Abstract: Objective: To compare the response rate and safety in patients with advanced non-small cell lung cancer (NSCLC) when treated with LND plus vinorelbine and cisplatin (NP) or placebo plus NP. Methods:A total of 30NSCLC pa -tients seen in our hospital between February 2006and June2007were collected and randomly assigned to the trial group or the control group. The trial group was treated with LND plus NP. Vinorelbine was administered intravenously on days
1-8, with 25mg/m2and cisplatin on days 1-3, with 80-100 mg/m2, every 3 weeks for at least 3 cycles. LND was administered orally after meal for the first 1-2 days, 150 mg/time, once a day, the first3-4 days, 150 mg/time, twice a day, the first5-21 days, 150 mg/time, 3 times a day, taking a row to the end of the trial or tumor progression. The treatment was repeated ev-ery 21days. Patients in the control group received placebo plus NP, at the same dose and route of administration as the tri-al group. The efficacy and side effects were observed. The trial endpoints included response rate (RR), clinical benefit rate (CBR), time to progression (TTP), quality of life and safety. Results: Of the 23assessable patients, the overall response rate was 36.4% in the trial group and 33.3% in the control group (P<0.05). The clinical benefit rate was 100 % in the trial group and 91.7% in the control group (P>0.05). The median TTP was 4 months and3.75months, respectively ( P>0.05). No significant difference was found in adverse effects between the two groups. After treatment, the incidence of thrombocy-topenia, anemia, constipation and fatigue was lower in the trial group ( P<0.05). The ECOG PS score in the trial group was lower than that in the control group ( P<0.05). Conclusion:NVB + DDP is safe and effective for non-small cell lung cancer. LND plus NP enhance efficacy and improve the quality of life, indicating good prospects for clinical application. Further eval-uation in clinical trials is warranted.