BIBF 1120 in Combination With Pemetrexed in Advanced Non Small Cell Lung Cancer (NSCLC)
Status:
Terminated
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
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