Spots Global Cancer Trial Database for A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Study of the Efficacy and Safety of MetMAb Combined With Tarceva in Patients With Met-Positive Non-Small Cell Lung Cancer
Official Title: A Randomized, Phase III, Multicenter, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Onartuzumab (MetMAb) in Combination With Erlotinib as Second- or Third-Line Treatment for Patients With MET-Positive Incurable Stage IIIB/IV Non-Small Cell Lung Cancer
Study ID: NCT02031744
Conditions
Study Description
Brief 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.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The Affiliated Hospital of Military Medical Sciences(The 307th Hospital of Chinese PLA), Beijing, , China
Jilin Cancer Hospital, Changchun, , China
Southwest Hospital , Third Military Medical University, Chongqing, , China
Third Affiliated Hospital of Third Military Medical University, ChongQing, , China
Sun Yet-sen University Cancer Center, Guangzhou, , China
Zhejiang Cancer Hospital, Hangzhou, , China
Harbin Medical University Cancer Hospital, Harbin, , China
Jiangsu Cancer Hospital, Nanjing, , China
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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