A Phase 3, Randomized, Double-Blinded, Placebo-Controlled Study of ARQ 197 Plus Erlotinib Versus Placebo Plus Erlotinib in Previously Treated Subjects With Locally Advanced or Metastatic, Non-Squamous, Non-Small-Cell Lung Cancer With Wild-type Epidermal Growth Factor Receptor
- Histologically or cytologically confirmed surgically unresectable locally advanced or
metastatic (stage IIIB/IV) non-squamous NSCLC with wild-type EGFR.
- Evaluable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
criteria, Version 1.1.
- Received one or two prior lines of systemic anti-cancer therapy for advanced or
metastatic disease, one of which must be a platinum-based therapy.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Prior therapy with an EGFR inhibitor and/or c-Met inhibitor.
- Any systemic anti-tumor treatment for NSCLC within 4 weeks prior to randomization.
- Major surgical procedure within 4 weeks prior to randomization
- Known symptomatic brain metastases.
Type of Study:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Japan: Ministry of Health, Labor and Welfare
- Non-Small-Cell Lung Cancer
- Carcinoma, Non-Small-Cell Lung
- Lung Neoplasms