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復宏漢霖(02696.HK):漢斯狀®(斯魯利單抗注射液)聯合化療一線治療廣泛期小細胞肺癌(ES-SCLC)的日本橋接試驗完成首例患者給藥

格隆匯6月24日丨復宏漢霖(02696.HK)發佈公告,近日,一項在日本一線治療廣泛期小細胞肺癌(ES-SCLC)患者中開展的漢斯狀®(斯魯利單抗注射液)聯合化療(卡鉑 - 依託泊苷)的橋接試驗已完成首例患者給藥。本次試驗系公司依據日本藥品醫療器械綜合機構(PMDA)的2期臨牀試驗默示許可開展的橋接試驗,用於支持未來漢斯狀®於日本的上市申報。此前,一項比較漢斯狀®或安慰劑聯合化療(卡鉑 - 依託泊苷)在一線治療廣泛期小細胞肺癌(ES-SCLC)患者中開展的國際多中心3期臨牀試驗已於2021年12月達到了總生存期(OS)的主要研究終點。

本研究爲一項在日本一線治療廣泛期小細胞肺癌(ES-SCLC)患者中進行的單臂、開放、2期的橋接試驗。合格的患者將每三週接受一次漢斯狀®聯合化療(卡鉑 - 依託泊苷)治療。本研究的主要目的爲評價漢斯狀®聯合化療在日本一線治療ES-SCLC患者中的療效,次要目的爲評估漢斯狀®聯合化療的安全性、藥代動力學及免疫原性。主要研究終點爲第24周緩解(完全緩解(CR)或部分緩解(PR))率,次要研究終點包括總生存期(OS)、無進展生存期(PFS)、客觀緩解率(ORR)、緩解持續時間(DOR)、生活質量、安全性、藥代動力學和免疫原性指標。

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