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

• 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: Boehringer Ingelheim
• Information provided by (Responsible Party): Boehringer Ingelheim

Tracking Information

• First Submitted Date: September 2, 2014
• First Posted Date: September 4, 2014
• Results First Submitted Date: December 20, 2016
• Results First Posted Date: February 13, 2017
• Last Update Posted Date: March 21, 2017
• Study Start Date: October 2014
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (submitted: September 2, 2014)

• Progression free Survival [ Time Frame: up to 36 months ]
• Overall Survival [ Time Frame: up to 36 months ]

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (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: LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
• 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
• 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double; Primary Purpose: Treatment
• Condition: Carcinoma, Non-Small-Cell Lung

Intervention

• Drug: docetaxel
  intravenous chemotherapy drug
• Drug: placebo
  oral placebo
• Drug: nintedanib
  oral experimental therapy

Study Arms

• 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

Recruitment Information

• Recruitment Status: Terminated
• Actual Enrollment (submitted: September 2, 2015): 12
• Original Estimated Enrollment (submitted: September 2, 2014): 800
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: 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: NCT02231164
• Other Study ID Numbers: 1199.128
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Boehringer Ingelheim
• Original Responsible Party: Same as current
• Current Study Sponsor: Boehringer Ingelheim
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Chair: Boehringer Ingelheim; Boehringer Ingelheim

• PRS Account: Boehringer Ingelheim
• Verification Date: February 2017