ChiCTR2500109581 版本V1.0 版本创建时间2025/09/22 16:03:04 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500109581 

最近更新日期：

Date of Last Refreshed on：

2025-09-22 16:02:13 

注册时间：

Date of Registration：

2025-09-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

皮下注射恩沃利单抗联合口服长春瑞滨一线治疗老年晚期非小细胞肺癌的临床单臂研究

Public title：

A single-arm clinical study of subcutaneous injection of enolumab combined with oral vinorelbine as the first-line treatment for elderly patients with advanced non-small cell lung cancer

注册题目简写：

English Acronym：

研究课题的正式科学名称：

皮下注射恩沃利单抗联合口服长春瑞滨一线治疗老年晚期非小细胞肺癌的临床单臂研究

Scientific title：

A single-arm clinical study of subcutaneous injection of enolumab combined with oral vinorelbine as the first-line treatment for elderly patients with advanced non-small cell lung cancer

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：

周承志 

研究负责人：

周承志 

Applicant：

Zhou Chengzhi 

Study leader：

Zhou Chengzhi 

申请注册联系人电话：

Applicant telephone：

+86 135 6035 1186

研究负责人电话：

Study leader's telephone：

+86 135 6035 1186

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：

doctorzcz@163.com

研究负责人电子邮件：

Study leader's E-mail：

doctorzcz@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：

广州市荔湾区桥中中路28号

研究负责人通讯地址：

广州市荔湾区桥中中路28号

Applicant address：

No. 28, Qiaozhong Middle Road, Liwan District, Guangzhou City

Study leader's address：

No. 28, Qiaozhong Middle Road, Liwan District, Guangzhou City

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：

广州医科大学呼吸健康研究院

Applicant's institution：

Guangzhou Medical University Respiratory Health Research Institute

研究负责人所在单位：

广州医科大学附属第一医院广州医科大学呼吸健康研究院

Affiliation of the Leader：

Guangzhou Medical University Respiratory Health Research Institute

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

ES-2025-081-01

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：

广州医科大学附属第一医院伦理委员会

Name of the ethic committee：

Ethics Committee of the First Affiliated Hospital of Guangzhou Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2025-03-26 00:00:00

伦理委员会联系人：

张晓露

Contact Name of the ethic committee：

Zhang Xiaolu

伦理委员会联系地址：

广州市荔湾区桥中中路28号

Contact Address of the ethic committee：

No. 28, Qiaozhong Middle Road, Liwan District, Guangzhou City

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 20 8156 6265

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：

广州医科大学附属第一医院广州医科大学呼吸健康研究院

Primary sponsor：

The First Affiliated Hospital of Guangzhou Medical University

研究实施负责（组长）单位地址：

广州市荔湾区桥中中路28号

Primary sponsor's address：

No. 28, Qiaozhong Middle Road, Liwan District, Guangzhou City

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

广州

Country：

China

Province：

Guangdong

City：

Guangzhou

单位(医院)：

广州医科大学附属第一医院

具体地址：

广州市荔湾区桥中中路28号

Institution
hospital：

The First Affiliated Hospital of Guangzhou Medical University

Address：

No. 28, Qiaozhong Middle Road, Liwan District, Guangzhou City

经费或物资来源：

课题组经费

Source(s) of funding：

Research group funds

Target disease：

Advanced non-small cell lung cancer

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： 评估恩沃利单抗联合长春瑞滨一线治疗晚期非小细胞肺癌的疗效（包括ORR、PFS等）。 次要目的： 评估恩沃利单抗联合长春瑞滨一线治疗晚期非小细胞肺癌的安全性。 探索性目的： 评估皮下注射恩沃利单抗联合口服长春瑞滨对老年患者的便利性和依从性，减轻患者负担。  

Objectives of Study：

Main objective: To evaluate the efficacy of enolumab combined with vinorelbine as the first-line treatment for advanced non-small cell lung cancer (including ORR, PFS, etc.). Secondary objective: To assess the safety of enolumab combined with vinorelbine as the first-line treatment for advanced non-small cell lung cancer. Exploratory objective: To evaluate the convenience and compliance of subcutaneous administration of enolumab combined with oral vinorelbine for elderly patients, and to alleviate the burden on patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.受试者自愿加入本研究，能完成知情同意书的签署，且依从性良好； 2.组织学或细胞学确认的局部晚期（ⅢB或ⅢC期不可手术或放疗）或转移性（Ⅳ期）NSCLC； 3.EGFR/ALK基因突变阴性； 4.至少有一处可测量的病灶； 5.既往未接受过系统治疗； 6.年龄≥70岁以及ECOG PS ≥1，或者65岁≤年龄<70岁以及ECOG PS≥2； 7.预计生存期≥3个月； 8.主要器官功能良好，符合下列标准： 1)血常规检查（14天内未输血、未使用造血刺激因子类药物纠正状态下）：血红蛋白（Hb）≥90g/L；绝对中性粒细胞计数（ANC）≥1.5×109/L；血小板（PLT）≥100×109/L； 2)生化检查：谷丙转氨酶（ALT）及谷草转氨酶（AST）≤2.5×ULN（肿瘤肝脏转移者，≤5×ULN）；血清总胆红素（TBIL）≤1.5×ULN（Gilbert综合症受试者，≤3×ULN）；血清肌酐（Cr）≤1.5×ULN，或肌酐清除率≥60mL/min； 3)尿常规：尿蛋白<2+；如果尿蛋白≥2+，则24小时尿蛋白定量显示蛋白质必须≤1g； 4)凝血功能：活化部分凝血活酶时间（APTT）、国际标准化比值（INR）、凝血酶原时间（PT）≤1.5×ULN； 5)甲状腺功能正常，定义为促甲状腺激素（TSH）在正常范围内。如基线TSH超出正常范围，如果总T3（或FT3）及FT4在正常范围内的受试者亦可入组； 9.有生育能力的受试者在本研究期间和研究结束后120天内，必须采用适当的方法避孕，在研究入组前的7天内血清妊娠试验阴性，且必须为非哺乳期受试者

Inclusion criteria

1. The subjects voluntarily participated in this study, were able to sign the informed consent form, and had good compliance; 2. Locally advanced (stage IIIB or IIIC, inoperable or unresectable, or intractable with no radiotherapy options) or metastatic (stage IV) NSCLC confirmed by histological or cytological examination; 3. Negative for EGFR/ALK gene mutations; 4. At least one measurable lesion; 5. No previous systemic treatment; 6. Age ≥ 70 years and ECOG PS >= 1, or 65 years <= age < 70 years and ECOG PS >= 2; 7. Expected survival period >= 3 months; 8. Major organ functions are satisfactory and meet the following criteria: 1) Complete blood count (without blood transfusion or the use of hematopoietic growth factor drugs in the last 14 days): Hemoglobin (Hb) >= 90 g/L; Absolute Neutrophil Count (ANC) >= 1.5 × 10^9/L; Platelet (PLT) >= 100 × 10^9/L; 2) Biochemical tests: Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) <= 2.5 × ULN (for tumors with liver metastasis, <= 5 × ULN); Total Bilirubin (TBIL) in serum ≤ 1.5 × ULN (for participants with Gilbert's syndrome, <= 3 × ULN); Serum Creatinine (Cr) <= 1.5 × ULN, or Creatinine Clearance >= 60 mL/min; 3) Urinalysis: Urinary protein < 2; if urinary protein >= 2, then the 24-hour urinary protein quantification must show protein <= 1 g; 4) Coagulation function: Activated Partial Thromboplastin Time (APTT), International Normalized Ratio (INR), Prothrombin Time (PT) <= 1.5 × ULN; 5) Thyroid function is normal, defined as Thyroid-Stimulating Hormone (TSH) within the normal range. If the baseline TSH exceeds the normal range, participants with total T3 (or FT3) and FT4 within the normal range may also be included; 9. Participants of childbearing potential must use appropriate contraceptive methods during the study and for 120 days after its completion, with a negative serum pregnancy test within 7 days prior to enrollment, and must not be lactating.

排除标准：

1.本研究治疗开始前5年内出现过或当前同时患有其它恶性肿瘤； 2.存在任何重度和/或未能控制的疾病的受试者； 3.血压控制不理想（收缩压≥140mmHg或舒张压≥90mmHg）； 4.有未能良好控制的心脏临床症状或疾病，如：（1）NYHA2级以上心力衰竭（2）不稳定型心绞痛（3）1年内发生过心肌梗死（4）有临床意义的室上性或室性心律失常需要治疗或干预的患者； 5.受试者有活动性感染或在筛选期间、首次给药前发生原因不明发热>38.5度（经研究者判断，受试者因肿瘤产生的发热可以入组）； 6.既往和目前有肺纤维化史、间质性肺炎、尘肺、放射性肺炎、药物相关肺炎、肺功能严重受损等的客观证据的患者； 7.急性或者慢性活动性乙型肝炎（乙型肝炎表面抗原(HBsAg)或乙型肝炎核心抗体(Hepatitis B core antibody. HBcAb)阳性患者需进行乙型肝炎病毒(HBV)DNA检测,如HBVDNA拷贝数≤2×103拷贝数/ml或≤200IU/ml或低于检测下限,则可以入组。HBsAg(+)受试者应在整个研究药物治疗期间接受抗HBV治疗以避免病毒激活。对于抗HBc(+)、HBsAg(-)、抗HBs(-)和HBV病毒载量(-)的受试者,不需要接受预防性抗HBV治疗,但是需要密切监测病毒是否再激活； 8.有免疫缺陷病史，包括HIV阳性或患有其它获得性、先天性免疫缺陷疾病，或有器官移植史者； 9.糖尿病控制不佳（空腹血糖[FBG]＞10mmol/L）； 10.存在临床活动性憩室炎、腹腔脓肿、胃肠道梗阻； 11.研究治疗开始前28天内接受了重大外科治疗、切开活检或明显创伤性损伤者；或者有长期未治愈的伤口或骨折； 12.研究治疗开始前6个月内发生过严重的动/静脉血栓事件，如脑血管意外(包括暂时性缺血性发作、脑出血、脑梗塞)、深静脉血栓及肺栓塞等； 13.具有精神类药物滥用史且无法戒除或有精神障碍者； 14.前期接受过肿瘤治疗的患者； 15.未能控制的，仍需反复引流的胸腔积液、心包积液或腹水（研究者判断）受试者； 16.具有已知中枢神经系统转移和/或癌性脑膜炎的受试者； 17.研究治疗开始前14天内减毒活疫苗接种史或者研究期间计划行减毒活疫苗接种； 18.研究治疗开始前2年内发生过需要全身性治疗（如使用缓解疾病药物、皮质类固醇或免疫抑制剂）的活动性自身性免疫疾病，替代疗法（例如甲状腺素、胰岛素或者用于肾上腺或垂体机能不全的生理性皮质类固醇等）除外； 19.诊断为免疫缺陷或正在接受全身性糖皮质激素治疗或任何其他形式的免疫抑制疗法。(剂量>10mg/天泼尼松或其他等疗效激素)，并首次给药2周内仍在继续使用的； 20.有活动性结核病史者； 21.研究开始前4周内，正在参加或参加过其他临床研究者； 22.既往曾行其他PD-1/PD-L1抑制剂治疗不能入组；已知受试者既往对大分子蛋白制剂，或已知对应用的药物成分过敏； 23.已知对本研究药物恩沃利单抗、西妥昔单抗β等活性成分或辅料过敏者； 26.根据研究者的判断，有严重危害受试者安全或影响完成研究的伴随疾病者，或认为存在其他原因不适合入组的受试者。

Exclusion criteria：

1. Participants who have had other malignant tumors within 5 years before the start of this study or currently have other malignant tumors simultaneously; 2. Participants with any severe and/or uncontrolled diseases; 3. Participants with uncontrolled blood pressure (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure >= 90 mmHg); 4. Participants with uncontrolled cardiac clinical symptoms or diseases, such as: (1) NYHA class 2 or above heart failure; (2) unstable angina pectoris; (3) myocardial infarction within 1 year; (4) patients with clinically significant supraventricular or ventricular arrhythmias requiring treatment or intervention; 5. Participants with active infections or unexplained fever > 38.5°C during the screening period or before the first dose (fever caused by the tumor as judged by the investigator is acceptable for inclusion); 6. Participants with objective evidence of a history of pulmonary fibrosis, interstitial pneumonia, pneumoconiosis, radiation pneumonitis, drug-related pneumonia, or severely impaired lung function; 7. Participants with acute or chronic active hepatitis B (HBsAg or HBcAb positive patients need to undergo HBV DNA testing. If the HBV DNA copy number is <= 2×10^3 copies/ml or <= 200 IU/ml or below the detection limit, they can be included. HBsAg(+) participants should receive anti-HBV treatment throughout the study drug treatment period to avoid viral activation. For participants who are anti-HBc(+), HBsAg(-), anti-HBs(-), and HBV viral load(-), no preventive anti-HBV treatment is required, but close monitoring for viral reactivation is necessary); 8. Participants with a history of immunodeficiency, including HIV positive or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 9. Participants with poorly controlled diabetes (fasting blood glucose [FBG] > 10 mmol/L); 10. Participants with clinically active diverticulitis, abdominal abscess, or gastrointestinal obstruction; 11. Participants who have undergone major surgery, incisional biopsy, or significant traumatic injury within 28 days before the start of the study treatment, or have long-term non-healing wounds or fractures; 12. Participants who have experienced severe arterial or venous thrombotic events within 6 months before the start of the study treatment, such as cerebrovascular accidents (including transient ischemic attack, cerebral hemorrhage, cerebral infarction), deep vein thrombosis, and pulmonary embolism, etc.; 13. Participants with a history of drug abuse of psychotropic substances and inability to quit or have mental disorders; 14. Participants who have received previous tumor treatment; 15. Participants with uncontrolled pleural effusion, pericardial effusion, or ascites that still require repeated drainage (judged by the investigator); 16. Participants with known central nervous system metastases and/or carcinomatous meningitis; 17. Participants with a history of live attenuated vaccine administration within 14 days before the start of the study treatment or plan to receive live attenuated vaccines during the study; 18. Participants with active autoimmune diseases requiring systemic treatment (such as disease-modifying drugs, corticosteroids, or immunosuppressants) within 2 years before the start of the study treatment, except for replacement therapy (such as thyroid hormone, insulin, or physiological corticosteroids for adrenal or pituitary insufficiency, etc.); 19. Participants diagnosed with immunodeficiency or currently receiving systemic glucocorticoid treatment or any other form of immunosuppressive therapy (dose > 10 mg/day prednisone or other equivalent efficacy hormones) and still continuing to use it within 2 weeks of the first dose; 20. Participants with a history of active tuberculosis; 21. Participants who are currently participating in or have participated in other clinical studies within 4 weeks before the start of the study; 22. Participants who have received other PD-1/PD-L1 inhibitor treatment in the past cannot be included. 1. Subjects with a known history of allergy to macromolecular protein preparations or to the components of the drugs to be used in this study; 23. Subjects known to be allergic to the active ingredients or excipients of the study drugs, such as Enfortumab Vedotin and Cetuximab β; 26. Subjects with concomitant diseases that, in the judgment of the investigator, pose a serious threat to the subject's safety or interfere with the completion of the study, or subjects deemed unsuitable for inclusion for other reasons.

研究实施时间：

Study execute time：

从 From 2025-09-21 00:00:00至 To 2027-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-10-01 00:00:00 至 To 2027-11-30 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

62

Group：

experimental group

Sample size：

干预措施：

皮下注射恩沃利单抗联合口服长春瑞滨

干预措施代码：

Intervention：

Subcutaneous injection of enverylumab combined with oral administration of vinorelbine

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

广州医科大学附属第一医院 

单位级别：

三甲 

Institution
hospital：

The First Affiliated Hospital of Guangzhou Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

无进展生存期

指标类型：

主要指标

Outcome：

Progression-free survival,pfs

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,ORR

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,DOR

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：

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

 其它  

说明

Fate of sample：

0thers  

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 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）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

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）：

2027-12+邮箱(doctorzcz@163.com)

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

2027-12+Email(doctorzcz@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：

病历记录表

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

Case Record Form, CRF

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：

  2025-09-22 16:02:13