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

January 29, 2025 updated by: Boehringer Ingelheim

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Georgia
      • Batumi, Georgia
        • 1199.128.64006 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1199.128.64001 Boehringer Ingelheim Investigational Site
      • Tbilisi, Georgia
        • 1199.128.64002 Boehringer Ingelheim Investigational Site
  • Thailand
      • Bangkok, Thailand
        • 1199.128.66004 Boehringer Ingelheim Investigational Site
  • United States
    • Arizona
      • Chandler, Arizona, United States
        • 1199.128.10032 Boehringer Ingelheim Investigational Site
    • Arkansas
      • Fayetteville, Arkansas, United States
        • 1199.128.10041 Boehringer Ingelheim Investigational Site
    • California
      • Highland, California, United States
        • 1199.128.10010 Boehringer Ingelheim Investigational Site
      • Rancho Mirage, California, United States
        • 1199.128.10044 Boehringer Ingelheim Investigational Site
    • Kentucky
      • Paducah, Kentucky, United States
        • 1199.128.10080 Boehringer Ingelheim Investigational Site
    • New Mexico
      • Farmington, New Mexico, United States
        • 1199.128.10016 Boehringer Ingelheim Investigational Site
    • North Dakota
      • Minot, North Dakota, United States
        • 1199.128.10013 Boehringer Ingelheim Investigational Site
    • Virginia
      • Blacksburg, Virginia, United States
        • 1199.128.10077 Boehringer Ingelheim Investigational Site
    • Washington
      • Kennewick, Washington, United States
        • 1199.128.10011 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Investigators

  • Study Chair: Boehringer Ingelheim, Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 14, 2014

Primary Completion (Actual)

December 24, 2015

Study Completion (Actual)

December 24, 2015

Study Registration Dates

First Submitted

September 2, 2014

First Submitted That Met QC Criteria

September 2, 2014

First Posted (Estimated)

September 4, 2014

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1199.128

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe