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

Carcinoma, Non-Small-Cell Lung Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02231164
• Other study ID #: 1199.128
• Status: Terminated
• Phase: Phase 3
• First received: September 2, 2014
• Last updated: April 26, 2016
• Start date: October 2014
• Est. completion date: December 2015

Study information

• Verified date: April 2016
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Health authority: Georgia: Ministry of HealthThailand: Food and Drug AdministrationUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 12
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

Intervention

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

Locations

Country	Name	City	State
Georgia	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
Thailand	1199.128.66004 Boehringer Ingelheim Investigational Site	Bangkok
United States	1199.128.10077 Boehringer Ingelheim Investigational Site	Blacksburg	Virginia
United States	1199.128.10032 Boehringer Ingelheim Investigational Site	Chandler	Arizona
United States	1199.128.10016 Boehringer Ingelheim Investigational Site	Farmington	New Mexico
United States	1199.128.10041 Boehringer Ingelheim Investigational Site	Fayetteville	Arkansas
United States	1199.128.10010 Boehringer Ingelheim Investigational Site	Highland	California
United States	1199.128.10011 Boehringer Ingelheim Investigational Site	Kennewick	Washington
United States	1199.128.10013 Boehringer Ingelheim Investigational Site	Minot	North Dakota
United States	1199.128.10080 Boehringer Ingelheim Investigational Site	Paducah	Kentucky
United States	1199.128.10044 Boehringer Ingelheim Investigational Site	Rancho Mirage	California

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Georgia,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free Survival		up to 36 months	No
Primary	Overall Survival		up to 36 months	No
Secondary	Objective tumour response by central independent review		up to 36 months	No
Secondary	Disease control rate by central independent review		up to 36 months	No
Secondary	Quality of life (QOL); time to deterioration of cough,		up to 36 months	No
Secondary	Quality of life; dyspnea		up to 36 months	No
Secondary	Quality of life; pain		up to 36 months	No
Secondary	Quality of life; the global health status/QOL summary score		up to 36 months	No