Clinical trial NCT02231164: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-04
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Disease Control According to Response Evaluation Criteria in Solid Tumours (RECIST), Version 1.1
timeFrame: Up to 6 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Chandler
country: United States
facility: 1199.128.10032 Boehringer Ingelheim Investigational Site
state: Arizona
city: Fayetteville
country: United States
facility: 1199.128.10041 Boehringer Ingelheim Investigational Site
state: Arkansas
city: Highland
country: United States
facility: 1199.128.10010 Boehringer Ingelheim Investigational Site
state: California
city: Rancho Mirage
country: United States
facility: 1199.128.10044 Boehringer Ingelheim Investigational Site
state: California
city: Paducah
country: United States
facility: 1199.128.10080 Boehringer Ingelheim Investigational Site
state: Kentucky
city: Farmington
country: United States
facility: 1199.128.10016 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Minot
country: United States
facility: 1199.128.10013 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Blacksburg
country: United States
facility: 1199.128.10077 Boehringer Ingelheim Investigational Site
state: Virginia
city: Kennewick
country: United States
facility: 1199.128.10011 Boehringer Ingelheim Investigational Site
state: Washington
city: Batumi
country: Georgia
facility: 1199.128.64006 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1199.128.64001 Boehringer Ingelheim Investigational Site
city: Tbilisi
country: Georgia
facility: 1199.128.64002 Boehringer Ingelheim Investigational Site
city: Bangkok
country: Thailand
facility: 1199.128.66004 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References: