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

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

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* Histologically or cytologically confirmed non-small cell lung cancer.
* The ECOG score of performance status is 0-1.
* Locally advanced or recurrent metastatic NSCLC that has never received systemic treatment.
* According to RECIST1.1 criteria, there is at least 1 measurable lesion that has not been previously irradiated.
* Prior to enrollment, a central laboratory testing report has confirmed that the tumor has one of two common EGFR mutations positive that are sensitive to EGFR-TKI therapy, accompanied with or not accompanied with other EGFR mutation, with the exception of exon 20 insertion.

Exclusion Criteria:

* Previously received systemic treatment for locally advanced or recurrent metastatic cancer.
* Primary T790M mutation-positive patient.
* Previous interstitial lung disease, drug-induced interstitial lung disease, radiation pneumonia requiring hormonal therapy, or any clinically proven active interstitial lung disease.
* Known active infections such as hepatitis B, hepatitis C, and human immunodeficiency virus.
* Local radiation therapy is carried out within 1 week; more than 30% bone marrow radiation therapy or extensive radiation therapy is performed within 4 weeks.
* ≤ 4 weeks from major surgery or ≤ 2 weeks from minor surgery.

• DERIVEDYang 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. PMID 41924561
• DERIVEDShi 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. PMID 39914443