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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

Tracking Information
First Submitted Date  ICMJE September 2, 2014
First Posted Date  ICMJE September 4, 2014
Results First Submitted Date  ICMJE December 20, 2016
Results First Posted Date  ICMJE February 13, 2017
Last Update Posted Date March 21, 2017
Study Start Date  ICMJE October 2014
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
  • Progression free Survival [ Time Frame: up to 36 months ]
  • Overall Survival [ Time Frame: up to 36 months ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 2, 2014)
  • Objective tumour response by central independent review [ Time Frame: up to 36 months ]
  • Disease control rate by central independent review [ Time Frame: up to 36 months ]
  • Quality of life (QOL); time to deterioration of cough, [ Time Frame: up to 36 months ]
  • Quality of life; dyspnea [ Time Frame: up to 36 months ]
  • Quality of life; pain [ Time Frame: up to 36 months ]
  • Quality of life; the global health status/QOL summary score [ Time Frame: up to 36 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE Carcinoma, Non-Small-Cell Lung
Intervention  ICMJE
  • Drug: docetaxel
    intravenous chemotherapy drug
  • Drug: placebo
    oral placebo
  • Drug: nintedanib
    oral experimental therapy
Study Arms  ICMJE
  • Placebo Comparator: Docetaxel and placebo
    patients to receive backbone chemotherapy and placebo
    Interventions:
    • Drug: docetaxel
    • Drug: placebo
  • Experimental: Docetaxel and Nintedanib
    patients to receive backbone chemotherapy and nintedanib
    Interventions:
    • Drug: docetaxel
    • Drug: nintedanib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: September 2, 2015)
12
Original Estimated Enrollment  ICMJE
 (submitted: September 2, 2014)
800
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Georgia,   Thailand,   United States
Removed Location Countries Australia,   Canada,   Egypt,   Lebanon,   Puerto Rico,   Serbia,   Singapore,   South Africa,   Taiwan,   Tunisia,   Turkey,   Ukraine
 
Administrative Information
NCT Number  ICMJE NCT02231164
Other Study ID Numbers  ICMJE 1199.128
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Boehringer Ingelheim
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Boehringer Ingelheim
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Boehringer Ingelheim Boehringer Ingelheim
PRS Account Boehringer Ingelheim
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP