A Multicenter, Open-Label, Phase IIIb Trial of Tarceva (Erlotinib Hydrochloride) in Patients With Advanced Non-Small Cell Lung Cancer

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