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：	ChiCTR2600124759
最近更新日期： Date of Last Refreshed on：	2026-05-17 19:28:07
注册时间： Date of Registration：	2026-05-17 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SHR-2554用于SWI/SNF复合物蛋白失活或相关基因突变的非小细胞肺癌的探索性临床研究
Public title：	An Exploratory Clinical Study of Adebrelimab in Combination with SHR-2554 in Patients with Non-Small Cell Lung Cancer with Inactivated SWI/SNF Complex Proteins or Related Gene Mutations
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SHR-2554用于SWI/SNF复合物蛋白失活或相关基因突变的非小细胞肺癌的探索性临床研究
Scientific title：	An Exploratory Clinical Study of Adebrelimab in Combination with SHR-2554 in Patients with Non-Small Cell Lung Cancer with Inactivated SWI/SNF Complex Proteins or Related Gene Mutations
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：	26/026-5751	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：	国家癌症中心/中国医学科学院北京协和医学院肿瘤医院伦理委员会
Name of the ethic committee：	Ethics Committee of the National Cancer Center / Cancer Hospital of the Chinese Academy of Medical Sciences and Peking Union Medical College
伦理委员会批准日期： Date of approved by ethic committee：	2026-03-04 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：

评估阿得贝利单抗联合SHR-2554用于SWI/SNF复合物蛋白失活或相关基因突变NSCLC的疗效和安全性

Objectives of Study：

To evaluate the efficacy and safety of adebrelimab in combination with SHR-2554 for NSCLC with inactivated SWI/SNF complex proteins or related gene mutations

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.  Aged 18–75 years at the time of signing the informed consent form; both men and women are eligible;
2. Recurrent/metastatic NSCLC confirmed by histology or cytology;
3. EGFR/ALK-negative;
4. Previous treatment with an immune checkpoint inhibitor followed by disease progression at least 3 months later;
5. Mutations in SWI/SNF complex proteins or related genes (e.g., BRG1 [SMARCA4] deletion, BRM [SMARCA2] deletion, INI1 [SMARCB1] deletion, ARID1A deletion, etc.)
6. ECOG Performance Status (PS): 0–1;
7. Patients must have at least one measurable lesion according to RECIST 1.1 criteria;
8. Normal function of major organs, i.e., meeting the following criteria:
a) Complete blood count (CBC) (without blood transfusion or use of hematopoietic growth factors within the past 14 days): Hemoglobin (Hb) >=90 g/L; absolute neutrophil count (ANC) >= 1.5 × 10^9/L; platelets (PLT) >= 100 × 10^9/L; White blood cell count (WBC) >=4.0 × 10^9/L and <=15 × 10^9/L;
b) Biochemical tests: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 3×ULN (if liver metastases are present, <= 5×ULN); total serum bilirubin (TBIL) <= 1.5×ULN; serum creatinine (Cr) <= 1.5×ULN or creatinine clearance >= 50 mL/min;
c) Coagulation function: Activated partial thromboplastin time (APTT), International Normalized Ratio (INR), and prothrombin time (PT) ≤ 1.5×ULN;
d) Doppler ultrasound assessment: Left ventricular ejection fraction (LVEF) >= 50%;
9. Expected survival >= 3 months;
10. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 14 days prior to enrollment and must agree to use appropriate contraception during the observation period and for 3 months following the last administration of the study drug; for men, they must be surgically sterilized or agree to use appropriate contraception during the observation period and for 3 months following the last administration of the study drug;

排除标准：

1. 未经治疗的脑转移（既往接受过针对脑转移治疗[放疗或手术]者，由研究者判断已稳定至少4周，且已停止全身性激素治疗[剂量＞10mg/天泼尼松或其他等效激素]、无临床症状者可以入组）； 2. 伴有脑膜转移、脊髓压迫等； 3. 伴有临床症状的需要进行引流的胸腔积液、心包积液或腹水，或在随机前 2 周内接受过以治疗为目的的浆膜腔积液引流者； 4. 间质性肺炎病、药物诱导的肺炎、需要类固醇治疗的放射性肺炎或有临床症状的活动性肺炎或重度的肺功能障碍； 5. 活动性肺结核或筛选前≤48周内有活动性肺结核感染病史的受试者，无论是否治疗； 6. 有出血倾向或凝血功能障碍。筛选前12周内出现过有临床意义的出血症状或具有明确的出血倾向，如消化道出血、出血性胃溃疡、基线期大便潜血++及以上；当前或近期（接受首剂研究药物前10天内）使用全剂量口服或胃肠外抗凝血药或血栓溶解剂进行治疗； 7. 人类免疫缺陷病毒（HIV）感染或已知有获得性免疫缺陷综合征（艾滋病），未经治疗的活动性肝炎（乙型肝炎，定义为乙肝病毒表面抗原[HBsAg]检测结果呈阳性、HBV-DNA ＞= 500 IU/ml且肝功能异常；丙型肝炎，定义为丙肝抗体[HCV-Ab]阳性、HCV-RNA 高于分析方法的检测下限且肝功能异常）或合并乙肝和丙肝共同感染； 8. 患有任何活动性自身免疫疾病或自身免疫疾病史（包括但不限于：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； 9. 首次用药前2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℃； 10. 入组前6个月内发生的动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作、脑出血、脑梗塞）、深静脉血栓及肺栓塞等； 11. 显著临床意义的心血管疾病史者，包括但不局限于；(a) 充血性心衰（NYHA 分级＞2级）；(b) 不稳定性心绞痛；(c) 签署ICF前3个月内发生过心肌梗塞； (d) 任何需要治疗或者干预的室上性心律失常或室性心律失常； 12. 最近5年内患过或伴有其它系统恶性肿瘤，（已治愈的皮肤基底细胞癌和宫颈原位癌及卵巢癌除外）； 13. 首次给药前4周内接种过预防疫苗或减毒疫苗； 14. 已知对任何研究药物或其辅料过敏者； 15. 妊娠、哺乳期患者，有生殖能力的患者不愿意采取有效的避孕措施； 16. 既往有明确的神经或精神障碍史，包括癫痫和痴呆； 17. 无法吞咽研究药物的患者，如存在慢性腹泻（包括但不限于肠易激综合症，Crohn's 病，溃疡性结肠炎）和肠梗阻等影响药物服用和吸收的多种因素； 18. 研究者认为不适合纳入的其他情况。

Exclusion criteria：

1. Untreated brain metastases (patients who have previously received treatment for brain metastases [radiotherapy or surgery] may be enrolled if the investigator determines that the disease has been stable for at least 4 weeks, systemic hormonal therapy [dose > 10 mg/day of prednisone or other equivalent hormones] has been discontinued, and the patient is asymptomatic); 2. Accompanied by meningeal metastases, spinal cord compression, etc.; 3. Clinical symptoms associated with pleural effusion, pericardial effusion, or ascites requiring drainage, or those who have undergone therapeutic drainage of serous cavity effusions within 2 weeks prior to randomization; 4. Interstitial pneumonia, drug-induced pneumonia, radiation pneumonitis requiring steroid treatment, or active pneumonia with clinical symptoms or severe pulmonary dysfunction; 5. Active pulmonary tuberculosis or a history of active pulmonary tuberculosis infection within ≤48 weeks prior to screening, regardless of treatment status; 6. A tendency to bleed or coagulation disorders. Clinically significant bleeding events within 12 weeks prior to screening or a clear tendency to bleed, such as gastrointestinal bleeding, hemorrhagic gastric ulcer, or baseline fecal occult blood test result of ++ or higher; current or recent (within 10 days prior to receiving the first dose of study drug) treatment with full-dose oral or parenteral anticoagulants or thrombolytic agents; 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); untreated active hepatitis (hepatitis B, defined as a positive hepatitis B surface antigen [HBsAg] test result, HBV-DNA ≥ 500 IU/ml, and abnormal liver function; hepatitis C, defined as positive hepatitis C antibodies [HCV-Ab], HCV-RNA above the lower limit of detection of the assay method, and abnormal liver function) or co-infection with hepatitis B and hepatitis C; 8. Patients with any active autoimmune disease or a history of autoimmune disease (including but not limited to: uveitis, enteritis, hepatitis, hypophysitis, vasculitis, myocarditis, nephritis, hyperthyroidism, hypothyroidism [eligible if on hormone replacement therapy]); Patients with childhood asthma that has completely resolved and requires no intervention in adulthood, or those with vitiligo, may be included; however, patients requiring medical intervention with bronchodilators are ineligible; 9. Severe infection within 2 weeks prior to the first dose (e.g., requiring intravenous antibiotics, antifungal, or antiviral medications), or unexplained fever >38.5°C occurring during screening or prior to the first dose; 10. Arterial or venous thromboembolic events occurring within 6 months prior to enrollment, such as cerebrovascular accidents (including transient ischemic attacks, cerebral hemorrhage, and cerebral infarction), deep vein thrombosis, and pulmonary embolism; 11. History of clinically significant cardiovascular disease, including but not limited to: (a) congestive heart failure (NYHA class > 2); (b) unstable angina; (c) myocardial infarction occurring within 3 months prior to signing the ICF; (d) any supraventricular or ventricular arrhythmia requiring treatment or intervention; 12. History of or concurrent malignant neoplasms in other systems within the past 5 years (excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, and ovarian cancer); 13. Receipt of a prophylactic or attenuated vaccine within 4 weeks prior to the first dose; 14. Known hypersensitivity to any study drug or its excipients; 15. Pregnant or lactating patients, or patients of childbearing potential who are unwilling to use effective contraception; 16. History of definite neurological or psychiatric disorders, including epilepsy and dementia; 17. Patients unable to swallow the study drug, such as those with chronic diarrhea (including but not limited to irritable bowel syndrome, Crohn’s disease, and ulcerative colitis) or intestinal obstruction, and other factors affecting drug administration and absorption; 18. Other conditions deemed ineligible for inclusion by the investigator.

研究实施时间：

Study execute time：

从 From 2025-12-31 00:00:00至 To 2028-12-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-05-20 00:00:00 至 To 2028-05-19 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	20
Group：	Treatment group	Sample size：	20
干预措施：	SHR-2554，口服给药，350 mg，bid，Q3W + 阿得贝利单抗，1200mg，静脉滴注，每3周为1个给药周期，每周期第1天给药	干预措施代码：
Intervention：	SHR-2554, oral administration, 350 mg, twice daily, every 3 weeks + adebelizumab, 1200 mg, intravenous infusion, with each 3-week period constituting one treatment cycle; administered on Day 1 of each cycle	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

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

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	Progression-Free Survival, PFS	Type：	Secondary 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：	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：	无	组织：
Sample Name：	None	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	75	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）：	研究公开发表后6月内通过ResMan http/ww.medresman.org.cn/login.aspx 共享原始数据，可通过联系研究者fkl6311@163.com征得同意后使用。
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	Research published after 6 months by ResMan http/ww.medresman.org.cn/login.aspx share the raw data, can be used after researchers by contacting fkl6311@163.com consent.
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：	EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	EDC
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：	2026-05-17 19:27:51