7691 Background: NVB i.v. with CDDP has reported an optimal activity/tolerance ratio when used in combination with RT. The new oral formulation of NVB should be easier to use assuming a similar activity profile. An international phase II trial with NVBo + CDDP as induction followed by NVBo+CDDP+RT was implemented in order to evaluate the efficacy of this combination. Methods: Patients (pts) between 18 and 70 years, with histologically proven untreated locally advanced inoperable stage IIIA/IIIB (supraclavicular LN and pleural effusion excluded) NSCLC, adequate bone marrow, hepatic and renal function, KPS ≥ 80% were treated with NVBo D1,8 60 mg/m2 cycle 1 and 80 mg/m2 cycle 2 (if no haematological/non-haematological grade 3–4 toxicity) and CDDP 80 mg/m2 every 3 weeks for 2 cycles as induction. OR/NC pts received NVBo D1,8 40 mg/m2 and CDDP 80 mg/m2 every 3 weeks for 2 more cycles and RT 66 Gy in 6.5 weeks. Results: Between 12/01 and 12/03 54 pts were enrolled; stages IIIA 48%, IIIB 52%; squamous 59%; median age 57 years (range 41;71), median KPS 100% (range 80; 100%) 7% pts ≥ 5% weight loss at baseline. RDI of NVBo/CDDP were 86%/93% and 97%/98% at induction and in combination with RT, respectively. Forty-one pts (76%) during induction increased NVBo from 60 to 80 mg/m2. Reasons for non- escalation: haematological 7 pts, non-haematological 2, mistake 4. After 2 cycles of CT induction, OR (ITT) in the 54 pts was 37%. Toxicity during induction: G3–4 Neutropenia (28%), febrile neutropenia (7%), G3 nausea (11%), G3–4 vomiting (9%), G3 anorexia (4%) G4 diarrhoea (2%); G3 constipation (2%). Forty-seven out of 54 pts received CT-RT. Median RT delivered dose: 66 Gy. Tolerance: 9% G3 Neutropenia; no G3/4 oesophagitis; 2% G3 radiation dermatitis. Late pulmonary fibrosis 1 pt. One month after CT-RT completion the overall RR (ITT) in the 54 pts was 54% (95% CI: 40%; 67%). Median PFS/OS: 12.5 (95% CI: 9.6; 16.4) /23.4 (95% CI: 17.6; 29.8) months, respectively. Conclusion: NVB Oral with CDDP is effective in stage IIIA/IIIB pts. The excellent tolerance profile allowed to complete the CT/RT treatment in 94% of pts. NVB oral is a new and promising option which facilitates the concomitant administration of CT/RT. [Table: see text]