LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
NCT ID: NCT02231164
Last Updated: 2025-02-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
12 participants
INTERVENTIONAL
2014-10-14
2015-12-24
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Docetaxel and placebo
patients to receive backbone chemotherapy and placebo
docetaxel
intravenous chemotherapy drug
placebo
oral placebo
Docetaxel and Nintedanib
patients to receive backbone chemotherapy and nintedanib
docetaxel
intravenous chemotherapy drug
nintedanib
oral experimental therapy
Interventions
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docetaxel
intravenous chemotherapy drug
docetaxel
intravenous chemotherapy drug
placebo
oral placebo
nintedanib
oral experimental therapy
Eligibility Criteria
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Inclusion Criteria
* Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.
Exclusion Criteria
* Patients known to be positive for activating Epidermal Growth Factor Receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation
* Previous therapy with other vascular endothelial growth factor (VEGF) or VEGFR inhibitors (other than bevacizumab) or docetaxel for the treatment of NSCLC at any time
* Prior monotherapy with an EGFR inhibitor except as maintenance therapy
18 Years
ALL
No
Sponsors
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Boehringer Ingelheim
INDUSTRY
Responsible Party
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Principal Investigators
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Boehringer Ingelheim
Role: STUDY_CHAIR
Boehringer Ingelheim
Locations
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1199.128.10032 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
1199.128.10041 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
1199.128.10010 Boehringer Ingelheim Investigational Site
Highland, California, United States
1199.128.10044 Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States
1199.128.10080 Boehringer Ingelheim Investigational Site
Paducah, Kentucky, United States
1199.128.10016 Boehringer Ingelheim Investigational Site
Farmington, New Mexico, United States
1199.128.10013 Boehringer Ingelheim Investigational Site
Minot, North Dakota, United States
1199.128.10077 Boehringer Ingelheim Investigational Site
Blacksburg, Virginia, United States
1199.128.10011 Boehringer Ingelheim Investigational Site
Kennewick, Washington, United States
1199.128.64006 Boehringer Ingelheim Investigational Site
Batumi, , Georgia
1199.128.64001 Boehringer Ingelheim Investigational Site
Tbilisi, , Georgia
1199.128.64002 Boehringer Ingelheim Investigational Site
Tbilisi, , Georgia
1199.128.66004 Boehringer Ingelheim Investigational Site
Bangkok, , Thailand
Countries
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Related Links
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Related Info
Other Identifiers
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1199.128
Identifier Type: -
Identifier Source: org_study_id
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