作者
Jiatao Zhang,Song Dong,Weizhong Gu,Ning Zhao,Yi Liang,Wen‐Fang Tang,Shuoyan Liu,Rui Wang,Guang-Suo Wang,Bin Peng,Nan Wu,Yan Shi,Guannan Geng,Zefeng Xie,Yanjie Yang,Jianhua Zhang,Tao� Zhang,Ning Yang,Wenjie Jiao,Yuanyuan Xiong,Chao‐Yu Miao,Fang Li,Rongrong Chen,Hong‐Hong Yan,Si‐Yang Maggie Liu,Xin Yi,Wen‐Zhao Zhong,Xue‐Ning Yang,Yi‐Long Wu
摘要
The utility of circulating tumor DNA to monitor molecular residual disease (MRD) has been clinically confirmed to predict disease recurrence in non-small cell lung cancer (NSCLC) patients after radical resection. Patients with longitudinal undetectable MRD show a favorable prognosis and might not benefit from adjuvant therapy.The CTONG 2201 trial is a prospective, multicenter, single-arm study (ClinicalTrials.gov identifier, NCT05457049), designed to evaluate the hypothesis that no adjuvant therapy is needed for patients with longitudinal undetectable MRD. Pathologically confirmed stage IB-IIIA NSCLC patients who have undergone radical resection will be screened. Only patients with 2 consecutive rounds of undetectable MRD will be enrolled (first at days 3-10, second at days 30 ± 7 after surgery), and admitted for imaging and MRD monitoring every 3 months without adjuvant therapy. The primary endpoint is the 2-year disease-free survival rate for those with longitudinal undetectable MRD. The recruitment phase began in August 2022 and 180 patients will be enrolled.This prospective trial will contribute data to confirm the negative predictive value of MRD on adjuvant therapy for NSCLC patients.NCT05457049 (CTONG 2201).