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

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+