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：	ChiCTR2500115235
最近更新日期： Date of Last Refreshed on：	2025-12-24 08:57:07
注册时间： Date of Registration：	2025-12-24 00:00:00
注册号状态：	预注册
Registration Status：	Prospective registration
注册题目：	阿美替尼单药长周期新辅助治疗在IB-ⅢB期EGFR阳性非小细胞肺癌的单臂、开放临床研究
Public title：	A Single-Arm, Open-Label Clinical Study of Aumolertinib Monotherapy as Long-Cycle Neoadjuvant Treatment for Stage IB-ⅢB EGFR-Positive Non-Small Cell Lung Cancer
注册题目简写：
English Acronym：
研究课题的正式科学名称：	阿美替尼单药长周期新辅助治疗在IB-ⅢB期EGFR阳性非小细胞肺癌的单臂、开放临床研究
Scientific title：	A Single-Arm, Open-Label Clinical Study of Aumolertinib Monotherapy as Long-Cycle Neoadjuvant Treatment for Stage IB-ⅢB EGFR-Positive 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：	杨洋	研究负责人：	杨洋
Applicant：	Yang Yang	Study leader：	Yang Yang
申请注册联系人电话： Applicant telephone：	+86 371 6627 9776	研究负责人电话： Study leader's telephone：	+86 371 6627 9776
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：	yangyang_2046@126.com	研究负责人电子邮件： Study leader's E-mail：	yangyang_2046@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：	中国河南省郑州市建设东路1号	研究负责人通讯地址：	中国河南省郑州市建设东路1号
Applicant address：	1 Jianshe East Road, Zhengzhou City, Henan Province, China	Study leader's address：	1 Jianshe East Road, Zhengzhou City, Henan Province, 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：	郑州大学第一附属医院
Applicant's institution：	The First Affiliated Hospital of Zhengzhou University
研究负责人所在单位：	郑州大学第一附属医院
Affiliation of the Leader：	The First Affiliated Hospital of Zhengzhou 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-KY-1594-001	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：	郑州大学第一附属医院临床试验伦理委员会
Name of the ethic committee：	The Ethics Committee for Clinical Trials of The First Affiliated Hospital of Zhengzhou University
伦理委员会批准日期： Date of approved by ethic committee：	2025-11-07 00:00:00
伦理委员会联系人：	杨志衡
Contact Name of the ethic committee：	Yang Zhiheng
伦理委员会联系地址：	中国河南省郑州市建设东路1号
Contact Address of the ethic committee：	1 Jianshe East Road, Zhengzhou City, Henan Province, China
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 371 6629 5219	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：

郑州大学第一附属医院

Primary sponsor：

The First Affiliated Hospital of Zhengzhou University

研究实施负责（组长）单位地址：

中国河南省郑州市建设东路1号

Primary sponsor's address：

1 Jianshe East Road, Zhengzhou City, Henan Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	河南	市(区县)：	郑州
Country：	China	Province：	Henan	City：	Zhengzhou
单位(医院)：	郑州大学第一附属医院	具体地址：	中国河南省郑州市建设东路1号
Institution hospital：	The First Affiliated Hospital of Zhengzhou University	Address：	1 Jianshe East Road, Zhengzhou City, Henan Province, China

经费或物资来源：

江苏豪森药业集团有限公司

Source(s) of funding：

Jiangsu Hansoh Pharmaceutical Group Co., Ltd.

研究疾病：

IB-ⅢB期EGFR阳性非小细胞肺癌

Target disease：

Stage IB-ⅢB EGFR-Positive 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：

其它

Study phase：

N/A

研究设计：

单臂

Study design：

Single arm

研究目的：

本研究为探索性研究，旨在观察与评估阿美替尼单药长周期新辅助治疗在IB-ⅢB期EGFR阳性非小细胞肺癌的疗效及安全性。

Objectives of Study：

This study is an exploratory research aimed at observing and evaluating the efficacy and safety of aumolertinib monotherapy as long-cycle neoadjuvant treatment in patients with stage IB-ⅢB EGFR-positive non-small cell lung cancer (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. Subjects voluntarily participate in this study and sign the informed consent form; 
2. Aged >= 18 years, regardless of gender; 
3. Patients diagnosed with non-small cell lung cancer (NSCLC) by histopathology or cytology; 
4. Patients with resectable stage IB-IIIB NSCLC (assessed according to the 8th edition of the International Association for the Study of Lung Cancer (IASLC) Thoracic Oncology Staging Manual); with confirmed EGFR 19del or L858R mutation positivity in the primary tumor or lymph node metastases; 
5. No prior treatment for NSCLC; 
6. According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, at least one unidimensionally measurable lesion with the longest diameter >= 10mm as measured by spiral CT; 
7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1; 
8. Estimated survival time of no less than 12 weeks; 
9. Male and female patients of childbearing age agree to use reliable contraceptive methods before entering the trial, during the study, and until 8 weeks after drug withdrawal; 
10. Patients who agree to receive surgical treatment; 
11. Patients without surgical contraindications as judged by specialist physicians; 
12. Normal function of major organs, meeting the following criteria: 
(1)Pulmonary ventilation function test forced expiratory volume in 1 second (FEV1) >= 1.5L, or predicted FEV1 >= 800ml after lobectomy/pneumonectomy; 
(2)Blood routine test standards (no blood transfusion or blood products within 14 days, no correction with granulocyte colony-stimulating factor (G-CSF) or other hematopoietic stimulants): 1)Hemoglobin (HB) >= 90g/L; 2)Absolute neutrophil count (ANC) >= 1.5×10^9/L; 3)Platelet (PLT) >= 80×10^9/L;  
(3)Biochemical test standards: 1)Total bilirubin (TBIL) <= 1.5 × upper limit of normal (ULN); 2)Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) <= 2.5×ULN; 3)Serum creatinine (Cr) <= 1.5×ULN or creatinine clearance rate (CCr) >= 60ml/min;
13. Female patients of childbearing age (15-49 years old) must undergo a urine pregnancy test within 7 days before the start of treatment with a negative result.

排除标准：

1.小细胞癌、大细胞癌及混合细胞肺癌； 2.针对NSCLC进行过任何全身性抗癌治疗，包括细胞毒性药物治疗、免疫药物治疗、试验性治疗等； 3.针对NSCLC进行过局部放疗； 4.入组前4周内或药物的5个半衰期内（以较长者为准），使用全身免疫刺激剂（包括但不限于干扰素、白介素2、肿瘤坏死因子）治疗（允许既往治疗中使用癌症疫苗）； 5.研究药物首次给药前14天内，使用了任何用于控制癌症的中草药； 6.在本研究的治疗开始之前的五年内患有除 NSCLC 以外的其它癌症的患者。除外宫颈原位癌、已治愈的基底细胞癌、膀胱上皮肿瘤； 7.存在任何重度和/或未能控制的疾病的患者，包括：血压控制不理想（收缩压>=150 mmHg，舒张压>=100 mmHg）患者，患有I级以上心肌缺血或者心肌梗塞、心律失常（包括QTc>=480ms）及>=2 级充血性心功能衰竭（纽约心脏病协会（NYHA）分级），活动性或未能控制的严重感染，肝硬化、失代偿性肝病，活动性肝炎或慢性肝炎需要接受抗病毒治疗，肾功能衰竭需要血液透析或者腹膜透析，有免疫缺陷病史，包括HIV阳性或患有其他获得性、先天性免疫缺陷疾病，或有器官移植史者，糖尿病控制不佳（空腹血糖（FBG）>10mmol/L），具有癫痫发作并需要治疗的患者，长期未治愈的伤口或骨折等； 8.既往患间质性肺病、药物诱导的间质性疾病、需要激素治疗的放射性肺炎或任何具临床证据的活动性间质性肺病； 9.6 个月内发生过动/静脉血栓事件，如脑血管意外（包括暂时性缺血性发作）、深静脉血栓及肺栓塞者； 10.目前存在>=CTCAE 2度的周围神经病，创伤导致除外； 11.做过大手术或有严重创伤的受试者在入组之前，手术或创伤的影响已消除不足14天； 12.患者正在参加其他临床研究或距离前一项临床研究治疗结束时间不足4周； 13.怀孕或哺乳期妇女； 14.患有不易控制的神经、精神疾病或精神障碍，依从性差，不能配合和叙述治疗； 15.经研究者判断，患者可能有其他可能导致本研究被迫中途终止的因素，如其他的严重疾病或严重的实验室检查异常或伴有其他会影响到受试者的安全，或试验资料及样品收集的家庭或社会等因素。

Exclusion criteria：

1. Small cell carcinoma, large cell carcinoma, and mixed cell lung cancer; 2. Any prior systemic anticancer treatment for NSCLC, including cytotoxic drug therapy, immunotherapy, investigational therapy, etc.; 3. Prior local radiotherapy for NSCLC; 4. Treatment with systemic immunostimulants (including but not limited to interferon, interleukin-2, tumor necrosis factor) within 4 weeks prior to enrollment or within 5 half-lives of the drug (whichever is longer) (prior use of cancer vaccines is permitted); 5. Use of any Chinese herbal medicine for cancer control within 14 days before the first administration of the study drug; 6. Patients with a history of other cancers (excluding NSCLC) within 5 years before the start of treatment in this study. Exceptions include carcinoma in situ of the cervix, cured basal cell carcinoma, and bladder epithelial tumors; 7. Patients with any severe and/or uncontrolled diseases, including: Poorly controlled blood pressure (systolic blood pressure >= 150 mmHg, diastolic blood pressure >= 100 mmHg),Myocardial ischemia of grade >= I, myocardial infarction, arrhythmia (including QTc >= 480ms), and congestive heart failure of grade >= 2 (New York Heart Association (NYHA) classification), Active or uncontrolled severe infection, Liver cirrhosis, decompensated liver disease, active hepatitis, or chronic hepatitis requiring antiviral treatment, Renal failure requiring hemodialysis or peritoneal dialysis, History of immunodeficiency, including HIV positivity, other acquired or congenital immunodeficiency diseases, or organ transplantation, Poorly controlled diabetes mellitus (fasting blood glucose (FBG) > 10 mmol/L),Patients with epilepsy requiring treatment, Long-term unhealed wounds, fractures, etc.; 8. Prior history of interstitial lung disease, drug-induced interstitial disease, radiation pneumonitis requiring hormone therapy, or any clinically evident active interstitial lung disease; 9. History of arterial/venous thromboembolic events (such as cerebrovascular accident including transient ischemic attack, deep vein thrombosis, and pulmonary embolism) within 6 months; 10. Current peripheral neuropathy of grade >= CTCAE 2 (excluding that caused by trauma); 11. Subjects who have undergone major surgery or suffered severe trauma with less than 14 days of resolution of surgical/traumatic effects before enrollment; 12. Patients currently participating in other clinical studies or with less than 4 weeks since the end of treatment in the previous clinical study; 13. Pregnant or lactating women; 14. Patients with poorly controlled neurological or psychiatric diseases/disorders, poor compliance, and inability to cooperate with or report treatment; 15. Patients judged by the investigator to have other factors that may force early termination of the study, such as other serious diseases, severe laboratory abnormalities, or family/social factors that may affect the subject's safety or the collection of study data and samples.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2029-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2026-01-01 00:00:00 至 To 2029-12-31 00:00:00

干预措施：

Interventions：

组别：	干预组	样本量：	30
Group：	Intervention group	Sample size：	30
干预措施：	甲磺酸阿美替尼片，口服，110mg，每天一次，至多6个月	干预措施代码：
Intervention：	Almonertinib Mesylate Tablets, PO, 110 mg once daily, up to 6 months	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	河南	市(区县)：	郑州
Country：	China	Province：	Henan	City：	Zhengzhou
单位(医院)：	郑州大学第一附属医院	单位级别：	三甲
Institution hospital：	The First Affiliated Hospital of Zhengzhou University	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	主要病理学缓解率	指标类型：	主要指标
Outcome：	Major Pathological Response Rate	Type：	Primary indicator
测量时间点：	所有入组患者完成手术切除	测量方法：	治疗后手术切除的肿瘤组织中，存活肿瘤细胞占比<=10%的病例比例
Measure time point of outcome：	All enrolled patients completed surgical resection?	Measure method：	The proportion of cases with <=10% viable tumor cells in the resected tumor tissue after treatment?

指标中文名：	完全病理缓解率	指标类型：	主要指标
Outcome：	Complete Pathological Response Rate	Type：	Primary indicator
测量时间点：	所有入组患者完成手术切除	测量方法：	治疗后的术后标本中肿瘤床内无残余存活肿瘤细胞（包括淋巴结无肿瘤残余）的病例比例
Measure time point of outcome：	All enrolled patients completed surgical resection?	Measure method：	The proportion of cases with no residual viable tumor cells in the tumor bed (including no tumor residual in lymph nodes) in postoperative specimens after treatment

指标中文名：	术前客观缓解率	指标类型：	次要指标
Outcome：	Preoperative Objective Response Rate	Type：	Secondary indicator
测量时间点：	新辅助治疗结束后术前评估	测量方法：	采用实体瘤缓解评估标准（RECIST 1.1 标准）来评估
Measure time point of outcome：	Preoperative assessment after neoadjuvant therapy	Measure method：	Evaluated using the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria

指标中文名：	R0 切除率	指标类型：	次要指标
Outcome：	R0 Resection Rate	Type：	Secondary indicator
测量时间点：	所有入组患者完成手术切除	测量方法：	计算R0 切除的受试者占手术切除受试者总数比例
Measure time point of outcome：	All enrolled patients completed surgical resection?	Measure method：	The proportion of subjects who achieved R0 resection among those who underwent surgical resection

指标中文名：	临床降期率	指标类型：	次要指标
Outcome：	Clinical Downstaging Rate	Type：	Secondary indicator
测量时间点：	新辅助治疗结束后术前评估	测量方法：	评估患者的肿瘤分期，对比治疗前的肿瘤分期，评估肿瘤临床分期降期率
Measure time point of outcome：	Preoperative assessment after neoadjuvant therapy	Measure method：	Evaluate the tumor stage of the patient, compare it with the pretreatment tumor stage, and assess the clinical downstaging rate of the tumor.

指标中文名：	淋巴结降期率	指标类型：	次要指标
Outcome：	Lymph Node Downstaging Rate	Type：	Secondary indicator
测量时间点：	新辅助治疗结束后术前评估	测量方法：	评估淋巴结在新辅助治疗后的降期率
Measure time point of outcome：	Preoperative assessment after neoadjuvant therapy	Measure method：	Evaluate the downstaging rate of lymph nodes after neoadjuvant therapy?

指标中文名：	治疗相关不良事件	指标类型：	次要指标
Outcome：	Treatment-Related Adverse Events	Type：	Secondary indicator
测量时间点：	新辅助治疗期间	测量方法：	统计受试者接受试验用药品后出现的所有不良医学事件
Measure time point of outcome：	During neoadjuvant therapy	Measure method：	Count all adverse medical events that occur after subjects receive the investigational medicinal product

指标中文名：	2 年无进展生存期	指标类型：	次要指标
Outcome：	2-Year Progression-Free Survival	Type：	Secondary indicator
测量时间点：	术后每6个月随访一次	测量方法：	电话随访
Measure time point of outcome：	Postoperative follow-up every 6 months	Measure method：	Telephone follow-up

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	18	岁 years
最大 Max age	≥18	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：	采用病例报告表进行数据记录，设置双人核查流程以确保录入数据的可靠性和准确性。研究数据将严格按照医院数据管理规范进行记录和保存，确保数据的准确性和完整性。
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	Data was recorded using case report forms (CRFs), with a dual-check process implemented to ensure the reliability and accuracy of data entry. The study data will be strictly recorded and stored in accordance with the hospital's data management protocols to guarantee the accuracy and integrity of the data.
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：	2025-12-24 08:57:03