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：	ChiCTR2600119570
最近更新日期： Date of Last Refreshed on：	2026-02-28 16:17:51
注册时间： Date of Registration：	2026-02-28 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塔戈利单抗用于既往经含铂化疗和PD-1/PD-L1抑制剂治疗后进展的晚期非小细胞肺癌的单臂、多中心、II期研究
Public title：	A single-arm, multicenter, phase II study of sacituzumab tirumotecan combined with tagitanlimab for the treatment of advanced non-small cell lung cancer that has progressed after previous platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy
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塔戈利单抗用于既往经含铂化疗和PD-1/PD-L1抑制剂治疗后进展的晚期非小细胞肺癌的单臂、多中心、II期研究
Scientific title：	A single-arm, multicenter, phase II study of sacituzumab tirumotecan combined with tagitanlimab for the treatment of advanced non-small cell lung cancer that has progressed after previous platinum-based chemotherapy and PD-1/PD-L1 inhibitor therapy
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：	田攀文	研究负责人：	田攀文
Applicant：	Panwen Tian	Study leader：	Panwen Tian
申请注册联系人电话： Applicant telephone：	+86 28 85422607	研究负责人电话： Study leader's telephone：	+86 28 85422607
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：	mrascend@163.com	研究负责人电子邮件： Study leader's E-mail：	mrascend@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：	四川省成都市武侯区国学巷37号	研究负责人通讯地址：	四川省成都市武侯区国学巷37号
Applicant address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province	Study leader's address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan 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：	四川大学华西医院
Applicant's institution：	West China Hospital, Sichuan University
研究负责人所在单位：	四川大学华西医院
Affiliation of the Leader：	West China Hospital of Sichuan University

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：	2025年审（2606）号	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：	四川大学华西医院生物医学伦理审查委员会
Name of the ethic committee：	Ethics Committee on Biomedical Research West China Hospital of Sichuan University
伦理委员会批准日期： Date of approved by ethic committee：	2026-02-05 00:00:00
伦理委员会联系人：	李娜
Contact Name of the ethic committee：	Na Li
伦理委员会联系地址：	四川省成都市武侯区国学巷37号
Contact Address of the ethic committee：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 28 85422654	伦理委员会联系人邮箱： Contact email of the ethic committee：	188974152@qq.com

研究实施负责（组长）单位：

四川大学华西医院

Primary sponsor：

West China Hospital of Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区国学巷37号

Primary sponsor's address：

No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan 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)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	具体地址：	四川省成都市武侯区国学巷37号
Institution hospital：	West China Hospital of Sichuan University	Address：	No. 37, Guoxue Lane, Wuhou District, Chengdu City, Sichuan Province

经费或物资来源：

四川科伦博泰生物医药股份有限公司

Source(s) of funding：

Sichuan Collenboetai Biopharmaceuticals Co., Ltd.

研究疾病：

晚期非小细胞肺癌

Target disease：

Advanced 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：评估芦康沙妥珠单抗联合塔戈利单抗用于含铂化疗和PD-(L)1抑制剂治疗后进展的晚期NSCLC人群的客观缓解率（ORR），由研究者基于实体瘤疗效评价标准1.1版（RECIST v1.1）进行评估。次要目的：评估芦康沙妥珠单抗联合塔戈利单抗用于含铂化疗和PD-(L)1抑制剂治疗后进展的晚期NSCLC人群的疾病控制率（DCR）、缓解持续时间（DOR）和无进展生存期（PFS），研究者基于RECIST v1.1评估；评估芦康沙妥珠单抗联合塔戈利单抗用于含铂化疗和PD-(L)1抑制剂治疗后进展的晚期NSCLC人群的总生存期（OS）；评估芦康沙妥珠单抗联合塔戈利单抗用于含铂化疗和PD-(L)1抑制剂治疗后进展的晚期NSCLC人群的安全性；探索性目的：生物标志物分析：本研究将于基线期、治疗期（C5D1）和疾病进展后采集组织和血液标本进行生物标志物分析： 1.收集入组患者在首次治疗前存档的或新鲜的肿瘤活检标本，用于WES检测、肿瘤免疫微环境、TROP2蛋白表达水平以及转录组的检测以及相关的组织学检测，探索TROP2表达水平、TME等与人体免疫应答反应的相关性，预测药物效果； 2.在基线、治疗期（C5D1）及疾病进展后分别采集血样检测ctDNA，以及相关的血液学检测，根据ctDNA水平的动态变化，评估治疗效果、以及与预后情况和进展风险的相关性。

Objectives of Study：

Main objective: To evaluate the objective response rate (ORR) of luconasertumab combined with tegolizumab in patients with advanced NSCLC who have progressed after platinum-based chemotherapy and PD-(L)1 inhibitor treatment. The assessment will be conducted by the investigators based on the Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Secondary objectives: To evaluate the disease control rate (DCR), duration of response (DOR), and progression-free survival (PFS) of luconasertumab combined with tegolizumab in patients with advanced NSCLC who have progressed after platinum-based chemotherapy and PD-(L)1 inhibitor treatment. The assessment will be conducted based on RECIST v1.1; To evaluate the overall survival (OS) of patients with advanced NSCLC who have progressed after platinum-based chemotherapy and PD-(L)1 inhibitor treatment; To evaluate the safety of luconasertumab combined with tegolizumab in patients with advanced NSCLC who have progressed after platinum-based chemotherapy and PD-(L)1 inhibitor treatment; Exploratory objectives: Biological marker analysis: This study will collect tissue and blood samples at baseline, during the treatment period (C5D1), and after disease progression for biomarker analysis: 1. Collect archived or fresh tumor biopsy specimens from enrolled patients before the first treatment for WES testing, tumor immune microenvironment, TROP2 protein expression level, and transcriptome detection, as well as related histological testing to explore the correlation between TROP2 expression level, TME, etc. and the human immune response response, and to predict drug efficacy; 2. Collect blood samples at baseline, during the treatment period (C5D1), and after disease progression to detect ctDNA, as well as related hematological tests. Based on the dynamic changes in ctDNA levels, evaluate treatment efficacy, and its correlation with prognosis and progression risk.

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. The age at signing the informed consent form should be between 18 and 75 years old (inclusive), with no gender restrictions;
2. Confirmed by histological or cytological examination, and being locally advanced (stage IIIB/III C) or metastatic (stage IV) NSCLC that is not suitable for radical surgery and/or radical radiotherapy (regardless of whether concurrent or sequential chemotherapy is received) [according to the International Union Against Cancer and the American Joint Committee on Cancer (AJCC) 9th edition of lung cancer TNM staging];
3. There should be no known driver gene alterations such as EGFR, ALK, ROS1, etc. For squamous NSCLC patients with a smoking history, if the previous EGFR and ALK gene status is unknown, no corresponding tests need to be conducted before enrollment in this study and it is regarded as negative;
4. For locally advanced or metastatic diseases that have received PD-1/L1 inhibitor and platinum-based double-drug chemotherapy (combined or sequential, with no specific order for sequential) treatment or experienced disease progression after treatment (the previous immunotherapy PFS is >= 3 months);
5. The ECOG performance status score of the US Eastern Cooperative Oncology Group (ECOG) was 0 or 1 within 7 days before the first administration;
6. The expected survival period is >= 3 months;
7. According to RECIST 1.1, at least one measurable lesion must be present. Patients with only skin lesions or bone lesions are not eligible for inclusion. Brain lesions are not considered as target lesions;
8. Gastrointestinal and bone radiation therapy for palliative purposes (including cranial radiotherapy for symptomatic brain metastases) is allowed, but the radiotherapy must be completed at least 2 weeks before the first administration and the radiotherapy-related toxicity must recover to less than or equal to grade 1 (CTCAE 5.0, except for hair loss);
9. Adequate organ and bone marrow functions (no blood transfusion, recombinant human thrombopoietin or colony-stimulating factor treatment within 2 weeks before the first administration), defined as follows: a) Blood routine: Neutrophil count (NEUT#) >= 1.5×10^9/L; Platelets (PLT) >= 100×10^9/L; Hemoglobin >= 90 g/L; b) Liver function: Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5×ULN; For subjects with baseline liver metastases, ALT and AST <= 5×ULN; Albumin >= 30 g/L; Total bilirubin (TBIL) <= 1.5×ULN; c) Kidney function: Creatinine clearance rate >= 50 ml/min (calculated using the standard Cockcroft-Gault formula); d) Coagulation function: International normalized ratio (INR), activated partial thromboplastin time (APTT), and prothrombin time (PT) <= 1.5×ULN;
10. For female subjects with reproductive capacity and male subjects whose partners have reproductive potential, they must agree to take effective medical contraceptive measures from the date of signing the informed consent form to 6 months after the last administration (see Appendix 2); The subjects voluntarily join this study, sign the informed consent form, and can comply with the visit and related procedures as stipulated in the protocol.

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.寡转移：由研究者依据患者具体的进展部位、数目及是否适用于局部治疗进行综合判断； 3.既往接受过下列任何一种治疗（包括在辅助、新辅助治疗背景下）： a)靶向TROP2的治疗； b)含靶向拓扑异构酶I的任何药物治疗，包括抗体偶联药物（ADC）治疗； 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脑转移受试者。对于既往接受过局部治疗的脑转移受试者，如果在研究治疗首次给药前至少4周内临床稳定并且首次给药前至少14天内无需使用糖皮质激素或抗惊厥药物可参与研究；对于筛选时首次发现的脑转移受试者，如果接受局部治疗（如放疗），须有影像学证据显示脑转移病灶距离首次影像学诊断脑转移无进展至少4周，确定脑转移稳定后方可入组； 5.在给药前3年内患有其他恶性肿瘤（已通过局部治疗治愈的肿瘤除外，例如皮肤基底细胞癌、皮肤鳞状细胞癌、宫颈原位癌等）； 6.研究首次给药前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）； 7.在首次给药前2周内接受> 10 mg/天泼尼松的全身皮质类固醇治疗或其他免疫抑制药物的受试者。需要使用支气管扩张剂、吸入或外用类固醇或局部类固醇注射治疗作为超敏反应的预防用药（如CT检查前用药等）的受试者可允许入组； 8.首次给药前4周接种活疫苗； 9.筛选期影像学显示肿瘤侵犯或压迫周围重要脏器及血管（或存在发生食管气管瘘或食管胸膜瘘风险；。 10.存在免疫缺陷病史或HIV抗体检测阳性者或在过去2年内需要系统性治疗的活动性自身免疫性疾病； 11.存在下列任何心脑血管疾病或者心脑血管风险因素： a)给药前6个月内，发生心肌梗塞、不稳定型心绞痛、急性或持续性的心肌缺血、3级或4级的心力衰竭【按照美国纽约心脏病学会（NYHA）分级】、症状性或控制不佳的严重心律失常，脑血管意外、短暂性脑缺血发作等其他严重的心脑血管疾病； b)既往有心肌炎、原发性心肌病、特异性心肌病等心肌疾病史； c)给药前3个月内有任何深静脉血栓（如果经过低分子肝素或类似功效药物治疗稳定>= 2周，可允许入组）、外周动脉血栓栓塞事件、肺栓塞或其他严重的血栓栓塞事件； d)存在主动脉瘤、主动脉夹层动脉瘤等可能危及生命或给药前6个月内需要手术的重大血管疾病； e)平均校正心室除极到复极的时间（QTcF）间期> 480 ms； 12.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）； 13.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； 14.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； 15.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个月内的严重哮喘、重度慢性阻塞性肺疾病、限制性肺疾病等）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； 17.既往抗肿瘤治疗的毒性尚未恢复至<=1级（基于NCI CTCAE v5.0评估）或入排标准规定的水平（脱发、乏力等研究者判断低安全风险的毒性除外）； 18.已知异体器官移植史和异体造血干细胞移植史； 19.活动性乙型肝炎[乙肝表面抗原（HBsAg）阳性，须进行HBV-DNA检测；HBV-DNA≥ 500 IU/mL或高于检测值下限，以较高者为准]或丙型肝炎（丙肝抗体阳性，且HCV-RNA高于检测值下限）。注：对于HBsAg阳性的受试者，要求在研究治疗期间接受抗乙肝病毒治疗； 20.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； 21.给药前4周内进行过大型手术者或预计在研究期间需要进行大手术者； 22.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；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； 23.给药前2周内接受过非特异性免疫调节治疗（包括但不限于干扰素、IL-2）、获批抗肿瘤适应症的中成药制剂等； 24.给药前的筛选过程中，病情快速恶化，例如体能状态的明显变化等； 25.妊娠期或者哺乳期妇女； 26.患有非恶性肿瘤导致的局部或全身性疾病，或肿瘤继发的疾病或症状，并可导致较高医学风险和/或生存期评价的不确定性，如肿瘤类白血病反应、恶病质表现等；研究者认为不宜参加本研究的其他任何情况。

Exclusion criteria：

1. Tumor histology or cytology confirmed the presence of combined small cell lung cancer, neuroendocrine carcinoma, or carcinosarcoma components; 2. Oligometastasis: Judged comprehensively by the investigators based on the specific progression site, number, and suitability for local treatment of the patient; 3. Previous treatment with any of the following (including in the context of adjuvant or neoadjuvant therapy): a) Targeted therapy against TROP2; b) Any drug treatment containing targeted topoisomerase I, including antibody-conjugated drug (ADC) therapy; 4. Subjects known to have meningeal metastasis, brainstem metastasis, spinal cord metastasis and/or compression, active or untreated brain metastases. For subjects with brain metastases who have received local treatment previously, if they are clinically stable at least 4 weeks before the first administration of the study treatment and did not need to use glucocorticoids or anticonvulsants at least 14 days before the first administration, they can participate in the study; for subjects with brain metastases identified for the first time during screening, if they have received local treatment (such as radiotherapy), there must be imaging evidence showing that the brain metastasis lesion is at least 4 weeks from the first imaging diagnosis of brain metastasis and stable before enrollment; 5. Within 3 years before administration of the study drug, had other malignant tumors (excluding those cured by local treatment, such as basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical carcinoma in situ, etc.); 6. Subjects who need to use strong inhibitors or inducers of cytochrome P450 3A4 enzyme (CYP3A4) (in this study, strong inhibitors or inducers of CYP3A4 are not allowed); 7. Subjects who received > 10 mg/day prednisone for systemic corticosteroid treatment or other immunosuppressive drugs within 2 weeks before the first administration of the study drug. Subjects who need to use bronchodilators, inhaled or topical steroids or local steroid injections as preventive medication for hypersensitivity reactions (such as before CT examination, etc.) can be allowed to enroll; 8. Subjects who received live vaccines 4 weeks before the first administration of the study drug; 9. Imaging during the screening period showed tumor invasion or compression of important surrounding organs and blood vessels (or there is a risk of esophageal-tracheal fistula or esophageal pleural fistula;. 10. Subjects with a history of immunodeficiency or positive HIV antibody test or active autoimmune diseases requiring systemic treatment in the past 2 years; 11. Subjects with any of the following cardiovascular or cerebrovascular diseases or risk factors: a) Within 6 months before administration, myocardial infarction, unstable angina pectoris, acute or persistent myocardial ischemia, grade 3 or 4 heart failure [according to the New York Heart Association (NYHA) classification], symptomatic or poorly controlled severe arrhythmia, cerebrovascular accident, transient cerebral ischemia attack, other serious cardiovascular diseases; b) Previous history of myocarditis, primary cardiomyopathy, specific cardiomyopathy, etc.; c) Any deep vein thrombosis within 3 months before administration (if treated with low molecular weight heparin or similar efficacy drugs and stable for >= 2 weeks, can be allowed to enroll), peripheral arterial thromboembolic events, pulmonary embolism or other serious thromboembolic events; d) Major vascular diseases that may endanger life or within 6 months before administration requiring surgery; e) Average corrected ventricular depolarization to repolarization time (QTcF) interval > 480 ms; 12. According to the investigator's judgment, uncontrolled systemic diseases: a) Poorly controlled diabetes (consecutive two fasting blood glucose >= 10 mmol/L); b) Poorly controlled hypertension (systolic blood pressure > 160 mmHg and/or diastolic blood pressure > 100 mmHg); c) Presence of clinical symptoms or need for repeated drainage of pleural effusion, pericardial effusion or ascites (> 1 time/week); 13. There is a history of (non-infectious) interstitial lung disease (ILD) or non-infectious pneumonia that requires steroid treatment, currently has ILD or non-infectious pneumonia, or there is a suspected ILD or non-infectious pneumonia that cannot be ruled out by imaging examination; 14. There is a documented severe dry eye syndrome, severe meibomian gland disease and/or blepharitis, or a history of corneal diseases that interfere with or delay corneal healing; 15. Clinical severe lung damage caused by concurrent pulmonary diseases, including but not limited to any underlying pulmonary diseases (such as severe asthma within 3 months before administration, severe chronic obstructive pulmonary disease, restrictive lung disease, etc.) or any autoimmune, connective tissue or inflammatory diseases that may involve the lungs (such as rheumatoid arthritis, Sjögren's syndrome, sarcoidosis, etc.), or previous total lung resection; 16. Subjects with active chronic inflammatory bowel disease, gastrointestinal obstruction, severe ulcers, gastrointestinal perforation, abdominal abscess or acute gastrointestinal bleeding; 17. Toxicity from previous anti-tumor treatment has not yet recovered to <=1 grade (based on NCI CTCAE v5.0 assessment) or has not reached the level specified in the inclusion/exclusion criteria (excluding toxicities judged by the investigators as low safety risk such as hair loss, fatigue, etc.); 18. Known history of allogeneic organ transplantation and allogeneic hematopoietic stem cell transplantation; 19. Active hepatitis B [positive for hepatitis B surface antigen (HBsAg), HBV-DNA testing is required; HBV-DNA ≥ 500 IU/mL or higher than the lower limit of the detection value, whichever is higher] or hepatitis C (positive for hepatitis C antibody, and HCV-RNA higher than the lower limit of the detection value). Note: For subjects with positive HBsAg, anti-hepatitis B virus treatment is required during the study treatment; 20. Known allergy to the study drug or any of its components, and known history of severe hypersensitivity reaction to other biologics; 21. Subjects who have undergone major surgery within 4 weeks before administration or are expected to undergo major surgery during the study; 22. Subjects who have had a severe infection within 4 weeks before administration, including but not limited to complications requiring hospitalization, sepsis or severe pneumonia; Subjects who have had active infections requiring systemic anti-infective treatment within 2 weeks before administration; 23. Subjects who have received non-specific immunomodulatory treatment (including but not limited to interferons, IL-2) or approved anti-tumor indications of traditional Chinese medicine preparations within 2 weeks before administration; 24. During the screening process before administration, the condition has rapidly deteriorated, such as significant changes in physical condition, etc.; 25. Pregnant or lactating women; 26. Subjects with local or systemic diseases caused by non-malignant tumors, or tumor-related diseases or symptoms that can lead to higher medical risks and/or uncertainty in survival period evaluation, such as tumor leukemia reaction, cachexia manifestations, etc.; Any other conditions deemed inappropriate for participation in this study by the investigator.

研究实施时间：

Study execute time：

从 From 2026-03-01 00:00:00至 To 2028-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-03-02 00:00:00 至 To 2027-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	42
Group：	Experimental group	Sample size：	42
干预措施：	芦康沙妥珠单抗联合塔戈利单抗	干预措施代码：
Intervention：	Ruconatuzumab combined with tagolizumab	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	四川大学华西医院	单位级别：	三级甲等
Institution hospital：	West China Hospital of Sichuan University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	宜宾市第三人民医院	单位级别：	三级甲等
Institution hospital：	The Third People's Hospital Of Yibin	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	重庆市	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	重庆大学附属三峡医院（重庆三峡中心医院）	单位级别：	三级甲等
Institution hospital：	Chongqing University Three Gorges Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	重庆市	市(区县)：
Country：	China	Province：	Chongqing	City：
单位(医院)：	中国人民解放军陆军军医大学第一附属医院	单位级别：	三级甲等
Institution hospital：	The First Hospital Affiliated to AMU	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	云南省	市(区县)：
Country：	China	Province：	Yunnan	City：
单位(医院)：	昆明医科大学第一附属医院	单位级别：	三级甲等
Institution hospital：	The First Affiliated Hospital of Kunming Medical University	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	宜宾市第二人民医院	单位级别：	三级甲等
Institution hospital：	The Second People's Hospital Of Yibin	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	四川省	市(区县)：
Country：	China	Province：	Sichuan	City：
单位(医院)：	自贡市第四人民医院（自贡市急救中心）	单位级别：	三级甲等
Institution hospital：	The Fourth People's Hospital of Zigong City (Zigong City Emergency Center)	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	不良事件	指标类型：	次要指标
Outcome：	Adverse event	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：	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 relief	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：	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：	肺肿瘤组织	组织：
Sample Name：	Lung tumor tissue	Tissue：
人体标本去向	使用后销毁	说明
Fate of sample：	Destruction after use	Note：

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:

不公开/Private

盲法：	无
Blinding：	None

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：	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：	无/No
注册人： Name of Registration：	2026-02-28 16:17:45