First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma (ETER100): a multicentre, randomised, open-label, phase 3 trial
Citation: Zhou A, et al. Lancet Oncology. 2025 Sep;26(9):1145–1157.
Methods: ETER100 was a multicentre, randomised, open-label, phase 3 trial at 37 sites in China. Patients aged 18–80 years with previously untreated, advanced clear-cell RCC and ECOG PS 0–1 were randomised 1:1 to benmelstobart (IV 1200 mg q3w) plus anlotinib (PO 12 mg daily, weeks 1–2 of each 3-week cycle) or sunitinib (PO 50 mg daily, weeks 1–4 of each 6-week cycle). Randomisation used stratified block design by IMDC risk. Primary endpoint was PFS by blinded independent central review (RECIST v1.1) in the full analysis and per-protocol sets. Prespecified interim analysis reported (NCT04523272).
