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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
12
1199.128.10032 Boehringer Ingelheim Investigational Site
Chandler, Arizona, United States
1199.128.10041 Boehringer Ingelheim Investigational Site
Fayetteville, Arkansas, United States
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.
Time frame: Up to 6 months.
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oral experimental therapy
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
...and 3 more locations