广州依沃西单抗注射液III期临床试验-依沃西单抗对比帕博利珠单抗一线治疗PD-L1高表达的转移性NSCLC

登记号	CTR20251989	试验状态	进行中
申请人联系人	李文婷	首次公示信息日期	2025-05-20
申请人名称	康方赛诺医药有限公司/ 康方药业有限公司

登记号	CTR20251989
相关登记号	暂无
药物名称	依沃西单抗注射液
药物类型	生物制品
临床申请受理号	企业选择不公示
适应症	PD-L1高表达的转移性非小细胞肺癌
试验专业题目	一项依沃西单抗对比帕博利珠单抗一线治疗PD-L1高表达的转移性非小细胞肺癌的随机，双盲，多地区III期临床研究(HARMONi-7)
试验通俗题目	依沃西单抗对比帕博利珠单抗一线治疗PD-L1高表达的转移性NSCLC
试验方案编号	AK112-3007	方案最新版本号	1.1
版本日期:	2025-02-28	方案是否为联合用药	否

申请人名称	[["康方赛诺医药有限公司"],["康方药业有限公司"]]
联系人姓名	李文婷	联系人座机	0760-89873925	联系人手机号
联系人Email	wenting01.li@akesobio.com	联系人邮政地址	上海市-上海市-徐汇区枫林路380号枫林国际中心A座	联系人邮编	200030

在接受一线治疗的肿瘤程序性细胞死亡配体-1(PD-L1)高表达且无驱动基因改变的转移性非小细胞肺癌(NSCLC)受试者中: 比较依沃西单抗与帕博利珠单抗的总生存期(OS) 比较独立影像评估委员会(IRRC)根据实体瘤疗效评价标准(RECIST)v1.1评估的依沃西单抗与帕博利珠单抗的无进展生存期(PFS)

试验分类	安全性和有效性	试验分期	III期	设计类型	平行分组
随机化	随机化	盲法	双盲	试验范围	国际多中心试验

年龄	18岁(最小年龄)至 无上限 (最大年龄)
性别	男+女
健康受试者	无
入选标准	[["自愿签署书面知情同意书（ICF）。"],["入组时年龄≥18周岁。"],["美国东部肿瘤协作组（ECOG）体能状态评分为0或1。"],["预期生存期≥3个月。"],["根据美国癌症联合委员会（AJCC）第8版，确诊为转移性（IV期）NSCLC。"],["经组织学或细胞学证实的鳞状或非鳞状NSCLC。"],["在符合国家规定的实验室使用批准或认可的试剂盒检测显示肿瘤PD-L1高表达。"],["根据RECIST v1.1，至少有一个可测量的非脑病灶。位于既往照射野的病灶如果放疗后明确进展，则可将这些病灶视为可测量病灶。"],["既往未接受过针对转移性NSCLC的系统性抗肿瘤治疗。"],["器官功能良好。"],["有生育能力的女性受试者在随机前或根据知情同意书中记录的地区特定指南，血清妊娠试验结果必须为阴性，并且在首次给药前尿妊娠试验结果必须为阴性。"],["与未绝育的男性伴侣发生性行为的有生育能力的女性受试者，必须同意从筛选开始至依沃西单抗/帕博利珠单抗末次给药后120 天，采取高效避孕措施。"],["未绝育的男性受试者，如与具有生育能力的女性伴侣、怀孕或哺乳期的伴侣发生性关系，必须同意在治疗期间以及依沃西单抗或帕博利珠单抗末次给药后 120 天内使用屏障避孕（男性避孕套）。有生育能力女性伴侣的男性受试者，必须确保其女性伴侣同意在治疗 期间直至依沃西单抗或帕博利珠单抗末次给药后120天内，至少使用一种高效的避孕措施。"]]
排除标准	[["经组织学或细胞病理学证实的小细胞肺癌。"],["已知的驱动基因改变（EGFR、ALK、ROS1和BRAF V600E等），这些基因改变已有一线获批疗法。对于非鳞状组织学的受试者，在随机化之前需要获得可靶向的驱动基因突变检测结果。"],["既往接受过任何针对转移性NSCLC的系统性治疗。"],["有症状的CNS转移，有出血特征的CNS转移，CNS转移灶≥1.5 cm，随机前7天内接受过CNS放疗，第一周期内可能需要CNS放疗，或患有软脑膜疾病。"],["在随机前2年内患有需要全身治疗的活动性自身免疫性或肺部疾病。"],["在随机前6个月内接受超过30 Gy的胸部放疗的受试者；在随机前4周内接受超过30 Gy的非胸部放疗的受试者，或在随机前7天内接受剂量≤30 Gy的姑息性放疗的受试者。随机前2周内接受过非特异性免疫调节治疗（如白介素、干扰素、胸腺肽、肿瘤坏死因子等，不包括用于治疗血小板减少的 IL-11）；随机前1周内曾接受具有抗肿瘤适应症的中草药或中成药。"],["随机前4周内出现重度感染；已知存在活动性肺结核（TB），怀疑有活动性 TB 的受试者，需进行临床检查排除；已知的活动性梅毒感染。"],["控制不佳的高血压，在口服降压治疗后仍反复出现收缩压≥150 mmHg或舒张压≥100 mmHg。"],["存在临床症状且未控制的胸腔积液、心包积液或腹水。 注：允许留置引流管（例如，PleurX引流导管）。"],["存在需要系统性糖皮质激素治疗的非感染性肺炎病史，或当前存在间质性肺疾病。"],["活动性或既往有炎症性肠病史（如克罗恩病、溃疡性结肠炎或慢性腹泻）。"],["已知人类免疫缺陷病毒（HIV）感染史，病毒载量未得到控制。"],["受试者若患有活动性乙型肝炎，需在随机前接受至少1个月耐受性良好的适当抗病毒治疗，且HBV DNA水平通过聚合酶链反应（PCR）检测显示稳定或下降。所有患有活动性丙型肝炎的受试者（丙型肝炎病毒[HCV]抗体呈阳性，且HCV RNA水平高于检测下 限）均被排除。"],["已知对任何研究药物的任何成分过敏；已知对其他单克隆抗体有重度超敏反应史。"],["受试者正在哺乳或计划在研究期间母乳喂养。"]]

试验药	[["中文通用名:依沃西单抗注射液 英文通用名:IvonescimabInjection 商品名称:依达方","剂型:注射剂 规格:100mg/10ml/瓶 用法用量:按方案规定使用 用药时程:按方案规定使用"]] 序号 名称 用法
对照药	[["中文通用名:帕博利珠单抗注射液 英文通用名:PembrolizumabInjection 商品名称:可瑞达","剂型:注射剂 规格:100mg/4ml/瓶 用法用量:按方案规定使用 用药时程:按方案规定使用"]] 序号 名称 用法

主要终点指标及评价时间	[["OS","首次用药至末次访视","有效性指标"],["IRRC 根据 RECIST v1.1 评估的 PFS。","首次用药至末次访视","有效性指标"]] 序号 指标 评价时间 终点指标选择
次要终点指标及评价时间	[["IRRC根据RECIST v1.1 评估的ORR、DCR和DoR","首次用药至末次访视","有效性指标"],["评价依沃西单抗的安全性和耐受性，并与帕博利珠单抗进行比较","首次用药至末次访视","安全性指标"],["评价依沃西单抗的药代动力学（PK）特征","首次用药至末次访视","有效性指标"],["评价依沃西单抗的免疫原性","首次用药至末次访视","有效性指标"]] 序号 指标 评价时间 终点指标选择

1	姓名	陈华军	学位	医学博士	职称	副主任医师
	电话	13710581145	Email	chenhuajun@gdph.org.cn	邮政地址	广东省-广州市-越秀区惠福西路123号广东省人民医院惠福院区
	邮编	510030	单位名称	广东省人民医院

[["广东省人民医院","陈华军","中国","广东省","广州市"],["广东省人民医院","吴一龙","中国","广东省","广州市"],["浙江大学医学院附属第二医院","董颖","中国","浙江省","杭州市"],["浙江省台州医院","吕冬青","中国","浙江省","台州市"],["浙江省肿瘤医院","范云","中国","浙江省","杭州市"],["云南省肿瘤医院","李高峰","中国","云南省","昆明市"],["天津市胸科医院","孙大强","中国","天津市","天津市"],["复旦大学附属中山医院","胡洁","中国","上海市","上海市"],["上海市肺科医院","任胜祥","中国","上海市","上海市"],["上海市胸科医院","钟华","中国","上海市","上海市"],["赣南医学院第一附属医院","李杰","中国","江西省","赣州市"],["江西省肿瘤医院","罗辉","中国","江西省","南昌市"],["南昌大学第一附属医院","孙龙华","中国","江西省","南昌市"],["湖南省肿瘤医院","罗永忠","中国","湖南省","长沙市"],["湖南省肿瘤医院","邬麟","中国","湖南省","长沙市"],["湖南省肿瘤医院","陈柏林","中国","湖南省","长沙市"],["哈尔滨医科大学附属肿瘤医院","刘宝刚","中国","黑龙江省","哈尔滨市"],["河南科技大学第一附属医院","张治业","中国","河南省","洛阳市"],["河南省肿瘤医院","赵艳秋","中国","河南省","郑州市"],["南阳市第二人民医院","王启船","中国","河南省","南阳市"],["新乡医学院第一附属医院","路平","中国","河南省","新乡市"],["广西医科大学第一附属医院","卜庆","中国","广西壮族自治区","南宁市"],["福建省肿瘤医院","徐海鹏","中国","福建省","福州市"],["中国医学科学院肿瘤医院","胡兴胜","中国","北京市","北京市"],["北京大学人民医院","杨帆","中国","北京市","北京市"],["温州医科大学附属第一医院","李玉苹","中国","浙江省","温州市"],["西南医科大学附属医院","林盛","中国","四川省","泸州市"],["南方医科大学珠江医院","张健","中国","广东省","广州市"],["青海大学附属医院","姜军","中国","青海省","西宁市"],["南昌大学第二附属医院","刘安文","中国","江西省","南昌市"],["青岛大学附属医院","李红梅","中国","山东省","青岛市"],["内蒙古医科大学附属医院","高俊珍","中国","内蒙古自治区","呼和浩特市"],["西安交通大学第二附属医院","杨拴盈","中国","陕西省","西安市"],["西安交通大学第二附属医院","郭卉","中国","陕西省","西安市"],["吉林省肿瘤医院","程颖","中国","吉林省","长春市"],["河北医科大学第四医院","耿楠","中国","河北省","石家庄市"],["河北医科大学第四医院","刘庆熠","中国","河北省","石家庄市"],["海南省人民医院","陈永倖","中国","海南省","海口市"],["贵州省人民医院","张瑜","中国","贵州省","贵阳市"],["常州市第一人民医院","李翀","中国","江苏省","常州市"],["安徽医科大学第一附属医院","郝吉庆","中国","安徽省","合肥市"],["齐齐哈尔市第一医院","杨铁波","中国","黑龙江省","齐齐哈尔市"],["徐州市中心医院","王翔","中国","江苏省","徐州市"],["重庆大学附属肿瘤医院","李禄椿","中国","重庆市","重庆市"],["浙江大学医学院附属邵逸夫医院","方勇","中国","浙江省","杭州市"],["郑州大学第一附属医院","黄思远","中国","河南省","郑州市"],["山东省肿瘤防治研究院","孟祥姣","中国","山东省","济南市"],["中南大学湘雅医院","李敏","中国","湖南省","长沙市"],["辽宁省肿瘤医院","刘宏旭","中国","辽宁省","沈阳市"],["成都市第三人民医院","杨懿","中国","四川省","成都市"],["山西省肿瘤医院","郭伟","中国","山西省","太原市"],["阜阳市人民医院","刘斌","中国","安徽省","阜阳市"],["宁波市医疗中心李惠利医院","吴宏成","中国","浙江省","宁波市"],["北京肿瘤医院","方健","中国","北京市","北京市"],["唐山市人民医院","王志武","中国","河北省","唐山市"],["徐州医科大学附属医院","韩正祥","中国","江苏省","徐州市"],["广西医科大学附属肿瘤医院","周韶璋","中国","广西壮族自治区","南宁市"],["包头市肿瘤医院","郭卫东","中国","内蒙古自治区","包头市"],["首都医科大学宣武医院","张毅","中国","北京市","北京市"],["重庆医科大学附属第一医院","郭述良","中国","重庆市","重庆市"],["昆明医科大学第一附属医院","董超","中国","云南省","昆明市"],["BRCR Global - Plantation, FL","Amin, Harshad","USA","Florida","Plantation"],["University of Southern California","Hsu,Robert","USA","California","Los Angeles"],["HealthPartners Cancer Research Center","Demel,Kurt","USA","Minnesota","St. Paul"],["Dana-Farber Cancer Institute","Rotow,Julia","USA","Massachusetts","Boston"],["Northwest Cancer Specialists dba Compass Oncology SCRI SITE (LEGACY USOR)","Van Ho, Anthony","USA","Washington","Vancouver"],["Oncology Assoc. of Oregon dba Willamette Valley Cancer Institute SCRI Site (Legacy USOR site)","Wang, Bo","USA","Oregon","Eugene"],["Regents of the University of Colorado, Rocky Mountain Cancer Centers SCRI / USOR Site (Legacy USOR Site)","Jotte, Robert M","USA","Colorado","Lone Tree"],["Texas Oncology Central South SCRI Site (Legacy USOR Site)","Uyeki,James","USA","Texas","Austin"],["Texas Oncology DFW ( Sammons Cancer Center) SCRI Site (Legacy USOR site)","Konduri, Kartilk","USA","Texas","Dallas"],["Florida Cancer Specialists-East (FCS East) (SCRI Site)","Gersten, Todd","USA","Florida","Sarasota"],["Zangmeister Cancer Center (SCRI Site)","Rios-Perez, Jorge","USA","Ohio","Columbus"],["Valkyrie Clinical Trials","Berz, David","USA","California","Los Angeles"],["Florida Cancer Specialists-South (FCS South) SCRI Site","Zafar, Syed","USA","Florida","Fort Myers"],["Florida Cancer Specialists-North (FCS North) SCRI Site","Bhanderi, Viralkumar","USA","Florida","St. Petersburg"],["Cancer Specialists of North Florida","Kobrinski, Daniel","USA","Florida","Jacksonville"],["BRCR Global- Tamarac, FL","Gandhi, Chintan","USA","Florida","Tamarac"],["The Oncology Institute of Hope & Innovation (California)","Ali, Sami","USA","California","Cerritos"],["Karmanos Cancer Institute","Uprety, Dipesh","USA","Michigan","Detroit"],["The Oncology Institute of Hope & Innovation (Florida)","Santos, Edgardo","USA","Florida","Fort Lauderdale"],["Genesis Cancer and Blood Institute ( SCRI Site)","Webb, Roy Timothy","USA","Arkansas","Hot Springs"],["Texas Oncology-Gulf Coast SCRI Site ( Legacy USOR Site)","Rodney, Alan","USA","Texas","Webster"],["SCRI SITE (LEGACY USOR): Oncology and Hematology Associates of SW Virginia dba Blue Ridge Cancer Care","Goldschmidt, Jerome","USA","Virginia","Blacksburg"],["Inspira Medical Center Mullica Hill","Tubb, Erev","USA","New Jersey","Mullica, Hill"],["Piedmont Cancer Institute","Feinstein, Trevor","USA","Georgia","Atlanta"],["Bioresearch Partner-Kendale Lakes","Perez-Fernandez, Javier","USA","Florida","Miami"],["MidAmerican Cancer Center","Singh, Jaswinder","USA","Missouri","Kansas City"],["BioResearch Partner-Hialeah Hospital","Rangel, Luis","USA","Florida","Hialeah"]]

序号	机构名称	主要研究者	国家	省（州）	城市

[["广东省人民医院伦理审查委员会","同意","2025-04-03"]]

序号	名称	审查结论	批准日期/备案日期

进行中（尚未招募）

目标入组人数	国内: 260 ； 国际: 780 ；
已入组人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；
实际入组总人数	国内: 登记人暂未填写该信息； 国际: 登记人暂未填写该信息；

第一例受试者签署知情同意书日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
第一例受试者入组日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；
试验完成日期	国内：登记人暂未填写该信息；     国际：登记人暂未填写该信息；