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
- 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.
Type of Study:
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
To examine the objective response rate of ARQ 197 plus erlotinib in advanced/metastatic EGFR-mutated NSCLC, given to patients who previously received erlotinib or gefitinib.
Outcome Time Frame:
Up to 6 months
Japan: Ministry of Health, Labor and Welfare
- Non-Small-Cell Lung Cancer
- EGFR mutation-positive
- EGFR-TKI resistance
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms