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

NCT02231164 | Terminated Phase 3 Results

• 1 other identifier: 1199.128
• Study Type: interventional
• Target: 12
• Locations: 3 countries
• Sites: 13

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Outcome Measures

Primary Outcomes (1)

• Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1

  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.

Study Arms (2)

Docetaxel and placebo

PLACEBO COMPARATOR

patients to receive backbone chemotherapy and placebo

Drug: docetaxel; Drug: placebo

Docetaxel and Nintedanib

EXPERIMENTAL

patients to receive backbone chemotherapy and nintedanib

Drug: docetaxel; Drug: nintedanib

Interventions

docetaxel DRUG

intravenous chemotherapy drug

Docetaxel and Nintedanib

placebo DRUG

oral placebo

Docetaxel and placebo

nintedanib DRUG

oral experimental therapy

Docetaxel and Nintedanib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (13)

1199.128.10032 Boehringer Ingelheim Investigational Site

Chandler, Arizona, United States

Location

1199.128.10041 Boehringer Ingelheim Investigational Site

Fayetteville, Arkansas, United States

Location

1199.128.10010 Boehringer Ingelheim Investigational Site

Highland, California, United States

Location

1199.128.10044 Boehringer Ingelheim Investigational Site

Rancho Mirage, California, United States

Location

1199.128.10080 Boehringer Ingelheim Investigational Site

Paducah, Kentucky, United States

Location

1199.128.10016 Boehringer Ingelheim Investigational Site

Farmington, New Mexico, United States

Location

1199.128.10013 Boehringer Ingelheim Investigational Site

Minot, North Dakota, United States

Location

1199.128.10077 Boehringer Ingelheim Investigational Site

Blacksburg, Virginia, United States

Location

1199.128.10011 Boehringer Ingelheim Investigational Site

Kennewick, Washington, United States

Location

1199.128.64006 Boehringer Ingelheim Investigational Site

Batumi, Georgia

Location

1199.128.64001 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1199.128.64002 Boehringer Ingelheim Investigational Site

Tbilisi, Georgia

Location

1199.128.66004 Boehringer Ingelheim Investigational Site

Bangkok, Thailand

Location

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

Docetaxel; nintedanib

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Limitations and Caveats

The sponsor cancelled this trial prematurely. Thus, enrollment for 1199.128 was significantly less than what was planned (800 planned vs. 12 entered). Therefore, the objectives of this study could not be fully assessed.

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2014
• First Posted: September 4, 2014
• Study Start: October 14, 2014
• Primary Completion: December 24, 2015
• Study Completion: December 24, 2015
• Last Updated: February 13, 2025
• Results First Posted: February 13, 2017

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1); GE (3); US (9)