Non-Small Cell Lung Cancer
Conditions
Brief summary
This 2 arm study will evaluate the efficacy, safety, and pharmacokinetics of Tarceva, compared with placebo, following platinum-based chemotherapy in patients with advanced, recurrent, or metastatic NSCLC who have not had disease progression or unacceptable toxicity during chemotherapy. Following 4 cycles of platinum-based chemotherapy, eligible patients will be randomized to receive either Tarceva 150mg po daily, or placebo daily. The anticipated time on study treatment is until disease progression; the target sample size is 500+ individuals.
Interventions
DRUGerlotinib [Tarceva]
150mg po daily
DRUGPlacebo
po daily
Sponsors
Hoffmann-La Roche
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
No
Inclusion criteria
* adult patients \>=18 years of age; * histologically documented, locally advanced , recurrent or metastatic NSCLC; * measurable disease; * no disease progression after 4 cycles of platinum-based chemotherapy.
Exclusion criteria
* unstable systemic disease; * any other malignancies in the last 5 years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| PFS in All Participants (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology. |
| Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 6 months | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) | 6 months | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months) | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. |
| PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 6 months | PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology. |
| Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | — |
| OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) | 1 year | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Time to Progression (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. |
| Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) | 6 months | TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology. |
| Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months). | — |
| Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. |
| Time to Symptom Progression (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology. |
| Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) | 6 months | LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology. |
| Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. |
| Time to Deterioration in TOI (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. |
| Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) | 6 months | TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology. |
| Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. |
| Time to Deterioration in QoL (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology. |
| Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) | 6 months | Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology. |
| Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. |
| Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL. |
| Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months) | Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method. |
| Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) | Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 1 year | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) | — |
| OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) | Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months) | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
| Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 1 year | OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology. |
Countries
Australia, Austria, Belgium, Canada, Chile, China, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Malaysia, Netherlands, New Zealand, Poland, Romania, Russia, Slovakia, Slovenia, South Africa, South Korea, Spain, Ukraine, United Kingdom, Venezuela
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Placebo Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | 451 |
| Erlotinib, 150 mg/Day Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months. | 438 |
| Total | 889 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 7 | 19 |
| Overall Study | Death | 5 | 10 |
| Overall Study | Failure to Return | 2 | 3 |
| Overall Study | Ongoing at Data Cutoff | 32 | 66 |
| Overall Study | Other | 2 | 2 |
| Overall Study | Progressive Disease | 383 | 320 |
| Overall Study | Protocol Violation | 3 | 2 |
| Overall Study | Refused Treatment | 17 | 16 |
Baseline characteristics
| Characteristic | Placebo | Erlotinib, 150 mg/Day | Total |
|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 9.39 | 59.8 years STANDARD_DEVIATION 9.52 | 59.8 years STANDARD_DEVIATION 9.44 |
| Sex: Female, Male Female | 113 Participants | 117 Participants | 230 Participants |
| Sex: Female, Male Male | 338 Participants | 321 Participants | 659 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 152 / 445 | 283 / 433 |
| serious Total, serious adverse events | 34 / 445 | 49 / 433 |
Outcome results
Primary
Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008)
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | 89.4 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Epidermal Growth Factor Receptor (EGFR) Immunohistochemistry (IHC) Positive Participants With PD or Death (Data Cutoff 17 May 2008) | 79.5 percentage of participants |
Primary
Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008)
Progression-free survival (PFS) was defined as the time from randomization to PD or death, whichever occurred first. For target lesions (TLs), PD was defined at least a 20 percent (%) increase in the sum of the largest diameter (SLD), taking as reference the smallest SLD recorded from baseline (BL) more the appearance of one or more new lesions. For non-target lesions (NTLs), PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Screening, BL [≤21 days after randomization], every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; participants with PD prior to randomization were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | 89.5 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With PD According to Response Evaluation Criteria in Solid Tumors (RECIST) or Death (Data Cutoff 17 May 2008) | 79.9 percentage of participants |
Primary
PFS in All Participants (Data Cutoff 17 May 2008)
The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% confidence interval (CI) was estimated using Kaplan-Meier methodology.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; participants with PD prior to randomization were excluded from analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | PFS in All Participants (Data Cutoff 17 May 2008) | 11.1 weeks |
| Erlotinib, 150 mg/Day | PFS in All Participants (Data Cutoff 17 May 2008) | 12.3 weeks |
p-value: <0.000195% CI: [0.62, 0.82]Log Rank
Primary
PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008)
The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS;only participants with EGFR IHC positive tumors were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) | 11.1 weeks |
| Erlotinib, 150 mg/Day | PFS in EGFR IHC Positive Population (Data Cutoff 17 May 2008) | 12.3 weeks |
p-value: <0.000195% CI: [0.58, 0.82]Log Rank
Primary
Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008)
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 6 months
Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) | 16.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive and Progression Free at 6 Months (Data Cutoff 17 May 2008) | 27.0 percentage of participants |
Primary
Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from BL more the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 6 months
Population: FAS; participants with PD prior to randomization were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 15.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 25.0 percentage of participants |
Secondary
Change From BL in FACT-L Scores (Data Cutoff 17 May 2008)
Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; n=number of participants assessed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-L Score (n=1,0) | 1.33 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Physical Well-Being (n=274,303) | 0.22 score on a scale | Standard Deviation 4.235 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Social Well-Being (n=274,303) | -0.24 score on a scale | Standard Deviation 4.901 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Emotional Well-Being (n=274,302) | -0.41 score on a scale | Standard Deviation 3.801 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Functional Well-Being (n=275,302) | 0.24 score on a scale | Standard Deviation 4.819 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: FACT-L Subscale Score (n=275,298) | -0.06 score on a scale | Standard Deviation 4.899 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Lung Cancer Subscale Score (n=275,298) | -0.32 score on a scale | Standard Deviation 4.148 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-G Score (n=273,299) | -0.20 score on a scale | Standard Deviation 12.256 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Trial Outcome Index (n=274,296) | 0.16 score on a scale | Standard Deviation 10.276 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-L Score (n=273,294) | -0.20 score on a scale | Standard Deviation 15.133 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Physical Well-Being (n=144,193) | 1.00 score on a scale | Standard Deviation 4.036 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Social Well-Being (n=143,194) | -0.43 score on a scale | Standard Deviation 4.918 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Emotional Well-Being (n=144,194) | 0.25 score on a scale | Standard Deviation 3.728 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Functional Well-Being (n=144,196) | 1.00 score on a scale | Standard Deviation 4.707 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: FACT-L Subscale Score (n=144,196) | 0.88 score on a scale | Standard Deviation 4.501 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Lung Cancer Subscale Score (n=144,196) | 0.19 score on a scale | Standard Deviation 3.666 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-G Score (n=144,191) | 1.83 score on a scale | Standard Deviation 11.637 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Trial Outcome Index (n=144,193) | 2.20 score on a scale | Standard Deviation 9.362 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-L Score (n=144,191) | 2.72 score on a scale | Standard Deviation 14.226 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Physical Well-Being (n=86,143) | 1.31 score on a scale | Standard Deviation 4.798 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Social Well-Being (n=86,143) | -0.01 score on a scale | Standard Deviation 4.454 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Emotional Well-Being (n=86,143) | 0.59 score on a scale | Standard Deviation 3.984 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Functional Well-Being (n=86,143) | 1.06 score on a scale | Standard Deviation 4.353 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: FACT-L Subscale Score (n=86,143) | 1.48 score on a scale | Standard Deviation 4.171 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Lung Cancer Subscale Score (n=86,143) | 0.49 score on a scale | Standard Deviation 3.55 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-G Score (n=86,143) | 2.95 score on a scale | Standard Deviation 12.047 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Trial Outcome Index (n=86,143) | 2.86 score on a scale | Standard Deviation 9.638 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-L Score (n=86,143) | 4.43 score on a scale | Standard Deviation 14.523 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Physical Well-Being (n=59,101) | 1.29 score on a scale | Standard Deviation 4.358 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Social Well-Being (n=59,101) | -0.25 score on a scale | Standard Deviation 4.804 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Emotional Well-Being (n=59,100) | 0.21 score on a scale | Standard Deviation 5.118 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Functional Well-Being (n=59,100) | 1.64 score on a scale | Standard Deviation 4.55 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: FACT-L Subscale Score (n=59,101) | 1.45 score on a scale | Standard Deviation 5.018 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Lung Cancer Subscale Score (n=59,101) | 0.48 score on a scale | Standard Deviation 4.051 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-G Score (n=59,99) | 2.89 score on a scale | Standard Deviation 13.739 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Trial Outcome Index (n=59,100) | 3.42 score on a scale | Standard Deviation 9.606 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-L Score (n=59,99) | 4.34 score on a scale | Standard Deviation 16.354 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Physical Well-Being (n=37,66) | 1.61 score on a scale | Standard Deviation 4.205 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Social Well-Being (n=37,66) | 0.00 score on a scale | Standard Deviation 5.51 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Emotional Well-Being (n=37,66) | -0.07 score on a scale | Standard Deviation 4.902 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Functional Well-Being (n=37,66) | 2.17 score on a scale | Standard Deviation 5.028 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: FACT-L Subscale Score (n=37,66) | 1.79 score on a scale | Standard Deviation 4.616 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Lung Cancer Subscale Score (n=37,66) | 0.69 score on a scale | Standard Deviation 3.818 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-G Score (n=37,66) | 3.71 score on a scale | Standard Deviation 13.827 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Trial Outcome Index (n=37,66) | 4.47 score on a scale | Standard Deviation 9.551 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-L Score (n=37,66) | 5.50 score on a scale | Standard Deviation 15.828 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Physical Well-Being (n=25,47) | 2.21 score on a scale | Standard Deviation 4.791 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Social Well-Being (n=25,47) | -0.36 score on a scale | Standard Deviation 5.659 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Emotional Well-Being (n=25,47) | 0.86 score on a scale | Standard Deviation 4.892 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Functional Well-Being (n=25,47) | 1.31 score on a scale | Standard Deviation 5.551 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: FACT-L Subscale Score (n=25,47) | 0.67 score on a scale | Standard Deviation 4.864 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Lung Cancer Subscale Score (n=25,47) | -0.10 score on a scale | Standard Deviation 3.963 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Total FACT-G Score (n=25,47) | 4.02 score on a scale | Standard Deviation 14.439 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Trial Outcome Index (n=25,47) | 3.42 score on a scale | Standard Deviation 11.186 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Total Fact-L Score (n=25,47) | 4.68 score on a scale | Standard Deviation 17.636 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Physical Well-Being (n=19,35) | 1.82 score on a scale | Standard Deviation 3.936 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Social Well-Being (n=19,35) | -1.14 score on a scale | Standard Deviation 6.006 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Emotional Well-Being (n=19,35) | -0.11 score on a scale | Standard Deviation 3.573 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Functional Well-Being (n=19,35) | 0.05 score on a scale | Standard Deviation 3.582 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Subscale Score (n=19,35) | 1.40 score on a scale | Standard Deviation 4.321 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Lung Cancer Subscale Score (n=19,35) | 0.42 score on a scale | Standard Deviation 2.858 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: FACT-G Score (n=19,35) | 0.62 score on a scale | Standard Deviation 10.871 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Trial Outcome Index (n=19,35) | 2.29 score on a scale | Standard Deviation 7.037 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Score (n=19,35) | 2.03 score on a scale | Standard Deviation 12.466 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Physical Well-Being (n=13,29) | 0.46 score on a scale | Standard Deviation 3.497 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Social Well-Being (n=13,29) | -1.96 score on a scale | Standard Deviation 7.987 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Emotional Well-Being (n=13,29) | -0.08 score on a scale | Standard Deviation 3.095 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Functional Well-Being (n=13,29) | -2.00 score on a scale | Standard Deviation 3.894 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: FACT-L Subscale Score (n=12,29) | 0.03 score on a scale | Standard Deviation 4.445 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Lung Cancer Subscale Score (n=12,29) | -0.79 score on a scale | Standard Deviation 3.1 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Total FACT-G Score (n=13,29) | -3.57 score on a scale | Standard Deviation 12.233 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Trial Outcome Index (n=12,29) | -1.79 score on a scale | Standard Deviation 7.57 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Total FACT-L Score (n=12,29) | -1.60 score on a scale | Standard Deviation 11.354 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Physical Well-Being (n=9,17) | 1.89 score on a scale | Standard Deviation 5.383 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Social Well-Being (n=9,17) | -0.57 score on a scale | Standard Deviation 7.368 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Emotional Well-Being (n=9,17) | -1.56 score on a scale | Standard Deviation 2.789 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Functional Well-Being (n=9,17) | -0.56 score on a scale | Standard Deviation 3.877 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: FACT-L Subscale Score (n=9,17) | 1.61 score on a scale | Standard Deviation 5.882 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Lung Cancer Subscale Score (n=9,17) | -0.22 score on a scale | Standard Deviation 4.438 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-G Score (n=9,17) | -0.79 score on a scale | Standard Deviation 12.27 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Trial Outcome Index (n=9,17) | 1.11 score on a scale | Standard Deviation 11.044 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-L Score (n=9,17) | 0.82 score on a scale | Standard Deviation 15.7 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Physical Well-Being (n=6,8) | 1.33 score on a scale | Standard Deviation 6.318 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Physical Well-Being (n=264,214) | -1.07 score on a scale | Standard Deviation 4.75 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Social Well-Being (n=6,8) | 0.31 score on a scale | Standard Deviation 6.723 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Emotional Well-Being (n=6,8) | -1.50 score on a scale | Standard Deviation 3.619 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Functional Well-Being (n=6,8) | -1.67 score on a scale | Standard Deviation 5.354 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: FACT-L Subscale Score (n=6,8) | -0.50 score on a scale | Standard Deviation 7.396 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Lung Cancer Subscale Score (n=6,8) | -1.17 score on a scale | Standard Deviation 5.193 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-G Score (n=6,8) | -1.53 score on a scale | Standard Deviation 11.929 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Trial Outcome Index (n=6,8) | -1.50 score on a scale | Standard Deviation 13.097 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-L Score (n=6,8) | -2.03 score on a scale | Standard Deviation 16.14 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Physical Well-Being (n=1,0) | 1.33 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Social Well-Being (n=1,0) | -2.00 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Emotional Well-Being (n=1,0) | -3.00 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Functional Well-Being (n=1,0) | -1.00 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: FACT-L Subscale Score (n=1,0) | 6.0 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Lung Cancer Subscale Score (n=1,0) | 2.0 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-G Score (n=1,0) | -4.67 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Trial Outcome Index (n=1,0) | 2.33 score on a scale | — |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Social Well-Being (n=263,216) | -0.66 score on a scale | Standard Deviation 4.973 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Emotional Well-Being (n=264,216) | -2.04 score on a scale | Standard Deviation 4.225 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Functional Well-Being (n=264,216) | -1.20 score on a scale | Standard Deviation 5.17 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: FACT-L Subscale Score (n=263,212) | -1.27 score on a scale | Standard Deviation 4.458 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Lung Cancer Subscale Score (n=263,212) | -1.74 score on a scale | Standard Deviation 3.882 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Total FACT-G Score (n=260,213) | -4.91 score on a scale | Standard Deviation 12.576 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Trial Outcome Index (n=261,210) | -4.03 score on a scale | Standard Deviation 10.658 |
| Placebo | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Total FACT-L Score (n=258,209) | -6.26 score on a scale | Standard Deviation 15.146 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Total Fact-L Score (n=25,47) | 2.79 score on a scale | Standard Deviation 16.662 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Functional Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Physical Well-Being (n=274,303) | -0.47 score on a scale | Standard Deviation 4.729 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Physical Well-Being (n=19,35) | 0.27 score on a scale | Standard Deviation 5.835 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Social Well-Being (n=274,303) | 0.23 score on a scale | Standard Deviation 4.202 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Physical Well-Being (n=6,8) | 2.63 score on a scale | Standard Deviation 7.13 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Emotional Well-Being (n=274,302) | 0.29 score on a scale | Standard Deviation 3.916 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Social Well-Being (n=19,35) | 0.28 score on a scale | Standard Deviation 7.784 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Functional Well-Being (n=275,302) | -0.09 score on a scale | Standard Deviation 4.711 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-L Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: FACT-L Subscale Score (n=275,298) | 0.24 score on a scale | Standard Deviation 4.623 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Emotional Well-Being (n=19,35) | 0.59 score on a scale | Standard Deviation 3.741 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Lung Cancer Subscale Score (n=275,298) | -0.03 score on a scale | Standard Deviation 4.16 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Trial Outcome Index (n=261,210) | -6.05 score on a scale | Standard Deviation 11.785 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-G Score (n=273,299) | 0.01 score on a scale | Standard Deviation 11.453 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Functional Well-Being (n=19,35) | 0.65 score on a scale | Standard Deviation 5.58 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Trial Outcome Index (n=274,296) | -0.73 score on a scale | Standard Deviation 10.201 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: FACT-L Subscale Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-L Score (n=273,294) | 0.14 score on a scale | Standard Deviation 14.155 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Subscale Score (n=19,35) | 0.87 score on a scale | Standard Deviation 4.974 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Physical Well-Being (n=144,193) | -0.14 score on a scale | Standard Deviation 4.908 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Social Well-Being (n=6,8) | 0.30 score on a scale | Standard Deviation 3.733 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Social Well-Being (n=143,194) | -0.43 score on a scale | Standard Deviation 5.566 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Lung Cancer Subscale Score (n=19,35) | 0.51 score on a scale | Standard Deviation 4.301 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Emotional Well-Being (n=144,194) | 0.20 score on a scale | Standard Deviation 4.115 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Functional Well-Being (n=264,216) | -1.98 score on a scale | Standard Deviation 5.355 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Functional Well-Being (n=144,196) | -0.38 score on a scale | Standard Deviation 4.806 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: FACT-G Score (n=19,35) | 1.80 score on a scale | Standard Deviation 15.245 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: FACT-L Subscale Score (n=144,196) | -0.06 score on a scale | Standard Deviation 4.57 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Emotional Well-Being (n=6,8) | -0.13 score on a scale | Standard Deviation 4.853 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Lung Cancer Subscale Score (n=144,196) | -0.48 score on a scale | Standard Deviation 4.004 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: Trial Outcome Index (n=19,35) | 1.44 score on a scale | Standard Deviation 12.405 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-G Score (n=144,191) | -0.84 score on a scale | Standard Deviation 12.145 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Lung Cancer Subscale Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Trial Outcome Index (n=144,193) | -1.04 score on a scale | Standard Deviation 10.051 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Score (n=19,35) | 2.67 score on a scale | Standard Deviation 18.499 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-L Score (n=144,191) | -0.90 score on a scale | Standard Deviation 14.536 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Functional Well-Being (n=6,8) | -1.13 score on a scale | Standard Deviation 5.384 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Physical Well-Being (n=86,143) | 0.40 score on a scale | Standard Deviation 4.89 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Physical Well-Being (n=13,29) | 1.37 score on a scale | Standard Deviation 6.388 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Social Well-Being (n=86,143) | -0.51 score on a scale | Standard Deviation 5.894 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Total FACT-G Score (n=260,213) | -5.71 score on a scale | Standard Deviation 13.588 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Emotional Well-Being (n=86,143) | 0.60 score on a scale | Standard Deviation 3.723 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Social Well-Being (n=13,29) | -0.68 score on a scale | Standard Deviation 6.851 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Functional Well-Being (n=86,143) | 0.18 score on a scale | Standard Deviation 4.903 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: FACT-L Subscale Score (n=6,8) | 1.03 score on a scale | Standard Deviation 4.818 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: FACT-L Subscale Score (n=86,143) | 0.27 score on a scale | Standard Deviation 4.587 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Emotional Well-Being (n=13,29) | 0.41 score on a scale | Standard Deviation 4.166 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Lung Cancer Subscale Score (n=86,143) | -0.26 score on a scale | Standard Deviation 4.125 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-G Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-G Score (n=86,143) | 0.68 score on a scale | Standard Deviation 12.668 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Functional Well-Being (n=13,29) | 0.55 score on a scale | Standard Deviation 5.448 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Trial Outcome Index (n=86,143) | 0.32 score on a scale | Standard Deviation 10.35 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Lung Cancer Subscale Score (n=6,8) | 1.78 score on a scale | Standard Deviation 4.141 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-L Score (n=86,143) | 0.95 score on a scale | Standard Deviation 15.386 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: FACT-L Subscale Score (n=12,29) | 0.82 score on a scale | Standard Deviation 5.967 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Physical Well-Being (n=59,101) | 0.16 score on a scale | Standard Deviation 4.881 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: FACT-L Subscale Score (n=263,212) | -1.32 score on a scale | Standard Deviation 4.708 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Social Well-Being (n=59,101) | 0.04 score on a scale | Standard Deviation 6.092 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Lung Cancer Subscale Score (n=12,29) | 0.34 score on a scale | Standard Deviation 5.15 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Emotional Well-Being (n=59,100) | -0.05 score on a scale | Standard Deviation 4.169 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-G Score (n=6,8) | 1.67 score on a scale | Standard Deviation 14.651 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Functional Well-Being (n=59,100) | 0.42 score on a scale | Standard Deviation 4.373 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Total FACT-G Score (n=13,29) | 1.64 score on a scale | Standard Deviation 14.463 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: FACT-L Subscale Score (n=59,101) | 0.50 score on a scale | Standard Deviation 5.048 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Trial Outcome Index (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Lung Cancer Subscale Score (n=59,101) | -0.12 score on a scale | Standard Deviation 4.321 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Trial Outcome Index (n=12,29) | 2.26 score on a scale | Standard Deviation 13.247 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-G Score (n=59,99) | 0.52 score on a scale | Standard Deviation 12.753 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Emotional Well-Being (n=37,66) | 0.74 score on a scale | Standard Deviation 4.775 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Trial Outcome Index (n=6,8) | 3.28 score on a scale | Standard Deviation 13.738 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Trial Outcome Index (n=59,100) | 0.43 score on a scale | Standard Deviation 10.348 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 48: Total FACT-L Score (n=12,29) | 2.46 score on a scale | Standard Deviation 18.177 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-L Score (n=59,99) | 1.10 score on a scale | Standard Deviation 15.954 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Physical Well-Being (n=264,214) | -2.19 score on a scale | Standard Deviation 5.506 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Physical Well-Being (n=37,66) | 0.49 score on a scale | Standard Deviation 5.129 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Physical Well-Being (n=9,17) | 1.82 score on a scale | Standard Deviation 6.307 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Social Well-Being (n=37,66) | -0.19 score on a scale | Standard Deviation 6.676 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-L Score (n=6,8) | 2.70 score on a scale | Standard Deviation 17.579 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Social Well-Being (n=9,17) | 0.06 score on a scale | Standard Deviation 9.116 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Functional Well-Being (n=37,66) | 0.83 score on a scale | Standard Deviation 5.243 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Total FACT-L Score (n=258,209) | -7.10 score on a scale | Standard Deviation 16.194 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: FACT-L Subscale Score (n=37,66) | 0.99 score on a scale | Standard Deviation 4.863 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Emotional Well-Being (n=9,17) | 0.28 score on a scale | Standard Deviation 4.478 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Lung Cancer Subscale Score (n=37,66) | 0.38 score on a scale | Standard Deviation 4.454 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Physical Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-G Score (n=37,66) | 1.88 score on a scale | Standard Deviation 14.268 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Functional Well-Being (n=9,17) | -0.53 score on a scale | Standard Deviation 7.434 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Trial Outcome Index (n=37,66) | 1.70 score on a scale | Standard Deviation 11.108 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Social Well-Being (n=263,216) | 0.09 score on a scale | Standard Deviation 4.824 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-L Score (n=37,66) | 2.86 score on a scale | Standard Deviation 16.864 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: FACT-L Subscale Score (n=9,17) | 0.43 score on a scale | Standard Deviation 6.275 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Physical Well-Being (n=25,47) | 0.77 score on a scale | Standard Deviation 5.093 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Social Well-Being (n=25,47) | -0.16 score on a scale | Standard Deviation 7.053 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Social Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Lung Cancer Subscale Score (n=9,17) | 0.47 score on a scale | Standard Deviation 5.535 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Emotional Well-Being (n=25,47) | 0.65 score on a scale | Standard Deviation 3.717 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Lung Cancer Subscale Score (n=263,212) | -1.78 score on a scale | Standard Deviation 4.199 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Functional Well-Being (n=25,47) | 1.10 score on a scale | Standard Deviation 5.28 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-G Score (n=9,17) | 1.64 score on a scale | Standard Deviation 17.542 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: FACT-L Subscale Score (n=25,47) | 0.43 score on a scale | Standard Deviation 5.459 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 84: Emotional Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Lung Cancer Subscale Score (n=25,47) | -0.06 score on a scale | Standard Deviation 4.535 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Trial Outcome Index (n=9,17) | 1.76 score on a scale | Standard Deviation 14.316 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Total FACT-G Score (n=25,47) | 2.37 score on a scale | Standard Deviation 13.991 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Off Trtmt: Emotional Well-Being (n=264,216) | -1.56 score on a scale | Standard Deviation 4.745 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 36: Trial Outcome Index (n=25,47) | 1.82 score on a scale | Standard Deviation 10.443 |
| Erlotinib, 150 mg/Day | Change From BL in FACT-L Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-L Score (n=9,17) | 2.07 score on a scale | Standard Deviation 22.086 |
Secondary
Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008)
Total FACT-L score=sum of TOI, SWB, and EWB of FACT-L questionnaires. TOI (PWB+FWB+LCS), SWB, and EWB scores obtained from 7-item (6-item for EWB) questionnaires from FACT-L V4. Participants responded to questions assessing symptoms (scale 0-4; 0=not at all and 4=very much). Higher score=more severe symptoms. The 7-item LCS assessed symptoms such as shortness of breath, loss of weight, tightness in chest. Participants responded to questions assessing symptoms (scale: 0-4; 0=not at all and 4=very much). Scores from 0-35; higher score=more severe symptoms. The 27 items of FACT-G were scored in the following domains: PWB (7 items, total score 0-28), SWB (7 items; total score 0-28), EWB (6 items, total score 0-24), and FWB (7 items; total score 0-28), higher scores=better QoL. Participants responded to items on 5-point Likert scale (0=Not at all to 4=Very much; total score: 0-108). Higher score=better QOL. TOI score=PWB+FWB+LCS; Total TOI score: 0-92; higher scores=better QOL.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; n=number of participants assessed for the given parameter at the specified timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: FACT-L Subscale Score (n=86,143) | 25.44 score on a scale | Standard Deviation 4.645 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Emotional Well-Being (n=397,393) | 16.92 score on a scale | Standard Deviation 4.534 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Functional Well-Being (n=397,393) | 16.15 score on a scale | Standard Deviation 5.488 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Lung Cancer Subscale Score (n=397,391) | 19.82 score on a scale | Standard Deviation 4.188 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Total FACT-General (FACT-G) Score (n=396,391) | 74.68 score on a scale | Standard Deviation 14.787 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Trial Outcome Index (n=396,390) | 56.83 score on a scale | Standard Deviation 11.83 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Total FACT-L Score (n=395,389) | 98.85 score on a scale | Standard Deviation 18.007 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Physical Well-Being (n=274,304) | 21.44 score on a scale | Standard Deviation 5.117 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Social Well-Being (n=274,303 | 20.62 score on a scale | Standard Deviation 5.437 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Emotional Well-Being (n=275,302) | 16.53 score on a scale | Standard Deviation 4.587 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Functional Well-Being (n=275,302) | 16.41 score on a scale | Standard Deviation 5.234 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: FACT-L Subscale Score (n=275,300) | 24.45 score on a scale | Standard Deviation 5.231 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Lung Cancer Subscale Score (n=275,300) | 19.78 score on a scale | Standard Deviation 4.463 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-G Score (n=274,300) | 74.82 score on a scale | Standard Deviation 14.38 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Trial Outcome Index (n=274,299) | 57.59 score on a scale | Standard Deviation 12.292 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-L Score (n=274,297) | 99.27 score on a scale | Standard Deviation 17.857 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Physical Well-Being (n=144,194) | 21.93 score on a scale | Standard Deviation 4.734 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Social Well-Being (n=143,194) | 20.38 score on a scale | Standard Deviation 5.637 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Emotional Well-Being (n=144,194) | 17.21 score on a scale | Standard Deviation 4.376 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Functional Well-Being (n=144,196) | 17.04 score on a scale | Standard Deviation 5.77 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: FACT-L Subscale Score (n=144,196) | 25.15 score on a scale | Standard Deviation 4.735 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Lung Cancer Subscale Score (n=144,196) | 20.22 score on a scale | Standard Deviation 4.015 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Trial Outcome Index (n=144,194) | 59.19 score on a scale | Standard Deviation 12.129 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-L Score (n=144,192) | 101.56 score on a scale | Standard Deviation 17.824 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Physical Well-Being (n=86,143) | 21.60 score on a scale | Standard Deviation 4.883 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Social Well-Being (n=86,143) | 21.08 score on a scale | Standard Deviation 5.328 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Emotional Well-Being (n=86,143) | 17.33 score on a scale | Standard Deviation 4.717 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Functional Well-Being (n=86,143) | 16.89 score on a scale | Standard Deviation 5.289 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Physical Well-Being (n=397,392) | 20.85 score on a scale | Standard Deviation 4.817 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Lung Cancer Subscale Score (n=86,143) | 20.28 score on a scale | Standard Deviation 4.003 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-G Score (n=86,143) | 76.89 score on a scale | Standard Deviation 14.385 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Trial Outcome Index (n=86,143) | 58.76 score on a scale | Standard Deviation 11.492 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-L Score (n=86,143) | 102.33 score on a scale | Standard Deviation 17.502 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Physical Well-Being (n=59,101) | 21.78 score on a scale | Standard Deviation 4.665 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Social Well-Being (n=59,101) | 20.79 score on a scale | Standard Deviation 5.641 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Emotional Well-Being (n=59,100) | 16.86 score on a scale | Standard Deviation 4.88 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Functional Well-Being (n=59,100) | 17.14 score on a scale | Standard Deviation 6.062 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: FACT-L Subscale Score (n=59,101) | 25.18 score on a scale | Standard Deviation 5.126 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Lung Cancer Subscale Score (n=59,101) | 20.07 score on a scale | Standard Deviation 4.246 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-G Score (n=59,99) | 76.58 score on a scale | Standard Deviation 16.091 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Trial Outcome Index (n=59,100) | 58.99 score on a scale | Standard Deviation 11.837 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-L Score (n=59,99) | 101.75 score on a scale | Standard Deviation 19.347 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Physical Well-Being (n=37,66) | 21.74 score on a scale | Standard Deviation 4.153 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Social Well-Being (n=37,66) | 20.50 score on a scale | Standard Deviation 5.18 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Emotional Well-Being (n=37,66) | 16.37 score on a scale | Standard Deviation 4.164 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Functional Well-Being (n=37,66) | 17.92 score on a scale | Standard Deviation 5.082 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: FACT-L Subscale Score (n=37,66) | 25.90 score on a scale | Standard Deviation 3.484 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Lung Cancer Subscale Score (n=37,66) | 20.66 score on a scale | Standard Deviation 3.073 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-G Score (n=37,66) | 76.54 score on a scale | Standard Deviation 11.915 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Trial Outcome Index (n=37,66) | 60.32 score on a scale | Standard Deviation 9.753 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-L Score (n=37,66) | 102.44 score on a scale | Standard Deviation 14.063 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Physical Well-Being (n=25,47) | 21.60 score on a scale | Standard Deviation 3.317 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Social Well-Being (n=25,47) | 20.02 score on a scale | Standard Deviation 5.769 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Emotional Well-Being (n=25,47) | 17.31 score on a scale | Standard Deviation 3.736 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Fuctional Well-Being (n=25,47) | 16.06 score on a scale | Standard Deviation 4.287 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: FACT-L Subscale Score (n=25,47) | 24.48 score on a scale | Standard Deviation 4.089 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Lung Cancer Subscale Score (n=25,47) | 19.36 score on a scale | Standard Deviation 3.893 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Total FACT-G Score (n=25,47) | 74.99 score on a scale | Standard Deviation 11.066 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Trial Outcome Index (n=25,47) | 57.02 score on a scale | Standard Deviation 9.426 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Total FACT-L Score (n=25,47) | 99.27 score on a scale | Standard Deviation 13.672 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Physical Well-Being (n=19,35) | 21.76 score on a scale | Standard Deviation 3.592 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Social Well-Being (n=19,35) | 18.45 score on a scale | Standard Deviation 6.262 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Emotional Well-Being (n=19,35) | 16.95 score on a scale | Standard Deviation 4.089 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Functional Well-Being (n=19,35) | 15.32 score on a scale | Standard Deviation 3.902 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Subscale Score (n=19,35) | 24.63 score on a scale | Standard Deviation 4.448 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Lung Cancer Subscale Score (n=19,35) | 19.50 score on a scale | Standard Deviation 4.092 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: FACT-G Score (n=19,35) | 72.74 score on a scale | Standard Deviation 12.406 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Trial Outcome Index (n=19,35) | 56.58 score on a scale | Standard Deviation 9.562 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Score (n=19,35) | 97.11 score on a scale | Standard Deviation 14.951 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Physical Well-Being (n=13,29) | 21.38 score on a scale | Standard Deviation 4.154 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Social Well-Being (n=13,29) | 17.23 score on a scale | Standard Deviation 7.567 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Emotional Well-Being (n=13,29) | 18.69 score on a scale | Standard Deviation 3.011 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Functional Well-Being (n=13,29) | 14.15 score on a scale | Standard Deviation 2.672 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: FACT-L Subscale Score (n=12,29) | 23.35 score on a scale | Standard Deviation 3.647 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Lung Cancer Subscale Score (n=12,29) | 18.75 score on a scale | Standard Deviation 3.646 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: FACT-G Score (n=12,29) | 71.46 score on a scale | Standard Deviation 12.069 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Trial Outcome Index (n=12,29) | 54.58 score on a scale | Standard Deviation 9.14 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: FACT-L Score (n=12,29) | 96.19 score on a scale | Standard Deviation 14.394 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Physical Well-Being (n=9,17) | 22.67 score on a scale | Standard Deviation 4.664 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Social Well-Being (n=9,17) | 17.78 score on a scale | Standard Deviation 6.405 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Emotional Well-Being (n=9,17) | 16.78 score on a scale | Standard Deviation 3.232 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Functional Well-Being (n=9,17) | 15.11 score on a scale | Standard Deviation 3.408 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: FACT-L Subscale Score (n=9,17) | 23.43 score on a scale | Standard Deviation 5.01 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Lung Cancer Subscale Score (n=9,17) | 17.89 score on a scale | Standard Deviation 3.919 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Trial Outcome Index (n=9,17) | 55.67 score on a scale | Standard Deviation 9.695 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-L Score (n=9,17) | 95.77 score on a scale | Standard Deviation 15.703 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Physical Well-Being (n=6,8) | 22.17 score on a scale | Standard Deviation 4.997 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Social Well-Being (n=6,8) | 19.00 score on a scale | Standard Deviation 7.251 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Emotional Well-Being (n=6,8) | 17.17 score on a scale | Standard Deviation 2.401 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Functional Well-Being (n=6,8) | 15.22 score on a scale | Standard Deviation 4.457 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: FACT-L Subscale Score (n=6,8) | 21.23 score on a scale | Standard Deviation 5.154 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Lung Cancer Subscale Score (n=6,8) | 17.17 score on a scale | Standard Deviation 4.021 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-G Score (n=6,8) | 73.67 score on a scale | Standard Deviation 14.82 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Trial Outcome Index (n=6,8) | 54.67 score on a scale | Standard Deviation 11.911 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-L Score (n=6,8) | 94.90 score on a scale | Standard Deviation 18.833 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Physical Well-Being (n=1,0) | 20.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Social Well-Being (n=1,0) | 14.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Emotional Well-Being (n=1,0) | 13.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Functional Well-Being (n=1,0) | 18.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: FACT-L Subscale Score (n=1,0) | 17.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Lung Cancer Subscale Score (n=1,0) | 13.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-G Score (n=1,0) | 65.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Trial Outcome Index (n=1,0) | 51.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-L Score (n=1,0) | 82.00 score on a scale | — |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Physical Well-Being (n=265,215) | 19.57 score on a scale | Standard Deviation 5.668 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Social Well-Being (n=263,216) | 20.01 score on a scale | Standard Deviation 5.38 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Emotional Well-Being (n=265,216) | 14.76 score on a scale | Standard Deviation 5.157 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Functional Well-Being (n=265,216) | 14.90 score on a scale | Standard Deviation 5.893 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: FACT-L Subscale Score (n=264,214) | 22.80 score on a scale | Standard Deviation 5.268 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Lung Cancer Subscale Score (n=264,214) | 18.06 score on a scale | Standard Deviation 4.629 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt:Total FACT-G Score (n=261,214) | 69.29 score on a scale | Standard Deviation 15.73 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt:Trial Outcome Index (n=263,213) | 52.61 score on a scale | Standard Deviation 13.475 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt:Total FACT-L Score (n=260,212) | 92.14 score on a scale | Standard Deviation 19.324 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Social Well-Being (n=397,392) | 20.84 score on a scale | Standard Deviation 5.496 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: FACT-L Subscale Score (n=397,391) | 24.17 score on a scale | Standard Deviation 4.892 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-G Score (n=144,192) | 76.42 score on a scale | Standard Deviation 14.889 |
| Placebo | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-G Score (n=9,17) | 72.34 score on a scale | Standard Deviation 11.607 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Physical Well-Being (n=6,8) | 23.25 score on a scale | Standard Deviation 4.097 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Physical Well-Being (n=397,392) | 20.96 score on a scale | Standard Deviation 4.781 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Social Well-Being (n=397,392) | 20.98 score on a scale | Standard Deviation 5.285 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Trial Outcome Index (n=25,47) | 60.87 score on a scale | Standard Deviation 11.963 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt:Trial Outcome Index (n=263,213) | 51.34 score on a scale | Standard Deviation 12.974 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Functional Well-Being (n=397,393) | 16.84 score on a scale | Standard Deviation 5.514 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: FACT-L Subscale Score (n=397,391) | 24.46 score on a scale | Standard Deviation 4.697 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Total FACT-L Score (n=25,47) | 103.86 score on a scale | Standard Deviation 19.244 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Lung Cancer Subscale Score (n=397,391) | 20.07 score on a scale | Standard Deviation 4.24 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Social Well-Being (n=6,8) | 21.44 score on a scale | Standard Deviation 5.852 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Total FACT-General (FACT-G) Score (n=396,391) | 75.52 score on a scale | Standard Deviation 14.612 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Physical Well-Being (n=19,35) | 22.19 score on a scale | Standard Deviation 5.035 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Trial Outcome Index (n=396,390) | 57.90 score on a scale | Standard Deviation 11.682 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-G Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Total FACT-L Score (n=395,389) | 100.02 score on a scale | Standard Deviation 17.751 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Social Well-Being (n=19,35) | 20.40 score on a scale | Standard Deviation 5.234 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Physical Well-Being (n=274,304) | 20.69 score on a scale | Standard Deviation 5.18 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Emotional Well-Being (n=6,8) | 18.25 score on a scale | Standard Deviation 5.007 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Social Well-Being (n=274,303 | 21.43 score on a scale | Standard Deviation 5.178 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Emotional Well-Being (n=19,35) | 17.43 score on a scale | Standard Deviation 4.984 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Emotional Well-Being (n=275,302) | 17.17 score on a scale | Standard Deviation 4.748 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: FACT-L Subscale Score (n=264,214) | 22.88 score on a scale | Standard Deviation 4.911 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Functional Well-Being (n=275,302) | 16.87 score on a scale | Standard Deviation 5.614 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Functional Well-Being (n=19,35) | 18.57 score on a scale | Standard Deviation 5.5 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: FACT-L Subscale Score (n=275,300) | 24.80 score on a scale | Standard Deviation 5 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Functional Well-Being (n=6,8) | 16.50 score on a scale | Standard Deviation 5.855 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Lung Cancer Subscale Score (n=275,300) | 20.13 score on a scale | Standard Deviation 4.336 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Subscale Score (n=19,35) | 26.67 score on a scale | Standard Deviation 5.357 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-G Score (n=274,300) | 76.14 score on a scale | Standard Deviation 15.132 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Trial Outcome Index (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Trial Outcome Index (n=274,299) | 57.64 score on a scale | Standard Deviation 12.482 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Lung Cancer Subscale Score (n=19,35) | 21.21 score on a scale | Standard Deviation 4.607 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 6: Total FACT-L Score (n=274,297) | 100.95 score on a scale | Standard Deviation 18.36 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: FACT-L Subscale Score (n=6,8) | 26.48 score on a scale | Standard Deviation 6.185 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Physical Well-Being (n=144,194) | 20.78 score on a scale | Standard Deviation 5.368 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: FACT-G Score (n=19,35) | 78.59 score on a scale | Standard Deviation 16.316 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Social Well-Being (n=143,194) | 20.04 score on a scale | Standard Deviation 5.691 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | BL: Emotional Well-Being (n=397,393) | 16.77 score on a scale | Standard Deviation 4.862 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Emotional Well-Being (n=144,194) | 16.85 score on a scale | Standard Deviation 4.521 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: Trial Outcome Index (n=19,35) | 61.97 score on a scale | Standard Deviation 12.622 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Functional Well-Being (n=144,196) | 16.35 score on a scale | Standard Deviation 5.745 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Lung Cancer Subscale Score (n=6,8) | 21.40 score on a scale | Standard Deviation 5.724 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: FACT-L Subscale Score (n=144,196) | 24.19 score on a scale | Standard Deviation 5.323 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 42: FACT-L Score (n=19,35) | 105.25 score on a scale | Standard Deviation 20.385 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Lung Cancer Subscale Score (n=144,196) | 19.50 score on a scale | Standard Deviation 4.6 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-G Score (n=144,192) | 74.06 score on a scale | Standard Deviation 15.754 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Total FACT-L Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Trial Outcome Index (n=144,194) | 56.57 score on a scale | Standard Deviation 13.276 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Physical Well-Being (n=13,29) | 23.23 score on a scale | Standard Deviation 4.016 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 12: Total FACT-L Score (n=144,192) | 98.30 score on a scale | Standard Deviation 19.337 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-G Score (n=6,8) | 79.44 score on a scale | Standard Deviation 16.176 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Physical Well-Being (n=86,143) | 21.40 score on a scale | Standard Deviation 4.945 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Social Well-Being (n=13,29) | 20.24 score on a scale | Standard Deviation 5.569 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Social Well-Being (n=86,143) | 19.94 score on a scale | Standard Deviation 6.13 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Lung Cancer Subscale Score (n=264,214) | 18.16 score on a scale | Standard Deviation 4.383 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Emotional Well-Being (n=86,143) | 17.14 score on a scale | Standard Deviation 4.356 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Emotional Well-Being (n=13,29) | 17.59 score on a scale | Standard Deviation 4.903 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Functional Well-Being (n=86,143) | 16.83 score on a scale | Standard Deviation 5.553 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Trial Outcome Index (n=6,8) | 61.15 score on a scale | Standard Deviation 14.343 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: FACT-L Subscale Score (n=86,143) | 24.52 score on a scale | Standard Deviation 5.344 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Functional Well-Being (n=13,29) | 18.48 score on a scale | Standard Deviation 4.501 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Lung Cancer Subscale Score (n=86,143) | 19.64 score on a scale | Standard Deviation 4.635 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Physical Well-Being (n=265,215) | 18.50 score on a scale | Standard Deviation 5.534 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-G Score (n=86,143) | 75.31 score on a scale | Standard Deviation 16.648 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: FACT-L Subscale Score (n=12,29) | 26.80 score on a scale | Standard Deviation 5.591 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Trial Outcome Index (n=86,143) | 57.87 score on a scale | Standard Deviation 12.803 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 72: Total FACT-L Score (n=6,8) | 105.92 score on a scale | Standard Deviation 21.282 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 18: Total FACT-L Score (n=86,143) | 99.83 score on a scale | Standard Deviation 20.558 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Lung Cancer Subscale Score (n=12,29) | 21.21 score on a scale | Standard Deviation 4.967 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Physical Well-Being (n=59,101) | 21.21 score on a scale | Standard Deviation 4.898 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt:Total FACT-L Score (n=260,212) | 91.89 score on a scale | Standard Deviation 18.738 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Social Well-Being (n=59,101) | 20.49 score on a scale | Standard Deviation 5.251 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: FACT-G Score (n=12,29) | 79.53 score on a scale | Standard Deviation 14.672 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Emotional Well-Being (n=59,100) | 16.54 score on a scale | Standard Deviation 4.615 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Physical Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Functional Well-Being (n=59,100) | 17.23 score on a scale | Standard Deviation 5.3 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: Trial Outcome Index (n=12,29) | 62.92 score on a scale | Standard Deviation 11.105 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: FACT-L Subscale Score (n=59,101) | 25.13 score on a scale | Standard Deviation 5.245 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Social Well-Being (n=263,216) | 20.68 score on a scale | Standard Deviation 5.265 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Lung Cancer Subscale Score (n=59,101) | 19.94 score on a scale | Standard Deviation 4.487 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 48: FACT-L Score (n=12,29) | 106.33 score on a scale | Standard Deviation 18.701 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Social Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Trial Outcome Index (n=59,100) | 58.37 score on a scale | Standard Deviation 12.686 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Physical Well-Being (n=9,17) | 23.65 score on a scale | Standard Deviation 4.212 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-L Score (n=59,99) | 100.69 score on a scale | Standard Deviation 19.831 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt:Total FACT-G Score (n=261,214) | 68.94 score on a scale | Standard Deviation 15.669 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Physical Well-Being (n=37,66) | 21.77 score on a scale | Standard Deviation 4.576 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Social Well-Being (n=9,17) | 21.31 score on a scale | Standard Deviation 6.53 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Social Well-Being (n=37,66) | 20.74 score on a scale | Standard Deviation 5.491 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Emotional Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Emotional Well-Being (n=37,66) | 17.23 score on a scale | Standard Deviation 4.675 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Emotional Well-Being (n=9,17) | 19.12 score on a scale | Standard Deviation 3.638 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Functional Well-Being (n=37,66) | 17.93 score on a scale | Standard Deviation 5.51 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Emotional Well-Being (n=265,216) | 15.11 score on a scale | Standard Deviation 5.183 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: FACT-L Subscale Score (n=37,66) | 25.86 score on a scale | Standard Deviation 4.817 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Functional Well-Being (n=9,17) | 18.65 score on a scale | Standard Deviation 6.828 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Lung Cancer Subscale Score (n=37,66) | 20.61 score on a scale | Standard Deviation 4.393 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Functional Well-Being (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-G Score (n=37,66) | 77.66 score on a scale | Standard Deviation 15.078 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: FACT-L Subscale Score (n=9,17) | 25.99 score on a scale | Standard Deviation 6.844 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Trial Outcome Index (n=37,66) | 60.30 score on a scale | Standard Deviation 11.876 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 24: Total FACT-G Score (n=59,99) | 75.50 score on a scale | Standard Deviation 15.754 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 30: Total FACT-L Score (n=37,66) | 103.52 score on a scale | Standard Deviation 18.367 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Lung Cancer Subscale Score (n=9,17) | 20.47 score on a scale | Standard Deviation 5.959 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Physical Well-Being (n=25,47) | 22.26 score on a scale | Standard Deviation 4.48 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-G Score (n=9,17) | 82.73 score on a scale | Standard Deviation 17.803 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Social Well-Being (n=25,47) | 20.15 score on a scale | Standard Deviation 4.988 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: FACT-L Subscale Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Emotional Well-Being (n=25,47) | 17.54 score on a scale | Standard Deviation 4.54 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Trial Outcome Index (n=9,17) | 62.76 score on a scale | Standard Deviation 14.316 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Fuctional Well-Being (n=25,47) | 18.06 score on a scale | Standard Deviation 5.72 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Off Trtmt: Functional Well-Being (n=265,216) | 14.58 score on a scale | Standard Deviation 5.934 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: FACT-L Subscale Score (n=25,47) | 25.83 score on a scale | Standard Deviation 5.305 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 60: Total FACT-L Score (n=9,17) | 108.71 score on a scale | Standard Deviation 23.069 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Lung Cancer Subscale Score (n=25,47) | 20.55 score on a scale | Standard Deviation 4.463 |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 84: Lung Cancer Subscale Score (n=1,0) | NA score on a scale | — |
| Erlotinib, 150 mg/Day | Functional Assessment of Chronic Illness Therapy - Lung (FACT-L) Scores (Data Cutoff 17 May 2008) | Week 36: Total FACT-G Score (n=25,47) | 78.02 score on a scale | Standard Deviation 15.688 |
Secondary
OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | 10.2 months |
| Erlotinib, 150 mg/Day | OS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | 8.6 months |
p-value: 0.479795% CI: [0.49, 1.4]Log Rank
Secondary
OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) | 11.0 months |
| Erlotinib, 150 mg/Day | OS in EGFR IHC Positive Population (Data Cutoff 12 January 2012) | 12.8 months |
p-value: 0.00595% CI: [0.66, 0.93]Log Rank
Secondary
Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: Screening, BL (≤ 21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) | 11.0 months |
| Erlotinib, 150 mg/Day | Overall Survival (OS) in All Participants (Data Cutoff 12 January 2012) | 12.4 months |
p-value: 0.009795% CI: [0.72, 0.96]Log Rank
Secondary
Percentage of All Participants Who Died (Data Cutoff 12 January 2012)
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months).
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | 87.1 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of All Participants Who Died (Data Cutoff 12 January 2012) | 82.0 percentage of participants |
Secondary
Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008)
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) | 50.8 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of EGFR IHC Negative Participants Who Died (Data Cutoff 17 May 2008) | 41.9 percentage of participants |
Secondary
Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008)
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 71 months)
Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) | 89.8 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of EGFR IHC Negative Participants With PD or Death (Data Cutoff 17 May 2008) | 77.4 percentage of participants |
Secondary
Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012)
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 12 January 2012 (up to 71 months)
Population: FAS; only participants with EGFR IHC positive tumors were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) | 87.5 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of EGFR IHC Positive Participants Who Died (Data Cutoff 12 January 2012) | 80.5 percentage of participants |
Secondary
Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008)
BOR was defined as CR or PR confirmed by repeat assessments performed no less than 4 weeks after the criteria for response was first met. For TLs, CR was defined as the disappearance of all TLs, and PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the baseline (BL) SLD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) | 5.4 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a Best Overall Response (BOR) of Confirmed Complete Response (CR) or Partial Response (PR) According to RECIST (Data Cutoff 17 May 2008) | 11.9 percentage of participants |
p-value: 0.000695% CI: [2.7, 10.3]Chi-squared
Secondary
Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008)
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | PR to CR | 0.4 percentage of participants |
| Placebo | Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | SD to PR | 0.9 percentage of participants |
| Placebo | Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | SD to CR | 0.0 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | PR to CR | 0.5 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | SD to PR | 4.8 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a Change of PR to CR or SD to PR or CR From BL to End of Treatment According to RECIST (Data Cutoff 17 May 2008) | SD to CR | 0.2 percentage of participants |
Secondary
Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008)
For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis; and 7 and 17 participants were not assessed from the Placebo and Erlotinib, 150 mg/day groups, respectively.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | CR | 0.7 percentage of participants |
| Placebo | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | PR | 4.7 percentage of participants |
| Placebo | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | SD | 45.4 percentage of participants |
| Placebo | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | PD | 47.6 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | PD | 35.6 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | CR | 0.9 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | SD | 48.6 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a CR, PR, Stable Disease (SD), or PD According to RECIST (Data Cutoff 17 May 2008) | PR | 11.0 percentage of participants |
Secondary
Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008)
Response upgrade was defined by a change of PR to CR or of SD to PR or CR from BL to the end of treatment. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD; and PD was defined as at least a 20% increase in the SLD of TLs, taking as reference the smallest SLD recorded since the treatment started. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits; and PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) | 1.3 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With a Response Upgrade From BL According to RECIST (Data Cutoff 17 May 2008) | 5.5 percentage of participants |
p-value: 0.000795% CI: [1.6, 6.7]Chi-squared
Secondary
Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008)
Disease control was defined as a best response of CR or PR or SD or a best response of SD for more than 12 weeks, or CR or PR. For TLs, CR was defined as the disappearance of all TLs; PR was defined as at least a 30% decrease in the SLD of the TLs, taking as a reference the BL SLD; SD was defined as neither sufficient decrease in SLD to qualify for PR nor sufficient increase in SLD to qualify for PD. For NTLs, CR was defined as the disappearance of all NTLs and normalization of tumor marker levels; SD/incomplete response was defined as the persistence of 1 or more NTLs and/or maintenance of tumor marker levels above normal limits. The 95% CI for one sample binomial was determined using the Pearson-Clopper method.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with CR, PR or SD at BL as determined by the Investigator were included in the analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Placebo | Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) | CR Plus (+) PR + SD | 50.8 percentage of participants |
| Placebo | Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) | CR + PR + SD >12 Weeks | 27.4 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) | CR Plus (+) PR + SD | 60.6 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With CR, PR, or SD or With SD [Maintained For Greater Than (>) 12 Weeks] or CR or PR (Data Cutoff 17 May 2008) | CR + PR + SD >12 Weeks | 40.8 percentage of participants |
Comparison: Analysis included CR + PR + SD rate.p-value: 0.003595% CI: [3.1, 16.4]Chi-squared
Comparison: Analysis included CR + PR + SD \> 12 weeks rate.p-value: <0.000195% CI: [7.1, 19.7]Chi-squared
Secondary
Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008)
The Trial Outcome Index (TOI) was defined as the sum of the scores of the Physical Well-Being (PWB), Functional Well-Being (FWB), and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; 59 and 49 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) | 43.1 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With Deterioration Assessed Using the Trial Outcome Index (Data Cutoff 17 May 2008) | 50.9 percentage of participants |
Secondary
Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008)
Deterioration in quality of life (QoL) was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, Social/Family Well-Being (SWB) and Emotional Well-Being (EWB) of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; 62 and 51 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively,
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) | 51.7 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With Deterioration in Quality of Life Assessed Using TOI, SWB, and EWB (Data Cutoff 17 May 2008) | 55.3 percentage of participants |
Secondary
Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008)
LCS scores were obtained from a 7-item questionnaire from the Functional Assessment of Cancer Therapy - Lung (FACT-L) version (V) 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 equaled (=) not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; 56 and 48 participants were not evaluated for this outcome measure from the Placebo and Erlotinib groups, respectively.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) | 44.1 percentage of participants |
| Erlotinib, 150 mg/Day | Percentage of Participants With Symptom Progression Assessed Using the Lung Cancer Subscale (LCS) (Data Cutoff 17 May 2008) | 47.7 percentage of participants |
Secondary
PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008)
The median time, in weeks, from randomization to PFS event. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | 9.0 weeks |
| Erlotinib, 150 mg/Day | PFS in EGFR IHC Negative Participants (Data Cutoff 17 May 2008) | 11.0 weeks |
p-value: 0.176895% CI: [0.51, 1.14]Log Rank
Secondary
Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008)
PFS was defined as the time from randomization to PD or death, whichever occurred first. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD or death were censored at the date of last tumor assessment where non-progression was documented. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 6 months
Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 11.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive and Free of Disease Progression at 6 Months (Data Cutoff 17 May 2008) | 22.0 percentage of participants |
Secondary
Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 1 year
Population: FAS; only participants with EGFR IHC negative tumors were included in the analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) | 20.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants in the EGFR IHC Negative Population Remaining Alive at 1 Year (Data Cutoff 17 May 2008) | 42.0 percentage of participants |
Secondary
Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 1 year
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 47.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants in the EGFR IHC Positive Population Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 52.0 percentage of participants |
Secondary
Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012)
OS was defined as the median time, in months, from the date of randomization to the date of death, due to any cause. Patients who have not died at the time of the final analysis will be censored at the date the patient was last known to be alive. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 1 year
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 45.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants Remaining Alive at 1 Year (Data Cutoff 12 January 2012) | 50.0 percentage of participants |
Secondary
Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008)
TTP was defined as the time from the date of randomization to the first date PD was recorded. For TLs, PD was defined at least a 20% increase in the SLD, taking as reference the smallest SLD recorded since treatment started or the appearance of one or more new lesions. For NTLs, PD was defined as the appearance of 1 or more new lesions and/or unequivocal progression of existing NTLs. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 6 months
Population: FAS; participants with PD prior to randomization were excluded from analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) | 15.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants Remaining Progression-Free in the TTP Analysis at 6 Months (Data Cutoff 17 May 2008) | 26.0 percentage of participants |
Secondary
Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008)
Deterioration in QoL was defined as a clinically meaningful decline in the total FACT-L score, the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 6 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) | 34.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants Remaining Without Deterioration in QoL at 6 Months (Data Cutoff 17 May 2008) | 32.0 percentage of participants |
Secondary
Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008)
TOI was defined as the sum of the scores of the PWB, FWB, and LCS. PWB, FWB, and LCS scores were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 6 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) | 41.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants Remaining Without Deterioration in TOI at 6 Months (Data Cutoff 17 May 2008) | 39.0 percentage of participants |
Secondary
Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008)
LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was estimated using Kaplan-Meier methodology.
Time frame: 6 months
Population: FAS
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Placebo | Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) | 35.0 percentage of participants |
| Erlotinib, 150 mg/Day | Probable Percentage of Participants Remaining Without Symptom Progression at 6 Months (Data Cutoff 17 May 2008) | 41.0 percentage of participants |
Secondary
Time to Deterioration in QoL (Data Cutoff 17 May 2008)
The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in total FACT-L or death, whichever occurred first. Total FACT-L score was defined as the sum of the TOI, SWB and EWB of the FACT-L questionnaires. TOI (PWB + FWB + LCS), SWB and EWB scores were obtained from 7-item (6-item in the case of EWB) questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in FACT-L score was defined as at least a 6 point decline from BL. Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Deterioration in QoL (Data Cutoff 17 May 2008) | 12.3 weeks |
| Erlotinib, 150 mg/Day | Time to Deterioration in QoL (Data Cutoff 17 May 2008) | 12.6 weeks |
p-value: 0.65395% CI: [0.79, 1.16]Log Rank
Secondary
Time to Deterioration in TOI (Data Cutoff 17 May 2008)
The median time, in weeks, from the date of randomization until a clinically meaningful decline from BL in TOI or death, whichever occurred first. TOI was defined as the sum of PWB, FWB, and LCS scores, which were obtained from 7-item questionnaires from the FACT-L V 4. Participants responded to questions assessing symptoms on a scale from 0-4, where 0 = not at all and 4 = very much. Higher score indicated more severe symptoms. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from BL Participants without a clinically meaningful decline in TOI at the time of analysis were censored at the time of the last FACT-L assessment. The 95% CI was determined using Kaplan-Meier methodology.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Deterioration in TOI (Data Cutoff 17 May 2008) | 18.9 weeks |
| Erlotinib, 150 mg/Day | Time to Deterioration in TOI (Data Cutoff 17 May 2008) | 18.1 weeks |
p-value: 0.538595% CI: [0.87, 1.31]Log Rank
Secondary
Time to Progression (Data Cutoff 17 May 2008)
The median time, in weeks, between randomization and TTP event. Participants without PD were censored at the date of last tumor assessment where non-progression was documented. If a participant received a second anti-cancer therapy without prior documentation of PD, the participant was censored at the date of last tumor assessment before starting new chemotherapy.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS; participants with PD prior to randomization were excluded from analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Progression (Data Cutoff 17 May 2008) | 11.3 weeks |
| Erlotinib, 150 mg/Day | Time to Progression (Data Cutoff 17 May 2008) | 12.3 weeks |
p-value: <0.000195% CI: [0.61, 0.82]Log Rank
Secondary
Time to Symptom Progression (Data Cutoff 17 May 2008)
The median time, in weeks, from the date of randomization to the date of documented clinically meaningful decline in LCS from BL or death, whichever occurred first. LCS scores were obtained from a 7-item questionnaire from the FACT-L V 4. Participants responded to questions assessing symptoms commonly reported by lung cancer patients; such as shortness of breath, loss of weight, and tightness in chest; on a scale from 0-4, where 0 = not at all and 4 = very much. The participants' responses were summed to result in an overall score, where a higher score indicated more severe symptoms. A change of 2 to 3 points in score was determined to be a clinically meaningful decline. The 95% CI was determined using Kaplan-Meier methodology.
Time frame: Screening, BL (≤21 days after randomization), every 6 weeks thereafter until Week 48, every 12 weeks thereafter until PD, discontinuation of study treatment, or end of survival follow-up, up to data cutoff of 17 May 2008 (up to 27 months)
Population: FAS
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Placebo | Time to Symptom Progression (Data Cutoff 17 May 2008) | 17.6 weeks |
| Erlotinib, 150 mg/Day | Time to Symptom Progression (Data Cutoff 17 May 2008) | 18.3 weeks |
p-value: 0.378795% CI: [0.74, 1.12]Log Rank