A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer
Status:
Completed
Trial end date:
2016-01-06
Target enrollment:
Participant gender:
Summary
This randomized, Phase III, double-blind, placebo-controlled study will evaluate the safety
and efficacy of MetMAb (onartuzumab) in combination with Tarceva (erlotinib) compared with
treatment with Tarceva alone in patients with incurable Met-positive non-small cell lung
cancer (NSCLC). Patients will be randomized in a 2:1 ratio to receive either MetMAb + Tarceva
or placebo + Tarceva. Tarceva (150 mg) will be given orally once daily, and MetMAb (15 mg/kg)
will be given intravenously every 3 weeks. Treatment will continue until disease progression,
unacceptable toxicity, a decision to discontinue, or death occurs. Total study length is
expected to be around 36 months.