TIGER-1: Safety and Efficacy Study of Rociletinib (CO-1686) or Erlotinib in Patients With EGFR-mutant/Metastatic NSCLC Who Have Not Had Any Previous EGFR Directed Therapy

Inclusion criteria

• ✓. Histologically or cytologically confirmed metastatic or unresectable locally advanced/metastatic NSCLC
• ✓. Documented evidence of a tumor with activating EGFR mutations by local testing. Patients with exon 20 insertions are not eligible with the exception of patients with documented evidence of the exon 20 insertion A763\_Y764insFQEA in the EGFR gene
• ✓. Have undergone a biopsy or surgical resection of either primary or metastatic tumor tissue within 60 days of the first day of study treatment, C1D1, and have tissue available to send to sponsor laboratories or are able to undergo a biopsy during screening and provide tissue to sponsor laboratories
• ✓. Measureable disease according to RECIST Version 1.1
• ✓. Life expectancy of at least 3 months
• ✓. ECOG (Eastern Cooperative Oncology Group) performance status of 0 to 1
• ✓. Minimum age 18 years (in certain territories, the minimum age requirement may be higher (e.g. 20 years in Japan and Taiwan)
• ✓. Adequate hematological and biological function, confirmed by defined laboratory values

Exclusion criteria