This multicenter, randomized, double-blind, placebo-controlled study will evaluate the safety and efficacy of onartuzumab in combination with erlotinib in patients with previously untreated, unresectable stage IIIB or IV non-small cell lung cancer identified to carry and activating EGFR mutation and MET-positive. Patients will be randomized to receive either onartuzumab 15 mg/kg intravenously every 3 weeks in combination with erlotinib 150 mg orally daily 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
DOUBLE
Enrollment
10
150 mg orally daily
15 mg/kg IV every 3 weeks
IV every 3 weeks
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Fullerton, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
San Luis Obispo, California, United States
Unnamed facility
Fort Myers, Florida, United States
Unnamed facility
Orlando, Florida, United States
Unnamed facility
St. Petersburg, Florida, United States
Unnamed facility
Chicago, Illinois, United States
...and 25 more locations
Progression-free survival (investigator-assessed according to RECIST v1.1)
Time frame: approximately 3 years
Overall survival
Time frame: approximately 3 years
Overall response rate
Time frame: approximately 3 years
Time to deterioration (>/= 10 points [transformed score] from baseline) in patient-reported lung cancer symptoms
Time frame: approximately 3 years
Patient reported outcomes: HRQoL/EORTC QLC-C30/EORTC QLQ-LC31 questionnaires
Time frame: approximately 3 years
Safety: Incidence of adverse events
Time frame: approximately 3 years
Pharmacokinetics: Area under the concentration-time curve (AUC)
Time frame: Day 1 Cycles 1, 2 and 4
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