A Phase 1 Dose-escalation Study of OSI-906 and Erlotinib (Tarceva®)

The study will open with Schedule 1 (S1), in which OSI-906 is administered on Days 1-3 every 7 days. Erlotinib will be administered daily starting on Day 2. A treatment period is defined as 21 days. Initiation of Schedule 2 (S2), in which OSI-906 is administered daily starting on Day 1 and erlotinib is administered daily starting on Day 2, will occur after observation of clinically significant related toxicity \>/= grade 2 in any patient on S1 or after \> 2 dose levels in S1 have been examined without evidence of Dose Limiting Toxicities (DLT). Initiation of Schedule 3 (S3), in which OSI-906 is administered twice daily starting on Day 1 and erlotinib is administered daily starting on Day 2, will occur after observation of clinically significant related toxicity \>/= grade 2 in any patient on S2 or after \> 2 dose levels in S2 have been examined without evidence of DLT. Once the phase 2 dose has been established for S3, 1 expansion cohort will be opened. The Expansion Cohort will enroll approximately 30 evaluable patients with stage IIIB/IV Non-small Cell Lung Carcinoma (NSCLC). Patients in the NSCLC Expansion Cohort will be required to have either archival tissue or fresh tumor tissue available at the start of study.