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：	ChiCTR2600119574
最近更新日期： Date of Last Refreshed on：	2026-02-28 16:30:58
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：	卡瑞利珠单抗联合化疗和艾玛昔替尼一线治疗晚期NSCLC的前瞻性、单臂、多中心研究
Public title：	A prospective, single-arm, multicenter study of Camrelizumab combined with chemotherapy and Ivarmacitinib as first-line treatment for advanced NSCLC
注册题目简写：
English Acronym：
研究课题的正式科学名称：	卡瑞利珠单抗联合化疗和艾玛昔替尼一线治疗晚期NSCLC的前瞻性、单臂、多中心研究
Scientific title：	A prospective, single-arm, multicenter study of Camrelizumab combined with chemotherapy and Ivarmacitinib as first-line treatment for 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：	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（2713）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：	2026-01-27 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：

江苏恒瑞医药股份有限公司

Source(s) of funding：

Jiangsu Hengrui Medicine 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：

1. 主要目的：探索卡瑞利珠单抗加化疗联合艾玛昔替尼一线治疗驱动基因阴性晚期NSCLC的有效性PFS； 2. 次要目的：探索卡瑞利珠单抗加化疗联合艾玛昔替尼一线治疗驱动基因阴性晚期NSCLC的其他有效性终点，包括OS、ORR及安全性等； 3.探索性目的：评价肿瘤生物学标志物与疗效的关联性。

Objectives of Study：

1. Main objective: To explore the efficacy of first-line treatment with carlimlimab plus chemotherapy combined with emabetuzumab in patients with driver gene-negative advanced NSCLC in terms of progression-free survival (PFS); 2. Secondary objective: To explore other efficacy endpoints of first-line treatment with carlimlimab plus chemotherapy combined with emabetuzumab in patients with driver gene-negative advanced NSCLC, including overall survival (OS), objective response rate (ORR), and safety, etc.; 3. Exploratory objective: To evaluate the correlation between tumor biological markers and therapeutic efficacy.

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 range: 18 - 75 years old, gender not restricted;
2. ECOG score: 0 - 1;
3. Estimated survival period: >= 3 months;
4. Histologically or cytologically confirmed, and for locally advanced (stage IIIB/IIIc) 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 for Cancer Control and the American Joint Committee on Cancer (AJCC) 9th edition lung cancer TNM staging];
5. According to the RECIST 1.1 standard, there must be at least one measurable lesion;
6. Before enrollment, no systemic anti-tumor treatment for advanced/metastatic NSCLC has been received. Chemotherapy and/or radiotherapy can be used as part of neoadjuvant/adjuvant treatment as long as the treatment has been completed at least 12 months before the diagnosis of advanced or metastatic disease;
7. 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 are required before enrolling in this study and it is considered negative;
8. Normal main laboratory tests;
9. Female participants of childbearing age must undergo a serum pregnancy test 3 days before starting the study medication, and the result must be negative. They are also willing to use a medically approved highly effective contraceptive method (such as intrauterine device, contraceptive pills, or condoms) during the study period and within 180 days after the last administration of the study medication;
For male participants whose partner is of childbearing age, surgical sterilization should be performed or they should agree to use an effective method of contraception during the study period and within 180 days after the last administration of the study medication;
10. Study participants voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with follow-up.

排除标准：

1.组织学证实含有小细胞肺癌成分； 2.已知的敏感性EGFR突变/ALK重排/ROS1融合； 3.在筛选期间和放射影像学评估之前，通过CT或MRI评估确认有症状性、未治疗或积极进展的中枢神经系统（CNS）转移。但只要同时满足以下所有条件，有稳定的CNS病灶且经过局部治疗的无症状患者也可入组： 1) 脑转移病灶<5个； 2) 根据RECIST v1.1 确定的可测量病灶必须存在于CNS 之外； 3) 患者无颅内出血或脊髓出血史； 4) 在开始研究治疗前28天内未进行神经外科切除术，14天内未进行全脑放疗或 7天内未进行立体定向放射治疗； 5) 入组前影像证实已稳定至少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）大于2周； 6) 没有转移至中脑、脑桥、髓质或脊髓； 4.首次使用研究药物前14天之内需要使用皮质类固醇或其他免疫抑制剂进行系统治疗的研究参与者，不包括喷鼻和吸入性皮质类固醇或生理剂量的系统性类固醇激素（即不超过10 mg/天强的松龙或同等药物生理学剂量的其他皮质类固醇）； 5.首次给药前4周内接受过抗肿瘤疫苗或具有抗肿瘤适应症的中草药或免疫调节作用的药物（包括胸腺肽、干扰素、白介素，除外为控制胸水局部使用）的系统性全身治疗； 6.曾接受过抗PD-1(L1)或CTLA4单抗治疗或预期在研究中需要任何其它形式的抗肿瘤治疗； 7.入组前 5 年内有其他恶性肿瘤病史，经治疗完全缓解且在研究期间不需要或预计不需要其他治疗的原位癌除外； 8.首次给药前4周内或计划在研究期间接种减毒活疫苗； 9.当前正在参与干预性临床研究治疗，或在首次给药前 4 周内接受过其他研究药物或研究器械治疗； 10.首次用药前4周内并发重度感染、局部感染（包括但不限于需住院治疗或>=2周抗生素静脉给药治疗的感染并发症、菌血症、重症肺炎等）或任何活动性感染者； 11.首次给药前1年内有活动性肺结核感染患者； 12.患有任何活动性、已知或可疑自身免疫疾病或自身免疫疾病史，允许入组处于稳定状态，不需要系统免疫抑制剂治疗的研究参与者； 13.HBsAg阳性且HBV DNA检测值超过正常值上限（1000拷贝数/mL或500 IU/mL），HCV阳性（HCV RNA或HCV Ab检测提示急慢性感染），或活动性乙型肝炎或丙型肝炎患者，已知HIV阳性病史或已知的AIDS； 14.首次用药前4周内接受重大外科手术者；首次给药前7天内经历创伤性小手术（置管、活检、支气管镜检查）者；首次用药前4周内>30Gy的非胸部放射治疗者，首次用药前24周内>30Gy的胸部放射者，以及首次用药前2周内接受<30Gy的姑息性放射者； 15.在首次给药前，尚未从任何干预措施引起的毒性和/或并发症中充分恢复（即，<=1级或达到基线，不包括乏力或脱发）者； 16.患有II级以上心肌缺血或心肌梗塞、控制不良的心律失常（包括 QTc间期男性>=450ms、女性>=470ms）。按NYHA标准，III～Ⅳ级心功能不全，或心脏彩超检查提示左室射血分数（LVEF）＜50%者； 17.有严重出血性事件或动静脉血栓、肺栓塞事件； 18.有胃肠穿孔风险的患者； 19.已知异体器官移植史或异体造血干细胞移植史； 20.伴有未控制的需要反复引流的胸腔积液、心包积液，或腹水的患者； 21.已知对研究药物或其辅料会产生变态反应、超敏反应或不耐受； 22.已知有精神障碍或药物滥用的患者和妊娠期、哺乳期或计划在研究期间妊娠的女性患者；研究者认为存在可能损害研究参与者或者导致研究参与者无法满足或执行研究要求的任何状况。

Exclusion criteria：

1. Small cell lung cancer components confirmed by histology; 2. Known sensitive EGFR mutation /ALK rearrangement /ROS1 fusion; 3. Confirm symptomatic, untreated, or actively progressing central nervous system (CNS) metastases by CT or MRI assessment during screening and before radiologic imaging assessment. However, asymptomatic patients with stable CNS lesions after local treatment were also eligible as long as all the following conditions were met: 1) <5 brain metastases; 2) Measurable lesions according to RECIST v1.1 must exist outside the CNS; 3) no history of intracranial hemorrhage or spinal cord hemorrhage; 4) no neurosurgical resection within 28 days, no whole brain radiotherapy within 14 days, or no stereotactic radiotherapy within 7 days before starting study treatment; 5) Stable disease confirmed by imaging for at least 4 weeks before enrollment, and cessation of systemic steroid therapy (dose <=10mg/ day prednisone or other equivalent hormone) for at least 2 weeks; 6) no metastases to the midbrain, pons, medulla or spinal cord; 4. Study participants requiring systemic treatment with corticosteroids or other immunosuppressive agents within 14 days before the first dose of study drug, excluding nasal spray and inhaled corticosteroids or physiological doses of systemic steroids (i.e., not more than 10 mg/ day of prednisolone or other corticosteroids at pharmacological physiological doses); 5. Received anti-tumor vaccine or Chinese herbal medicine with anti-tumor indications or immunomodulatory drugs (including thymosin, interferon and interleukin, except for local use to control pleural effusion) within 4 weeks before the first dose; 6. Prior treatment with anti-PD-1 (L1) or CTLA4 monoclonal antibody or anticipated need for any other form of antitumor therapy during the study; 7. A history of other malignant tumors within 5 years before enrollment, except for carcinoma in situ that achieved complete remission and did not require or was not expected to require additional treatment during the study period; 8. Administration of live attenuated vaccine within 4 weeks before the first dose or planned during the study; 9. Are currently participating in an interventional clinical study treatment, or have received another study drug or study device within 4 weeks before the first dose; 10. Severe infection, local infection (including but not limited to infectious complications requiring hospitalization or >=2 weeks of intravenous antibiotic treatment, bacteremia, severe pneumonia, etc.) or any active infection within 4 weeks before the first dose of medication; 11. Patients with active pulmonary tuberculosis infection within 1 year before the first dose; 12. Study participants with any active, known, or suspected autoimmune disease or history of autoimmune disease who were in stable condition and did not require systemic immunosuppressive therapy were allowed to be enrolled; 13. Patients who are HBsAg positive and have an HBV DNA test value above the upper limit of the normal range (1000 copies /mL or 500 IU/mL), are HCV positive (HCV RNA or HCV Ab tests suggest acute or chronic infection), or have active hepatitis B or C, a known history of HIV positivity, or known AIDS; 14. Patients who underwent major surgery within 4 weeks before the first medication; Patients who underwent minor traumatic surgery (catheterization, biopsy, bronchoscopy) within 7 days before the first administration; Patients receiving non-thoracic radiotherapy with a dose of >30Gy within 4 weeks before the first dose, patients receiving thoracic radiotherapy with a dose of >30Gy within 24 weeks before the first dose, and patients receiving palliative radiotherapy with a dose of <30Gy within 2 weeks before the first dose; 15. Those who have not fully recovered from any intervention-related toxicity and/or complications (i.e., grade <=1 or baseline, excluding fatigue or alopecia) before the first dose; 16. Grade II or above myocardial ischemia or myocardial infarction and uncontrolled arrhythmia (including QTc interval >=450ms in men and >=470ms in women). Patients with NYHA class III-IV cardiac dysfunction or left ventricular ejection fraction (LVEF) < 50% by echocardiography; 17. Severe hemorrhagic events or arteriovenous thrombosis, pulmonary embolism events; 18. Patients at risk for gastrointestinal perforation; 19. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation; 20. Patients with uncontrolled pleural effusion, pericardial effusion, or ascites requiring repeated drainage; 21. Known to have an allergy, hypersensitivity or intolerance to the study drug or its excipients; 22 patients with known mental disorders or substance abuse and women who are pregnant, breastfeeding, or planning to become pregnant during the study; Any condition that was considered by the investigator to be likely to harm the study participant or to prevent the study participant from meeting or performing the requirements of the study.

研究实施时间：

Study execute time：

从 From 2026-04-01 00:00:00至 To 2029-06-30 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-04-01 00:00:00 至 To 2027-03-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	60
Group：	Experimental Group	Sample size：	60
干预措施：	卡瑞利珠单抗联合化疗和艾玛昔替尼	干预措施代码：
Intervention：	Camrelizumab plus chemotherapy and Ivarmacitinib	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)：	河南省	市(区县)：
Country：	China	Province：	Henan	City：
单位(医院)：	河南省肿瘤医院	单位级别：	三级甲等
Institution hospital：	Henan Provincial Cancer Hospital	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山西省	市(区县)：
Country：	China	Province：	Shanxi	City：
单位(医院)：	山西省肿瘤医院	单位级别：	三级甲等
Institution hospital：	Shanxi Provincial Cancer Hospital	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)：	中国人民解放军西部战区总医院	单位级别：	三级甲等
Institution hospital：	The General Hospital of the Western Theater Command of the People's Liberation Army of China	Level of the institution：	Tertiary A

国家：	中国	省(直辖市)：	山东省	市(区县)：
Country：	China	Province：	Shandong	City：
单位(医院)：	山东第一医科大学附属肿瘤医院（山东省肿瘤防治研究院、山东省肿瘤医院）	单位级别：	三级甲等
Institution hospital：	Shandong First Medical University Affiliated Tumor Hospital (Shandong Provincial Tumor Prevention and Control Research Institute, Shandong Provincial Tumor Hospital)	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 events	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：	主要指标
Outcome：	Progression-free survival	Type：	Primary 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：	次要指标
Outcome：	Objective response 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 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：	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：	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：

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 16:30:52