CS-7017 in Combination With Erlotinib in Subjects With Stage IIIb/IV Non-small Cell Lung Cancer (NSCLC)

• Treatment Emergent Adverse Events [ Time Frame: treatment continues until desease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
  Evaluate the safety and tolerability of CS-7017 in combination with erlotinib Number of subjects reporting Treatment Emergent Adverse Events (TEAEs), as a measure of safety and tolerability.
• plasma concentration of CS-7017 [ Time Frame: 10 weeks ] [ Designated as safety issue: No ]
  To determine the plasma concentration of CS-7017 at Days 1, 8, 15, 22, 43, and 64 after study drug administration.
• treatment-emergent Serious Adverse Events [ Time Frame: treatment continues until desease progression, unacceptable toxicity or consent withdrawal ] [ Designated as safety issue: No ]
  Evaluate the safety and tolerability of CS-7017 in combination with erlotinib Number of subjects reporting treatment-emergent Serious Adverse Events (SAEs) as a measure of safety and tolerability.

The primary objectives of this study are to evaluate the safety and tolerability of CS-7017 administered orally twice a day in combination with erlotinib, and to assess the pharmacokinetics of CS-7017 in combination with erlotinib.

• Drug: CS-7017
  CS-7017 from 0.25 mg to 0.50 mg twice a daily
  Other Name: CS7017
• Drug: Erlotinib
  Erlotinib 150 mg once daily
  Other Name: Tarceva

Inclusion Criteria:

• Histologically or cytologically confirmed unresectable locally advanced or metastatic (stage IIIb or IV) Non-small Cell Lung Cancer (NSCLC)
• Recurrent disease (either no response to treatment or subsequent relapse after an objective response) that has progressed after first-line platinum based therapy
• Male or female ≥ 18 years of age
• Anticipation of more than 3 months survival
• Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 1
• Adequate organ and bone marrow function

Exclusion Criteria:

• Prior Tyrosine Kinase Inhibitor (TKI) therapy
• Anticipation of need for a major surgical procedure or radiation therapy during the study
• Remaining influence of previous therapies such as radiotherapy, surgery, immunotherapy within 4 weeks prior to start of study treatment
• Treatment with anticancer medication within 4 weeks before study treatment, currently enrolled in another investigational drug study, or enrolled in another investigational drug study within 4 weeks of start of treatment
• History of any of the following events within 6 months prior to start of study treatment: myocardial infarction, severe/unstable angina pectoris, coronary/peripheral artery bypass graft, New York Heart Association (NYHA) class ≥I Congestive Heart Failure (CHF), cerebrovascular accident or cerebral infarction, pulmonary embolism, deep vein thrombosis, or other clinically significant thromboembolic event; clinically significant pulmonary disease (eg, severe Chronic-Obstructive Pulmonary Disease (COPD) or asthma)
• Severe edema, ascites fluid, pericardial or pleural effusion or pericardial involvement with the tumor within 6 months prior to start of study treatment, or which require steroid therapy/ diuretic therapy
• Subjects with brain metastasis (defined as untreated, symptomatic or requiring steroids or anticonvulsant medications to control associated symptoms)
• Subjects with clinically significant active infection which requires antibiotic therapy, or who are hepatitis B surface antigen (HBsAg)-, hepatitis C virus (HCV)- or human immunodeficiency virus (HIV)-positive or receiving antiretroviral therapy
• Subjects with malabsorption syndrome, chronic diarrhea (lasting over 4 weeks), inflammatory bowel disease, or partial bowel obstruction
• Diabetes mellitus requiring insulin, or a history of poor serum glucose control with the use of non-insulin diabetes medications
• Treatment with Thiazolidinedione(TZDs) within 4 weeks prior to start of study treatment
• History of a second malignancy, with the exception of in situ cervical cancer or adequately treated basal cell or squamous cell carcinoma of the skin
• Poorly-controlled blood pressure as judged by the Investigator