappearance of all target and non-target lesions and the normalization of the tumour marker level. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions, taking as reference the baseline sum LD. Percentage of participants is calculated as a total number of participants with CR or PR / total number of participants treated \* 100.
Time frame: Randomization to measured progressive disease (PD) (up to 16.9 months)
Population: All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 31.0 percentage of participants |
| GCiC Plus Cixutumumab | Percentage of Participants With Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] | 20.0 percentage of participants |
Secondary
Cmax of Cixutumumab Cycle 5
Time frame: Week 13 (Cycle 5, Day 1)
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Cmax of Cixutumumab for Cycle 1
Time frame: Week 1 (Cycle 1, Day 1)
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Cmax of Cixutumumab for Cycle 3
Time frame: Week 7 (Cycle 3, Day 1)
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Cmin of Cixutumumab for Cycle 1
Time frame: Week 1 (Cycle 1, Day 1)
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Cmin of Cixutumumab for Cycle 3
Time frame: Week 7 (Cycle 3, Day 1)
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Cmin of Cixutumumab for Cycle 5
Time frame: Week 13 (Cycle 5, Day 1)
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Duration of Response
The duration of CR or PR was defined as the time from first objective status assessment of CR or PR to the first time of disease progression or death. Response was defined using RECIST v 1.0 criteria. CR was defined as the disappearance of all target lesions and non-target lesions. PR was defined as having at least a 30% decrease in sum of LD of target lesions. Duration of response was censored on the date of last tumor assessment for participants who were alive and have no evidence of disease progression.
Time frame: Date of first response to the date of PD or death due to any cause or censor ( up to 15.5 months)
Population: All pts randomized to GCiC and GCiC Plus Cixutumumab arms and who had CR or PR, except 1 pt in GCiC group eliminated d/t PR after starting additional treatment. Participants censored: GCiC = 0, GCiC Plus Cixutumumab = 1. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) due to the amended protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Duration of Response | 4.8 months |
| GCiC Plus Cixutumumab | Duration of Response | 4.8 months |
Secondary
Maximum Concentration (Cmax) of Cixutumumab at Study Day 1
Time frame: Day 1
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Minimum Concentration (Cmin) of Cixutumumab at Study Day 1
Time frame: Day 1
Population: Zero participants analyzed. No PK samples analyzed due to being expired prior to assay developed to analyze.
Secondary
Number of Participants With Adverse Events (AEs) or Deaths
Data presented are the number of participants who experienced 1 or more AEs, serious AEs (SAEs), and AEs that lead to death during the study including the 30-day follow-up. A summary of SAEs and other non-serious AEs, regardless of causality is located in the Reported Adverse Events section of this report.
Time frame: Randomization to last dose of study medication (up to 11.7 months) plus 30-day safety follow-up
Population: All randomized participants.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Number of Participants With Adverse Events (AEs) or Deaths | Deaths Due to AEs | 1 Participants |
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 4 Participants |
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 4 Participants |
| GCiC Plus Cixutumumab | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 5 Participants |
| GCiC Plus Cixutumumab | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 6 Participants |
| GCiC Plus Cixutumumab | Number of Participants With Adverse Events (AEs) or Deaths | Deaths Due to AEs | 1 Participants |
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 29 Participants |
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 20 Participants |
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Number of Participants With Adverse Events (AEs) or Deaths | Deaths Due to AEs | 4 Participants |
| GCiC Plus Cixutumumab | Number of Participants With Adverse Events (AEs) or Deaths | SAEs | 15 Participants |
| GCiC Plus Cixutumumab | Number of Participants With Adverse Events (AEs) or Deaths | Deaths Due to AEs | 1 Participants |
| GCiC Plus Cixutumumab | Number of Participants With Adverse Events (AEs) or Deaths | AEs | 25 Participants |
Secondary
Overall Survival (OS)
OS was defined as the duration from the date of randomization to the date of death from any cause. For participants who were alive, OS was censored at the date of last follow-up visit or at the date of last contact.
Time frame: Randomization to death due to any cause or censor (up to 30.4 months)
Population: All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 6, GCiC Plus cixutumumab = 6. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Overall Survival (OS) | 11.5 months |
| GCiC Plus Cixutumumab | Overall Survival (OS) | 8.9 months |
Secondary
Progression-Free Survival (PFS)
PFS was defined as the duration from the date of randomization until disease progression or death due to any cause, whichever occurred first. Response was defined using RECIST, v 1.0 criteria. PD was defined as having a ≥20% increase in sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants who were alive and without disease progression, PFS was censored at the date of last objective tumor assessment. For participants who did not experience disease progression and were lost to follow-up, PFS was censored at the date of the last objective tumor assessment or the date of last contact.
Time frame: Randomization to PD or death due to any cause or censor (up to 16.9 months)
Population: All participants randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 2, GCiC Plus cixutumumab = 10. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Progression-Free Survival (PFS) | 4.2 months |
| GCiC Plus Cixutumumab | Progression-Free Survival (PFS) | 5.6 months |
Secondary
Serum Anti-Cixutumumab Antibody Assessment (Immunogenicity)
Time frame: Prior to first infusions of Cycles 1, 3, and 5 and 30 days following the end of therapy
Population: Zero participants analyzed. Analysis was not performed due to lack of an appropriate validated assay.
Secondary
Time To Progression (TTP)
TTP was defined as the duration from the date of randomization until the date of disease progression. Response was defined using RECIST v 1.0 criteria. PD was defined as having a ≥20% increase in the sum of LD of target lesions or the appearance of new lesions and/or unequivocal progression of non-target lesions. For participants without disease progression, TTP was censored at the date of last objective tumor assessment. For participants without disease progression and were subsequently lost to follow-up, TTP was censored at the date of last follow-up visit or at the date of last contact.
Time frame: Randomization to months until PD or censor (up to 16.9 months)
Population: All participants (pts) randomized to GCiC and GCiC Plus Cixutumumab arms. Participants censored: GCiC = 9, GCiC Plus Cixutumumab = 12. Efficacy data were not summarized for the original treatment arms (GCC and GCC Plus Cixutumumab) since such summaries were not considered relevant to the study objectives under the amended protocol.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gemcitabine/Cisplatin/Cetuximab (GCiC) | Time To Progression (TTP) | 5.8 months |
| GCiC Plus Cixutumumab | Time To Progression (TTP) | 5.7 months |