Phase 2 Study of CS-7017 and Erlotinib in Subjects With Advanced Non-Small Cell Lung Cancer Who Failed First Line Therapy

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.