Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1314
Healthy volunteers: no

Brief summary:
The present trial will be performed to evaluate whether BIBF 1120 in combination with standard therapy of docetaxel in patients with stage IIIB/IV or recurrent NSCLC is more effective as compared to placebo in combination with standard therapy of docetaxel. A secondary aim is to obtain safety information as well as information on quality of life of patients treated with BIBF 1120 in combination to standard therapy with docetaxel. In addition, blood will be collected for pharmacokinetic analysis.

Detailed description:

Arms:
arm 1: BIBF 1120 2 times daily along with standard therapy of docetaxel arm 2: Placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel

Interventions: intervention 1: placebo plus docetaxel intervention 2: BIBF 1120 plus docetaxel
Intervention descriptions: intervention 1: placebo matching BIBF 1120 2 times daily along with standard therapy of docetaxel intervention 2: BIBF 1120 2 times daily along with standard therapy of docetaxel

Protocol document: