MILES-3: Cisplatin in Combination With Gemcitabine for Elderly Patients With Lung Cancer

Randomized Phase III Study of the Addition of Cisplatin in Combination With Gemcitabine as First-line Therapy for Elderly Patients With Advanced Non Small Cell Lung Cancer.

The purpose of this study is to evaluate the addition of cisplatin to first-line chemotherapy with gemcitabine in elderly patients with non small cell lung cancer in terms of overall survival.

Inclusion Criteria:

• Cytological or histological diagnosis of non small-cell lung cancer (NSCLC)
• Stage III B or Stage IV disease
• Age > or = 70 years
• ECOG Performance status 0 or 1
• Patient at first diagnosis or with recurrence after primary surgery
• At least one target or non-target lesion according to RECIST criteria
• Life expectancy of at least 3 months
• Neutrophils > 1500/mm3, platelets > 100,000/mm3, hemoglobin > 10g/dl
• Creatinine < 1.5 x the upper normal limit
• AST and ALT < 2.5 x the upper normal limits (< 5 x the upper normal limit in the presence of hepatic metastasis)
• Bilirubin < 1.5 x the upper normal limit
• Signed informed consent

Exclusion Criteria:

• Previous chemotherapy for advanced disease
• History of malignant neoplasm within the previous 5 years (not including non-melanoma skin carcinoma and in-situ carcinoma of the uterine cervix, provided they are being adequately treated)
• Symptomatic cerebral or spinal cord metastasis
• Myocardial infarct within the last 12 months
• Systemic disease not controlled with treatment (active infection, cardiovascular, hepatic, renal or metabolic) that would not, in the opinion of the investigator, permit the patient to undergo chemotherapy.
• Known or suspected hypersensitivity to any of the drugs used in the study
• Medical or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or give informed consent