This randomized, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with Tarceva (erlotinib) in participants with incurable non-small cell lung cancer identified to be Met diagnostic-positive. Participants will be randomized to receive either onartuzumab (MetMAb) or placebo in combination with erlotinib. Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
494
Participants will receive erlotinib 150 mg tablet orally once daily from Day 1, Cycle 1.
Participants will receive onartuzumab 15 mg/kg IV infusion on Day 1 of every 3-week cycle.
Participants will receive onartuzumab matching placebo on Day 1 of every 3-week cycle.
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Chandler, Arizona, United States
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Hayward, California, United States
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Modesto, California, United States
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Oakland, California, United States
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Orange, California, United States
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Overall Survival
Time frame: Randomization until death (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Lung Cancer Module (EORTC QLQ-LC13) Scores
Time frame: Screening, Day 1 of Cycles 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22 (cycle length = 21 days), study drug discontinuation visit (up to approximately 18 months)
Onartuzumab Serum Concentrations
Time frame: 1 hour pre-onartuzumab (Pr-O) infusion on Day 1 of Cycles 1, 2, and 4, 1 hour post-onartuzumab (Po-O) infusion on Day 1 of Cycle 1 (cycle length = 21 days and duration of infusion = 60 minutes), End of treatment (up to approximately 18 months)
Percentage of Participants With Disease Progression or Death
Time frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Progression Free Survival (PFS)
Time frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
Percentage of Participants with an Objective Response Assessed Using RECIST V 1.1
Time frame: Randomization until disease progression or death, whichever occurred first (up to approximately 18 months) (assessed at the treating physician's discretion using the local standard-of-care practice)
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Roseville, California, United States
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Sacramento, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Francisco, California, United States
...and 203 more locations