A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating The Efficacy And Safety Of Onartuzumab (MetMab) In Combination With Tarceva (Erlotinib) In Patients With Met Diagnosticâ??Positive Nonâ??Small Cell Lung Cancer (NSCLC) Who Have Received Standard Chemotherapy For Advanced Or Metastatic Disease
To determine if the combination of MetMab + Erlotinib is superior to Placebo + Erlotinib in patients with Met positive NSCLC after standard chemo and to further understand the biology of NSCLC and evaluate the impact of MetMab on ECG measurements
Patient with NSCLC, who have failed at least one prior platinum treatment, but no more than 2, with ECOG PS 0-1, and only patients with Met positive tumors will enroll.
Patients are randomized 1:1 to receive MetMab or placebo given at 15mg/kg on Day 1 of each 3 week cycle IV over 60minutes, in combination with Erlotinib orally once a day; 1 hour before or 2 hours after a meal with water.
06/19/2013 04:02 AM