LUME-Lung 1: BIBF 1120 Plus Docetaxel as Compared to Placebo Plus Docetaxel in 2nd Line Non Small Cell Lung Cancer
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ClinicalTrials.gov Identifier: NCT00805194 |
Recruitment Status :
Completed
First Posted : December 9, 2008
Results First Posted : December 1, 2014
Last Update Posted : December 5, 2018
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment |
Condition |
Carcinoma, Non-Small-Cell Lung |
Interventions |
Drug: placebo plus docetaxel Drug: BIBF 1120 plus docetaxel |
Enrollment | 1314 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Nintedanib Plus Docetaxel | Placebo Plus Docetaxel |
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Arm/Group Description | Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h). | Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h). |
Period Title: Overall Study | ||
Started | 655 [1] | 659 [1] |
Completed | 6 | 5 |
Not Completed | 649 | 654 |
Reason Not Completed | ||
Progressive disease (modified RECIST) | 404 | 435 |
Worsening or AE of underlying disease | 64 | 70 |
Other AE | 84 | 73 |
Protocol Violation | 9 | 9 |
Lost to Follow-up | 5 | 5 |
Withdrawal by Subject | 60 | 42 |
Not treated | 3 | 4 |
Reasons other than stated above | 20 | 16 |
[1]
randomised patients
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Baseline Characteristics
Arm/Group Title | Nintedanib Plus Docetaxel | Placebo Plus Docetaxel | Total | |
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Arm/Group Description | Nintedanib 200 mg twice daily administered orally in the form of a soft gelatin capsule plus docetaxel 75 milligram (mg)/square meter (m2) once every 3 weeks administered via intravenous infusion over 1 hour (h). | Placebo soft gelatin capsule matching that of nintedanib 2 times daily plus docetaxel 75 mg/m2 once every 3 weeks administered via intravenous infusion over 1 hour (h). | Total of all reporting groups | |
Overall Number of Baseline Participants | 655 | 659 | 1314 | |
Baseline Analysis Population Description |
Randomised Set (RS)- Includes all randomised patients, whether patients had received study treatment or not
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 655 participants | 659 participants | 1314 participants | |
59.7 (9.7) | 59.8 (9.0) | 59.7 (9.3) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 655 participants | 659 participants | 1314 participants | |
Female |
179 27.3%
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180 27.3%
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359 27.3%
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Male |
476 72.7%
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479 72.7%
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955 72.7%
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Tumour histology
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 655 participants | 659 participants | 1314 participants | |
Adenocarcinoma |
322 49.2%
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336 51.0%
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658 50.1%
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Squamous cell carcinoma |
276 42.1%
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279 42.3%
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555 42.2%
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Other |
57 8.7%
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44 6.7%
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101 7.7%
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Number of patients with adenocarcinoma and time since first line therapy in categories
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 322 participants | 336 participants | 658 participants | |
<9 month |
206 64.0%
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199 59.2%
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405 61.6%
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>=9 month |
112 34.8%
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134 39.9%
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246 37.4%
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Missing |
4 1.2%
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3 0.9%
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7 1.1%
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[1]
Measure Analysis Population Description: Randomised patients with adenocarcinoma and time since first line therapy.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
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 Pharmaceuticals |
Phone: | 1-800-243-0127 |
EMail: | clintriage.rdg@boehringer-ingelheim.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Boehringer Ingelheim |
ClinicalTrials.gov Identifier: | NCT00805194 |
Other Study ID Numbers: |
1199.13 2007-004803-36 ( EudraCT Number ) |
First Submitted: | December 8, 2008 |
First Posted: | December 9, 2008 |
Results First Submitted: | November 14, 2014 |
Results First Posted: | December 1, 2014 |
Last Update Posted: | December 5, 2018 |