A Study of Tarceva (Erlotinib) in Patients With Advanced Non-Small Cell Lung Cancer Naive to Chemotherapy

An Parallel Phase II Study of Tarceva (Erlotinib) in Patients With Advanced Non-small Cell Lung Cancer (Stage IIIB/IV) Not Pre-treated by Chemotherapy Including Dose Escalation to Toxicity in Current and Former Smokers

This study will evaluate the efficacy and safety of Tarceva in two groups of patients with non-small cell lung cancer who have not been pre-treated with chemotherapy. One group, consisting of patients who have never smoked, will receive Tarceva 150 mg/day, and the other group, consisting of current/former smokers, will receive Tarceva 150 mg/day increasing to a maximum of 300 mg/day. The anticipated time on study treatment is 1-2 years.

Inclusion Criteria:

• adult patients, >=18 years of age;
• histologically documented advanced non-small cell lung cancer (stage IIIB/IV);
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2;
• no previous chemotherapy.

Exclusion Criteria:

• previous therapy which acts on Epidermal Growth Factor Receptor (EGFR) axis;
• clinical evidence of brain metastasis;
• any unstable systemic disease;
• unable to take oral medication;
• any significant ophthalmological abnormality.