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NCT06709274
NA

Minimal Residual Disease Guiding Adjuvant Therapy in Stage I NSCLC

Sponsor: Guangdong Association of Clinical Trials

View on ClinicalTrials.gov

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

Interventions

DRUG

Osimertinib

80mg daily, for EGFR-positive patients

DRUG

Alectinib

600mg BID, for ALK-rearranged patients

DRUG

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