Exploring the Mechanism of Primary Resistance to Third-generation EGFR-TKIs as First-line Treatment in EGFR-positive Advanced NSCLC (PRECISE Study)

Lung cancer is currently the world's largest malignant tumor for cancer-related deaths with non-small cell lung cancer (NSCLC) accounting for 80%-85%. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs), especially the 3rd-generation EGFR-TKIs have demonstrated strong antitumor effects in EGFR-positive patients. However, approximately 20% of EGFR-positive were primarily resistant to 3rd generation EGFR-TKIs, i.e., clinical non-response or disease progression in the short term. This study aimed to clarify the molecular indicators that predict the benefits of 3-rd EGFR-TKIs as first-line therapy in NSCLCpatients with EGFR-positive. Further, to clarify their primary drug resistance mechanisms, which is of great significance for the treatment and clinical decision-making of NSCLC disease.

NCT Number	NCT05598528
Lead Sponsor	Second Xiangya Hospital of Central South University Collaborators: Xiangya Hospital of Central South University, Shanghai Chest Hospital, West China Hospital, Hunan Cancer Hospital, The Third Xiangya Hospital of Central South University, The First Affiliated Hospital of Xiamen University, Second Affiliated Hospital, Zhejiang University, School of Medicine, China-Japan Friendship Hospital, Fudan University, First Affiliated Hospital of Kunming Medical University, Loudi Central Hospital, ZhuZhou Central Hospital, Xiangtan Central Hospital, First People's Hospital of Chenzhou, Yueyang Central Hospital, Yongzhou Central Hospital, The First Affiliated Hospital of University of South China, Hunan Provincial People's Hospital, Shaoyang Central Hospital, Yiyang Central Hospital, Changsha Central Hospital, The First People's Hospital of Guiyang, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Renmin Hospital of Wuhan University, The First People's Hospital of Changde City, Zhuzhou Second Hospital, First Hospital of Changsha, Hengyang Central Hospital, Huaihua first people's Hospital, The First People's Hospital of Xiangtan, University of South China Affiliated Nanhua Hospital, Xiangxi Autonomous Prefecture People's Hospital, People's Hospital of Zhangjiajie, Second People's Hospital Of Huaihua, Hunan Academy of Traditional Chinese Medicine Affiliated Hospital, The Third Hospital of Changsha, Xiangya Changde Hospital, Changsha County first People's Hospital, Hunan Provincial Straight Hospital of Traditional Chinese Medicine, Liuyang Hospital of traditional Chinese Medicine, Second People's Hospital of Hunan, First Affiliated Hospital of Guangxi Medical University, Guiyang Public Health Treatment Center, The Affiliated Bethune Hospital of Shanxi Medical University, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine, Tongji Hospital, The First Affiliated Hospital of Nanchang University
Conditions	Lung Cancer, Non-small Cell, EGFR Gene Mutation, EGFR-TKI Resistant Mutation, Primary Resistance, Circulating Tumor DNA
Enrollment	210 participants
Start Date	2021-09-28
Primary Completion	2025-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2024-12-02