Trial · NCT01466660
LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
NCT01466660, Phase 2, Completed, Boehringer Ingelheim; results first posted 2017-06-19
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung. Trials, record NCT01466660. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01466660
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LUX-Lung 7: A Phase IIb Trial of Afatinib(BIBW2992) Versus Gefitinib for the Treatment of 1st Line EGFR Mutation Positive Adenocarcinoma of the Lung
- NCT number
- NCT01466660
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 319 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Lung Neoplasms
- Interventions
- Afatinib, gefitinib
- First posted
- 2011-11-08
- Last updated
- 2020-04-07
- Other registries' IDs
- eudract:2011-001814-33
- Results first posted
- 2017-06-19
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression-free Survival | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days. | Progression-free survival (PFS) defined as the time from date of randomisation to date of disease progression, or date of death if a patient died earlier. Participants with no event (Disease progression (PD) or death) were censored. PD was primarily evaluated for the primary analysis by an independent central imaging review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): PD, At least a 20% increase in the sum of the longest diameter (SoD) of target lesions taking as reference the smallest SoD of target lesions recorded since the treatment started, together with an absolute increase in the SoD of target lesions of at least 5 millimetre (mm) or the appearance of one or more new lesions. For the final analysis (analysis cut-off date 12 April 2019) status and date of PD were determined by investigator assessment. |
| Primary | Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016) | From first drug administration until last drug administration, up to 1482 days | Time to Treatment Failure (TTF) which was the time from the date of randomisation to the date of i.e. permanent treatment discontinuation for any reason. |
| Primary | Overall Survival | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days. | Overall survival (OS) which was defined as the time from the date of randomisation to the date of death. Participants for whom there is no evidence of death at the time of the analysis will be censored at the date that they were last known to be alive. |
| Secondary | Objective Response Rate | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days. | Objective response rate (ORR) which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions from baseline. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment. |
| Secondary | Time to Objective Response | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days. | Number of participants with objective response (best overall response of complete response or partial response) to study treatment over time, cumulative number of participants is displayed. Time to objective response was defined as the time from randomisation to the first recorded objective response. For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment. |
| Secondary | Duration of Objective Response | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days. | Duration of objective response defined as the time of first objective response (best overall response of complete response or partial response) to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) objective response was determined by investigator assessment. |
| Secondary | Disease Control | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days. | Percentage of participants with disease control which was defined as the number of participants with best overall response of complete response (CR) or partial response (PR) or stable disease (SD) as assessed by central independent review according to Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1. divided by the total number of participants who received treatment. Per RECIST version 1.1. for target lesions and assessed by Computed Tomography (CT)-scan or Magnetic Resonance Imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions from baseline; Stable Disease (SD), Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD. Responses of SD were only considered if they occur ≥42 days from date of randomisation. For the final analysis (analysis cut-off date 12 April 2019) disease control was determined by investigator assessment. |
| Secondary | Duration of Disease Control | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days. | Duration of disease control defined as the time from randomisation to the time of progression or death, whichever occurred first (or date of censoring for progression free survival). For the final analysis (analysis cut-off date 12 April 2019) the status and date of disease progression were determined by investigator assessment. |
| Secondary | Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016) | From first drug administration until last drug administration, up to 1482 days | Tumour shrinkage assessed by minimum sum of post-baseline target lesion diameters recorded after randomisation. A positive value shows a decrease in tumour size. |
| Secondary | Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015) | Every 8 weeks, up to 56 weeks | Health-related quality of life (HRQoL) measured using European Quality of life - 5 Dimensions (EQ-5D) score for United Kingdom (UK) and Belgium and European European Quality Visual Analogue Scale (EQ-VAS). EQ-5D utility scores range from 0 (worst health) to 1 (full health). EQ-VAS scores range from 0 (worst imaginable health state) to 100 (best imaginable health state). Results display the mean score up to 56 weeks. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Progression-free Survival | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days. | Randomised set which included all patients randomised to receive treatment, whether treated or not. | Months | MEDIAN |
| PRIMARY | Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016) | From first drug administration until last drug administration, up to 1482 days | Randomised set which included all patients randomised to receive treatment, whether treated or not. | Months | MEDIAN |
| PRIMARY | Overall Survival | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on death, up to 2465 days. | Randomised set which included all patients randomised to receive treatment, whether treated or not. | Months | MEDIAN |
| SECONDARY | Objective Response Rate | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days. | Randomised set which included all patients randomised to receive treatment, whether treated or not. | Percentage of participants | NUMBER |
| SECONDARY | Time to Objective Response | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days. | All participants in the randomised set with objective response. | Participants | NUMBER |
| SECONDARY | Duration of Objective Response | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression, further anti-cancer treatment and death, up to 2465 days. | Participants in the randomised set with objective response. | Months | MEDIAN |
| SECONDARY | Disease Control | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days. | Randomised set which included all patients randomised to receive treatment, whether treated or not. | Percentage of participants | NUMBER |
| SECONDARY | Duration of Disease Control | From first drug administration until 28 days after last drug administration + Follow-Up period for collecting information on disease progression or death, up to 2465 days. | All participants in the randomised set with disease control, that is, with best overall response of complete response or partial response or stable disease. | Months | MEDIAN |
| SECONDARY | Tumour Shrinkage (Main Overall Survival Analysis Cut-off Date, 08 April 2016) | From first drug administration until last drug administration, up to 1482 days | Participants in the randomised set with tumour assessments. | millimetre (mm) | LEAST_SQUARES_MEAN |
| SECONDARY | Health-related Quality of Life (Primary Analysis Cut-off Date, 21 August 2015) | Every 8 weeks, up to 56 weeks | All randomised subjects with health-related quality of life data. | Units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results 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 | Afatinib | 12.78 | 95% Confidence Interval 10.91 to 14.72 | Months | |
| Progression-free Survival | Gefitinib | 11.17 | 95% Confidence Interval 9.49 to 12.81 | Months | |
| Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016) | Afatinib | 13.67 | 95% Confidence Interval 11.89 to 14.95 | Months | |
| Time to Treatment Failure (TTF) (Main Overall Survival Analysis Cut-off Date, 08 April 2016) | Gefitinib | 11.53 | 95% Confidence Interval 10.09 to 13.11 | Months | |
| Overall Survival | Afatinib | 27.86 | 95% Confidence Interval 25.13 to 32.85 | Months | |
| Overall Survival | Gefitinib | 24.54 | 95% Confidence Interval 20.57 to 28.88 | Months | |
| Objective Response Rate | Afatinib | 79.4 | 95% Confidence Interval 72.3 to 85.4 | Percentage of participants | |
| Objective Response Rate | Gefitinib | 74.8 | 95% Confidence Interval 67.4 to 81.4 | Percentage of participants | |
| Time to Objective Response | Afatinib | Week 4 | 81 | Participants | |
| Time to Objective Response | Gefitinib | Week 4 | 74 | Participants |
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 | 160 | |
| Overall Study | STARTED | Gefitinib | 159 | |
| Overall Study | COMPLETED | Afatinib | 0 | |
| Overall Study | COMPLETED | Gefitinib | 0 | |
| Overall Study | NOT COMPLETED | Afatinib | 160 | |
| Overall Study | NOT COMPLETED | Gefitinib | 159 |
Source ClinicalTrials.gov
Adverse events430
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 | 14 | 160 | |
| other | Anaemia | Blood and lymphatic system disorders | Gefitinib | 5 | 159 | |
| other | Dry eye | Eye disorders | Afatinib | 15 | 160 | |
| other | Dry eye | Eye disorders | Gefitinib | 13 | 159 | |
| other | Abdominal pain | Gastrointestinal disorders | Afatinib | 14 | 160 | |
| other | Abdominal pain | Gastrointestinal disorders | Gefitinib | 11 | 159 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Afatinib | 17 | 160 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Gefitinib | 17 | 159 | |
| other | Constipation | Gastrointestinal disorders | Afatinib | 29 | 160 | |
| other | Constipation | Gastrointestinal disorders | Gefitinib | 24 | 159 |
1 to 10 of 430Source ClinicalTrials.gov
See all 430 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Afatinib | 126 | 160 |
| Total, all-cause mortality | Gefitinib | 132 | 159 |
| Total, other adverse events | Afatinib | 157 | 160 |
| Total, other adverse events | Gefitinib | 159 | 159 |
| Total, serious adverse events | Afatinib | 75 | 160 |
| Total, serious adverse events | Gefitinib | 64 | 159 |
Source ClinicalTrials.gov
Papers3
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Afatinib vs Gefitinib: deaths from any cause | Trial comparisons |
| Afatinib vs Gefitinib: 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/NCT01466660
GET https://conductscience.org/api/trials/v1/NCT01466660/results?page=2