Status:
TERMINATED
LUME-Columbus: Nintedanib Plus Docetaxel in Advanced Non-small Cell Lung Cancer With Translational Research
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Carcinoma, Non-Small-Cell Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 14 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 24 2015
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT02231164
Start Date
October 14 2014
End Date
December 24 2015
Last Update
February 13 2025
Active Locations (13)
Enter a location and click search to find clinical trials sorted by distance.
1
1199.128.10032 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
2
1199.128.10041 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
3
1199.128.10010 Boehringer Ingelheim Investigational Site
Highland, California, United States
4
1199.128.10044 Boehringer Ingelheim Investigational Site
Rancho Mirage, California, United States