Gemcitabine in Combination With Either Cisplatin or Carboplatin in Treating Patients With Stage III or Stage IV Non-Small Cell Lung Cancer

OBJECTIVES: Primary * Compare the efficacy of gemcitabine in combination with 2 different doses of cisplatin vs carboplatin, in terms of survival time, in patients with stage IIIB or IV non-small cell lung cancer. Secondary * Compare symptom control and quality of life of patients treated with these regimens. * Compare response in patients treated with these regimens. * Compare the dose intensity of these regimens in these patients. * Compare the ratio of courses of treatment given as in-patient vs out-patient in these patients. * Compare the intensity and number and duration of toxic episodes in patients treated with these regimens. * Compare cost and cost-effectiveness of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to WHO performance status (0 vs 1 or 2), disease stage (IIIB vs IV), and participating center. Patients are randomized to 1 of 3 treatment arms. * Arm I: Patients receive gemcitabine IV over 30 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. * Arm II: Patients receive gemcitabine as in arm I and cisplatin (at a lower dose than in arm I) IV over 1 hour on day 1. * Arm III: Patients receive gemcitabine as in arm I and carboplatin IV over 1 hour on day 1. In all arms, treatment repeats every 21 days for 2 courses. Patients are reassessed after 2 courses. Patients with responding disease or stable disease with symptom improvement receive 2 additional courses of therapy in the absence of disease progression or unacceptable toxicity. Patients with disease progression or stable disease without symptom improvement are removed from the study. Quality of life is assessed at baseline, on day 1 of courses 2-4, at completion of study treatment, and then monthly for 6 months. After completion of study treatment, patients are followed monthly for 6 months and then periodically thereafter for survival. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: A total of 1,350 patients (450 per treatment arm) will be accrued for this study within 6 years.