Treatment Rationale Study Design for the MetLung Trial: A Randomized, Double-Blind Phase III Study of Onartuzumab (MetMAb) in Combination With Erlotinib Versus Erlotinib Alone in Patients Who Have Received Standard Chemotherapy for Stage IIIB or IV Met-Positive Non–Small-Cell Lung Cancer

摘要: We present the treatment rationale and study design of MetLung phase III study. This will investigate onartuzumab (MetMAb) in combination with erlotinib compared alone, as second- or third-line treatment, patients advanced non-small-cell lung cancer (NSCLC) who are Met-positive by immunohistochemistry. Approximately 490 (245 per arm) receive (150 mg oral daily) plus placebo (15 mg/kg intravenous every 3 weeks) until disease progression, unacceptable toxicity, patient physician decision to discontinue, death. The efficacy objectives this compare overall survival (OS) (primary endpoint), progression-free survival, response rates between 2 arms. In addition, safety, quality life, pharmacokinetics, translational research be investigated across If primary objective is achieved, provide robust results toward an alternative option for NSCLC.