A Study of BPI-7711 Capsule in Non-small Cell Lung Cancer Patients

Summary

A randomized, double-blind, positive controlled phase III study to evaluate the efficacy and safety of BPI-7711 capsule in locally advanced or recurrent/metastatic treatment-naïve non-small cell lung cancer patients with EGFR mutation

Timeline

Start

2021-04-30

Primary completion

2023-11-30

Completion

2025-12-30

Outcome

Met primary endpoint

paper Median MICR-assessed progression-free survival was 19·3 months (95% CI 13·8-22·1) in the rezivertinib group and 9·6 months (8·4-11·3) in the gefitinib group (hazard ratio [HR] 0·48, 95% CI 0·36-0·63; p<0·0001) PMID 39914443 ↗

Publications

• Yang S, Zhao Y, Sun M, Bi M, Zhu B, Chen Z, Yu H, Zhang L, Wu L, Zhou R, Yao W, Li X, Han Z, Wang K, Wang L, Wen M, Guo Y, Lin Y, Sun S, Guo S, Yi T, Zhao W, Yu Z, Qin J, Pan Y, He Z, Ye F, Shi H, Fang J, Ma R, Lu H, Zhang H, Shi J, Gao J, Cui J, Li M, Yi S, Cang S, Shu Y, Zhang D, Peng J, Gao F, Wang T, Zhou A, Shi Y. Rezivertinib in EGFR-Mutated Non-Small Cell Lung Cancer Patients with Central Nervous System Metastasis: Central Nervous System Efficacy from the Phase III REZOR Study. Cancer Commun (Lond). 2026 Mar 31;46:0018. doi: 10.34133/cancomm.0018. eCollection 2026.
• Shi Y, Guo Y, Li X, Wu L, Chen Z, Yang S, Bi M, Zhao Y, Yao W, Yu H, Wang K, Zhao W, Sun M, Zhang L, He Z, Lin Y, Shi J, Zhu B, Wang L, Pan Y, Shi H, Sun S, Wen M, Zhou R, Guo S, Han Z, Yi T, Zhang H, Cang S, Yu Z, Zhong D, Cui J, Fang J, Gao J, Li M, Ma R, Jiang M, Qin J, Shu Y, Ye F, Hu S, Li W, Lu H, Yang M, Yi S, Zhang Y, Fan Y, Ji H, Liu Z, Wang H, Zhou X, Zhang D, Peng J, Shen H, Gao F, Wang T, Zhou A. Rezivertinib versus gefitinib as first-line therapy for patients with EGFR-mutated locally advanced or metastatic non-small-cell lung cancer (REZOR): a multicentre, double-blind, randomised, phase 3 study. Lancet Respir Med. 2025 Apr;13(4):327-337. doi: 10.1016/S2213-2600(24)00417-X. Epub 2025 Feb 3.

Drugs

Indications