Efficacy Study of GEMOX Combination and Vinorelbine in NSCL Patients

Inclusion Criteria: * Non-small cell bronchopulmonary cancer established by histological and/or cytological methods; * Advanced or metastatic disease (stage IIIB or IV); * At least one measurable lesion with one dimension (\>= 20 mm by CT scan or \>=10 mm by CT scan) outside of the irradiated area; * No prior chemotherapy; * Previous radiotherapy permitted as long as there has been a washout period of at least 4 weeks; * Age \>= 18 years old; * ECOG Performance Status (PS): 0-1; * Life expectancy \>3 months; * Hepatic and renal functions and blood count satisfactory: * Blood counts: white blood cells \>= 3.0 x 10\^9/l, neutrophils \>= 1.5 x 10\^9/l, platelets \>= 150 x 10\^9/l, haemoglobin \>= 9 g/dl, * Hepatic function: bilirubin within the limit of the normal upper value, aspartate transaminases (AST) or alanine transaminases (ALT) \<= 2.5 times the normal upper value * Renal function: creatinine clearance (calculated according to Cockroft and Gault) \>= 40 ml/min; * Patients of reproductive age must use an effective contraceptive method; * Informed consent form signed before any procedure undertaken connected with the study Exclusion Criteria: * Pregnant or breastfeeding patient; * Past record of other cancers (excluding basocellular or epidermoid cutaneous carcinoma or cured carcinoma of the cervix); * Symptomatic cerebral or leptomeningeal metastases; * Symptomatic peripheral neuropathy \> 1 (NCI-CTC grade); * Presence of a serious disease or medical condition incompatible with the study (at the discretion of the investigator); * Treatment with another test product or participation in another therapeutic trial in the 4 weeks preceding inclusion in the study; * Concomitant treatment by any other anticancer therapy; * Concomitant treatment with phenytoin. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.