A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Who Present EGFR Mutations

A 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 assess the efficacy and safety of Tarceva (erlotinib) in patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor (EGFR) mutations. Patients will receive Tarceva at a dose of 150 mg daily orally until disease progression or unacceptable toxicity occurs.

Inclusion Criteria:

• Adult patients, >/=18 years of age
• Locally advanced or metastatic (stage III/IV) non-small cell lung cancer with EGFR mutations
• Measurable disease according to RECIST criteria
• ECOG performance status 0-2
• Adequate haematological, renal and liver function

Exclusion Criteria:

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