Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: no

Brief summary:
The objectives of this trial are to estimate the following in Japanese patients with advanced NSCLC of stage IIIB/IV or with recurrence after failure of first-line chemotherapy.

Phase I part The objective of the phase I part is to define the Maximum Tolerated Dose (MTD) of BIBF 1120 at a dose level up to twice daily 200 mg with standard dose of pemetrexed (500 mg/m\^2) and to determine the Recommended Dose (RD) for the phase II part.

Phase II, to investigate the efficacy and safety of BIBF 1120 in combination with pemetrexed (500 mg/m\^2) as compared to pemetrexed (500 mg/m\^2) + placebo

Detailed description:

Arms:
arm 1: Phase I part: Find MTD by using low, medium or high BIBF 1120 twice daily and 500mg/m\^2 pemetrexed once every 3 weeks arm 2: PHase II part: Study arm arm 3: Phase II part: Comparator arm

Interventions: intervention 1: BIBF 1120 M + Pemetrexed intervention 2: BIBF 1120 H + Pemetrexed intervention 3: BIBF 1120 RD + Pemetrexed intervention 4: BIBF 1120 L + Pemetrexed intervention 5: BIBF 1120 Placebo + Pemetrexed
Intervention descriptions: intervention 1: BIBF 1120 medium dose bid+ Pemetrexed 500 mg/m\^2 intervention 2: BIBF 1120 high dose bid+ Pemetrexed 500 mg/m\^2 intervention 3: confirmed dose of BIBF 1120 bid + Pemetrexed 500 mg/m\^2 intervention 4: BIBF 1120 low dose bid+ Pemetrexed 500 mg/m\^2 intervention 5: placebo BIBF 1120 bid + Pemetrexed 500 mg/m\^2

Protocol document: