A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC
Study Details
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.
Protocol Summary
Objective tumor response rate
Timeframe: Response assessments will be obtained every 6 +/- 1 week until subjects develop disease progression.
Duration of response
Timeframe: Time from first objective tumor response to disease progression or death, if the death was due to disease progression.
Progression free survival
Timeframe: Number of days from randomization tot he date of radiological evidence of disease progression or death.
Overall survival
Timeframe: Time from randomization to death.
Pharmacokinetics of AMG 706 when administered with paclitaxel and carboplatin in Arms A and B
Timeframe: From randomization until disease progression or death.
Safety and tolerability in the 3 arms
Timeframe: From randomization until disease progression or death.