7119 Background: There are few data on optimal pre-operative chemotherapy (Cx) in early c-stage NSCLC. We conducted a randomized phase II trial in order to evaluate the safety and efficacy of the preoperative platinum-based doublet Cx and D monotherapy in c-stage IB/II, resectable NSCLC. Methods: Patients (pts) with pathologically documented c-stage IB/II NSCLC, performance status (PS) 0–1 and ample organ functions were eligible. Mediastinal nodes >=1cm on CT scan must be biopsied and proved to be negative via mediastinoscope. Pts were randomized to receive either two cycles of DP given q4 (q3 allowed) weeks: P 80mg/m2 and D 60mg/m2 on day 1, or, three cycles of D 70mg/m2 q3weeks. Pts went on to thoracotomy 4–5 weeks (DP) or 3–4 weeks (D) after completion of the Cx. Preoperative Cx could be stopped and switched to surgery when tumor size increased >=10% in diameter. Primary endpoint was 1-year disease-free survival (DFS) rate. Results: From Oct./02 to Nov./03, 80 pts were randomized. Median age 65 (range 30–74), M/F 62/18, c-IB/II 45/35, PS 0/1 66/14, histology Ad/Sq/Others 54/21/5 (including 1 ineligible sarcoma). As of Dec./04 monitoring, all 79 eligible pts (40 in DP and 39 in D) were reported to be treatment-off and followed up for 1 year. Cx toxicities were mainly hematologic and well tolerated. 5 pts (4 in DP, 1 in D) experienced major (>1L) intraoperative bleeding. Major post-operative morbidity was reported in 2 DP pts, which included empyema and pulmonary edema. There were 2 toxic deaths, both in DP; 1 intraoperative bleeding and 1 empyema. Efficacy endpoints are summarized in the table. P-N2 was documented in 8/39 (DP) and 9/35 (D) of the operated pts. Conclusions: These results suggest that platinum-based doublet is superior in resection rate and short-term DFS and thus should be selected as optimal preoperative Cx for future phase III trials. No significant financial relationships to disclose.