ChiCTR2600117161 版本V1.0 版本创建时间2026/01/20 16:43:09 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：

ChiCTR2600117161 

最近更新日期：

Date of Last Refreshed on：

2026-01-20 16:43:03 

注册时间：

Date of Registration：

2026-01-20 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

阿美替尼联合化疗诱导治疗潜在可切除Ⅲ期 EGFR 敏感突变非鳞 非小细胞肺癌的前瞻性、Ⅱ期单臂研究

Public title：

Prospective Phase II Single-Arm Study of Induction Therapy with Aumolertinib and Chemotherapy in Potentially Resectable Stage Ⅲ EGFR-Mutant Non-Squamous NSCLC

注册题目简写：

English Acronym：

研究课题的正式科学名称：

阿美替尼联合化疗诱导治疗潜在可切除Ⅲ期 EGFR 敏感突变非鳞 非小细胞肺癌的前瞻性、Ⅱ期单臂研究

Scientific title：

Prospective Phase II Single-Arm Study of Induction Therapy with Aumolertinib and Chemotherapy in Potentially Resectable Stage Ⅲ EGFR-Mutant Non-Squamous 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：

李鑫 

研究负责人：

李鑫;张芷旋 

Applicant：

Li Xin 

Study leader：

Li Xin;Zhang Zhixuan 

申请注册联系人电话：

Applicant telephone：

+86 28 8542 0295

研究负责人电话：

Study leader's telephone：

+86 28 8542 0295

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：

673362285@qq.com

研究负责人电子邮件：

Study leader's E-mail：

673362285@qq.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人民南路四段55号

研究负责人通讯地址：

四川省成都市武侯区人民南路四段55号

Applicant address：

No. 55, Fourth Section, Renmin South Road, Wuhou District, Chengdu City, Sichuan Province

Study leader's address：

No. 55, Fourth Section, Renmin South Road, 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：

四川省肿瘤医院

Applicant's institution：

Sichuan Cancer Hospital

研究负责人所在单位：

四川省肿瘤医院

Affiliation of the Leader：

Sichuan Cancer Hospital

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：

KY-2025-197-04

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：

四川省肿瘤医院医学科研与医疗新技术伦理委员会

Name of the ethic committee：

Ethics Committee for Medical Research and New Medical Technology of Sichuan Cancer Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2025-07-29 00:00:00

伦理委员会联系人：

王青青

Contact Name of the ethic committee：

Wang Qingqing

伦理委员会联系地址：

四川省成都市武侯区人民南路四段55号

Contact Address of the ethic committee：

No. 55, Fourth Section, Renmin South Road, Wuhou District, Chengdu City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 152 8262 9225

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：

四川省肿瘤医院

Primary sponsor：

Sichuan Cancer Hospital

研究实施负责（组长）单位地址：

四川省成都市武侯区人民南路四段55号

Primary sponsor's address：

No. 55, Fourth Section, Renmin South Road, 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

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川肿瘤医院

具体地址：

四川省成都市武侯区人民南路四段55号

Institution
hospital：

Sichuan Cancer Hospital

Address：

No. 55, Fourth Section, Renmin South Road, Wuhou District, Chengdu City, Sichuan Province

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

Target disease：

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：

观察在未接受过任何系统治疗的 EGFR 敏感突变的初始潜在可切除Ⅲ期非鳞非小细胞肺癌（NSCLC）患者采用阿美替尼联合化疗诱导治疗后转化手术的可行性及安全性。  

Objectives of Study：

To evaluate the feasibility and safety of conversion surgery following induction therapy with aumolertinib plus chemotherapy in patients with initially potentially resectable Stage Ⅲ EGFR-mutant non-squamous NSCLC who have received no prior systemic therapy.

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.年龄在 18 岁以上（含 18 岁）且 75 岁以下（含 75 岁）。 2.东部肿瘤组织协作组（ECOG）体力状态评分为 0 或 1 并且在研究药物治疗前 2 周内没有恶化，预期生存期不少于 12 周。 3.病理组织学或细胞学证实的、经 MDT 判断潜在可切除Ⅲ期（IIIA或者 IIIB 期）非鳞状细胞非小细胞肺癌（国际肺癌研究协会第八版肺癌分期）。 4.肿瘤组织样本或血液样本经研究者认同的实验室检测确认为EGFR 敏感突变（即，外显子 19 缺失或 L858R，两者单独存在或共存，或伴有其他 EGFR 位点突变均可，但伴有 EGFR20 外显子插入 突变的患者不能入组）。 5.按照 RECIST1.1 标准，受试者必须有至少一个影像学可测量病灶。肿瘤基线影像学评估在首次用药前的 28 天之内进行。 6.育龄女性从筛选到停止研究治疗后 3 个月需采取合适的避孕措施且不应该哺乳。开始给药前，妊娠试验为阴性，或者满足下列标准之一证明没有妊娠风险： a. 绝经后定义为年龄大于 50 岁和停止所有外源性激素替代治 疗后闭经至少 12 个月。 b.年龄小于 50 岁的女性，如果停止所有外源性激素治疗后闭经 12 个月或以上，且促黄体激素（LH）和卵泡刺激激素（FSH）水 平在实验室绝经后参考值范围内，也可认为是绝经后。 c.曾经接受不可逆的绝育手术，包括子宫切除，双侧卵巢切除或 双侧输卵管切除，但双侧输卵管结扎除外。 7. 从筛选到停止研究治疗后 3 个月男性受试者应使用屏障避孕即避孕套）。 8. 受试者本人自愿参加并书面签署知情同意书。

Inclusion criteria

1. Age should be above 18 years (inclusive of 18 years) and below 75 years (inclusive of 75 years). 2. Eastern Cooperative Oncology Group (ECOG) performance status score should be 0 or 1, and there should be no deterioration within 2 weeks before the treatment with the study drug. The expected survival period should be no less than 12 weeks. 3. Pathological histology or cytology confirmed, and judged by multidisciplinary team (MDT) as potentially resectable stage III (IIIA or IIIB) non-squamous cell non-small cell lung cancer (International Association for the Study of Lung Cancer 8th edition lung cancer staging). 4. Tumor tissue samples or blood samples should be confirmed as EGFR sensitive mutations by the researcher-approved laboratory tests (i.e., exon 19 deletion or L858R, either alone or coexisting, or accompanied by other EGFR site mutations, but patients with EGFR20 exon insertion mutation cannot be enrolled). 5. According to RECIST1.1 standard, the subjects must have at least one measurable lesion on imaging. The baseline imaging assessment should be conducted within 28 days before the first administration of the drug. 6. Pregnant women from the screening to the end of the study treatment should take appropriate contraceptive measures and should not breastfeed. Before starting the medication, the pregnancy test should be negative, or one of the following criteria should be met to prove no pregnancy risk: a. Postmenopausal defined as an age greater than 50 years and amenorrhea for at least 12 months after stopping all exogenous hormone replacement therapy. b. Women younger than 50 years old, if amenorrhea occurs after stopping all exogenous hormone therapy for 12 months or more, and the levels of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) are within the laboratory reference range for postmenopause, can also be considered postmenopausal. c. Male subjects from screening to the end of the study treatment should use barrier contraception, namely condoms. 7. Male subjects from screening to the end of the study treatment should use barrier contraception, namely condoms. 8. The subjects should voluntarily participate and sign the informed consent form in person.

排除标准：

1.接受过下列任一治疗： a.既往接受过肺部手术； b.既往使用过任何 EGFR 酪氨酸激酶抑制剂； c.既往接受任何针对肺癌的系统性化疗或免疫治疗； d.既往接受任何肺癌放疗； 2.在患者使用研究药物之前 14 天内接受过除肺部以外其他部位的开放性外科手术<=14 天。 3.除了 NSCLC 之外，近 5 年内还被诊断有另外一种恶性疾病（不包括完全切除的基底细胞癌、原位膀胱癌、宫颈原位癌）。 4.既往使用过抗肿瘤作用的中成药。如曾使用过抗肿瘤作用的中成药但使用时间不超过 7 天，且在本研究药物治疗前已停药 2 周及以上可以入组。 5.存在严重或不能控制的全身性疾病（如严重的精神、神经疾病、癫痫或痴呆，不稳定或不能代偿的呼吸、心血管、肝或肾脏疾病，左心室射血分数（LVEF）＜50%，未得到控制的高血压[即指经过药物治疗后仍为大于或等于 CTCAE 3 级高血压]）的证据；患有吞咽功能障碍、活动性胃肠道疾病或其他显著影响口服药物的吸收、分布、代谢以及排泄的疾病。既往做过胃大部分切除术者。 6.近 1 周内有发热且体温在 38℃以上，或有临床意义的活动性感染。活动性肺结核。需要全身治疗的活动性真菌、细菌和/或病毒感染。 7.有活动性出血或新发血栓性疾病正在服用治疗量抗凝药物或有出血倾向者。 8.静息心电图在节律、传导或形态上出现有临床意义的重大异常，如完全性左束支传导阻滞，Ⅱ度以上心脏传导阻滞，具有临床意义的室性心律失常或心房颤动，不稳定心绞痛，充血性心力衰竭，纽约心脏病协会（NYHA）分级>= 2 级的慢性心衰。 9.3 个月内发生过心肌梗塞、冠状动脉/外周动脉搭桥或脑血管意外。 10.12 导联心电图 QT 间期（QTc）男性>=450 ms、女性>=470 ms。 11.存在导致 QT 间期延长的危险因素或增加心律不齐的危险因素，如心衰，≥CTCAE（4.03 版）2 度低钾血症（2 度低钾血症定义为：血钾<正常值下限-3.0mmol/L，并且有症状、需要治疗），先天性长 QT 综合症，长 QT 综合症家族史。 12.首次给药前 2 周内正在使用任何已知延长 QT 间期的药物。 13.骨髓储备或器官功能不足，达到下列任何一项实验室限值（实验室检查抽血前 1 周内无纠正治疗）： a.绝对嗜中性粒细胞计数<1.5×10^9 / L； b.血小板计数<90×10^9 / L； c.血红蛋白<90 g/L（<9 g/dL）； d.丙氨酸氨基转移酶>3 倍的正常上限（ULN）； e.天冬氨酸氨基转氨酶>3×ULN f.总胆红素> 1.5×ULN； g.肌酐> 1.5×ULN 或肌酐清除率<45 mL/min（通过 Cockcroft - Gault 公式计算）； h.血清白蛋白（ALB）<28 g/L； 14.妊娠期、哺乳期或计划在研究期间妊娠的女性受试者。 15.有间质性肺病病史、药物性间质性肺病病史、需要类固醇治疗的间质性肺炎病史或有临床活动性间质性肺病的任何证据。 16. 对阿美替尼的任何活性或非活性成分或对与阿美替尼化学结构类似或阿美替尼同类别的药物有超敏反应史。 17. 2 周内使用/食用已知具有强效 CYP3A4 抑制作用的药物或食物，包括但不限于阿扎那韦、克拉霉素、茚地那韦、伊曲康唑、酮康唑、奈法唑酮、奈非那韦、利托那韦、沙奎那韦、泰利霉素、醋竹桃霉素、伏立康唑和葡萄柚或葡萄柚汁。 18. 2 周内使用已知具有强效 CYP3A4 诱导作用的药物，包括但不限于卡马西平、苯巴比 妥、苯妥英、利福布丁、利福平和贯叶连翘。 19. 2 周内使用作为 CYP3A4 底物（具有狭窄治疗指数）的药物，包括但不限于双氢麦角胺、麦角胺、匹莫齐特、阿司咪唑、西沙必利和特非那定。 20. 2 周内使用过 P-gp 强抑制剂（包括但不限于维拉帕米、环孢素 A、右维拉帕米）。 21. 经研究者判断可能对研究的程序和要求依从性不佳的受试者，如受试者既往有明确的神经或精神障碍病史（包括癫痫或痴呆）、目前患有精神障碍类疾病等。 22.丙型肝炎抗体阳性且 HCV-RNA 检测超标的患者、乙型肝炎表面抗原阳性且 HBV-DNA 检测超标的患者、肝硬化患者、HIV 抗体阳性、梅毒抗体阳性的患者。 23. 研究者判断存在任何危及受试者安全或干扰研究评估的状况的受试者。

Exclusion criteria：

1. Have received any of the following treatments: a. Previously underwent lung surgery; b. Previously used any EGFR tyrosine kinase inhibitor; c. Previously received any systemic chemotherapy or immunotherapy for lung cancer; d. Previously received any radiotherapy for lung cancer; 2. Within 14 days before the patient used the study drug, had undergone open surgical procedures in any part other than the lungs (<= 14 days). 3. In the past 5 years, have been diagnosed with another malignant disease (excluding completely resected basal cell carcinoma, in situ bladder cancer, cervical in situ cancer). 4. Have used anti-tumor effect traditional Chinese medicine. If using anti-tumor effect traditional Chinese medicine within 7 days and have stopped the medication for 2 weeks or more before the treatment with the study drug, can be enrolled. 5. Have evidence of severe or uncontrollable systemic diseases (such as severe mental, neurological diseases, epilepsy or dementia, unstable or non-compensable respiratory, cardiovascular, liver or kidney diseases, left ventricular ejection fraction (LVEF) < 50%, uncontrolled hypertension [that is, still greater than or equal to CTCAE grade 3 hypertension after drug treatment]), have swallowing dysfunction, active gastrointestinal diseases or other diseases that significantly affect the absorption, distribution, metabolism and excretion of oral drugs. Those who have undergone subtotal gastrectomy. 6. Within the past 1 week, have had fever with a body temperature above 38℃, or have clinically significant active infection. Active tuberculosis. Active fungal, bacterial and/or viral infections requiring systemic treatment. 7. Have active bleeding or new thrombotic diseases that are being treated with therapeutic doses of anticoagulants or have bleeding tendencies. 8. Have significant clinical abnormalities in the rhythm, conduction or morphology of the resting electrocardiogram, such as complete left bundle branch block, second-degree or above cardiac conduction block, clinically significant ventricular arrhythmias or atrial fibrillation, unstable angina pectoris, congestive heart failure, New York Heart Association (NYHA) class >= 2 chronic heart failure. 9. Have experienced myocardial infarction, coronary artery/peripheral artery bypass or cerebrovascular accident within 3 months. 10. QT interval (QTc) in 12-lead electrocardiogram for males >= 450 ms, for females >= 470 ms. 11. Have risk factors causing QT interval prolongation or increasing the risk of arrhythmia, such as heart failure, ≥ CTCAE (version 4.03) grade 2 hypokalemia (grade 2 hypokalemia is defined as: serum potassium < lower limit of normal value - 3.0 mmol/L and with symptoms requiring treatment), congenital long QT syndrome, family history of long QT syndrome. 12. Have been using any known drugs that prolong QT interval within 2 weeks before the first administration. 13. Have insufficient bone marrow reserve or organ function, reaching any of the following laboratory limits (no corrective treatment within 1 week before blood draw for laboratory tests): a. Absolute neutrophil count < 1.5 × 10^9 / L; b. Platelet count < 90 × 10^9 / L; c. Hemoglobin < 90 g/L (< 9 g/dL); d. Alanine aminotransferase > 3 times the upper limit of normal (ULN); e. Aspartate aminotransferase > 3 × ULN; f. Total bilirubin > 1.5 × ULN; g. Creatinine > 1.5 × ULN or creatinine clearance rate < 45 mL/min (calculated by Cockcroft-Gault formula); h. Serum albumin (ALB) < 28 g/L; 14. Pregnant women, lactating women or those planning to become pregnant during the study period. 15. History of interstitial lung disease, drug-induced interstitial lung disease, history of interstitial pneumonia requiring steroid treatment, or any evidence of clinical active interstitial lung disease. 16. Any history of active or inactive components of amepixel or any hypersensitivity reaction to drugs chemically similar to amepixel or in the same category as amepixel. 17. Use/Consumption of known drugs or foods with strong CYP3A4 inhibitory effect within 2 weeks, including but not limited to atazanavir, clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, acyclovir, voriconazole, and grapefruit or grapefruit juice. 18. Use of known drugs with strong CYP3A4 inducing effect within 2 weeks, including but not limited to carbamazepine, phenobarbital, phenytoin, rifabutin, rifampicin, and hops. 19. Use of drugs as CYP3A4 substrates (with narrow therapeutic index) within 2 weeks, including but not limited to dihydroergotamine, ergotamine, pimozide, aspermide, cisapride, and terfenadine. 20. Use of P-gp inhibitors within 2 weeks (including but not limited to verapamil, cyclosporine A, and right verapamil). 21. Subjects judged by the investigator to have poor compliance with the study procedures and requirements, such as those with a clear history of neurological or mental disorders (including epilepsy or dementia), current mental disorders, etc. 22. Patients with positive hepatitis C antibody and excessive HCV-RNA test results, patients with positive hepatitis B surface antigen and excessive HBV-DNA test results, patients with liver cirrhosis, HIV antibody positive, and syphilis antibody positive. 23. Subjects judged by the investigator to have any condition that endangers the safety of the subjects or interferes with the assessment of the study.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-20 00:00:00 至 To 2028-01-01 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

20

Group：

Experimental group

Sample size：

干预措施：

采用阿美替尼联合培美曲塞+卡铂治疗三周期后评估治疗疗效。 阿美替尼 110mg po qd，培美曲塞 500mg/m^2卡铂 AUC 4-5，化疗具体剂量可由研究者根据患者情况自行调整。 再经至少三学科 MDT（胸外科、肿瘤内科、放疗科）讨论决 定局部治疗手段，MDT 判断可手术患者采用手术治疗，判断不可手术患者采用 根治性放疗。局部治疗期若选择放疗，放疗期间是否同步靶向或化疗，由研究者 自行决定。放疗时机和手术时机由研究者根据患者情况决定，推荐放疗时机：第三周期化疗结束后，推荐手术时机：第三周期化疗结束后 4—6W，手术前停用阿美替尼两周。

干预措施代码：

Intervention：

After three cycles of treatment with aumolertinib combined with pemetrexed + carboplatin, treatment efficacy will be assessed. Aumolertinib is administered at 110 mg orally once daily (po qd); pemetrexed at 500 mg/m2, and carboplatin at an area under the curve (AUC) of 4–5. The specific chemotherapy doses may be adjusted by the investigator based on individual patient conditions. Subsequently, local treatment modalities will be determined following a multidisciplinary team (MDT) discussion involving at least three specialties (thoracic surgery, medical oncology, and radiation oncology). For patients deemed surgically resectable by the MDT, surgical intervention will be recommended; for those deemed non-resectable, definitive radiotherapy will be administered. If radiotherapy is selected during the local treatment phase, the decision to concurrent with targeted therapy or chemotherapy will be made at the investigator’s discretion. The timing of radiotherapy and surgery will be determined by the investigator based on patient conditions. Recommended timing: radiotherapy should be initiated after completion of the third chemotherapy cycle; surgery is recommended 4–6 weeks after completion of the third chemotherapy cycle, with aumolertinib discontinued for 2 weeks prior to surgery.

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)：

 成都市 

Country：

China 

Province：

Si Chuan  

City：

Chengdu 

单位(医院)：

四川省肿瘤医院 

单位级别：

三甲 

Institution
hospital：

Sichuan Cancer Hospital

Level of the institution：

NA

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

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病理缓解

指标类型：

次要指标

Outcome：

Pathological response

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

完全病理缓解

指标类型：

次要指标

Outcome：

Complete pathological remission

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：

无事件生存期

指标类型：

次要指标

Outcome：

Event-free survival period

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

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：

暂未确定/Not yet

注册人：

Name of Registration：

  2026-01-20 16:43:03