Randomised Study Comparing Three Chemotherapy Regimens in Non-small Cell Lung Cancer

A Phase III Randomised Study Comparing Three Combination Chemotherapy Regimens in Patients With Non Pre-treated Advanced Non-small Cell Lung Cancer

The purpose of this study is to determine if cisplatin-based chemotherapy, cisplatin-gemcitabine-ifosfamide or cisplatin-docetaxel, will improve survival in comparison to the combination gemcitabine-ifosfamide in patients with advanced NSCLC

Inclusion Criteria:

• Histological or cytological diagnosis of non-small cell lung cancer
• Advanced (unresectable or functionally inoperable) stage III or stage IV disease
• Availability for participating in the detailed follow-up of the protocol
• Presence of an evaluable or measurable lesion
• Informed consent

Exclusion Criteria:

• Prior treatment with chemotherapy
• Operable patient with resectable tumour
• Performance status < 60 on the Karnofsky scale
• A history of prior malignant tumour, except non-melanoma skin cancer or in situ carcinoma of the cervix and cured malignant tumour (more than 5-year disease free interval)
• Polynuclear cells < 2,000/mm³
• Platelet cells < 100,000/mm³
• Serum bilirubin >1.5 mg/100 ml
• Serum creatinine > 1.5 mg/100 ml and/or creatinine clearance < 60 ml/min
• Perception hypoacousia
• Peripheral neuropathy
• Recent myocardial infarction (less than 3 months prior to date of diagnosis)
• Congestive cardiac failure requiring medical therapy or uncontrolled cardiac arrhythmia
• Uncontrolled infectious disease
• Serious medical or psychological factors which may prevent adherence to the treatment schedule