This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of onartuzumab (MetMAb) in combination with paclitaxel plus platinum in patients with incurable Stage IIIB or Stage IV squamous non-small cell lung cancer (NSCLC). Patients will be randomized to receive either onartuzumab (MetMAb) 15 mg/kg iv or placebo on Day 1 of each 21-day cycle in combination with 4 cycles of paclitaxel 200 mg/m2 iv and platinum (carboplatin/cisplatin) iv on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will continue with either onartuzumab (MetMAb) or placebo as maintenance therapy until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
108
Matching onartuzumab (MetMAb) placebo iv, Day 1 of each 21-day cycle
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
15 mg/kg iv, Day 1 of each 21-day cycle
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
Unnamed facility
Huntsville, Alabama, United States
Unnamed facility
Scottsdale, Arizona, United States
Unnamed facility
Bakersfield, California, United States
Unnamed facility
Fullerton, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Progression-free survival (tumor assessments according to RECIST criteria)
Time frame: up to approximately 32 months
Progression-free survival: Subgroup of patients with Met diagnostic-positive squamous NSCLC
Time frame: up to approximately 32 months
Overall survival
Time frame: up to approximately 32 months
Overall response rate (tumor assessments according to RECIST criteria)
Time frame: up to approximately 32 months
Duration of response (time from first documented objective response to disease progression)
Time frame: up to approximately 32 months
Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)
Time frame: up to approximately 32 months
Safety: Incidence of adverse events
Time frame: up to approximately 32 months
Pharmacokinetics: serum concentration (Cmin/Cmax)
Time frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and up to 2 years
Plasma concentrations of paclitaxel/platinum
Time frame: Pre- and post-dose on Day 1 of Cycles 1 and 4
Serum levels of anti-therapeutic antibodies (MetMAb ATAs)
Time frame: Pre-dose Day 1 of Cycles 1, 2 and 4
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Los Angeles, California, United States
Unnamed facility
Northridge, California, United States
Unnamed facility
Sacramento, California, United States
Unnamed facility
San Luis Obispo, California, United States
Unnamed facility
Santa Barbara, California, United States
...and 59 more locations