BACKGROUND: Inhaled chemotherapy is under investigation as an alternative therapeutic modality for Non-Small Cell Lung Cancer.METHODS: 60 NSCLC patients were randomized into 3 groups in this study. 20/60 patients (group A-control group) received I.V. chemotherapy (carboplatin AUC ≈ 5.5 D1); 20/60 (group B) received 2/3 of I.V. predicted carboplatin dose by I.V. infusion and the rest 1/3 as aerosol (jet nebulised D1); and 20/60 (group C) received all the predicted I.V. dose of carboplatin as aerosol in 3 equally divided fractions D1-3. In all patients I.V. docetaxel 100/m(2) was as well administered (D1). Lung functional tests were performed in all groups before chemotherapy in the 3rd and 6th cycles.RESULTS: Group B had a statistically significant increase in survival compared to control group A [275 days (95% CI 249-300) vs. 211 (95% CI 185-236)]. In regard to lung functional tests, a statistically significant decline was observed only in FEV1 of group C in 6 months compared to the initial measurement.CONCLUSIONS: Inhaled carboplatin could be given as an alternative root of pulmonary drug delivery in selected patients, but further randomized studies remain to prove whether the inhaled chemotherapy is an efficient and safe treatment modality.