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

Phase 3

Terminated

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: docetaxel; Drug: placebo; Drug: nintedanib

• Registration Number: NCT02231164
• Lead Sponsor: Boehringer Ingelheim

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 available

Study Timeline

• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-02
• Study First Posted: 2014-09-04
• Study Start: 2014-10-14
• Primary Completion: 2015-12-24
• Study Completion: 2015-12-24
• Results First Submitted: 2016-12-20
• Results First Submitted QC: 2016-12-20
• Results First Posted: 2017-02-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-02-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docetaxel and Nintedanib	docetaxel	patients to receive backbone chemotherapy and nintedanib
Docetaxel and placebo	placebo	patients to receive backbone chemotherapy and placebo
Docetaxel and placebo	docetaxel	patients to receive backbone chemotherapy and placebo
Docetaxel and Nintedanib	nintedanib	patients to receive backbone chemotherapy and nintedanib

Primary Outcome Measures

Name	Time	Method
Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1	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.

Trial Locations

Locations (13)

1199.128.10032 Boehringer Ingelheim Investigational Site; 🇺🇸 Chandler, Arizona, United States

1199.128.10041 Boehringer Ingelheim Investigational Site; 🇺🇸 Fayetteville, Arkansas, United States

1199.128.10010 Boehringer Ingelheim Investigational Site; 🇺🇸 Highland, California, United States

1199.128.10044 Boehringer Ingelheim Investigational Site; 🇺🇸 Rancho Mirage, California, United States

1199.128.10080 Boehringer Ingelheim Investigational Site; 🇺🇸 Paducah, Kentucky, United States

1199.128.10016 Boehringer Ingelheim Investigational Site; 🇺🇸 Farmington, New Mexico, United States

1199.128.10013 Boehringer Ingelheim Investigational Site; 🇺🇸 Minot, North Dakota, United States

1199.128.10077 Boehringer Ingelheim Investigational Site; 🇺🇸 Blacksburg, Virginia, United States

1199.128.10011 Boehringer Ingelheim Investigational Site; 🇺🇸 Kennewick, Washington, United States

1199.128.64006 Boehringer Ingelheim Investigational Site; 🇬🇪 Batumi, Georgia

1199.128.64001 Boehringer Ingelheim Investigational Site; 🇬🇪 Tbilisi, Georgia

1199.128.64002 Boehringer Ingelheim Investigational Site; 🇬🇪 Tbilisi, Georgia

1199.128.66004 Boehringer Ingelheim Investigational Site; 🇹🇭 Bangkok, Thailand