Phase 2 Randomized Study of Carboplatin/Paclitaxel With or Without CS-7017 in Chemotherapy-Naïve 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
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