Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, Guangdong, China.
Department of Thoracic Surgery, The First People's Hospital of Foshan, Guangdong, China.
Clin Lung Cancer. 2024 Jan;25(1):e1-e4. doi: 10.1016/j.cllc.2023.09.008. Epub 2023 Oct 6.
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).
循环肿瘤 DNA 用于监测分子残留疾病 (MRD) 的实用性已在临床得到证实，可以预测非小细胞肺癌 (NSCLC) 患者根治性切除术后的疾病复发。纵向检测不到 MRD 的患者预后良好，可能不需要辅助治疗。
CTONG 2201 试验是一项前瞻性、多中心、单臂研究（ClinicalTrials.gov 标识符，NCT05457049），旨在评估纵向检测不到 MRD 的患者不需要辅助治疗的假设。将对接受根治性切除的病理证实为 IB-IIIA 期 NSCLC 的患者进行筛选。只有连续 2 轮检测不到 MRD 的患者才会被纳入（第一轮在术后 3-10 天，第二轮在术后 30±7 天），并在没有辅助治疗的情况下每 3 个月进行影像学和 MRD 监测。主要终点是纵向检测不到 MRD 的患者的 2 年无病生存率。招募阶段于 2022 年 8 月开始，将纳入 180 名患者。
这项前瞻性试验将提供数据来证实 MRD 对 NSCLC 患者辅助治疗的阴性预测价值。
NCT05457049（CTONG 2201）。
