A Study of TS-1 Plus Cisplatin in Patients With Advanced Non-small-cell Lung Cancer

Summary

Objectives: 1. Primary Objective: To bridge the data of efficacy in term of overall response rate of TS-1 plus cisplatin in Taiwanese advanced NSCLC patients from that gained from Japanese population 2. Secondary Objectives: A. To assess progression free survival B. To assess overall survival C. To bridge the safety profile by assessing the toxicities and tolerability

Timeline

Start

2011-03

Primary completion

2015-12

Completion

2015-12

Publications

• Background Okamoto I, Yoshioka H, Morita S, Ando M, Takeda K, Seto T, Yamamoto N, Saka H, Asami K, Hirashima T, Kudoh S, Satouchi M, Ikeda N, Iwamoto Y, Sawa T, Miyazaki M, Tamura K, Kurata T, Fukuoka M, Nakagawa K. Phase III trial comparing oral S-1 plus carboplatin with paclitaxel plus carboplatin in chemotherapy-naive patients with advanced non-small-cell lung cancer: results of a west Japan oncology group study. J Clin Oncol. 2010 Dec 20;28(36):5240-6. doi: 10.1200/JCO.2010.31.0326. Epub 2010 Nov 15.
• Background Ichinose Y, Yoshimori K, Sakai H, Nakai Y, Sugiura T, Kawahara M, Niitani H. S-1 plus cisplatin combination chemotherapy in patients with advanced non-small cell lung cancer: a multi-institutional phase II trial. Clin Cancer Res. 2004 Dec 1;10(23):7860-4. doi: 10.1158/1078-0432.CCR-04-1200.

Drugs

Indications