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LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02231164
Recruitment Status : Terminated
First Posted : September 4, 2014
Results First Posted : February 13, 2017
Last Update Posted : March 21, 2017
Sponsor:
Information provided by (Responsible Party):
Boehringer Ingelheim

Study Description
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Brief Summary:
The present trial will investigate the efficacy and safety of nintedanib in combination with docetaxel as compared to placebo in combination with docetaxel in patients with stage IIIB/IV or recurrent NSCLC of adenocarcinoma histology after failure of first-line platinum-based chemotherapy.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: docetaxel Drug: placebo Drug: nintedanib Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Multicentre, Randomised, Double-blind, Phase III Trial to Investigate the Efficacy and Safety of Oral Nintedanib Plus Docetaxel Therapy Compared to Placebo Plus Docetaxel Therapy in Patients With Stage IIIB/IV or Recurrent, Adenocarcinoma Subtype Non-small Cell Lung Cancer After Failure of First Line Chemotherapy
Study Start Date : October 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Docetaxel and placebo
patients to receive backbone chemotherapy and placebo
 Drug: docetaxel
intravenous chemotherapy drug

Drug: placebo
oral placebo
Experimental: Docetaxel and Nintedanib
patients to receive backbone chemotherapy and nintedanib
 Drug: docetaxel
intravenous chemotherapy drug

Drug: nintedanib
oral experimental therapy


Outcome Measures
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Primary Outcome Measures :
  1. Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1 [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Male or female patients of at least 18 years of age
  • Histologically confirmed, adenocarcinoma of the lung, after failure of first line platinum-based chemotherapy.

Exclusion criteria:

  • More than one prior line of chemotherapy (i.e., 2nd or 3rd line chemotherapy) for advanced and/or metastatic (stage III B or IV NSCLC) or recurrent disease.
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02231164


Locations
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United States, Arizona
Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
United States, Arkansas
Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
United States, California
Boehringer Ingelheim Investigational Site
Highland, California, United States
Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States
United States, Kentucky
Boehringer Ingelheim Investigational Site
Paducah, Kentucky, United States
United States, New Mexico
Boehringer Ingelheim Investigational Site
Farmington, New Mexico, United States
United States, North Dakota
Boehringer Ingelheim Investigational Site
Minot, North Dakota, United States
United States, Virginia
Boehringer Ingelheim Investigational Site
Blacksburg, Virginia, United States
United States, Washington
Boehringer Ingelheim Investigational Site
Kennewick, Washington, United States
Georgia
Boehringer Ingelheim Investigational Site
Batumi, Georgia
Boehringer Ingelheim Investigational Site
Tbilisi, Georgia
Thailand
Boehringer Ingelheim Investigational Site
Bangkok, Thailand
Sponsors and Collaborators
Boehringer Ingelheim
Investigators
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Study Chair: Boehringer Ingelheim Boehringer Ingelheim
More Information
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Additional Information:

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Responsible Party: Boehringer Ingelheim
ClinicalTrials.gov Identifier: NCT02231164    
Other Study ID Numbers: 1199.128
First Posted: September 4, 2014    Key Record Dates
Results First Posted: February 13, 2017
Last Update Posted: March 21, 2017
Last Verified: February 2017
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
 Docetaxel
Nintedanib
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors
Enzyme Inhibitors