A Study to Evaluate Tarceva in Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Inclusion Criteria: * Written (signed) informed consent(s) * Inoperable and incurable, locally advanced, recurrent or metastatic NSCLC * Relapse following standard chemotherapy (combination chemotherapy such as two-drug combination chemotherapy, or a single-agent chemotherapy agent for elderly or poor performance status patients) * Age \>=18 years * ECOG performance status of 0 to 3 * Recovered from the toxic effects of prior therapy * Able to comply with study and follow-up procedures * Able to take oral medication * Use of an effective means of contraception (for patients with reproductive potential) * Granulocyte count \>=1.0 x 10\^9/L * Platelet count \>=75 x 10\^9/L * Serum bilirubin \<1.5 x upper limit of normal (ULN) * SGOT (AST) \<2 x ULN unless elevation is clearly due to liver metastases; then SGOT (AST) must be \<5 x ULN * Serum creatinine \<=1.5 mg/dL Exclusion Criteria: * Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, myocardial infarction within the last 6 months, hepatic, renal, or metabolic disease) * Prior therapy with any systemic HER1/EGFR small molecule inhibitor, including gefitinib (Iressa), erlotinib (Tarceva), or other investigational agents in this class * History of another malignancy in the past 2 years unless the malignancy has been adequately treated and is associated with a 5-year anticipated survival of \>=90% * Known central nervous system (CNS) metastases that have not yet been definitively treated with surgery and/or radiation or that are symptomatic or unstable * Nursing mothers or pregnant females