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：	ChiCTR2600127528
最近更新日期： Date of Last Refreshed on：	2026-07-01 17:31:22
注册时间： Date of Registration：	2026-07-01 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	PD-1抑制剂联合短程芦康沙妥珠单抗一线治疗PD-L1阳性、驱动基因阴性且体能状态良好的老年晚期NSCLC患者疗效和安全性的单臂、多中心、II期临床研究
Public title：	A single-arm, multi-center phase II study of short course Sacituzumab Tirumotecan (Sac-TMT) plus PD-1 inhibitors as first-line therapy for now of FIT, elderly patients with PD-L1 positive and driver-negative advanced NSCLC
注册题目简写：
English Acronym：
研究课题的正式科学名称：	PD-1抑制剂联合短程芦康沙妥珠单抗一线治疗PD-L1阳性、驱动基因阴性且体能状态良好的老年晚期NSCLC患者疗效和安全性的单臂、多中心、II期临床研究
Scientific title：	A single-arm, multi-center phase II study of short course Sacituzumab Tirumotecan (Sac-TMT) plus PD-1 inhibitors as first-line therapy for now of FIT, elderly patients with PD-L1 positive and driver-negative advanced NSCLC
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：	张静	研究负责人：	胡洁
Applicant：	Zhang Jing	Study leader：	Hu Jie
申请注册联系人电话： Applicant telephone：	+86 21 5137 1990	研究负责人电话： Study leader's telephone：	+86 21 5137 1990
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：	suze0503@163.com	研究负责人电子邮件： Study leader's E-mail：	hujie73@yeah.net
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：	上海市闵行区春申路 2560 号	研究负责人通讯地址：	上海市闵行区春申路 2560 号
Applicant address：	No.2560 Chunshen Road, Minhang District, Shanghai, China.	Study leader's address：	No.2560 Chunshen Road, Minhang District, Shanghai, China.
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：	上海市老年医学中心
Applicant's institution：	Shanghai Geriatric Medical Center
研究负责人所在单位：	上海市老年医学中心
Affiliation of the Leader：	Shanghai Geriatric Medical Center

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：	B2026-004	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：	上海市老年医学中心伦理委员会
Name of the ethic committee：	Ethics Committee of Shanghai Geriatric Medical Center
伦理委员会批准日期： Date of approved by ethic committee：	2026-01-27 00:00:00
伦理委员会联系人：	陈宁华
Contact Name of the ethic committee：	Chen Ninghua
伦理委员会联系地址：	上海市闵行区春申路2560号
Contact Address of the ethic committee：	No. 2560, Chunshen Road, Minhang District, Shanghai, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 21 3111 8563	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：

上海市老年医学中心

Primary sponsor：

Shanghai Geriatric Medical Center

研究实施负责（组长）单位地址：

上海市闵行区春申路 2560 号

Primary sponsor's address：

No.2560 Chunshen Road, Minhang District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市老年医学中心	具体地址：	中国上海市闵行区春申路 2560 号
Institution hospital：	Shanghai Geriatric Medical Center	Address：	No.2560 Chunshen Road, Minhang District, Shanghai, China

经费或物资来源：

自筹

Source(s) of funding：

Self-raised

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：

主要目的：评估PD-1抑制剂联合短程芦康沙妥珠单抗一线治疗PD-L1阳性、驱动基因阴性且体能状态良好的老年晚期NSCLC患者的抗肿瘤活性。次要目的：进一步评估PD-1抑制剂联合短程芦康沙妥珠单抗一线治疗PD-L1阳性、驱动基因阴性且体能状态良好的老年晚期NSCLC患者的有效性和安全性。探索性目的：探索PD-1抑制剂联合短程芦康沙妥珠单抗一线治疗PD-L1阳性、驱动基因阴性且体能状态良好的老年晚期NSCLC患者与疗效具有相关性的生物标志物。

Objectives of Study：

Primary Objective: To evaluate the ORR per RECIST v1.1 by investigator assessment of the combination of short course Sac-TMT plus PD-(L)1 inhibitors in elderly patients with PD-L1 positive and driver-negative advanced NSCLC; Secondary Objectives: a.To evaluate the DCR, PFS and OS of the combination of short course Sac-TMT plus PD-(L)1 inhibitors in elderly patients with PD-L1 positive and driver-negative advanced NSCLC; b.To observe safety and tolerability based on incidence and severity of adverse events (AEs). Exploratory Objective: To explore biomarkers associated with treatment efficacy of PD-1 inhibitor combined with short-course lucatumumab as first-line therapy in elderly patients with PD-L1-positive, driver gene-negative, and functionally fit advanced 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 >= 70 years, male or female.
2.Geriatric 8 score >= 15.
3.Histologically or cytologically confirmed locally advanced or metastatic (stage IIIB–IV) non-small cell lung cancer (NSCLC) who are ineligible for surgical treatment or radical concurrent/sequential chemoradiotherapy.
4.Negative for EGFR sensitizing mutations (no exon 19 deletion or exon 21 L858R substitution) and negative for ALK fusion gene (for subjects with non-squamous NSCLC, non-smoking squamous NSCLC, or NSCLC with adenocarcinoma components, EGFR and ALK status must be histologically confirmed negative); no known driver gene alterations including ROS1, NTRK, and BRAF. For smoking subjects with squamous NSCLC, if prior EGFR and/or ALK status is unknown, testing is not required prior to enrollment and will be regarded as negative.
5.No prior systemic therapy for advanced or recurrent disease. Subjects who received prior adjuvant/neoadjuvant chemotherapy or radical concurrent/sequential chemoradiotherapy are eligible if disease progression occurred >= 6 months after the last treatment.
6.PD-L1 TPS >= 1%.
7.ECOG performance status 0–1 within 7 days before study treatment initiation.
8.Patients with brain metastases who received prior local therapy and have stable symptoms for >=4 weeks are eligible.
9.At least one measurable lesion per RECIST 1.1 criteria.
10.Life expectancy >=12 weeks.
11.Adequate organ and bone marrow function (no blood transfusion, recombinant human thrombopoietin, or colony-stimulating factor administered within 2 weeks before first dose), defined as follows:
a) Hematology: absolute neutrophil count (NEUT#) >= 1.5×10^9/L; platelet count (PLT) >=100×10^9/L; hemoglobin >= 9 g/dL.
b) Hepatic function: aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5× upper limit of normal (ULN); for subjects with baseline liver metastases, ALT and AST <= 5.0× ULN; albumin >= 30 g/L; total bilirubin (TBIL) <= 1.5× ULN.
c) Renal function: creatinine clearance (Ccr) >= 50 mL/min (calculated using the standard Cockcroft-Gault formula).
d) Coagulation: international normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5× ULN.
e) Cardiac function: left ventricular ejection fraction (LVEF) >= 50% on echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
12.Subjects voluntarily participate in this study, provide written informed consent, demonstrate good compliance, and agree to comply with follow-up procedures.

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）； 3.既往使用过包括PD-(L)1抑制剂在内的免疫检查点抑制剂治疗； 4.已知对研究药物或其任何成分过敏，已知对其他生物制剂产生严重超敏反应的病史； 5.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，附件5列出了CYP3A4强抑制剂或诱导剂的代表性药物）；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； 6.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参与研究； 7.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>=10mmol/L）；b)控制不佳的高血压（收缩压>160mmHg和/或舒张压>100mmHg）；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）； 8.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； 9.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； 10.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； 11.肺部并发疾病导致的临床严重肺损害； 12.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； 13.合并疾病及病史：a)5年内既往或同时患有其它恶性肿瘤者（已治愈的皮肤基底细胞癌、宫颈原位癌和浅表性膀胱癌除外）；b)先前治疗引起的不良事件（脱发除外）未恢复至<=CTCAE1度者；e)首次给药前28天内接受了重大外科治疗或明显创伤性损伤；d)6个月内发生过动/静脉血栓事件； 14.过去2年内需要全身治疗的活动性自身免疫性疾病（激素替代疗法不被认为是全身治疗）； 15.自身免疫性疾病史（自身免疫相关性甲状腺功能减退和可控制的1型糖尿病除外）、特发性肺纤维化（IPF）、组织性肺炎（如闭塞性细支气管炎）、药物性肺炎、特发性肺炎或活动性肺炎病史、已知人类免疫缺陷病毒（HIV）阳性、已知活动性乙型肝炎或丙型肝炎活动性结核病史； 16.研究者认为患者不适合参加本研究的任何其他情况。

Exclusion criteria：

1.Histologically or cytologically confirmed tumor with components of small cell lung cancer (SCLC), neuroendocrine carcinoma, or carcinosarcoma. 2.Prior treatment with TROP2-targeted therapies or topoisomerase I-targeted therapies (including ADC drugs). 3.Prior use of immune checkpoint inhibitors, including PD-(L)1 inhibitors. 4.Known hypersensitivity to the study drug or any of its components, or a history of severe hypersensitivity reactions to other biological agents. 5.Requirement for strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks before the first dose and during the study. (The use of strong 6.CYP3A4 inhibitors or inducers is prohibited in this study. Representative drugs are listed in Appendix 5.) All subjects must avoid concomitant use of any medications, herbal supplements, and/or consumption of foods known to induce CYP3A4. 7.Subjects with known leptomeningeal metastases, brainstem metastases, spinal cord metastases and/or compression, or active/untreated central nervous system (CNS) metastases. Subjects with previously treated brain metastases may participate if clinically stable for at least 4 weeks prior to dosing and off corticosteroids or anticonvulsants for at least 14 days. 8.Uncontrolled systemic diseases as judged by the investigator: a) Poorly controlled diabetes mellitus (fasting blood glucose >= 10 mmol/L on two consecutive occasions). b) Poorly controlled hypertension (systolic BP > 160 mmHg and/or diastolic BP > 100 mmHg). c) Clinically significant pleural effusion, pericardial effusion, or ascites requiring frequent drainage (> once/week). 9.Severe infection (including complications requiring hospitalization, sepsis, or severe pneumonia) within 4 weeks before the first dose; active infection requiring systemic antimicrobial therapy within 2 weeks before the first dose. 10.History of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia requiring steroids; current ILD or non-infectious pneumonia; or suspected ILD or non-infectious pneumonia on screening imaging that cannot be ruled out. 11.Documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal disease that impairs delayed corneal healing. 12.Clinically significant pulmonary impairment due to concurrent lung diseases. 13.Tumor invading or compressing vital organs and vessels (e.g., heart, esophagus, superior vena cava) with associated symptoms (e.g., superior vena cava syndrome), or at risk of esophagotracheal fistula or esophagopleural fistula. 14.Concurrent diseases and medical history: a) Other malignancies (past or concurrent) within 5 years, except cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, and superficial bladder cancer. b) Adverse events from prior therapy (except alopecia) that have not resolved to CTCAE Grade <= 1. c) Major surgical procedure or significant traumatic injury within 28 days before the first dose. d) Arterial/venous thrombotic event within 6 months. 15.Active autoimmune disease requiring systemic therapy in the past 2 years (hormone replacement therapy is not considered systemic therapy). History of autoimmune diseases (except autoimmune-related hypothyroidism and controlled type 1 diabetes), idiopathic pulmonary fibrosis (IPF), organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or active pneumonia; known HIV-positive; known active hepatitis B or C; or active tuberculosis. 16.Any other circumstances where, in the investigator's judgment, the patient is not suitable for participation in this study.

研究实施时间：

Study execute time：

从 From 2026-07-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-07-03 00:00:00 至 To 2028-06-30 00:00:00

干预措施：

Interventions：

组别：	PD-1抑制剂联合短程芦康沙妥珠单抗	样本量：	45
Group：	short course Sacituzumab Tirumotecan (Sac-TMT) plus PD-1 inhibitors	Sample size：	45
干预措施：	所有受试者将接受PD-1抑制剂联合芦康沙妥珠单抗（4mg/kg，静脉输注，第1天，每2周一次）治疗，其中芦康沙妥珠单抗最多应用6个周期，PD-1抑制剂治疗持续至疾病进展、出现不可耐受毒性、开始新抗肿瘤治疗、撤回知情同意、失访、死亡或研究终止，且总时长不超过24个月。	干预措施代码：
Intervention：	Patients will receive sac-TMT at a dose of 4mg/kg Q2W for 6 cycles and any of the investigator-selected PD-(L)1 inhibitors approved for first-line treatment of non-small cell lung cancer in China. Treatment with Sac-TMT will continue for 6 cycles, and PD-(L)1 inhibitors will continue until disease progression or unacceptable toxicity, with a maximum duration of no more than 24 months.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海市老年医学中心	单位级别：	三甲
Institution hospital：	Shanghai Geriatric Medical Center	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	复旦大学附属中山医院	单位级别：	三甲
Institution hospital：	Zhongshan Hospital, Fudan University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	上海	市(区县)：
Country：	China	Province：	Shanghai	City：
单位(医院)：	上海交通大学医学院附属瑞金医院	单位级别：	三甲
Institution hospital：	Ruijin Hospital, Shanghai Jiao Tong University School of Medicine	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 (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：	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：	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：	安全性和耐受性：包括不良事件发生率、严重程度、与药物相关性、剂量调整/停药情况、生命体征及实验室指标变化	指标类型：	次要指标
Outcome：	Safety and tolerability: including incidence and severity of adverse events, drug-relatedness, dose modification/discontinuation, vital signs and laboratory parameter changes, etc.	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：	外周血	组织：	外周血液
Sample Name：	Peripheral blood	Tissue：	Peripheral blood
人体标本去向	使用后销毁	说明	保存至研究结束后5年
Fate of sample：	Destruction after use	Note：	Samples will be preserved till the 5 years after study completion

标本中文名：	肿瘤组织	组织：
Sample Name：	Tumor tissue	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	70	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：	无
Blinding：	None
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)：	None
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：	无/No
注册人： Name of Registration：	2026-07-01 17:31:18