The purpose of this study is to determine the efficacy of CT-322 comparative to bevacizumab, both in combination with carboplatin and paclitaxel in the treatment of chemonaive subjects with recurrent or advanced non-squamous NSCLC

• Drug: Paclitaxel
  Solution, IV, 200 mg/m2, Q21days, 6 cycles
  Other Name: Taxol
• Drug: Carboplatin
  Solution, IV, AUC=6, Q21days, 6 cycles
  Other Name: Paraplatin
• Drug: CT-322
  Solution, IV, 2 mg/kg, Q7days, Until PD
  Other Name: BMS-844203
• Drug: Bevacizumab
  Solution, IV, 15 mg/kg, Q21days, Until PD
  Other Name: Avastin
• Drug: Bevacizumab placebo (ie saline solution)
  Solution, IV, 0 mg/kg, On days 8 and 15 of a 3-weekly cycle, Until PD
  Other Name: Saline solution

• Paclitaxel/Carboplatin/CT-322: Active Comparator
  Interventions:

  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Drug: CT-322
• Paclitaxel/Carboplatin/Bevacizumab/Placebo: Active Comparator
  Interventions:

  • Drug: Paclitaxel
  • Drug: Carboplatin
  • Drug: Bevacizumab
  • Drug: Bevacizumab placebo (ie saline solution)

Inclusion Criteria:

• ECOG Performance Status (PS) <=1
• Histologically or cytologically confirmed, stage IIIB (malignant pleural effusion), stage IV or recurrent NSCLC
• Measurable disease by RECIST guidelines

Exclusion Criteria:

• Evidence of predominantly squamous-cell histology
• Known CNS metastases
• Any prior antineoplastic systemic regimens for NSCLC
• Excessive risk of bleeding (including use of therapeutic anticoagulation) and history of thrombotic or embolic cerebrovascular accident
• Gross hemoptysis (≥1/2 tsp of red blood)
• Uncontrolled hypertension
• Clinically significant cardiovascular disease
• History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
• Serious non-healing wound, active peptic ulcer, non-healing bone fracture, or bleeding skin metastasis