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：	ChiCTR2600126107
最近更新日期： Date of Last Refreshed on：	2026-06-03 17:18:22
注册时间： Date of Registration：	2026-06-03 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安罗替尼用于晚期二线WT NSCLC治疗的单臂、II期临床研究
Public title：	Sacituzumab Tirumotecan Plus Anlotinib in Advanced Second-Line Wild-Type NSCLC: A Single-Arm, Phase II Study
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安罗替尼用于晚期二线WT NSCLC治疗的单臂、II期临床研究
Scientific title：	Sacituzumab Tirumotecan Plus Anlotinib in Advanced Second-Line Wild-Type NSCLC: A Single-Arm, Phase II Study
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：	徐凌	研究负责人：	徐凌
Applicant：	Ling Xu	Study leader：	Ling Xu
申请注册联系人电话： Applicant telephone：	+86 551 6362 2603	研究负责人电话： Study leader's telephone：	+86 551 6362 2603
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：	xuling810628@126.com	研究负责人电子邮件： Study leader's E-mail：	xuling810628@126.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：	安徽省合肥市蜀山区绩溪路397号	研究负责人通讯地址：	安徽省合肥市蜀山区绩溪路397号
Applicant address：	No. 397 Jixi Road, Shushan District, Hefei City, Anhui Province	Study leader's address：	No. 397 Jixi Road, Shushan District, Hefei City, Anhui Province
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：	安徽省胸科医院
Applicant's institution：	Anhui Chest Hospital
研究负责人所在单位：	安徽省胸科医院
Affiliation of the Leader：	Anhui Chest Hospital

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：	KJ2025-071	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：	安徽省胸科医院医学研究伦理委员会
Name of the ethic committee：	Medical Research Ethics Committee of Anhui Chest Hospital
伦理委员会批准日期： Date of approved by ethic committee：	2025-09-04 00:00:00
伦理委员会联系人：	原洪旭
Contact Name of the ethic committee：	HongxuYuan
伦理委员会联系地址：	安徽省合肥市蜀山区绩溪路397号
Contact Address of the ethic committee：	No. 397 Jixi Road, Shushan District, Hefei City, Anhui Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 551 6363 5591	伦理委员会联系人邮箱： Contact email of the ethic committee：	ahsxkyyjg@163.com

研究实施负责（组长）单位：

安徽省胸科医院

Primary sponsor：

Anhui Chest Hospital

研究实施负责（组长）单位地址：

安徽省合肥市蜀山区绩溪路397号

Primary sponsor's address：

No. 397 Jixi Road, Shushan District, Hefei City, Anhui Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	安徽	市(区县)：
Country：	China	Province：	Anhui	City：
单位(医院)：	安徽省胸科医院	具体地址：	安徽省合肥市蜀山区绩溪路397号
Institution hospital：	Anhui Chest Hospital	Address：	No. 397 Jixi Road, Shushan District, Hefei City, Anhui Province

经费或物资来源：

吴阶平医学基金会

Source(s) of funding：

Wu Jieping Medical Foundation

研究疾病：

肺癌

Target disease：

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：

研究目标一：探索芦康沙妥珠单抗联合安罗替尼在晚期二线WT NSCLC患者中的疗效是本研究的首要研究目标。研究目标二：探索芦康沙妥珠单抗联合安罗替尼在晚期二线WT NSCLC患者中的安全性与耐受性是本研究的重要研究目标。研究目标三：探索芦康沙妥珠单抗联合安罗替尼在晚期二线WT NSCLC患者中的疗效生物标志物是本研究的第三个研究目标。

Objectives of Study：

Primary Objective: To evaluate the efficacy of Sacituzumab Tirumotecan combined with Anlotinib in patients with advanced second-line wild-type non-small cell lung cancer (WT NSCLC). Secondary Objective: To assess the safety and tolerability of Sacituzumab Tirumotecan combined with Anlotinib in patients with advanced second-line WT NSCLC. Exploratory Objective: To explore the efficacy biomarkers of Sacituzumab Tirumotecan combined with Anlotinib in patients with advanced second-line WT NSCLC.

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 > = 18 years old, open to both men and women;
2. Locally advanced (stage IIIB/IIIC), metastatic (stage IV) NSCLC driver genes (no EGFR, ALK, ROS1, etc.) confirmed histologically or cytologically confirmed incurable surgical resection and unresponsive to radical simultaneous/sequential chemoradiotherapy;
3. Disease progression after at least one line of platinum-based chemotherapy combined with anti-PD-(L)1 therapy; and at least 4 weeks after the most recent radiotherapy;
4. ECOG physical condition score 0-1;
5. At least one measurable lesion (RECIST 1.1 criteria);
6. Expected survival > = 12 weeks;
7. Possesses adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor therapy within 2 weeks prior to the first dose), defined as follows:
(1) Blood count: Neutrophil count (NEUT#) > = 1.5 x 10^9/L; Platelet (PLT) > = 100 x 10^9/L; Hemoglobin > = 9 g/dL;
(2) Liver function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < = 2.5 x upper limit of normal (ULN); For subjects with baseline liver metastases, ALT and AST < = 5.0 x ULN; Albumin > = 30 g/L; Total bilirubin (TBIL) < = 1.5 x ULN;
(3) Renal function: Creatinine clearance (Ccr) > = 50 ml/min (calculated using the standard Cockcroft-Gault formula);
(4) Coagulation function: International Normalized Ratio (INR), Activated Partial Thromboplastin Time (APTT), and Prothrombin Time (PT) < = 1.5 x ULN;
(5) Cardiac function: echocardiography (ECHO) or multi-circuit controlled acquisition (MUGA) scans show left ventricular ejection fraction (LVEF) >=50%;
8. For female subjects of reproductive potential and male subjects whose partners have fertility, consent to effective medical contraception must be given within 6 months from the signing of the informed consent form until the last dose;
9. Subjects voluntarily join this study, sign informed consent forms, and are able to comply with the visit and related procedures specified in the program.

排除标准：

1.肿瘤组织学或细胞学证实合并小细胞肺癌、神经内分泌癌、癌肉瘤成分； 2.既往5年内患有其他恶性肿瘤，不包括已治愈的宫颈原位癌、皮肤基底癌或皮肤鳞状细胞癌； 3.具有大咯血风险的中央型鳞癌； 4.既往接受过靶向TROP2的治疗，或含靶向拓扑异构酶I的治疗（包括ADC药物）； 5.既往使用过盐酸安罗替尼胶囊或其他抗血管生成药物的患者； 6.在首次给药前2周内和研究期间需要使用细胞色素P450 3A4酶（CYP3A4）的强抑制剂或诱导剂者（本研究中不允许使用CYP3A4的强抑制剂或诱导剂）；所有受试者必须尽量避免合并使用任何已知对CYP3A4有诱导作用的药物、草药补充剂和/或摄入此类食物 7.入组前4周内参加过其他药物临床试验； 8.已知对本方案药物及其组分有过敏史； 9.人类免疫缺陷病毒（HIV）检查阳性或存在获得性免疫缺陷综合征（艾滋病）病史；已知活动性梅毒感染； 10.有异体器官移植史和异体造血干细胞移植史； 11.首次研究给药之前30天内接种过活疫苗； 12.已知患有脑膜转移、脑干转移、脊髓转移和/或压迫、活动性的中枢神经系统（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参与研究；对于未经治疗的无症状脑转移的受试者，经研究者评估后可以允许入组； 13.根据研究者判断，无法控制的系统性疾病：a) 控制不佳的糖尿病（连续两次空腹血糖≥ 10 mmol/L）；b) 控制不佳的高血压（收缩压> 160 mmHg和/或舒张压> 100 mmHg）；c) 存在有临床症状或需要反复引流的胸腔积液、心包积液或腹水（> 1次/周）； 14.首次给药前4周内发生严重感染，包括但不限于伴有需要住院治疗的并发症、败血症或严重肺炎；首次给药前2周内存在需要接受全身系统性抗感染治疗的活动性感染； 15.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；肺部并发疾病导致的临床严重肺损害，包括但不限于任何基础肺部疾病（如给药前3个月内的肺栓塞、严重哮喘、重度慢性阻塞性肺疾病、限制性肺疾病、胸腔积液等）或任何可能累及肺部的自身免疫、结缔组织或炎性疾病（即类风湿关节炎、干燥综合征、结节病等），或既往全肺切除术； 16.患有活动性、且过去2年内需要系统性治疗的自身免疫性疾病（激素替代治疗不认为是系统性治疗，如Ⅰ型糖尿病、只需接受甲状腺素替代治疗的甲状腺功能减退症、只需要接受生理剂量的糖皮质激素替代治疗的肾上腺或垂体功能不全）； 17.肿瘤侵犯或压迫周围重要脏器及血管（如心脏、食管、上腔静脉等）且伴随相关症状（如上腔静脉综合征），或存在发生食管气管瘘或食管胸膜瘘风险； 18.影像学显示肿瘤侵犯大血管者或经判断后续研究期间肿瘤极有可能侵袭重要血管引起致命大出血者； 19.无论严重程度如何，患者出现出血症状；在首次给药前1个月内，患者发生任何出血或出血事件（≥CTCAE 3）伴未愈合伤口、溃疡或骨折； 20.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 21.妊娠期、哺乳期女性患者，有生育能力且基线妊娠试验检测阳性的女性患者，在试验药物治疗期间及最后一次用药6个月内不愿意采取有效避孕措施的育龄女性患者； 22.研究者认为患者不适合参加本研究的其他任何情况。

Exclusion criteria：

1. Histology: Histologically or cytologically confirmed NSCLC with mixed small cell lung cancer, neuroendocrine carcinoma, or sarcomatoid components. 2. Other Malignancies: History of other malignant tumors within the past 5 years, with the exception of cured carcinoma in situ of the cervix, basal cell carcinoma of the skin, or cutaneous squamous cell carcinoma. 3. Hemoptysis Risk: Central squamous cell carcinoma with a risk of massive hemoptysis. 4. Prior Targeted Therapy: Previous treatment with TROP2-targeted therapies or therapies targeting Topoisomerase I (including ADC drugs). 5. Anti-angiogenic Therapy: Prior use of Anlotinib Hydrochloride capsules or other anti-angiogenic drugs. 6. Drug Interactions: Requirement for strong inhibitors or inducers of Cytochrome P450 3A4 (CYP3A4) within 2 weeks prior to the first dose or during the study. The use of strong CYP3A4 inhibitors or inducers is prohibited in this study. All subjects must avoid concomitant use of any drugs, herbal supplements, and/or foods known to induce CYP3A4. 7. Prior Clinical Trials: Participation in other clinical drug trials within 4 weeks prior to enrollment. 8. Allergy: Known history of allergy to the study drugs or their components. 9. Infectious Diseases: Positive for Human Immunodeficiency Virus (HIV) or history of Acquired Immunodeficiency Syndrome (AIDS); known active syphilis infection. 10. Transplant History: History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation. 11. Vaccination: Receipt of live vaccines within 30 days prior to the first study dose. 12. CNS Metastases: Known meningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active central nervous system (CNS) metastases. Subjects with brain metastases previously treated with local therapy may participate if they are clinically stable for at least 4 weeks prior to dosing and have not required corticosteroids or anticonvulsants for at least 14 days. Subjects with untreated, asymptomatic brain metastases may be enrolled at the investigator's discretion. 13. Uncontrolled Systemic Disease: Uncontrolled systemic diseases as judged by the investigator, including: (1) Poorly controlled diabetes (fasting blood glucose >= 10 mmol/L on two consecutive occasions); (2) Poorly controlled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg); (3) Symptomatic pleural effusion, pericardial effusion, or ascites requiring repeated drainage (> 1 time/week). 14. Infection: Severe infection within 4 weeks prior to the first dose, including but not limited to complications requiring hospitalization, sepsis, or severe pneumonia; active infection requiring systemic anti-infective therapy within 2 weeks prior to the first dose. 15. Lung Disease: History of non-infectious interstitial lung disease (ILD) or pneumonitis requiring steroid treatment; current ILD or non-infectious pneumonitis; or suspected ILD/pneumonitis that cannot be ruled out by imaging at screening. Severe pulmonary impairment due to concurrent lung diseases, including but not limited to any underlying lung disease (e.g., pulmonary embolism within 3 months prior to dosing, severe asthma, severe COPD, restrictive lung disease, pleural effusion) or any autoimmune, connective tissue, or inflammatory disease that may affect the lungs (i.e., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis, etc.), or prior pneumonectomy. 16. Autoimmune Disease: Active autoimmune disease requiring systemic treatment within the past 2 years (hormone replacement therapy is not considered systemic treatment, e.g., Type I diabetes, hypothyroidism requiring only thyroxine replacement, adrenal or pituitary insufficiency requiring only physiological doses of glucocorticoid replacement). 17. Tumor Invasion: Tumor invasion or compression of surrounding vital organs and blood vessels (e.g., heart, esophagus, superior vena cava) with associated symptoms (e.g., superior vena cava syndrome), or risk of esophageal-tracheal fistula or esophageal-pleural fistula. 18. Vascular Invasion: Imaging showing tumor invasion of major blood vessels, or judgment that the tumor is highly likely to invade major blood vessels during the study, causing fatal massive hemorrhage. 19. Bleeding: Presence of hemorrhage symptoms regardless of severity; any bleeding or hemorrhagic event (>= CTCAE Grade 3) with unhealed wounds, ulcers, or fractures within 1 month prior to the first dose. 20. Ocular Disorders: Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or history of corneal disease that impairs or delays corneal healing. 21. Pregnancy/Lactation: Pregnant or lactating female patients; female patients of childbearing potential with a positive baseline pregnancy test; or female patients of childbearing potential unwilling to take effective contraceptive measures during the treatment period and for 6 months after the last dose. 22. Other: Any other condition that the investigator considers unsuitable for the patient to participate in this study.

研究实施时间：

Study execute time：

从 From 2025-10-01 00:00:00至 To 2027-10-01 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-06-10 00:00:00 至 To 2027-10-01 00:00:00

干预措施：

Interventions：

组别：	SKB264 (4mg/kg, d1, Q2W)＋安罗替尼 (8mg, d1-14, Q3W)	样本量：	30
Group：	SKB264 (4 mg/kg, Day 1, Q2W) + Anlotinib (8 mg, Days 1-14, Q3W)	Sample size：	30
干预措施：	SKB264 (4mg/kg, d1, Q2W)＋安罗替尼 (8mg, d1-14, Q3W) 用药直至疾病进展、死亡、毒性不能耐受或方案规定的其他原因。	干预措施代码：
Intervention：	SKB264 (4 mg/kg, Day 1, Q2W) + Anlotinib (8 mg, Days 1-14, Q3W) will be administered until disease progression, death, unacceptable toxicity, or other reasons specified in the protocol.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	安徽	市(区县)：
Country：	China	Province：	Anhui	City：
单位(医院)：	安徽省胸科医院	单位级别：	三甲
Institution hospital：	Anhui Chest Hospital	Level of the institution：	Tertiary A

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	Type：	Primary 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	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	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	至缓解时间	指标类型：	次要指标
Outcome：	Time to Response	Type：	Secondary indicator
测量时间点：		测量方法：
Measure time point of outcome：		Measure method：

指标中文名：	无进展生存期	指标类型：	次要指标
Outcome：	Progression-Free Survival	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：	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		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	否No
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）：	无
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	NA
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
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Case Record Form
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：	2026-06-03 17:18:16