Abstract：
BACKGROUND: In the AEGEAN trial, neoadjuvant durvalumab plus platinum-based chemotherapy (D+CT) followed by adjuvant durvalumab, versus neoadjuvant chemotherapy alone, significantly improved pathological complete response (pCR) rate and event-free survival (EFS) in patients with resectable NSCLC. In the PACIFIC trial, consolidation durvalumab significantly improved progression-free (PFS) and overall survival (OS) for patients with unresectable stage III NSCLC after chemoradiotherapy. Strong pathological and clinical outcomes with chemoimmunotherapy have generated interest in its use to enable patients with borderline-resectable NSCLC to undergo surgery. Additionally, for patients initially deemed resectable but who later become unresectable/inoperable during neoadjuvant treatment, consolidation immunotherapy after chemoradiotherapy should be explored.
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.
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.
摘要：
背景：在AEGEAN试验中，新辅助durvalumab加铂类化疗（D+CT），然后辅助durvalumab，与单独的新辅助化疗相比，可切除NSCLC患者的病理完全缓解（pCR）率和无事件生存期（EFS）显着提高。在太平洋试验中，巩固durvalumab显着改善了化疗后无法切除的III期NSCLC患者的无进展生存期（PFS）和总生存期（OS）。化学免疫疗法的强烈病理和临床结果引起了人们对其使用的兴趣，以使具有临界可切除NSCLC的患者能够接受手术。此外,对于最初认为可切除但后来在新辅助治疗期间无法切除/无法手术的患者，应探索放化疗后的巩固免疫治疗。
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。
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。
