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