Non-small Cell Lung Cancer
Conditions
Keywords
Adjuvant Non-small Cell Lung Cancer, Tarceva, Early-stage Lung Cancer, Adjuvant, RADIANT, NSCLC, EGFR-positive tumor, Stage IB Non-small Cell Lung Cancer, Stage II Non-small Cell Lung Cancer, Stage IIIA Non-small Cell Lung Cancer
Brief summary
This is a study to evaluate the effectiveness of erlotinib compared with a placebo sugar pill following complete surgical removal of the tumor with or without chemotherapy after surgery in Stage IB-IIIA NSCLC patients.
Detailed description
After the initiation of the study, the sponsor became aware of an error in the drug dispensing module of the interactive voice response such that most patients who were randomized prior to 07 November 2007 were dispensed the incorrect study drug at least once. Since the integrity of the data from these patients was seriously compromised, these patients were considered unevaluable for the protocol-specified analyses. These participants are referred to as the breached protocol cohort (BPC) and those still on study treatment at the time of the breach were offered the option of receiving open-label erlotinib for up to 2 years (including posttreatment and long-term follow-up assessments), not receiving open-label erlotinib but remaining in the study for posttreatment and long-term follow-up assessment, or withdrawing consent from treatment and further assessments. Participants who had discontinued study treatment prior to the breach were not offered open-label erlotinib and remained in long-term follow-up. Data from the BPC participants were analyzed separately and were not included in the assessments of primary or secondary endpoints in the randomized cohort and were not considered part of the primary analyses.The sample size for the randomized cohort was not changed due to the BPC and the data from RC and BPC were analyzed separately.
Interventions
DRUGErlotinib
150 mg tablet
DRUGPlacebo
Placebo tablet
Sponsors
OSI Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Primary tissue from patient's surgery must be epidermal growth factor receptor (EGFR)-positive by certain tests * Patients may have up to 4 cycles of chemotherapy after surgery * Complete removal of the tumor by surgery * Able to start drug under the following timelines: * 6 months from the day of surgery for patients who get chemotherapy * 3 months from the day of surgery for those who do not get chemotherapy * Confirmed diagnosis of Stage IB-IIIA NSCLC * Patients must be accessible for follow-up visits
Exclusion criteria
* History of prior radiotherapy for NSCLC either before or after surgery * History of heart disease or uncontrolled heart arrhythmias within the previous year * History of poorly controlled gastrointestinal (GI) disorders that could affect the absorption of study drug * History of other cancer except certain skin or cervical cancers, patients who have had other cancer are eligible if they have remained disease free for at least 5 years * Patients who have received chemotherapy for NSCLC before surgery * Tumors with mixed histology of NSCLC and Small Cell Lung Cancer (SCLC). Patients with carcinoid tumors are not eligible.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease Free Survival (DFS) | Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months). | DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival (OS) | Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months). | Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. |
| Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months). | Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected. |
| Overall Survival in Participants With EGFR Mutation - Positive Tumors | Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months) | Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected. |
| Number of Participants With Adverse Events (AEs) | From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date. | An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List. A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug. |
Countries
Argentina, Australia, Austria, Belgium, Canada, Czechia, France, Germany, Greece, Hungary, Italy, Poland, Romania, Russia, South Korea, Spain, Taiwan, United Kingdom, United States
Participant flow
Recruitment details
Patients with stage IB to IIIA epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC) were enrolled globally. 1252 patients were enrolled however 2 patients did not have adequate Health Insurance Portability and Accountability Act (HIPAA) documentation and were removed from the database.
Pre-assignment details
Participants randomized prior to 7 November 2007 comprise the Breached-Protocol Cohort (BPC); those who had not discontinued were offered open-label erlotinib for up to 2 years. Participants randomized subsequently are referred to as the Randomized Cohort.
Participants by arm
| Arm | Count |
|---|---|
| RC: Erlotinib Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity. | 623 |
| RC: Placebo Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity. | 350 |
| BPC-NOLC: Erlotinib/Placebo The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib. | 134 |
| BPC-NOLC: Placebo Only The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib. | 11 |
| BPC-OLC: Erlotinib The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period. | 132 |
| Total | 1,250 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 191 | 22 | 59 | 0 | 34 |
| Overall Study | Death | 7 | 0 | 3 | 1 | 0 |
| Overall Study | Medical/ethical/noncompliance reason | 21 | 9 | 10 | 2 | 5 |
| Overall Study | Patient request | 35 | 18 | 43 | 6 | 7 |
| Overall Study | Relapse of NSCLC | 116 | 104 | 19 | 2 | 26 |
Baseline characteristics
| Characteristic | Total | RC: Erlotinib | RC: Placebo | BPC-NOLC: Erlotinib/Placebo | BPC-NOLC: Placebo Only | BPC-OLC: Erlotinib |
|---|---|---|---|---|---|---|
| Adjuvant Chemotherapy No | 599 participants | 308 participants | 150 participants | 71 participants | 6 participants | 64 participants |
| Adjuvant Chemotherapy Yes | 651 participants | 315 participants | 200 participants | 63 participants | 5 participants | 68 participants |
| Age, Continuous Breached Protocol Cohort, No Open label | 64.3 years STANDARD_DEVIATION 9.13 | NA years | NA years | 64.4 years STANDARD_DEVIATION 9.33 | 62.7 years STANDARD_DEVIATION 6.23 | NA years |
| Age, Continuous Breached Protocol Cohort, Open label | 61.8 years STANDARD_DEVIATION 9.35 | NA years | NA years | NA years | NA years | 61.8 years STANDARD_DEVIATION 9.35 |
| Age, Continuous Randomized Cohort | 61.9 years STANDARD_DEVIATION 9.3 | 62.0 years STANDARD_DEVIATION 9.28 | 61.8 years STANDARD_DEVIATION 9.34 | NA years | NA years | NA years |
| Cigarette Smoking History Current smoker | 133 participants | 71 participants | 40 participants | 12 participants | 1 participants | 9 participants |
| Cigarette Smoking History Former smoker | 879 participants | 423 participants | 240 participants | 103 participants | 9 participants | 104 participants |
| Cigarette Smoking History Never smoked or ≤ 100 cigarettes in lifetime | 238 participants | 129 participants | 70 participants | 19 participants | 1 participants | 19 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 0 | 753 participants | 385 participants | 211 participants | 75 participants | 5 participants | 77 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 1 | 479 participants | 230 participants | 134 participants | 55 participants | 6 participants | 54 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Grade 2 | 15 participants | 6 participants | 5 participants | 3 participants | 0 participants | 1 participants |
| Eastern Cooperative Oncology Group (ECOG) Performance Status Not measured | 3 participants | 2 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| EGFR Gene Amplification Negative | 338 participants | 167 participants | 87 participants | 49 participants | 3 participants | 32 participants |
| EGFR Gene Amplification Positive | 892 participants | 445 participants | 255 participants | 84 participants | 8 participants | 100 participants |
| EGFR Gene Amplification Undetermined | 20 participants | 11 participants | 8 participants | 1 participants | 0 participants | 0 participants |
| Epidermal Growth Factor Receptor (EGFR) Mutation Status Activating mutation not positive | 68 participants | 30 participants | 27 participants | 5 participants | 0 participants | 6 participants |
| Epidermal Growth Factor Receptor (EGFR) Mutation Status Activating mutation-positive | 187 participants | 102 participants | 59 participants | 10 participants | 0 participants | 16 participants |
| Epidermal Growth Factor Receptor (EGFR) Mutation Status Not Available | 11 participants | 4 participants | 3 participants | 2 participants | 0 participants | 2 participants |
| Epidermal Growth Factor Receptor (EGFR) Mutation Status Undetermined | 47 participants | 29 participants | 16 participants | 1 participants | 0 participants | 1 participants |
| Epidermal Growth Factor Receptor (EGFR) Mutation Status Wild-type | 937 participants | 458 participants | 245 participants | 116 participants | 11 participants | 107 participants |
| Extent of Disease at Diagnosis Stage IA | 4 participants | 1 participants | 2 participants | 1 participants | 0 participants | 0 participants |
| Extent of Disease at Diagnosis Stage IB | 644 participants | 329 participants | 167 participants | 64 participants | 4 participants | 80 participants |
| Extent of Disease at Diagnosis Stage IIA | 86 participants | 42 participants | 24 participants | 10 participants | 1 participants | 9 participants |
| Extent of Disease at Diagnosis Stage IIB | 317 participants | 155 participants | 99 participants | 36 participants | 4 participants | 23 participants |
| Extent of Disease at Diagnosis Stage IIIA | 190 participants | 93 participants | 58 participants | 21 participants | 1 participants | 17 participants |
| Extent of Disease at Diagnosis Stage IIIB | 7 participants | 2 participants | 0 participants | 2 participants | 0 participants | 3 participants |
| Extent of Disease at Diagnosis Stage IV | 2 participants | 1 participants | 0 participants | 0 participants | 1 participants | 0 participants |
| Histology Adenocarcinoma | 730 participants | 367 participants | 211 participants | 73 participants | 3 participants | 76 participants |
| Histology Mixed NSCLC | 53 participants | 29 participants | 18 participants | 5 participants | 0 participants | 1 participants |
| Histology Other | 15 participants | 9 participants | 2 participants | 2 participants | 0 participants | 2 participants |
| Histology Squamous cell carcinoma | 412 participants | 196 participants | 111 participants | 48 participants | 8 participants | 49 participants |
| Histology Undifferentiated large cell | 40 participants | 22 participants | 8 participants | 6 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 2 participants | 1 participants | 0 participants | 1 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized Asian | 200 participants | 107 participants | 60 participants | 15 participants | 1 participants | 17 participants |
| Race/Ethnicity, Customized Black | 33 participants | 14 participants | 11 participants | 4 participants | 0 participants | 4 participants |
| Race/Ethnicity, Customized Hispanic or Latino | 87 participants | 40 participants | 28 participants | 11 participants | 0 participants | 8 participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 1163 participants | 583 participants | 322 participants | 123 participants | 11 participants | 124 participants |
| Race/Ethnicity, Customized Other | 1 participants | 1 participants | 0 participants | 0 participants | 0 participants | 0 participants |
| Race/Ethnicity, Customized White | 1014 participants | 500 participants | 279 participants | 114 participants | 10 participants | 111 participants |
| Sex: Female, Male Female | 504 Participants | 257 Participants | 141 Participants | 47 Participants | 2 Participants | 57 Participants |
| Sex: Female, Male Male | 746 Participants | 366 Participants | 209 Participants | 87 Participants | 9 Participants | 75 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 590 / 611 | 288 / 343 | 125 / 134 | 4 / 11 | 130 / 132 |
| serious Total, serious adverse events | 118 / 611 | 79 / 343 | 21 / 134 | 1 / 11 | 41 / 132 |
Outcome results
Primary
Disease Free Survival (DFS)
DFS is the time from the date of randomization until the first day non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Population: Randomized cohort full analysis set (all randomized participants).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Disease Free Survival (DFS) | 50.5 months |
| Placebo | Disease Free Survival (DFS) | 48.2 months |
Comparison: The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level. The primary analysis of DFS was performed when at least 410 events had accrued. If the result of the primary analysis of DFS was statistically significant favoring the erlotinib treatment arm, the null hypothesis of no treatment difference of key secondary efficacy variables was tested under a hierarchical testing procedure.p-value: 0.323595% CI: [0.741, 1.104]Log Rank
Primary
Disease Free Survival (DFS)
DFS is the time from the date of randomization until the first day that non-small cell lung cancer (NSCLC) relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cutoff date of 11 June 2014 (maximum time on follow-up was 78 months).
Population: Randomized cohort full analysis set (all randomized participants).
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Disease Free Survival (DFS) | 55.0 months |
| Placebo | Disease Free Survival (DFS) | 56.2 months |
Comparison: The null hypothesis that DFS distributions of the 2 arms were equivalent was tested using an unstratified 2-sided log-rank test at the 0.05 level.p-value: 0.56295% CI: [0.78, 1.144]Log Rank
Secondary
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Population: Randomized cohort full analysis set participants who are EGFR mutation positive
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 47.8 months |
| Placebo | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 28.5 months |
Secondary
Disease-free Survival in Participants With EGFR Mutation - Positive Tumors
Disease-free survival (DFS) is the time from the date of randomization until the first day NSCLC relapse is documented by radiological exam and/or biopsy, or until death in the absence of relapse. After randomization, NSCLC relapse was based on radiological evidence or biopsy, as determined by the investigator. Participants without a DFS event were censored on the last adequate radiological assessment date. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Population: Randomized cohort full analysis set participants who are EGFR mutation positive
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 46.4 months |
| Placebo | Disease-free Survival in Participants With EGFR Mutation - Positive Tumors | 28.5 months |
Secondary
Number of Participants With Adverse Events (AEs)
An AE was defined as any untoward medical occurrence in a study participant and did not necessarily have a causal relationship with study treatment. An AE was considered serious if it resulted in death, a life-threatening situation, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect in the offspring of a participant, other important medical events, or is on the Astellas Always Serious List. A drug-related AE was any AE with at least a possible relationship to study treatment as assessed by the investigator. Severity was graded by the investigator according to the National Cancer Institute Common Terminology Criteria for Adverse Events, v3.0, where Grade 1=Mild AE; Grade=2 Moderate AE; Grade 3=Severe AE; Grade 4=Life-threatening or disabling; Grade 5=Death related to AE. AEs leading to death include deaths that occurred more than 30 days after the last dose of study drug.
Time frame: From the date of first dose of study drug until 30 days after the last dose. The median time on treatment was 11.9 months for erlotinib and 21.9 months for placebo. Data are based off the 11 June 2014 data cut-off date.
Population: Randomized Cohort, safety analysis set: all randomized participants who received at least one dose of study drug. One participant in the Randomized Cohort assigned to the erlotinib arm received placebo instead due to a dispensing error and is included in the placebo group for safety analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Erlotinib | Number of Participants With Adverse Events (AEs) | Any adverse event (AE) | 599 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | Grade 3 or higher adverse event | 279 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | Serious adverse event (SAE) | 118 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | AE leading to discontinuation of study drug | 205 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | AE leading to death | 14 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | AE leading to dose reduction | 150 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | AE leading to dose interruption | 114 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | AE leading to dose interruption and reduction | 156 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | Drug-related AE | 572 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | Drug-related serious AE | 15 participants |
| Erlotinib | Number of Participants With Adverse Events (AEs) | Drug-related AE leading to discontinuation | 163 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Drug-related serious AE | 5 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Any adverse event (AE) | 307 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | AE leading to dose reduction | 9 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Grade 3 or higher adverse event | 96 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Drug-related AE | 181 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Serious adverse event (SAE) | 79 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | Drug-related AE leading to discontinuation | 8 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | AE leading to discontinuation of study drug | 29 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | AE leading to dose interruption | 23 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | AE leading to dose interruption and reduction | 5 participants |
| Placebo | Number of Participants With Adverse Events (AEs) | AE leading to death | 5 participants |
Secondary
Overall Survival in Participants With EGFR Mutation - Positive Tumors
Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months)
Population: Randomized cohort full analysis participants who were EGFR mutation positive
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival in Participants With EGFR Mutation - Positive Tumors | NA months |
| Placebo | Overall Survival in Participants With EGFR Mutation - Positive Tumors | NA months |
Secondary
Overall Survival in Participants With EGFR Mutation - Positive Tumors
Overall survival is defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive. Activating EGFR mutation-positive is defined as exon 19 deletion or exon 21 L858R (or both) detected.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months)
Population: Randomized cohort full analysis participants who were EGFR mutation positive
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival in Participants With EGFR Mutation - Positive Tumors | NA months |
| Placebo | Overall Survival in Participants With EGFR Mutation - Positive Tumors | NA months |
Secondary
Overall Survival (OS)
Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 11 June 2014 (maximum time on follow-up was 78 months).
Population: Randomized cohort full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival (OS) | NA months |
| Placebo | Overall Survival (OS) | NA months |
Secondary
Overall Survival (OS)
Overall survival was defined as the time from the date of randomization until the documented date of death. Participants who were still alive were censored on the last day they were known to be alive.
Time frame: Every 3 months during active phase and every 6 months during long term follow-up up to 5 years and yearly thereafter until the data cut-off date of 08 April 2013 (maximum time on follow-up was 64 months).
Population: Randomized cohort full analysis set
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Erlotinib | Overall Survival (OS) | NA months |
| Placebo | Overall Survival (OS) | NA months |