Trial · NCT00805194
LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
NCT00805194, Phase 3, Completed, Boehringer Ingelheim; results first posted 2014-12-01
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer. Trials, record NCT00805194. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00805194
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
- NCT number
- NCT00805194
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 1,314 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- placebo plus docetaxel, BIBF 1120 plus docetaxel
- First posted
- 2008-12-09
- Last updated
- 2018-12-05
- Other registries' IDs
- eudract:2007-004803-36
- Results first posted
- 2014-12-01
Source ClinicalTrials.gov
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Progression Free Survival (PFS) as Assessed by Central Independent Review | From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed) | Progression Free Survival (PFS) as assessed by central independent review according to the modified Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) . Progression free survival (PFS) is defined as the duration of time from date of randomisation to date of progression or death (whatever occurs earlier). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. |
| Secondary | Overall Survival (Key Secondary Endpoint) | From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients ) | Overall Survival (OS) defined as the duration from randomisation to death (irrespective of the reason of death). Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. A fixed-sequence-testing was implemented for key secondary endpoint if both the primary and the follow-up analysis showed a treatment benefit (P\<0.05) of nintedanib over placebo. In this case, the OS would be tested using hierarchical testing of statistical hypotheses in (1) patients with adenocarcinoma and \<9 months since start of first-line therapy, (2) patients with adenocarcinoma, and (3) all patients. Each hypothesis could be only tested at the pre-specified alpha level if the previous null hypothesis in the testing sequence had been. |
| Secondary | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review | From randomisation until cut-off date 15 February 2013 | Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by central independent review according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. |
| Secondary | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator | From randomisation until cut-off date 15 February 2013 | Follow-up analysis was conducted at the time of overall survival analysis. Progression Free Survival (PFS) as assessed by investigator according to the modified RECIST (version 1.0) criteria. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. |
| Secondary | Objective Tumour Response | From randomisation until cut-off date 15 February 2013 | Confirmed objective response is defined as confirmed Complete Response (CR) and Partial Response (PR) and evaluated according to the modified RECIST criteria version 1.0. As per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. This endpoint was analysed based on the central independent reviewer as well as the investigator. |
| Secondary | Duration of Confirmed Objective Tumour Response | From randomisation until cut-off date 15 February 2013 | The duration of objective response is the time from first documented (CR) or (PR) to the time of progression or death and evaluated according to the modified RECIST criteria version 1.0. As per RECIST v1.0, Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. |
| Secondary | Time to Confirmed Objective Tumour Response | From randomisation until cut-off date 15 February 2013 | Time to confirmed objective response is defined as time from randomisation to the date of first documented (CR) or (PR) and evaluated according to the modified RECIST criteria version 1.0. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. |
| Secondary | Disease Control | From randomisation until cut-off date 15 February 2013 | Disease control was defined as a best overall response of Complete Response (CR), Partial Response (PR), or Stable Disease (SD) and evaluated according to the modified RECIST criteria version 1.0. As per RECIST v1.0 for target lesions : Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; progression, as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. This endpoint was analysed based on the central independent reviewer as well as the investigator. |
| Secondary | Duration of Disease Control | From randomisation until cut-off date 15 February 2013 | The duration of disease control was defined as the time from randomisation to the date of disease progression or death (which ever occurs first) for patients with disease control. Median, 25th and 75th percentiles are calculated from an unadjusted Kaplan-Meier curve. This endpoint was analysed based on the central independent reviewer as well as the investigator. |
| Secondary | Change From Baseline in Tumour Size | From randomisation until cut-off date 15 February 2013 | Percentage change from baseline in tumour size is defined as decrease in the sum of the longest diameter of the target lesion. Presented means are in fact adjusted best means percentage changes generated from ANOVA model adjusted for baseline ECOG PS (0 vs. 1), tumour histology (squamous vs non-squamous), brain metastases at baseline (yes vs no) and prior treatment with bevacizumab (yes vs no) This endpoint was analysed based on the central independent reviewer as well as the investigator. |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 registered outcomesOutcomes14
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) as Assessed by Central Independent Review | From randomisation until cut-off date 2 November 2010 (when 713 PFS events were observed) | Randomised Set | months | MEDIAN |
| SECONDARY | Overall Survival (Key Secondary Endpoint) | From randomisation until cut-off date 15 February 2013 (approximately 48 months or 1151 deaths among all patients ) | Randomised Set | months | MEDIAN |
| SECONDARY | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review | From randomisation until cut-off date 15 February 2013 | Randomised Set | months | MEDIAN |
| SECONDARY | Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Investigator | From randomisation until cut-off date 15 February 2013 | Randomised Set | months | MEDIAN |
| SECONDARY | Objective Tumour Response | From randomisation until cut-off date 15 February 2013 | Randomised Set | % of participants | NUMBER |
| SECONDARY | Duration of Confirmed Objective Tumour Response | From randomisation until cut-off date 15 February 2013 | Randomised Set | months | MEDIAN |
| SECONDARY | Time to Confirmed Objective Tumour Response | From randomisation until cut-off date 15 February 2013 | Randomised Set | months | MEDIAN |
| SECONDARY | Disease Control | From randomisation until cut-off date 15 February 2013 | Randomised Set | % of participants | NUMBER |
| SECONDARY | Duration of Disease Control | From randomisation until cut-off date 15 February 2013 | Randomised Set | months | MEDIAN |
| SECONDARY | Change From Baseline in Tumour Size | From randomisation until cut-off date 15 February 2013 | Randomised Set | percentage of change in tumor size in mm | MEAN |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 outcomesResults by group60
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) as Assessed by Central Independent Review | Nintedanib Plus Docetaxel | 3.4 | Inter-Quartile Range 1.5 to 5.7 | months | |
| Progression Free Survival (PFS) as Assessed by Central Independent Review | Placebo Plus Docetaxel | 2.7 | Inter-Quartile Range 1.4 to 4.6 | months | |
| Overall Survival (Key Secondary Endpoint) | Nintedanib Plus Docetaxel | Adenocarcinoma and <9 months | 10.9 | Inter-Quartile Range 5.1 to 21.9 | months |
| Overall Survival (Key Secondary Endpoint) | Placebo Plus Docetaxel | Adenocarcinoma and <9 months | 7.9 | Inter-Quartile Range 4.5 to 14.5 | months |
| Overall Survival (Key Secondary Endpoint) | Nintedanib Plus Docetaxel | Adenocarcinoma | 12.6 | Inter-Quartile Range 5.5 to 24.2 | months |
| Overall Survival (Key Secondary Endpoint) | Placebo Plus Docetaxel | Adenocarcinoma | 10.3 | Inter-Quartile Range 5.5 to 19.9 | months |
| Overall Survival (Key Secondary Endpoint) | Nintedanib Plus Docetaxel | All patients | 10.1 | Inter-Quartile Range 5.0 to 19.4 | months |
| Overall Survival (Key Secondary Endpoint) | Placebo Plus Docetaxel | All patients | 9.1 | Inter-Quartile Range 4.8 to 17.2 | months |
| Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review | Nintedanib Plus Docetaxel | 3.5 | Inter-Quartile Range 1.5 to 5.7 | months | |
| Follow-up Analysis of Progression Free Survival (PFS) as Assessed by Central Independent Review | Placebo Plus Docetaxel | 2.7 | Inter-Quartile Range 1.4 to 5.5 | months |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Nintedanib Plus Docetaxel | 655 | |
| Overall Study | STARTED | Placebo Plus Docetaxel | 659 | |
| Overall Study | COMPLETED | Nintedanib Plus Docetaxel | 6 | |
| Overall Study | COMPLETED | Placebo Plus Docetaxel | 5 | |
| Overall Study | NOT COMPLETED | Nintedanib Plus Docetaxel | 649 | |
| Overall Study | NOT COMPLETED | Placebo Plus Docetaxel | 654 |
Source ClinicalTrials.gov
Adverse events528
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 | Nintedanib Plus Docetaxel | 33 | 652 | |
| other | Anaemia | Blood and lymphatic system disorders | Placebo Plus Docetaxel | 43 | 655 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nintedanib Plus Docetaxel | 69 | 652 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo Plus Docetaxel | 73 | 655 | |
| other | Abdominal pain | Gastrointestinal disorders | Nintedanib Plus Docetaxel | 35 | 652 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo Plus Docetaxel | 37 | 655 | |
| other | Constipation | Gastrointestinal disorders | Nintedanib Plus Docetaxel | 35 | 652 | |
| other | Constipation | Gastrointestinal disorders | Placebo Plus Docetaxel | 76 | 655 | |
| other | Diarrhoea | Gastrointestinal disorders | Nintedanib Plus Docetaxel | 260 | 652 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Plus Docetaxel | 130 | 655 |
1 to 10 of 528Source ClinicalTrials.gov
See all 528 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nintedanib Plus Docetaxel | 107 | 652 |
| Total, all-cause mortality | Placebo Plus Docetaxel | 77 | 655 |
| Total, other adverse events | Nintedanib Plus Docetaxel | 569 | 652 |
| Total, other adverse events | Placebo Plus Docetaxel | 547 | 655 |
| Total, serious adverse events | Nintedanib Plus Docetaxel | 224 | 652 |
| Total, serious adverse events | Placebo Plus Docetaxel | 206 | 655 |
Source ClinicalTrials.gov
Papers2
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 |
|---|---|
| Nintedanib Plus Docetaxel vs Placebo Plus Docetaxel: deaths from any cause | Trial comparisons |
| Nintedanib Plus Docetaxel vs Placebo Plus Docetaxel: 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/NCT00805194
GET https://conductscience.org/api/trials/v1/NCT00805194/results?page=2