REGARD: The pivotal phase III trial for CYRAMZA monotherapy (N=355)¹

A multicenter, randomized, placebo-controlled, double-blind trial of patients with locally advanced or metastatic gastric OR GEJ adenocarcinoma previously treated with fluoropyrimidine- or platinum-containing chemotherapy*


Trial schematic

ECOG=Eastern Cooperative Oncology Group; PS=performance status; BSC=best supportive care.

Major Efficacy Outcome Measure: Overall survival (OS)

Supportive Efficacy Outcome Measure: Progression-free survival (PFS)

  • The REGARD trial did not include or exclude patients based on any specific biomarker2

*Patients received prior platinum/fluoropyrimidine combination therapy (81%), fluoropyrimidine-containing regimens without platinum (15%), or platinum-containing regimens without fluoropyrimidine (4%).

85% of patients received prior first-line chemotherapy for metastatic disease and 15% received prior adjuvant chemotherapy.

Stratification factors: Weight loss over prior 3 months(≤10% vs >10%), geographic region, and location of primary tumor.

  1. CYRAMZA (ramucirumab) [package insert]. India, Eli Lilly & Company (India) Pvt. Ltd.
  2. Supplement to: Fuchs CS, Tomasek J, Yong CJ, et al; REGARD Trial Investigators. Ramucirumab monotherapy for previously treated advanced gastric or gastro-oesophageal junction adenocarcinoma (REGARD): an international, randomised, multicentre, placebo-controlled, phase 3 trial. Lancet. 2014;383:31-39.