Conditions: Metastatic Non-small Cell Lung Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 111
Healthy volunteers: no

Brief summary:
The study has a safety and a Phase 2 portion. In the safety portion of the study, subjects with metastatic non-small cell lung cancer will be treated with study drug (CS-7017) in combination with carboplatin and paclitaxel to evaluate safety. In the Phase 2 portion of the study, subjects will receive study drug (CS-7017) or placebo in combination with carboplatin and paclitaxel to evaluate effectiveness and safety. The study will find out if adding CS-7017 to carboplatin and paclitaxel will be safe and improve progression free survival in subjects with metastatic non-small cell lung cancer.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: CS7017 tablets intervention 2: Paclitaxel intervention 3: Carboplatin intervention 4: Placebo Tablets
Intervention descriptions: intervention 1: CS7017 tablets, strength 0.25 mg, two tablets, two times daily for twenty-five to thirty months intervention 2: Intravenous (IV), 200 mg/m\^2, once every three weeks for up to 18 weeks intervention 3: IV, area under the curve (AUC) of 6, once every three weeks for up to 18 weeks intervention 4: Placebo tablets matching CS-7017 tablets

Protocol document: