Randomized Trial With Vinorelbine and Gemcitabine Versus Docetaxel and Gemcitabine in Patients With Non-Small Cell Lung Cancer

Inclusion Criteria: * Histologically or cytologically confirmed, unresectable locally advanced (stage IIIB with pleural effusion) and/or metastatic (stage IV) NSCLC * No previous therapy for advanced/metastatic NSCLC is allowed * Age \> 18 years * Bidimensionally measurable disease * Performance status (WHO) 0-2 * Adequate liver (serum bilirubin \< 1.5 times the upper normal limit (UNL); AST and ALT \< 2.5 times the UNL in the absence of demonstrable liver metastases, or \< 5 times the UNL in the presence of liver metastases); adequate renal function (serum creatinine \< 1.5 times the UNL); and bone marrow (neutrophils ≥ 1.5x 109 /L, and platelets ≥ 100x 109 /L) function * Previous radiotherapy, either in the adjuvant setting or for the treatment of metastatic disease is allowed provided that the measurable lesions are outside the radiation fields * Life expectancy of more than 3 months * Patient able to take oral medication * At least 4 weeks since prior radiotherapy * Written informed consent Exclusion Criteria: * Active infection * History of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias) * Malnutrition (loss of ≥ 20% of the original body weight) * Performance status: 3-4 * Sensor or motor neuropathy \> grade I * Second primary malignancy, except for non-melanoma skin cancer * Psychiatric illness or social situation that would preclude study compliance * Pregnant or lactating women * Known, symptomatic central nervous system metastases