Trial · NCT01523587
LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
NCT01523587, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-11-21
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy. Trials, record NCT01523587. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01523587
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LUX-Lung 8: A Phase III Trial of Afatinib (BIBW 2992) Versus Erlotinib for the Treatment of Squamous Cell Lung Cancer After at Least One Prior Platinum Based Chemotherapy
- NCT number
- NCT01523587
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 795 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- afatinib, erlotinib
- First posted
- 2012-02-01
- Last updated
- 2019-02-15
- Other registries' IDs
- eudract:2011-002380-24
- Results first posted
- 2014-11-21
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | Progression Free Survival (PFS) was defined as the time from randomization to disease progression (or death if the patient died before progression) by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. RECIST is a set of published rules that define when tumors in cancer patients improve ("respond"), stay the same ("stabilize") or worsen ("progress") during treatment. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Overall Survival | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | Overall Survival is defined as the time from randomisation to death. It was a key secondary endpoint. |
| Secondary | Number of Participants With Objective Response According to RECIST 1.1 | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | A patient with a best overall response of Complete Responder (CR) or Partial Responder (PR) was considered to show objective response to study medication. For patients with an objective response, time to objective response was defined as the time from randomization to the first objective response; duration of objective response was defined as the time from the first objective response to progression (or death if the patient died before progression). Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Number of Participants With Disease Control According to RECIST 1.1 | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | Disease control was assessed based on Independent Radiologic Review (IRR) and investigator assessment. A patient with a best overall response of CR, PR, or Stable Disease (SD) was considered to have disease control. Patients with no baseline target lesions who had no evidence of disease progression in their non-target lesions and had no new lesions were considered to have disease control. Per RECIST v1.1 for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. |
| Secondary | Tumour Shrinkage | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | Maximum percentage decrease from baseline in the sum of target lesion diameters following independent review. The change in the size (i.e. the sum of diameters (SOD)) of target lesions from baseline was derived. Tumour shrinkage for each patient was measured (based on Independent Radiologic Review (IRR)) as the minimum SOD of target lesions after randomisation. A negative percentage indicates decrease from baseline; positive numbers indicate an increase of tumour size. The mean maximum decrease from baseline of +5 and +9.4 reflect an average increase in tumour size. Post-baseline mean is adjusted for baseline sum of diameters and race. |
| Secondary | Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the european organization for research and treatment of cancer (eortc) quality of life questionnaire (QLQ-C30) questionnaire and its lung cancer specific supplementary module EORTC QLQ-LC13 and the EQ-5D health status self-assessment questionnaire. The questionnaires were assessed at the first visit of each treatment course, at end of treatment (EOT) and follow up prior to clinical assessment. The results displayed show number of patients with improvement in the relevant criteria. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: The number of patients that were improved: Change in cough; dyspnoea and pain scores over time. |
| Secondary | Summary of Time to Deterioration in Coughing, Dyspnoea and Pain. | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | Health-related quality of life (HRQoL) was measured with the following multi-dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of: Time to deterioration. |
| Secondary | Change in Score Over Time in Coughing,Dyspnoea and Pain | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | Health related quality of life (HRQoL) was measured with the following multi dimensional questionnaires: the EORTC QLQ-C30. The questionnaires were assessed at the first visit of each treatment course. For each of the summary scales and items measuring cough, dyspnoea and pain, the two treatment arms were compared in terms of change in score over time, adjusted for baseline score and race. Questionnaires have items relating to Cough, Dyspnoea and Pain. Overall Scores are transformed to a standardised scale of 0 to 100 with the larger value indicating a worse outcome. A change of (+/-) 10 points is considered to be relevant. The change in cough, dyspnea and pain will be assessed using a mixed effects growth curve model with the average profile over time for each endpoint described by a piecewise linear model (presented as post baseline in data table). Post-baseline mean is adjusted for baseline and race. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | Randomized Set (RS): All patients who were randomized, regardless of whether they received investigational treatment. | Months | MEDIAN |
| SECONDARY | Overall Survival | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | RS | Months | MEDIAN |
| SECONDARY | Number of Participants With Objective Response According to RECIST 1.1 | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | RS | Participants | NUMBER |
| SECONDARY | Number of Participants With Disease Control According to RECIST 1.1 | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | RS | Participants | NUMBER |
| SECONDARY | Tumour Shrinkage | First treatment administration up until cut off date of 02 March 2015 (up to 1058 days). | Patients from the randomised set with tumour assessments are considered for the analysis of this endpoint. | Millimeter (mm) | LEAST_SQUARES_MEAN |
| SECONDARY | Number of Participants With Status Change in Cough, Dyspnoea and Pain Related Items Over Time in Health Related Quality of Life Questionnaire | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | RS | Participants | NUMBER |
| SECONDARY | Summary of Time to Deterioration in Coughing, Dyspnoea and Pain. | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | RS | Months | MEDIAN |
| SECONDARY | Change in Score Over Time in Coughing,Dyspnoea and Pain | From first drug administration from 9 April 2012 until study closure on 27 Dec 2017 (approximately 2089 days). | RS | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group30
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 | Afatinib | 2.63 | 95% Confidence Interval 2.00 to 2.86 | Months | |
| Progression-free Survival, Based on Central Independent Review as Determined by Response Evaluation Criteria in Solid Tumours 1.1 | Erlotinib | 1.94 | 95% Confidence Interval 1.87 to 2.10 | Months | |
| Overall Survival | Afatinib | 7.82 | 95% Confidence Interval 7.19 to 8.71 | Months | |
| Overall Survival | Erlotinib | 6.77 | 95% Confidence Interval 5.85 to 7.79 | Months | |
| Number of Participants With Objective Response According to RECIST 1.1 | Afatinib | 22 | Participants | ||
| Number of Participants With Objective Response According to RECIST 1.1 | Erlotinib | 11 | Participants | ||
| Number of Participants With Disease Control According to RECIST 1.1 | Afatinib | 201 | Participants | ||
| Number of Participants With Disease Control According to RECIST 1.1 | Erlotinib | 157 | Participants | ||
| Tumour Shrinkage | Afatinib | 78.8 | Standard Error 1.26 | Millimeter (mm) | |
| Tumour Shrinkage | Erlotinib | 80.0 | Standard Error 1.24 | Millimeter (mm) |
1 to 10 of 30Source ClinicalTrials.gov
See all 30 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Afatinib | 398 | |
| Overall Study | STARTED | Erlotinib | 397 | |
| Overall Study | Treated | Afatinib | 392 | |
| Overall Study | Treated | Erlotinib | 395 | |
| Overall Study | COMPLETED | Afatinib | 0 | |
| Overall Study | COMPLETED | Erlotinib | 0 | |
| Overall Study | NOT COMPLETED | Afatinib | 398 | |
| Overall Study | NOT COMPLETED | Erlotinib | 397 |
Source ClinicalTrials.gov
Adverse events486
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 | 31 | 392 | |
| other | Anaemia | Blood and lymphatic system disorders | Erlotinib | 41 | 395 | |
| other | Constipation | Gastrointestinal disorders | Afatinib | 43 | 392 | |
| other | Constipation | Gastrointestinal disorders | Erlotinib | 42 | 395 | |
| other | Diarrhoea | Gastrointestinal disorders | Afatinib | 284 | 392 | |
| other | Diarrhoea | Gastrointestinal disorders | Erlotinib | 158 | 395 | |
| other | Nausea | Gastrointestinal disorders | Afatinib | 81 | 392 | |
| other | Nausea | Gastrointestinal disorders | Erlotinib | 62 | 395 | |
| other | Stomatitis | Gastrointestinal disorders | Afatinib | 54 | 392 | |
| other | Stomatitis | Gastrointestinal disorders | Erlotinib | 21 | 395 |
1 to 10 of 486Source ClinicalTrials.gov
See all 486 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afatinib | 77 | 392 |
| Total, all-cause mortality | Erlotinib | 71 | 395 |
| Total, other adverse events | Afatinib | 383 | 392 |
| Total, other adverse events | Erlotinib | 371 | 395 |
| Total, serious adverse events | Afatinib | 174 | 392 |
| Total, serious adverse events | Erlotinib | 175 | 395 |
Source ClinicalTrials.gov
Papers4
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Afatinib vs Erlotinib: Number of Participants With Disease Control According to RECIST 1.1 | Trial comparisons |
| Afatinib vs Erlotinib: Number of Participants With Objective Response According to RECIST 1.1 | Trial comparisons |
| Afatinib vs Erlotinib: deaths from any cause | Trial comparisons |
| Afatinib vs Erlotinib: serious adverse events | 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/NCT01523587
GET https://conductscience.org/api/trials/v1/NCT01523587/results?page=2