Trial · NCT00656136
BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
NCT00656136, Phase 3, Completed, Boehringer Ingelheim; results first posted 2013-11-27
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1). Trials, record NCT00656136. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00656136
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- BIBW 2992 and BSC Versus Placebo and BSC in Non-small Cell Lung Cancer Patients Failing Erlotinib or Gefitinib (LUX-LUNG 1)
- NCT number
- NCT00656136
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 585 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- placebo, BIBW 2992
- First posted
- 2008-04-10
- Last updated
- 2016-07-26
- Other registries' IDs
- eudract:2007-005983-28
- Results first posted
- 2013-11-27
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival | From randomization until death or the last patient out date, an average of 12 months | Overall survival was the duration from the date of randomization to the date of death. Patients who were alive were censored at the last contact date prior to the database lock. For the primary analysis 11 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Primary analysis data cut-off date was 08 July 2010. For the final analysis 13 patients were lost to follow-up and were censored at the last contact date when they were known to be still alive. Final analysis data cut-off date was 04 October 2013. |
| Secondary | Progression-free Survival (PFS) | From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months | PFS is defined as time from randomisation to disease progression or death whichever occurs first. Assessed by central independent review according to the Response Evaluation Criteria in Solid Tumours version 1.0 (RECIST 1.0). |
| Secondary | Objective Response Rate (OR) | From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months | OR is defined as complete response (CR) and partial response (PR). Assessed by central independent review according to RECIST 1.0. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival | From randomization until death or the last patient out date, an average of 12 months | Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication. | Months | MEDIAN |
| SECONDARY | Progression-free Survival (PFS) | From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months | Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication. | Months | MEDIAN |
| SECONDARY | Objective Response Rate (OR) | From randomization to disease progression, death or the data cutoff on 07 July 2010, an average of 3.3 months | Randomized set was all patients who were randomized and for this study all of these patients received at least one dose of study medication. | Percentage of patients with OR | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival | Placebo Plus Best Supportive Care (BSC) | Primary analysis (358 deaths) | 11.96 | 95% Confidence Interval 10.15 to 14.26 | Months |
| Overall Survival | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | Primary analysis (358 deaths) | 10.78 | 95% Confidence Interval 9.95 to 11.99 | Months |
| Overall Survival | Placebo Plus Best Supportive Care (BSC) | Final analysis (526 deaths) | 11.73 | 95% Confidence Interval 10.05 to 14.06 | Months |
| Overall Survival | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | Final analysis (526 deaths) | 10.87 | 95% Confidence Interval 9.95 to 12.25 | Months |
| Progression-free Survival (PFS) | Placebo Plus Best Supportive Care (BSC) | 1.08 | 95% Confidence Interval 0.95 to 1.68 | Months | |
| Progression-free Survival (PFS) | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | 3.29 | 95% Confidence Interval 2.79 to 4.40 | Months | |
| Objective Response Rate (OR) | Placebo Plus Best Supportive Care (BSC) | 0.5 | 95% Confidence Interval 0.0 to 2.8 | Percentage of patients with OR | |
| Objective Response Rate (OR) | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | 7.4 | 95% Confidence Interval 5.0 to 10.5 | Percentage of patients with OR |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo Plus Best Supportive Care (BSC) | 195 | |
| Overall Study | STARTED | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | 390 | |
| Overall Study | COMPLETED | Placebo Plus Best Supportive Care (BSC) | 0 | |
| Overall Study | COMPLETED | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | 0 | |
| Overall Study | NOT COMPLETED | Placebo Plus Best Supportive Care (BSC) | 195 | |
| Overall Study | NOT COMPLETED | Afatinib 50 mg/Day Plus Best Supportive Care (BSC) | 390 |
Source ClinicalTrials.gov
Adverse events382
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 | Placebo | 3 | 195 | |
| other | Anaemia | Blood and lymphatic system disorders | Afatinib 50 mg/Day | 23 | 390 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Placebo | 8 | 195 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Afatinib 50 mg/Day | 25 | 390 | |
| other | Constipation | Gastrointestinal disorders | Placebo | 24 | 195 | |
| other | Constipation | Gastrointestinal disorders | Afatinib 50 mg/Day | 43 | 390 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 18 | 195 | |
| other | Diarrhoea | Gastrointestinal disorders | Afatinib 50 mg/Day | 334 | 390 | |
| other | Mouth ulceration | Gastrointestinal disorders | Placebo | 0 | 195 | |
| other | Mouth ulceration | Gastrointestinal disorders | Afatinib 50 mg/Day | 51 | 390 |
1 to 10 of 382Source ClinicalTrials.gov
See all 382 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | ||
| Total, all-cause mortality | Afatinib 50 mg/Day | ||
| Total, other adverse events | Placebo | 167 | 195 |
| Total, other adverse events | Afatinib 50 mg/Day | 383 | 390 |
| Total, serious adverse events | Placebo | 36 | 195 |
| Total, serious adverse events | Afatinib 50 mg/Day | 136 | 390 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22452896 | DERIVED |
Source PubMed
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 50 mg/Day vs Placebo: 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/NCT00656136
GET https://conductscience.org/api/trials/v1/NCT00656136/events?page=2