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)