Study of Erlotinib With or Without Investigational Drug (CS-7017) in Subjects With Advanced Non-small Cell Lung Cancer

Inclusion Criteria:

• Histologically or cytologically confirmed stage IIIB or IV NSCLC.
• Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first line therapy.
• Measurable disease according to Response Evaluation Criteria In Solid Tumors (RECIST) Version 1.1 criteria.
• ≥ 18 years of age.
• ECOG performance status of 0, 1, or 2.
• Adequate organ and bone marrow function.
• Resolution of any toxic effects of prior therapy (except alopecia) to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 4.0 grade ≤ 1.
• Agreement to use effective contraception while on treatment and for at least 3 months after end of treatment.

Exclusion Criteria:

• No treatment with anticancer therapy within 4 weeks before study treatment.
• No therapeutic or palliative radiation therapy or major surgery within 4 weeks before study treatment (except for radiotherapy for brain metastases).
• No administration of other thiazolidinediones (TZDs) within 4 weeks before study treatment.
• No current need for concomitant use of other TZDs during the study.
• No uncontrolled infection requiring IV antibiotics, antivirals, or antifungals, known human immunodeficiency virus (HIV) infection, or active hepatitis B or C infection at time of screening.
• No history of any of the following conditions within 6 months before initiating study treatment: diabetes mellitus requiring treatment with insulin or TZD agents; myocardial infarction with significant impairment of cardiac function; severe/unstable angina pectoris; coronary/peripheral artery bypass graft; New York Heart Association (NYHA) class III or IV congestive heart failure; malabsorption syndrome, chronic diarrhea (lasting > 4 weeks), inflammatory bowel disease, or partial bowel obstruction.
• No pericardial or pleural effusion (eg, requiring drainage) or pericardial involvement with the tumor. Subjects with minimal pleural effusion may be eligible upon request by Investigator and approval by Sponsor.
• Neither pregnant nor breast feeding.
• No known EGFR mutations.