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：	ChiCTR2600116542
最近更新日期： Date of Last Refreshed on：	2026-01-12 15:09:23
注册时间： Date of Registration：	2026-01-12 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	芦康沙妥珠单抗联合ICI新辅助治疗可切除IIIA-IIIB（N2）NSCLC的单臂、单中心、II期临床研究
Public title：	Sacituzumab tirumotecan plus Immune Checkpoint Inhibitor as Neoadjuvant Therapy for Resectable Stage IIIA–IIIB (N2) Non-small-cell Lung Cancer: A Single-arm, Single-center, Phase II Trial
注册题目简写：
English Acronym：
研究课题的正式科学名称：	芦康沙妥珠单抗联合ICI新辅助治疗可切除IIIA-IIIB（N2）NSCLC的单臂、单中心、II期临床研究
Scientific title：	Sacituzumab tirumotecan plus Immune Checkpoint Inhibitor as Neoadjuvant Therapy for Resectable Stage IIIA–IIIB (N2) Non-small-cell Lung Cancer: A Single-arm, Single-center, Phase II Trial
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：	王振	研究负责人：	吕镗烽
Applicant：	Zhen Wang	Study leader：	Tangfeng Lv
申请注册联系人电话： Applicant telephone：	+86 135 1511 6632	研究负责人电话： Study leader's telephone：	+86 138 1452 0736
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：	wangzhensdu@163.com	研究负责人电子邮件： Study leader's E-mail：	lvtangfeng1972@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：	中国江苏省南京市玄武区中山东路305号	研究负责人通讯地址：	中国江苏省南京市玄武区中山东路305号
Applicant address：	No. 305 Zhongshan East Road, Xuanwu District, Nanjing, Jiangsu, China	Study leader's address：	No. 305 Zhongshan East Road, Xuanwu District, Nanjing, Jiangsu, China
申请注册联系人邮政编码： Applicant postcode：	210002	研究负责人邮政编码： Study leader's postcode：	210002
申请人所在单位：	中国人民解放军东部战区总医院
Applicant's institution：	The General Hospital of the Eastern Theater Command of the People's Liberation Army of China
研究负责人所在单位：	中国人民解放军东部战区总医院
Affiliation of the Leader：	The General Hospital of the Eastern Theater Command of the People's Liberation Army of China

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：	2025DZKY-061-01	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：	中国人民解放军东部战区总医院临床研究伦理委员会
Name of the ethic committee：	Clinical Research Ethics Committee of the Eastern Theater Command General Hospital of the People's Liberation Army of China
伦理委员会批准日期： Date of approved by ethic committee：	2025-06-04 00:00:00
伦理委员会联系人：	吴琼
Contact Name of the ethic committee：	Wu Qiong
伦理委员会联系地址：	中国江苏省南京市玄武区中山东路305号
Contact Address of the ethic committee：	No. 305 Zhongshan East Road, Xuanwu District, Nanjing, Jiangsu, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 25 8086 3234	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：

中国人民解放军东部战区总医院

Primary sponsor：

The General Hospital of the Eastern Theater Command of the People's Liberation Army of China

研究实施负责（组长）单位地址：

中国江苏省南京市玄武区中山东路305号

Primary sponsor's address：

No. 305 Zhongshan East Road, Xuanwu District, Nanjing, Jiangsu, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	中国人民解放军东部战区总医院	具体地址：	中国江苏省南京市玄武区中山东路305号
Institution hospital：	The General Hospital of the Eastern Theater Command of the People's Liberation Army of China	Address：	No. 305 Zhongshan East Road, Xuanwu District, Nanjing, Jiangsu, China

经费或物资来源：

南京大学

Source(s) of funding：

Nanjing University

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：

通过临床试验评估芦康沙妥珠单抗联合特瑞普利单抗在可切除IIIA-IIIB (N2)期NSCLC新辅助治疗中的疗效和安全性，基于患者的肿瘤特征、免疫状态等因素，分析影响疗效的可能因素，为进一步的个体化治疗提供理论依据。

Objectives of Study：

To evaluate the efficacy and safety of neoadjuvant treatment with ruconatuzumab combined with toripalimab in patients with resectable IIIA-IIIB (N2) non-small cell lung cancer (NSCLC), analyze the factors affecting the efficacy based on tumor characteristics, immune status and other factors, and provide theoretical basis for further individualized treatment.

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. Subjects voluntarily participated in clinical research; Fully understand and informed the study and sign the informed consent form (ICF); Be willing to follow and be able to complete all trial procedures;
2. Male or female subjects aged 18-75 years old (including the cut-off) at the time of signing the ICF;
3. Confirm negative for epidermal growth factor receptor (EGFR) sensitive mutations, anaplastic lymphoma kinase (ALK), or proto-oncogene tyrosine protein kinase ROS (ROS1) rearrangement;
4. Histologically or cytologically confirmed stage IIIA-IIIB (N2) NSCLC (International Association for the Study of Lung Cancer and American Joint Committee on Classification of Cancer 8th Edition TNM staging of lung cancer), which can tolerate complete resection of lung cancer;
5. No previous systemic treatment;
6. At least one measurable target lesion, as assessed by the investigator according to RECIST v1.1, within 4 weeks before the first dose;
Patients must provide eligible tumor tissue for PD-L1 (Dako 22C3) and TROP2 IHC testing;
8. ECOG PS score of 0-1;
9. Expected survival time >=12 weeks;
10. Both hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) are negative. If HBsAg was positive or HBcAb was positive, hepatitis B virus DNA (HBV-DNA) had to be less than 2500 copies per milliliter or 500 IU per milliliter. Subjects with negative HCV antibody or negative HCV-RNA were eligible for enrollment. If HCV-RNA is positive, subjects must have alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <=3×ULN to be enrolled. Subjects with co-infection of hepatitis B and C (positive for HBsAg or HBcAb and positive for anti-HCV) were excluded.
11. Good vital organ function, defined as no blood transfusion, albumin, recombinant human thrombopoietin, or colony-stimulating factor (CSF) therapy within 14 days before the first dose of this study;
12. Female subjects must have a negative serum pregnancy test within 3 days before treatment, and agree to take effective contraceptive measures during and after treatment for 6 months, and refrain from breastfeeding during treatment; Male patients had to consent to use contraception during treatment.
13. Male patients had to: agree to abstain from sex (avoid heterosexual intercourse) or to use contraception as follows: if the partner was a woman of reproductive age or was pregnant, male patients had to either abstain from sex or use condoms to prevent embryonic exposure to the drug during the study treatment and for at least 6 months after the last dose of the study drug. Regular abstinence (e.g., calendar day, ovulation, basal body temperature, or postovulatory contraception) and in vitro ejaculation are ineligible methods of contraception.

排除标准：

1. 其他病理组织学类型的非小细胞肺癌受试者，包括鳞腺混合癌受试者、含小细胞肺癌及神经内分泌癌等成份的NSCLC受试者； 2. EGFR敏感性突变或ALK、ROS1基因重排的受试者； 3. 已知知对研究药物或其任何成分过敏； 4. 已知患有脑膜转移、脑干转移、脊髓转移和/或压迫、活动性或未经局部治疗的中枢神经系统（CNS）转移受试者。对于既往接受过局部治疗的脑转移受试者，如果在用药前至少4周临床稳定并且至少14天内无需使用糖皮质激素或抗惊厥药物可允许入组； 5. 首次给药前14天内，出现任何需要全身性抗感染治疗的活动性感染，或受试者在筛选期的COVID-19感染RT-PCR检测呈阳性。有COVID-19感染史的受试者在首次给药前的RT-PCR检测必须呈阴性； 6. 首次给药前6个月内发生过心肌梗塞、控制不良的心律失常（包括QTc间期男性≥450 ms，女性≥470 ms）（QTc间期以Fridericia公式计算）；或按照NYHA标准的III-IV级心功能不全或心脏彩超检查左心室射血分数<50%；或需要临床干预的胸腔积液、心包积液或腹水； 7. 受试者存在不可控或症状性高钙血症（>1.5 mmol/L离子钙或钙>12 mg/dL或校正血清钙>ULN）； 8. 既往和筛选时有间质性肺炎、尘肺、放射性肺炎、药物相关性肺炎、肺功能严重受损等经研究者判断可能会干扰可疑的药物相关肺毒性的检测和处理的受试者； 9. 乙肝患者[乙肝表面抗原（HBsAg）阳性且检测HBV-DNA提示有病毒复制]；或丙肝患者[丙型肝炎病毒（HCV）抗体阳性且检测HCV-RNA提示有病毒复制]；或梅毒筛查阳性（特异性抗体检测阳性，非特异性抗体检测阴性且结合临床判断确证为非活动期感染者除外）；或已知人类免疫缺陷病毒（HIV）阳性病史或HIV筛查阳性； 10. 受试者存在已知活动性或疑似自身免疫性疾病。处于稳定状态，不需要全身免疫抑制剂治疗的受试者允许入组； 11. 5年内或同时患有其他活动性恶性肿瘤。已治愈达到5年以上的局限性肿瘤，如皮肤基底细胞癌、皮肤鳞癌、浅表膀胱癌、前列腺原位癌、宫颈原位癌和乳腺原位癌等可以入组。 12. 首次给药前28天内接种活疫苗或减毒疫苗者或在研究期间有接种此类疫苗的计划；但用于季节性流感的灭活病毒疫苗允许使用； 13. 首次给药前3个月内接受过根治性放射治疗； 14. 受试者既往曾接受以TROP2为靶点的治疗或拓扑异构酶Ⅰ抑制剂的治疗，或之前用抗PD-1、抗PD-L1、抗PD-L-2或抗CTLA-4抗体，或任何其他特异性靶向T细胞共刺激或检查点途径的抗体或药物进行治疗 15. 手术和/或放疗未能根治性治疗的脊髓压迫受试者； 16. 存在深静脉血栓、正在使用抗凝抗或血小板治疗或既往因使用抗血管生成药物而引发深静脉血栓或严重出血者； 17. 血压控制不佳者（控制不佳定义为：在最佳高血压治疗方案下血压仍≥160/100mmHg）； 18. 首次给药前28天内，接受过重大手术（本研究的重大手术定义：术后至少需要3周恢复时间，才能够接受本研究治疗的手术）； 19. 正在参加其他临床研究，或筛选前3个月内或5个半衰期内（以更长的为准）参与过其他任何临床试验（包括药物和器械等）且接受干预者； 20. 准备进行或既往接受过器官或骨髓移植的患者； 21. 受试者已知有精神类药物滥用或吸毒史； 22. 有记录的重度干眼综合征，重度睑板腺疾病和或睑缘炎，或存在妨碍延迟角膜愈合的角膜疾病病史； 23. 患有活动性慢性炎症性肠病、胃肠道梗阻、严重溃疡、胃肠穿孔、腹腔脓肿或急性胃肠道出血的受试者； 24. 既往抗肿瘤治疗的毒性尚未恢复至≤ 1级； 25. 存在需要类固醇治疗的（非感染性）间质性肺病（ILD）或非感染性肺炎病史，目前有ILD或非感染性肺炎，或筛选时存在无法经影像学检查排除的可疑ILD或非感染性肺炎； 26. 研究者认为具有任何不宜参加此试验因素的受试者。

Exclusion criteria：

1. Other histopathological types of non-small cell lung cancer (NSCLC), including squamous cell carcinoma mixed with adenocarcinoma, NSCLC with components of small cell lung cancer and neuroendocrine carcinoma; 2. Patients with EGFR sensitizing mutations or ALK or ROS1 gene rearrangements; 3. Known allergy to the study drug or any of its components; 4. Subjects with known central nervous system (CNS) metastases with leptomeningeal metastases, brainstem metastases, spinal cord metastases and/or compression, active or no local treatment. Patients with brain metastases who had received local treatment were allowed if they had been clinically stable for at least 4 weeks before treatment and were free from the use of glucocorticoids or anticonvulsants for at least 14 days. 5. Any active infection requiring systemic anti-infective therapy within 14 days before the first dose or a positive RT-PCR test for COVID-19 infection during the screening period. Subjects with a history of COVID-19 infection had to have a negative RT-PCR test before the first dose. 6. Myocardial infarction with uncontrolled arrhythmias (including QTc interval >=450 msec in men or >=470 msec in women) within 6 months before the first dose (QTc interval calculated with Fridericia's formula); Or grade III-IV cardiac dysfunction according to the New York Heart Association (NYHA) standard or left ventricular ejection fraction <50% by echocardiography; Or pleural effusion, pericardial effusion or ascites requiring clinical intervention; 7. Uncontrolled or symptomatic hypercalcemia (>1.5 mmol/L ionized calcium or calcium >12 mg/dL or corrected serum calcium >ULN); 8. Subjects with interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, and severe pulmonary function impairment in the past or during screening, which may interfere with the detection and treatment of suspected drug-related pulmonary toxicity according to the investigator's judgment; 9. Patients with hepatitis B [hepatitis B surface antigen (HBsAg) positive and detection of HBV-DNA suggesting viral replication]; Or patients with hepatitis C (positive for hepatitis C virus (HCV) antibody and detection of HCV-RNA suggesting viral replication); Or syphilis screening positive (except specific antibody test positive, nonspecific antibody test negative and clinical judgment confirmed as inactive infection); Or a known history of human immunodeficiency virus (HIV) positivity or screening positive for HIV; 10. The subject has a known active or suspected autoimmune disease. Subjects who were in a stable state and did not require systemic immunosuppressive therapy were allowed to enroll. 11. Other active malignancies within 5 years or at the same time. Localized tumors that had been cured for more than 5 years, such as skin basal cell carcinoma, skin squamous cell carcinoma, superficial bladder cancer, prostate cancer in situ, cervical cancer in situ, and breast cancer in situ, were eligible for inclusion. 12. Persons who received live or attenuated vaccine within 28 days before the first dose or who have plans to receive such vaccine during the study period; However, inactivated virus vaccines for seasonal influenza are permitted; 13. Received radical radiotherapy within 3 months before the first dose; 14. Subjects had previously received Trop2-targeted therapy or topoisomerase I inhibitor therapy, or had been previously treated with anti-PD-1, anti-PD-L1, anti-PD-L-2, or anti-CTLA-4 antibodies or any other antibody or agent specifically targeting T cell costimulation or checkpoint pathways 15. Subjects with spinal cord compression that could not be cured by surgery and/or radiotherapy; 16. Patients with deep vein thrombosis, current anticoagulant or platelet therapy, or previous use of antiangiogenic drugs to cause deep vein thrombosis or severe bleeding; 17. Patients with poorly controlled blood pressure (poorly controlled defined as blood pressure ≥160/100 MMHG despite optimal hypertension treatment); 18. Had undergone major surgery within 28 days before the first dose (major surgery for this study was defined as a procedure requiring at least 3 weeks of recovery before being able to undergo study treatment); 19. Participants who are participating in other clinical studies or who have participated in any other clinical trials (including drugs, devices, etc.) and received interventions within 3 months or 5 half-lives before screening, whichever is longer; 20. Patients who are scheduled for or have previously received organ or bone marrow transplantation; 21. Subjects were known to have a history of psychotropic drug abuse or drug use; 22. A documented history of severe dry eye syndrome, severe meibomian gland disease and or blepharitis, or a corneal disease that prevents delayed corneal healing; 23. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcer, gastrointestinal perforation, abdominal abscess, or acute gastrointestinal bleeding; 24. Toxicity from previous antineoplastic therapy has not recovered to grade 1 or less; 25. A history of (noninfectious) interstitial lung disease (ILD) or noninfectious pneumonia requiring steroid therapy, current ILD or noninfectious pneumonia, or suspected ILD or noninfectious pneumonia at screening that could not be ruled out by imaging studies; 26. Subjects with any factors considered by the investigator to be ineligible for participation in the trial.

研究实施时间：

Study execute time：

从 From 2025-12-01 00:00:00至 To 2030-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-02 00:00:00 至 To 2028-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	34
Group：	Experimental group	Sample size：	34
干预措施：	患者接受1次静脉芦康沙妥珠单抗芦康沙妥珠单抗 4mg/kg+特瑞普利单抗3mg/kg Q2W，共4周期	干预措施代码：
Intervention：	Patients receive one intravenous dose of Sacituzumab tirumotecan 4 mg/kg plus toripalimab 3 mg/kg every 2 weeks for a total of 4 cycles.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	江苏	市(区县)：
Country：	China	Province：	Jiangsu	City：
单位(医院)：	中国人民解放军东部战区总医院	单位级别：	三甲
Institution hospital：	The General Hospital of the Eastern Theater Command of the People's Liberation Army of China	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	病理学完全缓解率	指标类型：	主要指标
Outcome：	Pathological complete response rate, pCR	Type：	Primary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	主要病理缓解率	指标类型：	次要指标
Outcome：	Main pathological remission rate, MPR	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无事件生存期	指标类型：	次要指标
Outcome：	Event-free survival period	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	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	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）：	2030-12-31，wangzhensdu@163.com
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	2030-12-31,wangzhensdu@163.com
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：	病例记录表及电子管理系统
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form and an electronic data capture
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：	2026-01-12 15:09:18