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

• Status: Completed
• Trial end date: 2010-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will compare the efficacy and safety of Tarceva (erlotinib) and vinorelbine in chemo-naive elderly patients with advanced non-small cell lung cancer. Patients will be randomized to receive either Tarceva (150 mg po daily) or vinorelbine (60 mg/m2 on days 1 and 8 of cycle 1 and 80 mg/m2 for the other 21 days cycles). The anticipated time on study treatment is until disease progression.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Adult patients, >=70 years of age

• Non-small cell lung cancer

• Naive to prior chemotherapy or specific immunotherapy

• Presence of at least 1 measurable lesion

Exclusion Criteria:

• Active non-controlled infection or disease

• CNS metastases

• Any other malignancies (other than adequately treated basal cell cancer of skin, or in situ cancer of the cervix)