A Study of First or Second Line Treatment With Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer

This single arm study will assess the safety and efficacy of Tarceva monotherapy in patients with advanced non-small cell lung cancer. Patients will receive Tarceva 150mg p.o. daily. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

Inclusion Criteria:

• adult patients >= 18 years of age;
• inoperable, locally advanced, recurrent or metastatic (Stage IIIB/IV) non-small cell lung cancer;
• ECOG performance status of 0-3;
• previously untreated, or failed on one prior course of standard systemic chemotherapy and/or radiotherapy.

Exclusion Criteria:

• prior systemic anti-tumor therapy with HER1/EGFR inhibitors;
• unstable systemic disease;
• any other malignancies within 5 years (except for adequately treated cancer in situ of the cervix, or basal or squamous cell skin cancer;
• any significant ophthalmologic abnormality.