Zhou Qing, Chen Ming, Wu Gang, Chang Jian-Hua, Jiang Ou, Cui Jiu-Wei, Han Guang, Lin Qin, Fang Jian, Chen Gong-Yan, Wu Yi-Long
Guangdong Lung Cancer Institute, Guangdong Provincial People's Hospital and Guangdong Academy of Medical Sciences, School of Medicine, South China University of Technology, Guangzhou, China.
Zhejiang Cancer Hospital, Hangzhou, China.
Transl Lung Cancer Res. 2020 Oct;9(5):2008-2015. doi: 10.21037/tlcr-20-608.
In China, platinum-based doublet chemotherapy is the standard treatment for patients who have unresectable stage III non-small cell lung cancer (NSCLC), administered with radiotherapy on either a concurrent or sequential basis. However, NSCLC patients who undergo this treatment can expect poor median progression-free survival (PFS) of around 8-10 months and a dismal 5-year overall survival (OS) rate of about 15%. In the recent PACIFIC trial, durvalumab was demonstrated to hold significant clinical benefit for patients with locally advanced/unresectable NSCLC who experienced no disease progression after definitive concurrent chemoradiotherapy (cCRT). CS1001 is the first full-length, fully human immunoglobin G4 (IgG4) monoclonal antibody (mAb) that targets programmed death ligand-1 (PD-L1) created through the OMT transgenic rat platform. The phase Ia/Ib study indicated CS1001 was well tolerated and exhibited anti-tumor potential with a range of tumors. GEMSTONE-301 is a phase III randomized, double-blind, study to explore the efficacy and safety of CS1001 compared with a placebo as consolidation therapy for stage III unresectable NSCLC patients.
In this trial, eligible patients will be randomized to receive CS1001 1,200 mg or placebo, every 3 weeks (Q3W). The primary endpoint will be investigator-assessed PFS, based on the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. The secondary endpoints will include OS, PFS assessment based on Blinded Independent Center Review (BICR), objective response rate (ORR), other efficacy measurements, safety, and tolerability.
This phase III trial will determine the efficacy and safety of CS1001 as consolidation therapy in patients with locally advanced/unresectable (stage III) NSCLC who did not have disease progression after prior concurrent/sequential chemoradiotherapy (cCRT or sCRT), and is the first phase III trial on an anti-PD-L1 mAb initiated in China for this indication.
Version 3.0/September 12, 2019.
在中国，铂类双联化疗是不可切除的 III 期非小细胞肺癌（NSCLC）患者的标准治疗方案，同时或序贯联合放疗。然而，接受这种治疗的 NSCLC 患者中位无进展生存期（PFS）约为 8 - 10 个月，预后较差，5 年总生存率（OS）约为 15%，令人沮丧。在最近的 PACIFIC 试验中，度伐利尤单抗被证明对局部晚期/不可切除的 NSCLC 患者具有显著临床益处，这些患者在确定性同步放化疗（cCRT）后未出现疾病进展。CS1001 是首个通过 OMT 转基因大鼠平台产生的靶向程序性死亡配体 1（PD-L1）的全长、全人免疫球蛋白 G4（IgG4）单克隆抗体（mAb）。Ia/Ib 期研究表明 CS1001 耐受性良好，并在一系列肿瘤中显示出抗肿瘤潜力。GEMSTONE - 301 是一项 III 期随机、双盲研究，旨在探索 CS1001 与安慰剂相比作为 III 期不可切除 NSCLC 患者巩固治疗的疗效和安全性。
在本试验中，符合条件的患者将被随机分组，每 3 周（Q3W）接受 1200mg CS1001 或安慰剂治疗。主要终点将是研究者根据实体瘤疗效评价标准（RECIST）v1.1 评估的 PFS。次要终点将包括 OS、基于盲法独立中心评估（BICR）的 PFS 评估、客观缓解率（ORR）、其他疗效指标、安全性和耐受性。
本 III 期试验将确定 CS1001 作为巩固治疗在局部晚期/不可切除（III 期）NSCLC 患者中的疗效和安全性，这些患者在先前同步/序贯放化疗（cCRT 或 sCRT）后未出现疾病进展，并且是中国针对该适应症启动的首个关于抗 PD - L1 mAb 的 III 期试验。
版本 3.0/2019 年 9 月 12 日。
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