An Open-Label, Randomized, Multicenter, Phase Iii Study Of S-1 And Cisplatin Versus Docetaxel And Cisplatin In Patients With Untreated Advanced Non-Small-Cell Lung Cancer.

8039 Background: Platinum-based doublet chemotherapy is the standard chemotherapy regimen for treatment-naive advanced Non-Small-Cell Lung Cancer (NSCLC). S-1, an oral fluoropyrimidine, combined with carboplatin or cisplatin (CDDP) has shown no less efficacy than standard platinum doublet chemotherapy in Japanese NSCLC patients. However, the effectiveness in Chinese NSCLC patients is uncertain. We aimed to compare the efficacy and safety of these chemotherapy regimens in Chinese NSCLC patients. Methods: In this study, we recruited patients aged 18-70 years with stage IIIB, IV or recurrence, histologically or cytologically confirmed NSCLC, ECOG performance status of 0-1, have at least one measurable lesion, and adequate organ function. Patients were randomized in 1:1 ratio to receive either S-1 (80–120 mg/day, PO, BID, days 1 to 21) with 60 mg/m2 CDDP on day 8 every 5 weeks (SP) or docetaxel and CDDP (both 75 mg/m2) on day 1 every 3 weeks (DP), for up to 6 cycles. The primary endpoint was progression-free ...