Abstract：
There is still a substantial need of more treatment options for patients with limited-stage small cell lung cancer (LS-SCLC). The standard therapy for LS-SCLC is platinum-based doublet chemotherapy administered concurrently with thoracic radiotherapy (cCRT). In China, sequential chemoradiotherapy (sCRT) is also a common practice. However, the disease inevitably progresses in most patients despite the curative intent and initial response.
Sugemalimab is an anti-programmed death ligand-1 (PD-L1) antibody that improved clinical outcomes for patients with stage III non-small cell lung cancer after cCRT or sCRT. The SUPPASS study is a phase II/III, randomized, double-blind, placebo-controlled, multicenter study (NCT05623267) that aims to investigate the efficacy and tolerability of sugemalimab as consolidation therapy in patients with LS-SCLC who have no progression following cCRT or sCRT. Approximately 346 patients will be randomized in a 1:1 ratio to receive sugemalimab 1200 mg or placebo every 3 weeks for up to 12 months. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include overall survival (OS), landmark PFS rate, landmark OS rate, objective response rate and safety. Longitudinal molecular residual disease (MRD) testing will be performed as preplanned exploratory analysis.
Study results will help demonstrate the efficacy and tolerability of anti-PD-L1 antibody consolidation therapy in LS-SCLC patients who have not progressed following cCRT or sCRT, and help determine the clinical implications of MRD in LS-SCLC.
Sugemalimab is an anti-programmed death ligand-1 (PD-L1) antibody that improved clinical outcomes for patients with stage III non-small cell lung cancer after cCRT or sCRT. The SUPPASS study is a phase II/III, randomized, double-blind, placebo-controlled, multicenter study (NCT05623267) that aims to investigate the efficacy and tolerability of sugemalimab as consolidation therapy in patients with LS-SCLC who have no progression following cCRT or sCRT. Approximately 346 patients will be randomized in a 1:1 ratio to receive sugemalimab 1200 mg or placebo every 3 weeks for up to 12 months. The primary endpoint is progression-free survival (PFS). Key secondary endpoints include overall survival (OS), landmark PFS rate, landmark OS rate, objective response rate and safety. Longitudinal molecular residual disease (MRD) testing will be performed as preplanned exploratory analysis.
Study results will help demonstrate the efficacy and tolerability of anti-PD-L1 antibody consolidation therapy in LS-SCLC patients who have not progressed following cCRT or sCRT, and help determine the clinical implications of MRD in LS-SCLC.
摘要：
背景：对于局限期小细胞肺癌（LS-SCLC）患者，仍然需要更多的治疗选择。LS-SCLC的标准疗法是基于铂的双重化疗，同时进行胸部放疗（cCRT）。在中国,序贯放化疗（sCRT）也是一种常见的做法。然而,尽管有治愈意图和初始反应,但大多数患者的疾病不可避免地进展.
方法：Sugemalimab是一种抗程序性死亡配体-1（PD-L1）抗体，可改善cCRT或sCRT后III期非小细胞肺癌患者的临床预后。SUPPASS研究是II/III阶段，随机化，双盲,安慰剂对照,多中心研究（NCT05623267），旨在研究Sugemalimab作为巩固治疗在cCRT或sCRT后无进展的LS-SCLC患者中的疗效和耐受性。大约346名患者将以1：1的比例随机分配，每3周接受Sugemalimab1200mg或安慰剂，为期12个月。主要终点是无进展生存期（PFS）。关键次要终点包括总生存期(OS)，具有里程碑意义的PFS率，具有里程碑意义的操作系统速率，客观反应率和安全性。纵向分子残留病（MRD）测试将作为预先计划的探索性分析进行。
结论：研究结果将有助于证明抗PD-L1抗体巩固治疗在cCRT或sCRT后未进展的LS-SCLC患者中的疗效和耐受性，并帮助确定MRD在LS-SCLC中的临床意义。
方法：Sugemalimab是一种抗程序性死亡配体-1（PD-L1）抗体，可改善cCRT或sCRT后III期非小细胞肺癌患者的临床预后。SUPPASS研究是II/III阶段，随机化，双盲,安慰剂对照,多中心研究（NCT05623267），旨在研究Sugemalimab作为巩固治疗在cCRT或sCRT后无进展的LS-SCLC患者中的疗效和耐受性。大约346名患者将以1：1的比例随机分配，每3周接受Sugemalimab1200mg或安慰剂，为期12个月。主要终点是无进展生存期（PFS）。关键次要终点包括总生存期(OS)，具有里程碑意义的PFS率，具有里程碑意义的操作系统速率，客观反应率和安全性。纵向分子残留病（MRD）测试将作为预先计划的探索性分析进行。
结论：研究结果将有助于证明抗PD-L1抗体巩固治疗在cCRT或sCRT后未进展的LS-SCLC患者中的疗效和耐受性，并帮助确定MRD在LS-SCLC中的临床意义。
