LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
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| ClinicalTrials.gov Identifier: NCT02231164 |
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Recruitment Status :
Terminated
First Posted : September 4, 2014
Results First Posted : February 13, 2017
Last Update Posted : March 21, 2017
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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| Study Type | Interventional |
|---|---|
| Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment |
| Condition |
Carcinoma, Non-Small-Cell Lung |
| Interventions |
Drug: docetaxel Drug: placebo Drug: nintedanib |
| Enrollment | 12 |
Participant Flow
| Recruitment Details | |
| Pre-assignment Details |
| Arm/Group Title | Placebo | Nintedanib |
|---|---|---|
 Arm/Group Description |
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. |
| Period Title: Overall Study | ||
| Started | 6 | 6 |
| Completed | 0 | 0 |
| Not Completed | 6 | 6 |
| Reason Not Completed | ||
| Adverse Event | 1 | 1 |
| Lack of Efficacy | 4 | 3 |
| Withdrawal by Subject | 1 | 2 |
Baseline Characteristics
| Arm/Group Title | Placebo | Nintedanib | Total | |
|---|---|---|---|---|
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Arm/Group Description |
Placebo soft gelatin capsule matching that of nintedanib twice daily on Day 2 to 21 of each 21-day treatment course administered orally plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of placebo could be reduced to 150 mg twice daily (b.i.d.) or 100 mg b.i.d and one dose reduction was permitted for docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | Nintedanib 200 mg twice daily (b.i.d.) on Day 2 to 21 of each 21-day treatment course administered orally in the form of a soft gelatin capsule plus docetaxel 75 mg/m^2 on Day 1 of each 21-day treatment course administered via intravenous infusion. If required the dose of nintedanib, could be reduced to 150 mg b.i.d. or 100 mg b.i.d. and one dose reduction was permitted for Docetaxel (according to the protocol-defined dose-reduction scheme). No dose increase was allowed after a dose reduction. | Total of all reporting groups | |
| Overall Number of Baseline Participants | 6 | 6 | 12 | |
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Baseline Analysis Population Description |
Randomised Set: The randomised set included all randomised patients.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| 59.7 (12.2) | 63.3 (8.3) | 61.5 (10.1) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 6 participants | 6 participants | 12 participants | |
| Female |
1 16.7%
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2 33.3%
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3 25.0%
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| Male |
5 83.3%
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4 66.7%
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9 75.0%
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Outcome Measures
Adverse Events
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.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Results Point of Contact
| Name/Title: | Boehringer Ingelheim Call Center |
| Organization: | Boehringer Ingelheim |
| Phone: | 1-800-243-0127 |
| EMail: | clintriage.rdg@boehringer-ingelheim.com |
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT02231164 |
| Other Study ID Numbers: |
1199.128 |
| First Submitted: | September 2, 2014 |
| First Posted: | September 4, 2014 |
| Results First Submitted: | December 20, 2016 |
| Results First Posted: | February 13, 2017 |
| Last Update Posted: | March 21, 2017 |