Final survival and safety results from a multicenter, open-label, phase IIIb trial of erlotinib in patients with advanced non-small cell lung cancer

7169 Background: Erlotinib is an orally available, reversible inhibitor of the EGFR tyrosine kinase with a proven survival advantage for patients with locally advanced or metastatic NSCLC who have failed one prior chemotherapy regimen. Preliminary data suggest that never smokers respond particularly well, as assessed by both response and survival. Method: This is a phase IIIb, multicenter, open-label trial of erlotinib in patients with advanced NSCLC who have progressed following standard chemotherapy treatment. The trial allowed patients access to erlotinib therapy prior to FDA approval; patients could remain on study up to 9 months following approval. The co-primary objectives were best ORR (as assessed by investigator) and OS associated with erlotinib therapy in this group, and in patient subsets defined by tobacco history. Secondary objectives include evaluating safety; characterization of OS and RR in sub-populations, including histology, sex, ethnicity; duration of time on treatment. Patients and Tr...