Cetuximab in Combination With S-1 and Cisplatin in Gastric Cancer

Phase 2 Completed 40 enrolled Merck KGaA, Darmstadt, Germany

NaSingle-groupOpen-labelTreatment

Summary

This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction (GEJ) who have not previously received systemic chemotherapy for this setting. All eligible participants will receive the combination of cetuximab plus S-1 (a combination of tegafur, gimeracil, and oteracil) and cisplatin.

Timeline

Start: 2011-06
Primary completion: 2012-08
Completion: 2013-05

Outcome

Missed primary endpoint

paper The observed overall response rate according to the independent review committee was 40.0% (95% confidence interval, 24.9-56.7; P = 0.7043 [one-sided null hypothesis: overall response rate ≤ 43%]); PMID 33561262 ↗

Publications

Yamaguchi K, Fuse N, Komatsu Y, Fujii H, Hironaka S, Omuro Y, Muro K, Yasui H, Ueda S, Nishina T, Watanabe M, Ohtsu A. Phase II study of cetuximab plus S-1/cisplatin therapy in Japanese patients with advanced gastric cancer. Jpn J Clin Oncol. 2021 May 28;51(6):879-885. doi: 10.1093/jjco/hyaa276.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cetuximab	Monoclonal antibody	250 mg/m2	Intravenous
Subject	Cisplatin	Other / unclassified	60 mg/m2	Intravenous
Subject	S-1	Small molecule	40 mg/m2	Oral
Subject	S-1	Small molecule	60 mg/m2	Oral