drugset / Trial / NCT04523272
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus sunitinib in subjects with advanced renal cancer.
Timeline
- Start
- 2020-08-25
- Primary completion
- 2025-06
- Completion
- 2025-12
Outcome
Met primary endpoint
paper median progression-free survival was significantly longer with benmelstobart plus anlotinib than with sunitinib PMID 40907513 ↗
Publications
- Li J, Tian H, Xu H, Yan X, Tang B, Li S, Zhou L, Wu X, Chi Z, Cui C, Si L, Guo J, Sheng X. Evaluation and analysis of renal injury in patients with advanced renal cell carcinoma receiving first-line benmelstobart plus anlotinib: results from the ETER100 study. BMC Med. 2026 Jul 1. doi: 10.1186/s12916-026-05026-0. Online ahead of print.
- Zhou A, Shen P, Li J, Qu W, Wang Z, Ren X, Li Y, Jiang S, Li G, Zeng Y, Qin W, Wu J, Chen P, Zhou F, Guo H, Ji Z, Wang Y, He Z, Wu J, Shi B, Liu L, Yao X, Ma L, Liu Z, Gou X, Fu B, Wang S, Jiang K, Chong T, Tu X, Zhang X, Yu D, Rexiati M, Xue X, Fei J, Wan J, Jia L, He Y, Cui T, Yang AQ, Guo J, Sheng X. First-line benmelstobart plus anlotinib versus sunitinib in advanced renal cell carcinoma (ETER100): a multicentre, randomised, open-label, phase 3 trial. Lancet Oncol. 2025 Sep;26(9):1145-1157. doi: 10.1016/S1470-2045(25)00343-2.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Benmelstobart | Monoclonal antibody | 1200 mg | Intravenous |
| Subject | Catequentinib | Small molecule | 12 mg | Oral |
| Comparator | Sunitinib | Small molecule | 50 mg | Oral |