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

• overall survival [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
  estimate the overall survival in both treatment groups
• overall response rate [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
  estimate the overall response rate for the two treatment groups
• plasma concentration of CS-7017 [ Time Frame: week 3 ] [ Designated as safety issue: No ]
  determine the plasma concentration of CS-7017 at scheduled time points
• number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE, and treatment-emergent SAEs. [ Time Frame: 4-12 months ] [ Designated as safety issue: No ]
  The number and percentage of subjects reporting Treatment Emergent Adverse Events (TEAE) will be summarized by treatment, the worst NCI CTCAE grade, system organ class, and preferred term. Similarly the number and percentage of subjects reporting treatment-emergent SAEs will be summarized.

This is a Phase 2 and open-label (subject will know the treatment he or she is receiving) study. The subject will receive either Erlotinib alone or Erlotinib + CS-7017 in this study.

The study will determine what effect adding CS-7017 to Erlotinib has on safety and length of survival in subjects with advanced non-small cell lung cancer who failed the first treatment.

• Drug: CS-7017
  CS-7017, Two 0.25mg Tablets administered twice daily
• Drug: erlotinib
  Erlotinib; One 150mg tablet administered once daily
  Other Name: Tarceva

• Experimental: CS-7017 plus erlotinib
  Interventions:

  • Drug: CS-7017
  • Drug: erlotinib
• Active Comparator: erlotinib
  Intervention: Drug: erlotinib

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.