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
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