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Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC
Sponsor: Guangdong Association of Clinical Trials
Summary
This investigator-initiated study aims to evaluate the effectiveness of minimal residual disease (MRD) as a biomarker for guiding adjuvant therapy decisions in patients with Stage I non-small-cell lung cancer (NSCLC). The study will compare outcomes between an MRD-guided management group and a standard-of-care group, focusing on whether the use of MRD information can improve the 3-year disease-free survival rate compared to existing treatment protocols. Participants in the MRD-guided management group will receive targeted therapy, immunotherapy, or observation based on their postoperative MRD status, while those in the standard-of-care group will receive treatments or observation according to current clinical guidelines.
Official title: Minimal Residual Disease (MRD)-Guided Adjuvant Therapy in Stage I Non-Small Cell Lung Cancer: A Prospective, Multicenter, Randomized Controlled Study
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
342
Start Date
2024-11
Completion Date
2032-01
Last Updated
2024-11-29
Healthy Volunteers
No
Conditions
Interventions
Osimertinib
80mg daily, for EGFR-positive patients
Alectinib
600mg BID, for ALK-rearranged patients
TORIPALIMAB INJECTION (JS001 ) combine with chemotherapy
Toripalimab 240mg + Platinum-based chemotherapy (Q3W for 4 cycles), followed by Toripalimab maintenance therapy (240mg Q3W for one year), for EGFR/ALK wildtype patients
Locations (15)
Dongguan People's Hospital
Dongguan, Guangdong, China
The First People's Hospital of Foshan
Foshan, Guangdong, China
Guangdong Provincial People's Hostpital
Guangzhou, Guangdong, China
ZhuJiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
The Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology
Wuhan, Hubei, China
Hunan Cancer Hospital
Changsha, Hunan, China
Xiangya Hospital of Central South University
Changsha, Hunan, China
Jiangsu Cancer Hospital
Nanjing, Jiangsu, China
Affiliated Hospital of Nantong University
Nantong, Jiangsu, China
Sichuan Provincial People's Hospital
Chengdu, Sichuan, China
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China