A Study of Tarceva (Erlotinib) in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (TRIGGER)

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 (EGFR) - (TRIGGER)

This single-arm, open-label study evaluated the efficacy and safety of Tarceva (erlotinib) in participants with locally advanced or metastatic non-small cell lung cancer. Participants received daily oral doses of 150 mg Tarceva. The anticipated time on study treatment was 12 months.

Inclusion Criteria:

• Adult patients, >/=18 years of age
• Locally advanced or metastatic non-small cell lung cancer
• Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST)
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Life expectancy over >/=12 weeks
• Adequate hematological, liver, or kidney function

Exclusion Criteria:

• Previous therapy against epidermal growth factor receptor for metastatic disease
• Treatment with investigational drug during the 3 weeks before enrollment
• History of neoplasm
• Patients with symptomatic cerebral metastases
• Unstable systemic disease