Conditions: Carcinoma, Non-Small-Cell Lung
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 16
Healthy volunteers: no

Brief summary:
The LUME-Lung3 study is in 2 parts:

Run-in Phase I - Open label study to identify the Maximum Tolerated Dose of BIBF 1120 that can be added to standard first-line treatment with 3 weekly schedules of gemcitabine and cisplatin.

Phase II - Placebo controlled efficacy study of BIBF 1120 added to standard 3 weekly cycles of gemcitabine and cisplatin therapy in patients with at least Stable Disease after 2 previous courses of the chemotherapy

Detailed description:

Arms:
arm 1: VEGF inhibitor arm 2: BIBF 1120 placebo

Interventions: intervention 1: BIBF 1120 intervention 2: Placebo
Intervention descriptions: intervention 1: VEGF inhibitor intervention 2: BIBF 1120 placebo

Protocol document: