Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 43
Healthy volunteers: no

Brief summary:
To confirm the safety of BIBF 1120 at a dose level up to 200 mg x 2/day (i.e., overseas recommended Phase III dose for combination treatment) with standard therapy of docetaxel (60 mg/m2 and 75 mg/m2) in Japanese advanced non small cell lung cancer (NSCLC) patients with stage IIIB/IV or recurrent after failure of first line chemotherapy and to determine the recommended dose for the Phase II trial.

Detailed description:

Arms:
arm 1: Low, medium and high dose of BIBF 1120 and 60 mg/m2, 75 mg/m2 docetaxel every 3 weeks

Interventions: intervention 1: BIBF 1120 M + docetaxel M intervention 2: BIBF 1120 M + docetaxel H intervention 3: BIBF 1120 H + docetaxel H intervention 4: BIBF 1120 L + docetaxel M intervention 5: BIBF 1120 H + docetaxel M
Intervention descriptions: intervention 1: BIBF 1120 Medium dose bid + docetaxel 60 mg/m2 intervention 2: BIBF 1120 Medium dose bid + docetaxel 75mg/m2 intervention 3: BIBF 1120 HIgh dose bid + docetaxel 75 mg/m2 intervention 4: BIBF 1120 Low dose bid + docetaxel 60 mg/m2 intervention 5: BIBF 1120 HIgh dose bid + docetaxel 60 mg/m2

Protocol document: