A Phase 2 Trial of AMG 706 or Bevacizumab in Combination With Chemo for Advanced NSCLC

A Phase 2, Multicenter, Open Label, Randomized Trial of AMG 706 or Bevacizumab in Combination With Paclitaxel and Carboplatin for Advanced Non-squamous Non-small Cell Lung Cancer

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.

Inclusion Criteria:

• Men or women 18 years or older with histologically or cytologically confirmed advanced non-squamous NSCLC (unresectable stage IIIB with pericardial or pleural effusion or stage IV/recurrent)
• Measureable disease per RECIST criteria modified
• ECOG performance status of 0 or 1
• Ability to take oral medications
• Competent to give written informed consent

Exclusion Criteria:

• Current or prior history of CNS metastases
• Any prior chemotherapy for advanced NSCLC
• History of pulmonary hemorrhage or gross hemoptysis within 6 months prior to randomization
• Prior targeted therapies
• Known history of allergy or hypersensitivity to paclitaxel or carboplatin
• History of arterial or venous thrombosis within 52 weeks prior to randomization
• History of bleeding diathesis or non-pulmonary bleeding within 14 days prior to randomization
• Peripheral neuropathy > grade 1 per CTCAE Version 3.0
• Myocardial infarction, cerebrovascular accident, grade 2 or greater peripheral vascular disease, transient ischemic attack, congestive heart failure, percutaneous transluminal coronary angioplasty/stent, ongoing arrythmias requiring medication or unstable angina within 52 weeks prior to randomization
• Any kind of disorder that compromises the ability of the subject to comply with the study procedures
• Uncontrolled hypertension as defined by resting blood pressure > 150/90 mm Hg. Anti-hypertensive medications are allowed if hypertension is stably controlled at the time of randomization.
• Participation in therapeutic clinical trials or currently receiving other investigational treatment(s) within 30 days prior to randomization
• Pregnant or breast feeding women
• Known to be HIV, hepatitis B surface antigen, or hepatitis C positive