ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

A Phase 2, Multicenter, Open-label, Single-arm Study of ARQ 197 Plus Erlotinib in Patient With Locally Advanced or Metastatic EGFR Mutation-positive Non-small-cell Lung Cancer

The primary objective of this study is to examine if the combination regimen of ARQ 197 with erlotinib is active in subjects with locally advanced or metastatic NSCLC with activating mutation EGFR who progressed on EGFR-TKI monotherapy.

Key Inclusion Criteria:

• Histologically or cytologically confirmed surgically unresectable locally advanced or metastatic (stage IIIB/IV) NSCLC with EGFR activating mutation.
• Measurable disease and documented disease progression following the first and immediate EGFR-TKI monotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate organ function

Key Exclusion Criteria:

• Prior therapy with a c-Met inhibitor.
• Any systemic anti-tumor treatment for NSCLC within 7 days prior to randomization.
• Major surgical procedure within 4 weeks prior to randomization
• Known symptomatic brain metastases.