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
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 |