Phase II Trial of Tarceva in Patients With Non-Small Cell Lung Cancer

Inclusion Criteria: * Age 18 years. * Patients must have histologically confirmed diagnosis of non-small cell lung cancer, which is not surgically resectable (stage IA- IIIB). * Measurable disease. * Written informed consent must be obtained prior to the inclusion into the trial. * Karnofsky performance status of 80%. * Patients must have been treated with no prior chemotherapy or radioterapy. * Patients must have adequate bone marrow, liver and renal function. * Bone Marrow: WBC \> 3000 x 103/mm3, * Platelets \> 100 x 103/mm3, * Hgb \> 10.0 gm/dl, * ANC \>1500 x 103/mm3, * Hepatic:Bilirubin \< 2 mg/dl (34 µmol/l); AST, ALT, and Alkaline Phosphatase \< 5 x normal, * Renal:Creatinine \< 1.5 mg/dl (132 µmol/l). Exclusion Criteria: * Female patients who are pregnant or lactating. * Patients who have used other investigational agents within 21 days prior to study entry. * Patients who have received prior treatment with erlotinib or other anti-EGFR agent. * Significant comorbidity.