A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib

Exclusion Criteria

• •1. Prior therapy with an EGFR inhibitor and/or tivantinib
• •2. Any systemic anti-tumor treatment for NSCLC or investigational agents within 4 weeks prior to randomization
• •3. Palliative radiotherapy within 2 weeks, or radiotherapy for curative intent of target lesions within 8 weeks for chest and within 4 weeks for other areas prior to randomization
• •4. Major surgical procedure within 4 weeks prior to randomization
• •5. History of cardiac disease
• •6. Known symptomatic brain metastases
• •7. Need to breastfeed a child during or within 12 weeks of completing the study
• •8. Significant gastrointestinal disorder that could interfere with absorption of tivantinib and/or erlotinib
• •9. History of malignancy other than NSCLC
• •10. Known infection with HIV, active HBV or HCV
• •11. Clinically significant interstitial lung diseases detected by CT scan or prior history of such diseases
• •12. Psychiatric disease that could affect the informed consent process
• •13. Subjects who wish to have a child and who would not agree to use one or more contraceptive measures that are highly effective
• •14. Positive serum or urine pregnancy test in female subjects of childbearing potential
• •15. Any other significant co-morbid condition that, in opinion of the investigator/sub-investigator, would impair study participation or cooperation