1. Adjuvant Therapy-Free Strategy for Stage IB to IIIA Non-Small-Cell Lung Cancer Patients After Radical Resection Based on Longitudinal Undetectable Molecular Residual Disease: Prospective, Multicenter, Single-Arm Study (CTONG 2201).
- Author
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Zhang JT, Dong S, Gu WQ, Zhao N, Liang Y, Tang WF, Liu SY, Wang F, Wang GS, Peng B, Wu N, Yan S, Geng GJ, Xie ZF, Yang YL, Zhang JH, Zhang T, Yang N, Jiao WJ, Xiong YY, Cai M, Li F, Chen RR, Yan HH, Maggie Liu SY, Yi X, Zhong WZ, Yang XN, and Wu YL
- Subjects
- Humans, Chemotherapy, Adjuvant, Neoplasm Recurrence, Local drug therapy, Neoplasm, Residual drug therapy, Prospective Studies, Carcinoma, Non-Small-Cell Lung diagnosis, Carcinoma, Non-Small-Cell Lung surgery, Carcinoma, Non-Small-Cell Lung drug therapy, Lung Neoplasms diagnosis, Lung Neoplasms genetics, Lung Neoplasms surgery
- Abstract
Background: 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., Patients and Methods: 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., Conclusions: This prospective trial will contribute data to confirm the negative predictive value of MRD on adjuvant therapy for NSCLC patients., Clinical Trial Registration: NCT05457049 (CTONG 2201)., Competing Interests: Disclosure W.-Z. Zhong declares honoraria from AstraZeneca, BMS, MSD, Roche, and Innovent outside the submitted work. Y.-L. Wu declares advisory services for AstraZeneca, Boehringer Ingelheim, Novartis, and Takeda; speaker fees from AstraZeneca, Beigene, Boehringer Ingelheim, BMS, Eli Lilly, MSD, Pfizer, Roche, and Sanofi; and grants from AstraZeneca, Boehringer Ingelheim, BMS, Hengrui, and Roche outside the submitted work. The authors declare no potential conflicts of interest., (Copyright © 2023 Elsevier Inc. All rights reserved.)
- Published
- 2024
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