辉瑞Sigvotatug Vedotin启动III期临床适应症为PD-L1高表达的非小细胞肺癌

新浪财经08-28

药物临床试验登记与信息公示平台数据显示，Pfizer Inc./ 辉瑞投资有限公司/ BSP Pharmaceuticals S.p.A.的一项在PD-L1高表达（≥ 50% 的肿瘤细胞表达PD-L1）、局部晚期、不可切除或转移性非小细胞肺癌研究参与者中评估Sigvotatug Vedotin与帕博利珠单抗联合治疗相比帕博利珠单抗单药治疗作为一线治疗的开放性、随机、对照III期研究已启动。临床试验...

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辉瑞投资有限公司/ BSP Pharmaceuticals S.p.A.的一项在PD-L1高表达（≥ 50% 的肿瘤细胞表达PD-L1）、局部晚期、不可切除或转移性非小细胞肺癌研究参与者中评估Sigvotatug Vedotin与帕博利珠单抗联合治疗相比帕博利珠单抗单药治疗作为一线治疗的开放性、随机、对照III期研究已启动。临床试验登记号为CTR20253393，首次公示信息日期为2025年8月28日。该试验药Sigvotatug Vedotin剂型为注射用浓缩粉针，用法用量为静脉输注，1.8 mg/kg AiBW，每42天为一个周期的第1、15和29天(Q2W)，直至患者符合出组条件；帕博利珠单抗剂型为注射溶液，用法用量为静脉输注，400 mg，每42天为一个周期的第1天 (Q6W)，最长使用18个周期。本次试验主要目的为证明Sigvotatug Vedotin + 帕博利珠单抗在延长OS和BICR评估的PFS方面优于帕博利珠单抗单药；次要目的包括比较两组间BICR评估的客观缓解率，评价其他有效性指标，评估安全性和耐受性特征，以及评估联合给药时的药代动力学和免疫原性。Sigvotatug Vedotin为生物制品，适应症为PD-L1高表达的非小细胞肺癌。非小细胞肺癌是最常见的肺癌类型，包括腺癌、鳞癌等。症状有咳嗽、咯血、胸痛等。诊断依靠影像学检查和病理活检，治疗有手术、放化疗、靶向及免疫治疗等。本次试验主要终点指标包括OS；BICR使用RECIST v1.1评估的PFS。次要终点指标包括BICR使用RECIST v1.1评估的已确认ORR；研究者评估的PFS、已确认ORR、DOR及BICR评估的DOR；不良事件(AE) 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辉瑞Sigvotatug Vedotin启动III期临床 适应症为PD-L1高表达的非小细胞肺癌

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辉瑞Sigvotatug Vedotin启动III期临床适应症为PD-L1高表达的非小细胞肺癌