This is a Phase IIIb, multicenter, open-label trial of daily oral Tarceva in patients with advanced (inoperable Stage IIIb or IV) NSCLC who have progressed following standard chemotherapy treatment.

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