思路迪医药股份(01244):恩维达®非小细胞肺癌新辅助╱辅助治疗III期临床研究提前完成入组

智通财经
May 21

智通财经APP讯,思路迪医药股份(01244)发布公告,本公司与康宁杰瑞生物制药(股票代码:9966.HK)共同开发的恩维达®(通用名:恩沃利单抗注射液,研发代号:KN035)用于可切除非小细胞肺癌(NSCLC)患者新辅助╱辅助治疗的随机、对照、双盲、多中心III期临床研究(研究编号:KN035-CN-017)已提前完成入组。

本次III期临床研究由天津医科大学肿瘤医院王长利教授担任主要研究者,在全国约60家临床研究中心开展,计划入组约390例可切除III期非小细胞肺癌患者,实际入组人数符合研究方案要求,已提前完成入组工作。该研究的核心目的是评估恩维达®联合含铂双药化疗对比安慰剂联合含铂双药化疗,用于可切除III期非小细胞肺癌患者新辅助╱辅助治疗的有效性和安全性,研究终点包括无事件生存期 (EFS)、主要病理学缓解(MPR)率和完全病理学缓解(pCR)率等。

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