Trial · NCT00949650
BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
NCT00949650, Phase 3, Completed, Boehringer Ingelheim; results first posted 2013-11-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation. Trials, record NCT00949650. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00949650
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIBW 2992 (Afatinib) Versus Chemotherapy as First Line Treatment in NSCLC With EGFR Mutation
- NCT number
- NCT00949650
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 345 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Non-Small-Cell Lung, Adenocarcinoma
- Interventions
- Pemetrexed, BIBW 2992, Cisplatin
- First posted
- 2009-07-30
- Last updated
- 2018-04-06
- Other registries' IDs
- eudract:2008-005615-18
- Results first posted
- 2013-11-19
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-Free Survival (PFS) Time | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | PFS was defined as time from randomisation to disease progression or death whichever occured first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours (RECIST 1.1). Median time results from unstratified Kaplan-Meier estimates. |
| Secondary | Percentage of Patients With Objective Response (OR) | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | OR was defined as Complete Response (CR) or Partial Response (PR). Assessed by central independent review according to RECIST 1.1. |
| Secondary | Percentage of Participants With Disease Control (DC) | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | DC was defined as a patient with OR or Stable Disease (SD). Assessed by central independent review according to the RECIST 1.1. |
| Secondary | Overall Survival (OS) Time | From randomisation to cut-off date (17MAR2017). | OS was defined as time from randomisation to death. |
| Secondary | Tumour Shrinkage | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | Tumour shrinkage was calculated as the minimum Sum of Diameters (SoD) of target lesions from all post-baseline tumour assessments, as read by the central independent review. The mean of these minimum values were presented after adjusting for baseline SoD, EGFR mutation group and race. |
| Secondary | Change From Baseline in Body Weight | Baseline and throughout the trial until progression (every 3 weeks), up to 28 months. | Because the PFS was longer for patients in the Afatinib arm than for patients in the chemotherapy arm, the period of data collection for ECOG status and body weight continued for a longer time in the Afatinib arm. |
| Secondary | Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Throughout the trial until progression (every 3 weeks), up to 28 months. | ECOG PS measured on 6 point scale to assess participant's performance status. 0=Fully active, able to carry on all pre-disease activities without restriction. 1. Restricted in physically strenuous activity, but ambulatory and able to carry out light or sedentary work. 2. Ambulatory (\>50 percent of waking hours), capable of all self-care, unable to carry out any work activities. 3. Capable of only limited self-care, confined to bed or chair more than 50 percent of waking hours. 4. Completely disabled, cannot carry on any self-care, totally confined to bed or chair. 5. Dead. |
| Secondary | Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing | Throughout the trial until progression (every 3 weeks). | HRQOL was measured by European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire C30 (QLQ-C30) and its lung cancer specific module LC13 (QLQ-LC13). Analysis for cough is based on QLQ-LC13 question 1. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates. |
| Secondary | HRQOL: Time to Deterioration in Dyspnoea | Throughout the trial until progression (every 3 weeks). | HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for dyspnoea is based on composite of QLQ-LC13 questions 3-5. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates. |
| Secondary | HRQOL: Time to Deterioration in Pain | Throughout the trial until progression (every 3 weeks). | HRQOL was measured by EORTC QLQ-C30 and its lung cancer specific module QLQ-LC13. Analysis for pain is based on composite of QLQ-C30 questions 9 and 19. Time to deterioration was defined as the time from randomisation to a score increased (worsened) by at least 10 points from baseline (0-100 point scale). Patients were considered deteriorated at time of death. Median time results from unstratified Kaplan-Meier estimates. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes13
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-Free Survival (PFS) Time | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | Randomised set (RS) | Months. | MEDIAN |
| SECONDARY | Percentage of Patients With Objective Response (OR) | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | RS. | Percentage of patients with OR. | NUMBER |
| SECONDARY | Percentage of Participants With Disease Control (DC) | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | RS. | Percentage of participants with DC. | NUMBER |
| SECONDARY | Overall Survival (OS) Time | From randomisation to cut-off date (17MAR2017). | RS. | Months. | MEDIAN |
| SECONDARY | Tumour Shrinkage | Tumour assessments were performed at Screening, Week 6, Week 12, Week 18 and then every 12-18 weeks until disease progression | RS. There were only 203 patients in the Afatinib 40 mg arm and 101 patients in the Pemetrexed/Cisplatin Chemotherapy with tumour measurements. | mm. | MEAN |
| SECONDARY | Change From Baseline in Body Weight | Baseline and throughout the trial until progression (every 3 weeks), up to 28 months. | RS. Only patients with baseline and at least one post-baseline assessment were included. | Kg. | MEAN |
| SECONDARY | Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) | Throughout the trial until progression (every 3 weeks), up to 28 months. | RS. Only patients with baseline and at least one post-baseline assessment were included. | Participants | NUMBER |
| SECONDARY | Health Related Quality of Life (HRQOL): Time to Deterioration in Coughing | Throughout the trial until progression (every 3 weeks). | RS. | Months. | MEDIAN |
| SECONDARY | HRQOL: Time to Deterioration in Dyspnoea | Throughout the trial until progression (every 3 weeks). | RS. | Months. | MEDIAN |
| SECONDARY | HRQOL: Time to Deterioration in Pain | Throughout the trial until progression (every 3 weeks). | RS. | Months. | MEDIAN |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 outcomesResults by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-Free Survival (PFS) Time | Afatinib 40 mg | 11.17 | 95% Confidence Interval 9.63 to 13.70 | Months. | |
| Progression-Free Survival (PFS) Time | Pemetrexed/Cisplatin Chemotherapy | 6.90 | 95% Confidence Interval 5.39 to 8.25 | Months. | |
| Percentage of Patients With Objective Response (OR) | Afatinib 40 mg | 56.5 | 95% Confidence Interval 49.8 to 63.0 | Percentage of patients with OR. | |
| Percentage of Patients With Objective Response (OR) | Pemetrexed/Cisplatin Chemotherapy | 22.6 | 95% Confidence Interval 15.3 to 31.3 | Percentage of patients with OR. | |
| Percentage of Participants With Disease Control (DC) | Afatinib 40 mg | 90.4 | 95% Confidence Interval 85.9 to 93.9 | Percentage of participants with DC. | |
| Percentage of Participants With Disease Control (DC) | Pemetrexed/Cisplatin Chemotherapy | 80.9 | 95% Confidence Interval 72.5 to 87.6 | Percentage of participants with DC. | |
| Overall Survival (OS) Time | Afatinib 40 mg | 28.16 | 95% Confidence Interval 24.64 to 33.58 | Months. | |
| Overall Survival (OS) Time | Pemetrexed/Cisplatin Chemotherapy | 28.22 | 95% Confidence Interval 20.73 to 33.22 | Months. | |
| Tumour Shrinkage | Afatinib 40 mg | 33.19 | Standard Error 1.12 | mm. | |
| Tumour Shrinkage | Pemetrexed/Cisplatin Chemotherapy | 43.00 | Standard Error 1.59 | mm. |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Afatinib 40 mg | 230 | |
| Overall Study | STARTED | Pemetrexed/Cisplatin Chemotherapy | 115 | |
| Overall Study | COMPLETED | Afatinib 40 mg | 0 | |
| Overall Study | COMPLETED | Pemetrexed/Cisplatin Chemotherapy | 0 | |
| Overall Study | NOT COMPLETED | Afatinib 40 mg | 230 | |
| Overall Study | NOT COMPLETED | Pemetrexed/Cisplatin Chemotherapy | 115 |
Source ClinicalTrials.gov
Adverse events324
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Afatinib 40 mg | 19 | 229 | |
| other | Anaemia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin Chemotherapy | 29 | 111 | |
| other | Leukopenia | Blood and lymphatic system disorders | Afatinib 40 mg | 6 | 229 | |
| other | Leukopenia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin Chemotherapy | 21 | 111 | |
| other | Neutropenia | Blood and lymphatic system disorders | Afatinib 40 mg | 4 | 229 | |
| other | Neutropenia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin Chemotherapy | 35 | 111 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Afatinib 40 mg | 1 | 229 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Pemetrexed/Cisplatin Chemotherapy | 8 | 111 | |
| other | Dry eye | Eye disorders | Afatinib 40 mg | 14 | 229 | |
| other | Dry eye | Eye disorders | Pemetrexed/Cisplatin Chemotherapy | 0 | 111 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afatinib 40 mg | ||
| Total, all-cause mortality | Pemetrexed/Cisplatin Chemotherapy | ||
| Total, other adverse events | Afatinib 40 mg | 229 | 229 |
| Total, other adverse events | Pemetrexed/Cisplatin Chemotherapy | 108 | 111 |
| Total, serious adverse events | Afatinib 40 mg | 72 | 229 |
| Total, serious adverse events | Pemetrexed/Cisplatin Chemotherapy | 25 | 111 |
Source ClinicalTrials.gov
Papers9
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Afatinib 40 mg vs Pemetrexed/Cisplatin Chemotherapy: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00949650
GET https://conductscience.org/api/trials/v1/NCT00949650/results?page=2