Trial · NCT02231164
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
NCT02231164, Phase 3, Terminated, Boehringer Ingelheim; results first posted 2017-02-13
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research. Trials, record NCT02231164. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02231164
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
- NCT number
- NCT02231164
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 12 participants, actual
- Lead sponsor
- Boehringer Ingelheim
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Interventions
- docetaxel, docetaxel, placebo, nintedanib
- First posted
- 2014-09-04
- Last updated
- 2025-02-13
- Results first posted
- 2017-02-13
- Limitations and caveats
The sponsor cancelled this trial prematurely. Thus, enrollment for 1199.128 was significantly less than what was planned (800 planned vs. 12 entered). Therefore, the objectives of this study could not be fully assessed.
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Up to 6 months. | This outcome measure presents the number of patients with disease control according to RECIST, version 1.1, defined as number of patients with Complete response, partial response or stable disease. |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Up to 6 months. | Randomised Set: The randomised set included all randomised patients. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Placebo | Yes | 66.7 | Percentage of participants | |
| Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Nintedanib | Yes | 50.0 | Percentage of participants | |
| Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Placebo | No | 33.3 | Percentage of participants | |
| Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 | Nintedanib | No | 50.0 | Percentage of participants |
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 | 6 | |
| Overall Study | STARTED | Nintedanib | 6 | |
| Overall Study | COMPLETED | Placebo | 0 | |
| Overall Study | COMPLETED | Nintedanib | 0 | |
| Overall Study | NOT COMPLETED | Placebo | 6 | |
| Overall Study | NOT COMPLETED | Nintedanib | 6 |
Source ClinicalTrials.gov
Adverse events186
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 | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Nintedanib | 0 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Placebo | 2 | 6 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nintedanib | 1 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Placebo | 2 | 6 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nintedanib | 3 | 6 | |
| other | Lacrimation increased | Eye disorders | Placebo | 1 | 6 | |
| other | Lacrimation increased | Eye disorders | Nintedanib | 1 | 6 | |
| other | Visual impairment | Eye disorders | Placebo | 0 | 6 | |
| other | Visual impairment | Eye disorders | Nintedanib | 2 | 6 |
1 to 10 of 186Source ClinicalTrials.gov
See all 186 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 | Nintedanib | ||
| Total, other adverse events | Placebo | 5 | 6 |
| Total, other adverse events | Nintedanib | 6 | 6 |
| Total, serious adverse events | Placebo | 3 | 6 |
| Total, serious adverse events | Nintedanib | 3 | 6 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Nintedanib 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/NCT02231164
GET https://conductscience.org/api/trials/v1/NCT02231164/events?page=2