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Backbround. In this Phase I/II trial, the maximumtolerateddose (MTD) and activity of cisplatin plusvinorelbine (VRL) administered in continuous infusionas first-line treatment of advanced non smallcell lung cancer (NSCLC) was determined in 12consecutive chemotherapy-naive patients with advancedNSCLC.Patients and methods. The dose of cisplatin was100 mg/m2 in all patients, and vinorelbine was administeredas an initial intravenous (iv) bolus of 8mg/m2 on day 1 followed by a 4-day continuous ivinfusion at 4 different 24 h dose levels (DLs) to berepeated every 21 days. All 12 patients (47 cycles)were evaluable for response and toxicity.Results. The MTD was 8 mg/m2 bolus followed by acontinuous iv infusion of 8 mg/m2 per day over 4days. The dose limiting toxicities (DLT) were febrileneutropenia in 4 patients and grade 3 mucositis in 1patient. There was less neuro-toxicity and comparedto the weekly bolus scheme. There was nosignificant cumulative toxicity after 3 cycles. Partialresponses were observed in 6 patients; an overall responserate of 50% (95% CI: 30-65%). Median time toprogression was 5,5 months (95% CI: 1,5-11 months)and median survival was 11 months (95% CI: 5-20months).Conclusions. The results demonstrate that, in thissetting of first-line treatment of NSCLC, cisplatinplus vinorelbine at 8 mg/m2 bolus followed by acontinuous infusion of 8 mg/m2 per day over 4 daysis the recommended schedule. Further trials wouldbe useful to establish activity of this combination