METHODS: MDT-BRIDGE (NCT05925530) is a multicenter, phase II, non-randomized study in ∼140 patients with EGFR/ALK wild-type, stage IIB-IIIB (N2) NSCLC. Following baseline multidisciplinary team (MDT) assessment to determine resectable/borderline-resectable status, all patients receive 2 cycles of neoadjuvant D+CT every 3 weeks, followed by MDT reassessment of resectability. Patients deemed resectable receive 1-2 additional cycles of D+CT followed by surgery (Cohort 1). Patients deemed unresectable receive standard-of-care chemoradiotherapy (Cohort 2). Cohort 1 patients who become ineligible for surgery can enter Cohort 2. Following surgery or chemoradiotherapy, patients receive adjuvant or consolidation durvalumab for 1 year. The primary endpoint is resection rate in all patients. Additional endpoints include resection rates by baseline resectable/borderline-resectable status, resection outcomes, EFS/PFS, OS, pCR rate, circulating tumor DNA dynamics pre- and post-surgery (including correlation with clinical outcomes), and safety.
CONCLUSIONS: Enrollment began in February 2024; primary completion is anticipated in April 2026.
方法:MDT-BRIDGE(NCT05925530)是一个多中心,第二阶段,~140例EGFR/ALK野生型患者的非随机研究,IIB-IIIB(N2)期非小细胞肺癌。在基线多学科小组(MDT)评估以确定可切除/临界可切除状态之后,所有患者每3周接受2个周期的新辅助D+CT,其次是MDT重新评估可切除性。认为可切除的患者接受1-2个额外的D+CT周期,然后进行手术(队列1)。认为不可切除的患者接受标准护理放化疗(队列2)。不符合手术条件的队列1患者可以进入队列2。手术或放化疗后,患者接受durvalumab辅助治疗或巩固治疗1年.主要终点是所有患者的切除率。其他终点包括基线可切除/临界可切除状态的切除率,切除结果,EFS/PFS,操作系统,pCR率,手术前后循环肿瘤DNA动力学(包括与临床结果的相关性),和安全。
结论:报名于2024年2月开始;预计在2026年4月完成初选。