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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
530
150 mg oral administration once daily
15 mg/kg intravenous administration every 3 weeks
15 mg/kg intravenous administration every 3 weeks
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
Overall survival (OS)
Time frame: Up to 36 months
Incidence of adverse events
Time frame: Up to 33 months
Progression-free survival (PFS), defined as time from randomization until progression as measured by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or death.
Time frame: Up to 36 months
Overall response rate (ORR), as measured by RECIST v1.1
Time frame: Up to 36 months
Health-related quality of life (HRQOL) as measured by the European Organization for the Research and Treatment of Cancer (EORTC) assessments
Time frame: Up to 33 months
Incidence of anti-therapeutic antibodies against MetMAB
Time frame: Up to 33 months
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