CAPPA-2: Cisplatin Added to Gemcitabine in Poor Performance Advanced NSCLC Patients

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of advanced non small cell lung cancer, not amenable to surgical or curative radiation therapy (stage IIIB or IV); * No prior or concomitant chemotherapy (adjuvant/neoadjuvant chemotherapy permitted if concluded at least one year prior to enrollment); * ECOG performance status 2; * Age: \> or = 18 and \< 70 years; * Life expectancy at least 4 weeks; * Normal bone marrow, hepatic and renal function defined as: neutrophils \> or = 2000/mm3, PLT \> or = 100,000/mm3, Hb \> or = 10.0 g/dl, Bilirubin \> or = 1.5 times the upper normal limit (UNL), AST and ALT \< or = 3 times the UNL (5 times in the presence of liver metastases), creatinine within normal limits; * Signed informed consent. Exclusion Criteria: * Active systemic infections; * Severe concomitant illness (congestive heart failure, angina pectoris, myocardial infarction within previous 6 months, cardiac arrhythmias under treatment, severe arterial hypertension, severe or uncontrolled diabetes mellitus); * Inadequate hepatic or renal function; * Radiation therapy ongoing or concluded within two weeks prior to enrollment; * Symptomatic cerebral metastases; * Previous chemotherapy for advanced disease; * Any condition that would, in the investigator's opinion, limit the patients ability to provide informed consent or to comply with study procedures; * Pregnant or nursing females; * Any malignancy within the past 5 years (except for adequately treated carcinoma in situ of the cervix or non melanoma skin cancer)