Study of Carboplatin/Paclitaxel With or Without Investigational Drug (CS-7017) in Subjects With Metastatic Non-small Cell Lung Cancer

Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve Subjects With Metastatic Non-Small Cell Lung Cancer

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.

Inclusion Criteria:

• Histologically or cytologically confirmed metastatic (stage IV) NSCLC with no significant pleural effusion or pleural involvement from the tumor
• Age greater than or equal to 18 years
• Adequate organ and bone marrow function

Exclusion Criteria:

• Any prior systemic therapy for NSCLC
• Major surgical procedure or other investigational agents within 4 weeks before study enrollment
• Need for concomitant use of other thiazolidinediones during the study
• History of any of the following conditions within 6 months prior to initiating study treatment: Diabetes mellitus requiring treatment with insulin or sulfonylureas or thiazolidinediones (TZDs) agents; Myocardia infarction with significant impairment of cardia function; Malabsorption syndrome, chronic diarrhea, inflammatory bowel disease or partial bowel obstruction;
• Clinically active brain metastases, uncontrolled seizure disorder; spinal cord compression or carcinomatous meningitis