A Study of Tarceva (Erlotinib) and Gemcitabine in Treatment-Naive Patients With Advanced Non-Small Cell Lung Cancer.

• Status: Completed
• Trial end date: 2009-02-01
• Target enrollment: 0
• Participant gender: All

Summary

This 2 arm study will assess the efficacy and safety of Tarceva plus gemcitabine, compared with gemcitabine alone, in the treatment of chemotherapy-naive patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva 150mg po daily plus gemcitabine on days 1, 8, 15 and every 4 weeks subsequently, or with gemcitabine monotherapy. The anticipated time on study treatment is until disease progression, and the target sample size is 100-500 individuals.

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

Details

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

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• non-small cell lung cancer, stage IIIb (with effusion) or stage IV with measurable disease ;

• ECOG PS 2;

• adequate organ function.

Exclusion Criteria:

• prior chemotherapy or systemic anti-tumor therapy;

• hypersensitivity to erlotinib;

• any condition contraindicating the use of the study medication and/or impairing the interpretation of results and/or leading to treatment-related complications.