The purpose of this study is to estimate the difference in objective response rates between each paclitaxel/carboplatin plus AMG 706 arm (Arm A and B) and paclitaxel/carboplatin plus bevacizumab arm (Arm C) in subjects with advanced non-squamous NSCLC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
186
15 mg/kg bevacizumab, delivered via intravenous (IV) infusion once every 3 weeks
subjects in Arms A and B will take AMG 706 orally in one of two dosing regimens over each 21-day cycle: •Arm A: 125 mg once daily (QD) •Arm B: 75 mg twice daily every 12 ± approximately 1 hour for 5 days followed by a 2 day treatment free period every 7 days
All subjects will receive a paclitaxel chemotherapy regimen (paclitaxel 200 mg/m2) on day 1 of each 3-week cycle for a maximum of 6 cycles.
Objective tumor response rate
Time frame: Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.
Duration of response
Time frame: Time from first objective tumor response to disease progression or death, if the death was due to disease progression.
Progression free survival
Time frame: Number of days from randomization tot he date of radiological evidence of disease progression or death.
Overall survival
Time frame: Time from randomization to death.
Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B
Time frame: From randomization until disease progression or death.
Safety and tolerability in the 3 arms
Time frame: From randomization until disease progression or death.
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All subjects will receive carboplatin chemotherapy regimen (carboplatin at AUC of 6 mg/mL x min) on day 1 of each 3-week cycle for a maximum of 6 cycles.