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

• Status: Completed
• Trial end date: 2010-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Erlotinib Hydrochloride

Criteria

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.