Study design and treatment
non-Asia
METASTASES
GLOW is a global, randomized, double-blind, phase 3 trial. Patients were randomly assigned 1:1 to receive intravenous infusion of zolbetuximab 800 mg/mRandomization was performed by blinded site staff using interactive response technology by block randomization with block sizes of two and was stratified according to region (Asia versus non-Asia), number of organs with metastases (0–2 versus ≥3) and prior gastrectomy (yes versus no). Countries in the Asia subgroup analysis were mainland China, Japan, South Korea, Malaysia, Taiwan (province of China) and Thailand, and countries in the non-Asia subgroup analysis were Argentina, Canada, Croatia, Greece, Ireland, The Netherlands, Portugal, Romania, Spain, Turkey, UK and USA. The randomization list and study drug blinding were maintained by the interactive response technology system. The sponsor, investigators, clinical staff and patients remained blinded to treatment throughout the study. To maintain blinding, zolbetuximab and placebo, which were identical in appearance and form, were provided to investigators or designees by an unblinded pharmacist and administered in identical volumes, routes and schedules.