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

A Phase II Randomized Trial of Erlotinib or Vinorelbine in Chemo-naive, Advanced, Non-Small-Cell Lung Cancer Patients Aged 70 Years or Older in Taiwan

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.

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)