A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase IIIb, Open-Label Study of Erlotinib (Tarceva®) Treatment in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer Who Present Activating Mutations in the Tyrosine Kinase Domain of the Epidermal Growth Factor Receptor

This open-label, multi-center study will evaluate the progression-free survival and safety of erlotinib in participants with locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the epidermal growth factor receptor (EGFR). Participants will receive daily oral doses of erlotinib until disease progression or unacceptable toxicity.

Inclusion Criteria:

• Diagnosis of locally advanced or metastatic non-small cell lung cancer with activating mutations in the tyrosine kinase domain of the EGFR
• Measurable disease according to RECIST
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy greater than or equal to (>/=) 12 weeks
• Adequate hematological, liver and renal function
• Participants with asymptomatic and stable cerebral metastases receiving medical treatment

Exclusion Criteria:

• Previous chemotherapy or treatment against EGFR for metastatic disease
• Treatment with an investigational agent less than 3 weeks before enrollment
• History of neoplasm other than non-small cell lung cancer (except carcinoma in situ of the uterine cervix, basal cell skin carcinoma, or prostate carcinoma)
• Participants with symptomatic cerebral metastases
• Any significant ophthalmologic abnormality
• Unstable systemic disease
• Coumarins use
• Evidence of any other disease, neurological or metabolic dysfunction, physical examination or laboratory finding contraindicating the use of an investigational drug
• Participants with pre-existing parenchymal lung disease such as pulmonary fibrosis, lymphangiosis carcinomatosis
• Participants with known infection with human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)