A Comparison Between BMS-690514 and Erlotinib in Patients Who Were Previously Treated for NSCLC

A Double-Blind, Randomized, Parallel Two-Arm Phase II Trial of BMS-690514 Versus Erlotinib in Previously Treated NSCLC Patients

The purpose of this study is to improve disease control and survival for patients who were treated with chemotherapy using BMS-690514 over erlotinib

Inclusion Criteria:

• ECOG PS of 0 or 1
• Histologically confirmed NSCLC
• Adequate amount of tumor (archived or fresh) for biomarker evaluation
• Received one to two regimens of chemotherapy (with at least one platinum-containing)
• Serum creatinine of less than 1.0 mg/dL or a 24 hour creatinine clearance of greater than 60 mL/min
• Stable control of blood pressure on agents other than calcium channel blockers
• Women of child-bearing potential must avoid pregnancy or maintain adequate contraception
• Must be able to swallow pills and take the medications at the same time every day on an empty stomach

Exclusion Criteria:

• ECOG PS 2 or greater
• Women unwilling to avoid pregnancy or use adequate contraception
• Symptomatic brain metastases
• Recent history of TIA, CVA, or thrombotic/thromboembolic event (within 6 months)
• History of hemoptysis greater than 10 mL/day
• Significant cardiovascular disease
• Uncontrolled diarrhea, Crohn's disease, ulcerative colitis, or any malabsorptive disease
• History of use of other TKIs
• Uncontrolled hypertension
• HIV+