TGRX-326 Chinese Phase II for Advanced Non-small Cell Lung Cancer (NSCLC)

This is a multi-center, single-arm, open-label, Phase II clinical trial which explores the safety and efficacy of TGRX-326 in patients with ALK-positive advanced NSCLC who have failed prior 2nd-generation ALK treatments due to progressive disease or intolerance.

NCT Number	NCT05955391
Lead Sponsor	Shenzhen TargetRx Co., Ltd. Collaborators: Sun Yat-Sen University Cancer Center, Tongji Hospital, Sichuan Cancer Hospital and Research Institute, The First Affiliated Hospital of Zhengzhou University, West China Hospital, First Affiliated Hospital of Zhejiang University, Jilin Provincial Tumor Hospital, Hunan Cancer Hospital, Shandong Cancer Hospital and Institute, Jiangxi Provincial Cancer Hospital, First Hospital of China Medical University, The Affiliated Hospital of Qingdao University, Liaoning Cancer Hospital & Institute, Haerbin Medical University Cancer Hospital, Xinxiang Central Hospital, Xiangyang Central Hospital, Mianyang Central Hospital, Zhejiang Cancer Hospital, Henan Cancer Hospital, First Affiliated Hospital, Sun Yat-Sen University, The First Affiliated Hospital of Bengbu Medical University, Cancer Hospital Chinese Academy of Medical Science, Shenzhen Center, Bingzhou Medical University Affiliated Hospital, Fujian Cancer Hospital, Ningbo No. 1 Hospital, First Affiliated Hospital Xi'an Jiaotong University, The Second Affiliated Hospital of AFMU, Yunnan Cancer Hospital, Capital Medical School Beijing Chest Hospital, Shijiazhuang People's Hospital, Tianjin Cancer Hospital, Affiliated Cancer Hospital of Guizhou Medical University, Nanchang University First Affiliated Hospital, Jingzhou First People's Hospital, Shanghai Chest Hospital
Conditions	Non-small Cell Lung Cancer
Enrollment	164 participants
Start Date	2023-01-18
Primary Completion	2024-12-29 (estimated)
Study Completion	2025-12-31 (estimated)
Updated on ClinicalTrials.gov	2025-05-18