This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of RO5490258 (MetMab) in combination with either of two backbone chemotherapy regimens in the first-line setting in patients with incurable Stage IIIB or IV non-squamous non-small cell lung cancer. In Cohort 1, patients will be randomized to receive 4 cycles of bevacizumab (Avastin) 15 mg/kg iv, paclitaxel 200 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMab 15 mg/kg iv or placebo on Day 1 of each 21-day cycle. In Cohort 2, patients will be randomized to receive pemetrexed 500 mg/m2 iv, platinum (cisplatin/carboplatin) iv plus either MetMAb 15 mg/m2 iv or placebo on Day 1 of each 21-day cycle. Patients who have not progressed after 4 cycles will be offered maintenance therapy with their assigned treatment of bevacizumab plus either MetMAb or placebo (Cohort 1) or pemetrexed plus either MetMAb or placebo (Cohort 2). Anticipated time on study treatment is until disease progression or unacceptable toxicity occurs.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
259
Matching RO5490258 (MetMAb) placebo iv, Day 1 of each 21-day cycle
15 mg/kg iv, Day 1 of each 21-day cycle
15 mg/kg iv, Day 1 of each 21-day cycle
standard dose iv, Day 1 of each 21-day cycle, 4 cycles
200 mg/m2 iv, Day 1 of each 21-day cycle, 4 cycles
500 mg/m2, Day 1 of each 21-day cycle
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 23 months
Progression-free survival: Subgroup of patients with Met diagnostic positive tumors
Time frame: up to approximately 23 months
Overall survival
Time frame: up to approximately 23 months
Overall response rate (tumor assessments according to RECIST criteria)
Time frame: up to approximately 23 months
Duration of response (time from first documented objective response to disease progression)
Time frame: up to approximately 23 months
Disease control rate (rate of partial response plus complete response plus stable disease for at least 6 weeks)
Time frame: up to approximately 23 months
Safety: Incidence of adverse events
Time frame: up to approximately 23 months
Pharmacokinetics: serum concentration (Cmin/Cmax)
Time frame: Pre- and post-dose on Day 1 of Cycles 1, 2 and 4 and at study termination
Serum concentrations of bevacizumab/paclitaxel/pemetrexed/platinum in combination with MetMAb
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
San Luis Obispo, California, United States
Unnamed facility
Santa Barbara, California, United States
Unnamed facility
Stanford, California, United States
...and 77 more locations