Non-Small Cell Lung Cancer
Conditions
Keywords
NSCLC, Tarceva, Positron emission technology, PET, Computerized tomography, CT
Brief summary
This is a single-arm, open-label, multicenter, international pilot study to evaluate changes that occur in 2-deoxy-2-\[18F\]fluoro-D-glucose (FDG)- and 3'-deoxy-3'-\[18F\]fluorothymidine(FLT)-PET (Positron Emission Tomography) imaging as a result of treatment with erlotinib in patients with recurrent or refractory non-small cell lung cancer (NSCLC). The study will enroll approximately 30 patients at approximately 4 sites in Australia and 2 sites in the United States.
Interventions
FDG prepared in sterile buffered solution for intravenous injection. Dosage was based on the participant's weight not to exceed 15 mCi (millicurie).
FLT 7 mCi dose prepared in sterile buffered solution for intravenous injection.
DRUGerlotinib HCl
Tablets taken orally 150 mg/day.
Sponsors
Roche Pharma AG
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Signed Informed Consent Form(s) * Histologically confirmed NSCLC * Recurrent or progressive disease after receiving at least one chemotherapy regimen for advanced or metastatic NSCLC * Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 * Age ≥ 18 years * Recovery from reversible acute effects of prior anti-cancer therapy (chemotherapy, radiotherapy, or investigational treatment) to NCI Common Toxicity Criteria for Adverse Events (NCI CTCAE) Grade ≤ 1 (excluding alopecia) * Ability to comply with the study and follow-up procedures, including all specified imaging studies * Ability to take oral medication * Availability of archival diagnostic paraffin-embedded tumor tissue and willingness to provide sufficient tissue for testing for EGFR levels in tumor by both immunohistochemistry (IHC) and fluorescence in situ hybridization (FISH) * Life expectancy ≥ 3 months * Measurable disease on computed tomography (CT) * At least one detectable lesion on FDG-PET scan and/or FLT-PET scan that is measurable on CT * Use of an acceptable means of contraception (men and women of childbearing potential) or documentation of infertility
Exclusion criteria
* Prior treatment with an investigational or marketed agent for the purpose of inhibiting epidermal growth factor receptor (EGFR) (including, but not limited to, erlotinib and gefitinib) * Chemotherapy, radiotherapy, or investigational treatment within 14 days or within 5 half-lives of the active molecules in the chemotherapy or investigational treatment, whichever is longer, prior to study entry or from which patients have not yet recovered * Inability to take oral medications, disease affecting gastrointestinal absorption, or prior surgical procedure affecting gastrointestinal absorption * Uncontrolled diabetes * Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within 1 month prior to study entry, hepatic, renal, or metabolic disease) * Pregnancy or lactation * History of another malignancy in the past 2 years, unless the malignancy has been adequately treated, is currently not detectable, and is associated with a 5-year survival \> 90% * Claustrophobia * Any other disease, condition, physical examination finding, or clinical laboratory finding which, in the opinion of the investigator, makes the patient inappropriate for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | From first erlotinib treatment to death, assessed up to 2 years | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. |
| Progression Free Survival of Groups by FLT Response at Day 56 | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%. |
| Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. |
| Overall Survival of Groups by FDG Response at Day 56 | From first erlotinib treatment to death, assessed up to 2 years | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%. |
| Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56 | From first erlotinib treatment to death, assessed up to 2 years | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. |
| Overall Survival of Groups by FLT Response at Day 56 | From first erlotinib treatment to death, assessed up to 2 years | Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%. |
| Progression Free Survival (PFS) of Groups by FDG Response at Day 56 | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax \<-25%. |
| PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56 | Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years | PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of \<-25% and FDG-PET disease progression; defined as a mSUVmax \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With FLT-PET Responses | Day 14 and Day 56 | In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. |
| FDG Response in Subgroups by CT Response at Day 56 | Day 56 | In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions. |
| FLT Response in Subgroups by CT Response at Day 56 | Day 56 | In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions. |
| Number of Participants With Adverse Events Due to FLT-PET Imaging | From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded. | The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET. |
| Percentage of Patients With FDG-PET Responses | Day 14 and Day 56 | In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started. |
Participant flow
Recruitment details
A single-arm, open-label, multicenter, international pilot study. The study was expected to enroll approximately 100 evaluable patients at approximately eight sites in Australia and the United States. The study was initiated on 6 DEC 2006 and completed on 23 APR 2010.
Participants by arm
| Arm | Count |
|---|---|
| Erlotinib Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity. | 74 |
| Total | 74 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 5 |
| Overall Study | Death | 7 |
| Overall Study | Physician Decision | 2 |
| Overall Study | Progression of disease | 56 |
| Overall Study | Screening Failure | 14 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Erlotinib |
|---|---|
| Age, Continuous | 62.9 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 31 Participants |
| Sex: Female, Male Male | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 46 / 85 |
| serious Total, serious adverse events | 37 / 85 |
Outcome results
Primary
Overall Survival of Groups by FDG Response at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. Overall survival (OS) was compared between patients with FDG-PET response and patients without FDG-PET response, independent of Response Evaluation Criteria in Solid Tumors (RECIST 1.0) computed tomography (CT) response at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Population: FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | Overall Survival of Groups by FDG Response at Day 56 | NA months |
| Erlotinib_ FDG Non-Responders | Overall Survival of Groups by FDG Response at Day 56 | 7.8 months |
Comparison: The null hypothesis is that there is no difference in OS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG responders would have prolonged OS compared with FDG Non-Responders.p-value: 0.07395% CI: [0.11, 1.16]Log Rank
Primary
Overall Survival of Groups by FLT Response at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Population: FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the last date patients known to be alive.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | Overall Survival of Groups by FLT Response at Day 56 | NA months |
| Erlotinib_ FDG Non-Responders | Overall Survival of Groups by FLT Response at Day 56 | 8.4 months |
Comparison: The null hypothesis is that there is no difference in OS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Non-Responders.p-value: 0.16395% CI: [0.09, 1.57]Log Rank
Primary
Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FDG-PET response and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease (SD) on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25% and FDG-PET disease progression was defined as a mSUVmax from FDG-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Population: Patients who were treated with erlotinib, underwent all FDG-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56 | 12.2 months |
| Erlotinib_ FDG Non-Responders | Overall Survival of Patients With FDG CR/PR Versus FDG PD in Patients With CT SD at Day 56 | 8.8 months |
Comparison: The null hypothesis is that there is no difference in Overall Survival between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have prolonged OS compared with FDG Progressive Disease.p-value: 0.61895% CI: [0.14, 3.21]Log Rank
Primary
Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
Overall survival (OS) was defined as the time from the date of first erlotinib dose to death. OS was compared between patients with FLT-PET response and patients with FLT-PET progression, within the subset of patients who demonstrated SD on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans of \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: From first erlotinib treatment to death, assessed up to 2 years
Population: Patients who were treated with erlotinib,underwent all FLT-PET scans thru Day 56 and had SD by CT at Day 56. Censoring at last date patients known to be alive.~CT SD defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | NA months |
| Erlotinib_ FDG Non-Responders | Overall Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | 8 months |
Comparison: The null hypothesis is that there is no difference in OS between FLT Responders and FLT Progressive Disease. The alternative hypothesis is that FLT Responders would have prolonged OS compared with FLT Progressive Disease.p-value: 0.32795% CI: [0.04, 3.16]Log Rank
Primary
PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response (Complete /Partial Responses) and patients with FDG-PET progression, within the subset of patients who demonstrated stable disease on CT (per RECIST 1.0) at Day 56 of treatment with erlotinib. FDG-PET response; defined as a mSUVmax from FDG-PET scans of \<-25% and FDG-PET disease progression; defined as a mSUVmax \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Population: FDG-Evaluable patients were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56 | 32.1 weeks |
| Erlotinib_ FDG Non-Responders | PFS of Patients With FDG-PET Complete Response (CR)/Partial Response (PR) Versus FDG-PET Progressive Disease (PD) in Patients With Computed Tomography (CT) Stable Disease (SD) at Day 56 | 14.9 weeks |
Comparison: The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Progressive Disease. The alternative hypothesis is that FDG Responders would have a prolonged PFS compared to FDG Progressive Disease.p-value: 0.07695% CI: [0.06, 1.42]Log Rank
Primary
Progression Free Survival of Groups by FLT Response at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Population: FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | Progression Free Survival of Groups by FLT Response at Day 56 | 39.9 weeks |
| Erlotinib_ FDG Non-Responders | Progression Free Survival of Groups by FLT Response at Day 56 | 13.1 weeks |
Comparison: The null hypothesis is that there is no difference in PFS between FLT Responders and FLT Non-Responders. The alternative hypothesis is that FLT Responders would have prolonged PFS compared with FLT Non-Responders.p-value: 0.00895% CI: [0.04, 0.73]Log Rank
Primary
Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FLT-PET response and patients without FLT-PET response, independent of computed tomography (CT) response (per RECIST 1.0) at Day 56 of treatment with erlotinib. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25% and FLT-PET disease progression was defined as a mSUVmax from FLT-PET scans \>+25% or the development of a new lesion with a mSUVmax above background not explained by another cause.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Population: FLT-Evaluable patients were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had SD by CT at Day 56. Censoring at last tumor assessment.~CT SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since treatment start.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | NA weeks |
| Erlotinib_ FDG Non-Responders | Progression Free Survival of Patients With FLT CR/PR Versus FLT PD in Patients With CT SD at Day 56 | 12.9 weeks |
Comparison: The null hypothesis is that there is no difference between FLT Responders and FLT Progressive Disease. Alternative hypothesis is that FLT responders would have prolonged PFS compared to FLT Progressive Disease.p-value: 0.049Log Rank
Primary
Progression Free Survival (PFS) of Groups by FDG Response at Day 56
PFS was defined as the time from the date of first erlotinib dose to disease progression or death, whichever occurs first. PFS was compared between patients with FDG-PET response and patients without FDG-PET response, independent of CT response (per RECIST 1.0) at Day 56 of treatment with erlotinib. Mean of the percent changes in maximal standard uptake values (mSUVmax) from FDG-PET scans was used to define FDG-PET response. Based on European Organization for Research on the Treatment of Cancer (EORTC) definitions, an objective FDG-PET response was defined an mSUVmax \<-25%.
Time frame: Time from first erlotinib treatment to disease progression on CT (per RECIST 1.0) or death, whichever occurs first, assessed up to 2 years
Population: FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis. Censoring occurred at the date of the last tumor assessment.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib_FDG Responders | Progression Free Survival (PFS) of Groups by FDG Response at Day 56 | 28.1 weeks |
| Erlotinib_ FDG Non-Responders | Progression Free Survival (PFS) of Groups by FDG Response at Day 56 | 12.1 weeks |
Comparison: The null hypothesis is that there is no difference in PFS between FDG Responders and FDG Non-Responders. The alternative hypothesis is that FDG Responders would have prolonged PFS compared with FDG Non-Responders.p-value: 0.01795% CI: [0.11, 0.87]Log Rank
Secondary
FDG Response in Subgroups by CT Response at Day 56
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses on Day 56 defined as a mSUVmax from FDG-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Time frame: Day 56
Population: FDG-Evaluable Patients. Participants who were treated with erlotinib and underwent all FDG-PET scans through Day 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib_FDG Responders | FDG Response in Subgroups by CT Response at Day 56 | CT Partial response (n=4) | 75 Percentage of participants |
| Erlotinib_FDG Responders | FDG Response in Subgroups by CT Response at Day 56 | CT Progressive Disease (n=21) | 0 Percentage of participants |
Secondary
FLT Response in Subgroups by CT Response at Day 56
In patients with partial response or progressive disease on CT (per RECIST 1.0) after 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses on Day 56 defined as a mSUVmax from FLT-PET scans \<-25%. CT Partial Response defined as a 30% decrease in the sum of the longest diameter (LD) of target lesion taking as reference the baseline sum of the LD. CT Progressive disease defined as a 20% increase in the sum of the longest diameter of target lesions taking as reference the smallest sum LD since treatment started or appearance of 1 or more new lesions.
Time frame: Day 56
Population: FLT-Evaluable Patients. Participants who were treated with erlotinib and underwent all FLT-PET scans through Day 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib_FDG Responders | FLT Response in Subgroups by CT Response at Day 56 | CT Partial response (n=4) | 50 Percentage of participants |
| Erlotinib_FDG Responders | FLT Response in Subgroups by CT Response at Day 56 | CT Progressive Disease (n=20) | 0 Percentage of participants |
Secondary
Number of Participants With Adverse Events Due to FLT-PET Imaging
The number of participants who experienced an adverse event judged by the investigator to be related to FLT-PET.
Time frame: From screening to Day 112 assessment visit or study discontinuation or termination, whichever is first. On visits after Day 112, only SAE were recorded.
Population: Patients with non-small cell lung cancer (NSCLC) who underwent FLT-PET scans.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Erlotinib_FDG Responders | Number of Participants With Adverse Events Due to FLT-PET Imaging | 0 Participants |
Secondary
Percentage of Patients With FDG-PET Responses
In patients with computed tomography (CT)-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FDG-PET responses after the initial 14 days and 56 days of erlotinib treatment. FDG-PET response was defined as a mSUVmax from FDG-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Time frame: Day 14 and Day 56
Population: FDG-Evaluable patients. Participants who were treated with erlotinib, underwent all FDG-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib_FDG Responders | Percentage of Patients With FDG-PET Responses | Day 14 response | 7.7 Percentage of Participants |
| Erlotinib_FDG Responders | Percentage of Patients With FDG-PET Responses | Day 56 response | 11.5 Percentage of Participants |
Secondary
Percentage of Patients With FLT-PET Responses
In patients with CT-stable disease (according to RECIST 1.0) at 56 days of erlotinib treatment, the percentage of patients who demonstrated FLT-PET responses after the initial 14 days and 56 days of erlotinib treatment. FLT-PET response was defined as a mSUVmax from FLT-PET scans \<-25%. CT SD was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the treatment started.
Time frame: Day 14 and Day 56
Population: FLT-Evaluable Patients. Participants who were treated with erlotinib, underwent all FLT-PET scans through Day 56 and had stable disease by CT at Day 56 were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib_FDG Responders | Percentage of Patients With FLT-PET Responses | Day 14 response | 7.7 Percentage of Participants |
| Erlotinib_FDG Responders | Percentage of Patients With FLT-PET Responses | Day 56 response | 7.7 Percentage of Participants |