A Study of Tarceva (Erlotinib) in Combination With Platinum Based Chemotherapy in Patients With Non-Small Cell Lung Cancer.

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy and safety of sequential administration of Tarceva and gemcitabine/platinum chemotherapy in patients with stage IIIb/IV non-small cell lung cancer. Patients will be randomized to receive Tarceva (150 mg po) or placebo on days 15-28 of a 4 week cycle of intravenous platinum-based chemotherapy, for a total of 6 cycles. The anticipated time on study treatment is until disease progression or unacceptable toxicity.

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

Details

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

Criteria

Inclusion Criteria:

• adult patients, >=18 years of age;

• histologically documented advanced or recurrent stage IIIB or IV non-small cell lung cancer;

• measurable disease;

• no previous chemotherapy for non-small cell lung cancer.

Exclusion Criteria:

• unstable systemic disease;

• any other malignancies in the last 5 years.