A Study of Erlotinib in Participants With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor Mutations

Phase II, 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 single arm, open-label study will evaluate the efficacy and safety of erlotinib (Tarceva) in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.

Inclusion Criteria:

• Locally advanced or metastatic NSCLC with EGFR mutations
• Measurable disease according to RECIST criteria
• Adequate hematological, renal and liver function

Exclusion Criteria:

• Previous chemotherapy or therapy against EGFR for metastatic disease
• Symptomatic cerebral metastases
• Pre-existing disease of the lung parenchyma such as lung fibrosis, lymphangitic carcinomatosis
• History of another malignancy except for carcinoma in-situ of the cervix, adequately treated basal cell skin carcinoma, or radically treated prostate carcinoma with good prognosis
• Concomitant use of coumarins