中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500103606
最近更新日期： Date of Last Refreshed on：	2025-06-03 09:17:45
注册时间： Date of Registration：	2025-06-03 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阿得贝利单抗联合化疗和瑞卡西单抗治疗免疫经治 NSCLC患者的II期临床研究
Public title：	A phase II clinical study of adebrelimab in combination with chemotherapy and recaticimab for the treatment of immune checkpoint inhibitors pretreated NSCLC patients
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阿得贝利单抗联合化疗和瑞卡西单抗治疗免疫经治 NSCLC患者的II期临床研究
Scientific title：	A phase II clinical study of adebrelimab in combination with chemotherapy and recaticimab for the treatment of immune checkpoint inhibitors pretreated NSCLC patients
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	费凯伦	研究负责人：	王志杰
Applicant：	Kailun Fei	Study leader：	Zhijie Wang
申请注册联系人电话： Applicant telephone：	+86 137 1784 3508	研究负责人电话： Study leader's telephone：	+86 10 8778 8029
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	fkl6311@163.com	研究负责人电子邮件： Study leader's E-mail：	jie_969@163.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	北京市朝阳区潘家园南里17号	研究负责人通讯地址：	北京市朝阳区潘家园南里17号
Applicant address：	17 Panjiayuan Nanli, Chaoyang District, Beijing	Study leader's address：	17 Panjiayuan Nanli, Chaoyang District, Beijing
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	中国医学科学院肿瘤医院
Applicant's institution：	Cancer Hospital Chinese Academy of Medical Sciences
研究负责人所在单位：	中国医学科学院肿瘤医院
Affiliation of the Leader：	Cancer Hospital Chinese Academy of Medical Sciences

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	25/065-5011	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	国家抗肿瘤药 GCP 中心，伦理委员会
Name of the ethic committee：	National GCP Center for Anticancer Drugs, The Independent Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2025-02-19 00:00:00
伦理委员会联系人：	薛奇
Contact Name of the ethic committee：	Qi Xue
伦理委员会联系地址：	北京市朝阳区潘家园南里 17号
Contact Address of the ethic committee：	17 Panjiayuan Nanli, Chaoyang District, Beijing P.R.China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 10 8778 8495	伦理委员会联系人邮箱： Contact email of the ethic committee：

研究实施负责（组长）单位：

中国医学科学院肿瘤医院

Primary sponsor：

Cancer Hospital Chinese Academy of Medical Sciences

研究实施负责（组长）单位地址：

北京市朝阳区潘家园南里17号

Primary sponsor's address：

17 Panjiayuan Nanli, Chaoyang District, Beijing

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	北京	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	中国医学科学院肿瘤医院	具体地址：	北京市朝阳区潘家园南里17号
Institution hospital：	Cancer Hospital Chinese Academy of Medical Sciences	Address：	17 Panjiayuan Nanli, Chaoyang District, Beijing

经费或物资来源：

无

Source(s) of funding：

None

研究疾病：

非小细胞肺癌

Target disease：

Non-small-cell lung cancer

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

II期临床试验

Study phase：

2

研究设计：

单臂

Study design：

Single arm

研究目的：

探索阿得贝利单抗联合化疗和瑞卡西单抗治疗免疫经治NSCLC患者的II期临床研究

Objectives of Study：

Exploring a Phase II Clinical Study of Adubelimab in Combination with Chemotherapy and Recamycin for the Treatment of Immune-pretreated NSCLC Patients.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

1.  Age is 18 years or older, regardless of gender.
2.  ECOG PS score of 0–1.
3.  Confirmed diagnosis of Stage IV NSCLC (AJCC 8th edition TNM classification) by histopathology or cytopathology.
4.  Patients who have progressed radiologically (assessed by RECIST v1.1) after receiving first-line treatment regimens containing immune checkpoint inhibitors (PD-1/L1) for advanced disease.
5.  Progression-free survival (PFS) of >= 6 months with first-line immune checkpoint inhibitor therapy.
6.  Presence of measurable disease (according to RECIST 1.1 criteria: tumor lesions with a long-axis diameter of >= 10 mm on CT scan, and lymph node lesions with a short-axis diameter of >= 15 mm on CT scan).
7.  Normal function of major organs, which meets the following criteria:
•  Hematological tests must meet the following criteria (within 14 days without transfusion, without the use of hematopoietic factors, and without pharmacological correction): a. ANC >=  1.8×10^9/L; b. HB >=  100 g/L; c. PLT >=  125×10^9/L.
•  Biochemical tests must meet the following criteria: a. TBIL <=  1.5×ULN; b. ALT, AST <=  2.5×ULN; serum creatinine (sCr) <=  1.5×ULN, and endogenous creatinine clearance rate >=  50 ml/min (Cockcroft-Gault formula).
8.  Women of childbearing potential must have a negative urine pregnancy test within 3 days prior to the start of study treatment and agree to use a medically accepted highly effective method of contraception (e.g., intrauterine device, oral contraceptives, or condoms) during the study period and for 180 days after the last administration of the study drug. Male participants with partners of childbearing potential must agree to use effective contraception during the study period and for 180 days after the last study drug administration.
9.  Participants voluntarily join the study, sign the informed consent form, have good compliance, and are willing to cooperate with follow-up visits.

排除标准：

1.已知EGFR敏感突变（19Exon del/21Exon L858R）、ALK/ROS1融合阳性、BRAFV600E突变、MET基因14外显子跳跃突变、RET基因融合阳性的患者； 2.首次使用研究药物前4周之内使用过免疫抑制药物，不包括喷鼻和吸入性皮质类固醇或生理剂量的系统性类固醇激素（即不超过10 mg/天强的松龙或同等药物生理学剂量的其他皮质类固醇，且停药≥1周）； 3.活动性脑转移或脑膜转移。但允许以下患者入组：既往接受过脑或脑膜转移治疗（放疗或手术），如入组前影像证实已稳定至少2周，且已停止全身性激素治疗大于2周（允许泼尼松剂量≤10mg/天或其他等效激素替代治疗）、无临床症状者；针对胸部和全脑的放疗在入组前>4周完成（骨病灶的姑息性放疗在首次给药前完成允许入组）； 4.首次给药前3周内接受过具有抗肿瘤适应症的中草药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）的系统性全身治疗 5.入组前 5 年内出现过 NSCLC 以外的恶性肿瘤； 6.首次给药前4周内或计划在研究期间接种减毒活疫苗； 7.当前正在参与干预性临床研究治疗，或在首次给药前 4 周内接受过其他研究药物或研究器械治疗；在首次给药前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即，≤1级或达到基线，不包括乏力或脱发）； 8.首次用药前4周内并发重度感染（如：需要静脉滴注抗生素、抗真菌或抗病毒药物），或在筛选期间/首次给药前出现不明原因的发热>38.5°C； 9.有或怀疑有肺炎/间质性肺病或任何会影响肺功能检查的肺部疾病病史； 10.患有任何活动性自身免疫疾病或自身免疫疾病史（如间质性肺炎、葡萄膜炎、肠炎、肝炎、垂体炎、血管炎、心肌炎、肾炎、甲状腺功能亢进、甲状腺功能降低（激素替代治疗后可纳入）；患有童年期哮喘已完全缓解且成人后无需任何干预或白癜风可纳入，需要支气管扩张剂进行医学干预的患者则不可纳入； 11.患有先天或后天免疫功能缺陷，如人类免疫缺陷病毒（HIV）感染者，活动性乙型肝炎，丙型肝炎，合并乙肝和丙肝共同感染以及酒精性肝硬化的患者； 12.患有II级以上心肌缺血或心肌梗塞、控制不良的心律失常（包括 QTc间期男性≥450ms、女性≥470ms）。按NYHA标准，III～Ⅳ级心功能不全，或心脏彩超检查提示左室射血分数（LVEF）＜50%者入组前6个月内发生过心肌梗死，纽约心脏学会II级或以上心力衰竭，未得到控制的心绞痛，未得到控制的严重室性心律失常，有临床意义的心包疾病，或者心电图提示急性缺血或活动性传导系统异常； 13.谷丙转氨酶(ALT)、天冬氨酸转氨酶(AST)超过正常值上限的2倍，或总胆红素超过正常值上限(ULN)的1.5倍；肌酸激酶(CK)超过正常值上限的3倍；有严重出血性事件或动静脉血栓事件； 14.已知异体器官移植史或异体造血干细胞移植史； 15.已知对研究药物或其辅料会产生变态反应、超敏反应或不耐受； 16.已知有精神障碍或药物滥用的患者； 17.研究者认为存在可能损害受试者或者导致受试者无法满足或执行研究要求的任何状况。

Exclusion criteria：

1. Patients with known EGFR sensitizing mutations (19Exon del/21Exon L858R), ALK/ROS1 fusion positivity, BRAF V600E mutation, MET exon 14 skipping mutation, or RET fusion positivity. 2. Use of immunosuppressive agents within 4 weeks prior to the first administration of the study drug, excluding intranasal and inhaled corticosteroids or physiologic doses of systemic corticosteroids (i.e., <= 10 mg/day of prednisolone or equivalent physiologic doses of other corticosteroids, and discontinued for >= 1 week). 3. Active brain metastases or leptomeningeal metastases. However, patients who have previously received treatment for brain or leptomeningeal metastases (radiation or surgery) are eligible if imaging confirms stability for at least 2 weeks prior to enrollment, systemic corticosteroid therapy has been discontinued for more than 2 weeks (low-dose corticosteroid replacement therapy <= 10 mg/day of prednisone or equivalent is allowed), and there are no clinical symptoms. Radiotherapy to the chest and whole brain must be completed more than 4 weeks prior to enrollment (palliative radiotherapy for bone lesions completed before the first dose is allowed). 4. Systemic treatment with traditional Chinese medicine or immunomodulatory agents (including thymosin, interferon, interleukin, excluding local use for pleural effusion control) with antitumor indications within 3 weeks prior to the first dose. 5. History of malignancies other than NSCLC within 5 years prior to enrollment. 6. Receipt of live-attenuated vaccines within 4 weeks prior to the first dose or planned during the study period. 7. Participation in another interventional clinical study treatment, or receipt of other investigational drugs or devices within 4 weeks prior to the first dose. Not fully recovered from toxicities and/or complications caused by any previous interventions (i.e., <= Grade 1 or returned to baseline, excluding fatigue or alopecia). 8. Severe infection within 4 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungal, or antiviral agents), or unexplained fever >38.5°C during the screening period or prior to the first dose. 9. History of or suspected pneumonia/interstitial lung disease, or any pulmonary condition that may affect pulmonary function tests. 10. Active autoimmune diseases or history of autoimmune diseases (e.g., interstitial pneumonia, uveitis, colitis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism (eligible if on hormone replacement therapy); childhood asthma that has been completely resolved and requires no intervention in adulthood or vitiligo are eligible; patients requiring bronchodilators for medical intervention are not eligible). 11. Congenital or acquired immune deficiencies, such as human immunodeficiency virus (HIV) infection, active hepatitis B, hepatitis C, co-infection of hepatitis B and C, or alcoholic cirrhosis. 12. Grade II or higher myocardial ischemia or myocardial infarction, uncontrolled arrhythmias (including QTc interval >= 450 ms for males, >= 470 ms for females). NYHA Class III–IV heart failure, or left ventricular ejection fraction (LVEF) <50% on echocardiogram. Myocardial infarction within 6 months prior to enrollment, NYHA Class II or higher heart failure, uncontrolled angina, uncontrolled severe ventricular arrhythmias, clinically significant pericardial disease, or ECG indicating acute ischemia or active conduction system abnormalities. 13. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) more than 2 times the upper limit of normal (ULN), or total bilirubin more than 1.5 times ULN; creatine kinase (CK) more than 3 times ULN; history of severe hemorrhagic events or arterial/venous thrombotic events. 14. History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 15. Known hypersensitivity, allergic reaction, or intolerance to the study drug or its excipients. 16. Known history of psychiatric disorders or drug abuse. 17. Any condition that the investigator deems may jeopardize the participant or prevent the participant from meeting or complying with study requirements.

研究实施时间：

Study execute time：

从 From 2025-06-15 00:00:00至 To 2028-06-15 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-06-15 00:00:00 至 To 2027-06-15 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	43
Group：	Treatment group	Sample size：	43
干预措施：	阿得贝利单抗1200mg，D1，Q3W，IV + 瑞卡西单抗 150mg，D1，Q3W，SC + 化疗	干预措施代码：
Intervention：	Adubelimab 1200 mg, Day 1, every 3 weeks (Q3W), intravenous (IV) infusion + Recamycin 150 mg, Day 1, every 3 weeks (Q3W), subcutaneous (SC) injection + chemotherapy	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	Beijing	市(区县)：
Country：	China	Province：	Beijing	City：
单位(医院)：	中国医学科学院肿瘤医院	单位级别：	三级
Institution hospital：	Cancer Hospital Chinese Academy of Medical Sciences	Level of the institution：	Tertiary

测量指标：

Outcomes：

指标中文名：	无进展生存期	指标类型：	主要指标
Outcome：	Progression-Free Survival, PFS	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	总生存期	指标类型：	次要指标
Outcome：	Overall Survival, OS	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	客观缓解率	指标类型：	次要指标
Outcome：	Objective response rate, ORR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	缓解持续时间	指标类型：	次要指标
Outcome：	Duration of Response, DoR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	疾病控制率	指标类型：	次要指标
Outcome：	Disease control rate, DCR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	安全性	指标类型：	次要指标
Outcome：	Safety	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	血液	组织：
Sample Name：	Blood	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：

最小 Min age	18	岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

无

Randomization Procedure (please state who generates the random number sequence and by what method)：

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：
Blinding：
试验完成后的统计结果（上传文件）：	点击下载
Calculated Results after the Study Completed(upload file)：	download

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	研究完成后（2027年6月）通过中国临床试验注册中心公布
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	The study results will be published through the Chinese Clinical Trial Registry after the completion of the study. (June 2027)
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	CRF
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF
数据与安全监察委员会： Data and Safety Monitoring Committee：	暂未确定/Not yet
注册人： Name of Registration：	2025-06-03 09:17:38