ChiCTR2600122043 版本V1.0 版本创建时间2026/04/08 14:31:09 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：

ChiCTR2600122043 

最近更新日期：

Date of Last Refreshed on：

2026-04-08 14:30:37 

注册时间：

Date of Registration：

2026-04-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

利厄替尼辅助治疗根治术后 EGFR 罕见突变 II-IIIA 期非小细胞肺癌患者的疗效和安全性探索

Public title：

Exploration of the Efficacy and Safety of Limertinib as Adjuvant Therapy in Patients with Stage II-IIIA Non-Small Cell Lung Cancer Harboring EGFR Uncommon Mutations After Radical Resection.

注册题目简写：

English Acronym：

研究课题的正式科学名称：

利厄替尼辅助治疗根治术后 EGFR 罕见突变 II-IIIA 期非小细胞肺癌患者的疗效和安全性探索

Scientific title：

Exploration of the Efficacy and Safety of Limertinib as Adjuvant Therapy in Patients with Stage II-IIIA Non-Small Cell Lung Cancer Harboring EGFR Uncommon Mutations After Radical Resection.

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：

温士旺 

研究负责人：

温士旺 

Applicant：

Shiwang Wen 

Study leader：

Shiwang Wen 

申请注册联系人电话：

Applicant telephone：

+86 311 8609 5588

研究负责人电话：

Study leader's telephone：

+86 138 3310 3689

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：

whx116@126.com

研究负责人电子邮件：

Study leader's E-mail：

whx116@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：

河北省石家庄市健康路12号

研究负责人通讯地址：

河北省石家庄市健康路12号

Applicant address：

No. 12, Jiankang Road, Shijiazhuang City, Hebei Province

Study leader's address：

No. 12, Jiankang Road, Shijiazhuang City, Hebei 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：

河北医科大学第四医院

Applicant's institution：

The Fourth Hospital of Hebei Medical University

研究负责人所在单位：

河北医科大学第四医院

Affiliation of the Leader：

The Fourth Hospital of Hebei Medical University

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：

2025KY062

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：

河北医科大学第四医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of The Fourth Hospital of Hebei Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

2026-02-09 00:00:00

伦理委员会联系人：

何宏涛

Contact Name of the ethic committee：

Hongtao He

伦理委员会联系地址：

河北省石家庄市健康路12号

Contact Address of the ethic committee：

No. 12, Jiankang Road, Shijiazhuang City, Hebei Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 311 8609 5794

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：

河北医科大学第四医院

Primary sponsor：

The Fourth Hospital of Hebei Medical University

研究实施负责（组长）单位地址：

河北省石家庄市健康路12号

Primary sponsor's address：

No. 12, Jiankang Road, Shijiazhuang City, Hebei 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)：

河北省

市(区县)：

Country：

China

Province：

Hebei

City：

单位(医院)：

河北医科大学第四医院

具体地址：

河北省石家庄市健康路12号

Institution
hospital：

The Fourth Hospital of Hebei Medical University

Address：

No. 12, Jiankang Road, Shijiazhuang City, Hebei Province

经费或物资来源：

自筹

Source(s) of funding：

self-raised funds

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：

 上市后药物 

Study phase：

4

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的： ? 评价利厄替尼辅助治疗存在 EGFR 罕见突变 II-IIIA 期非小细胞肺癌患者完全切除术后的疗效； 次要目的： ? 评价利厄替尼辅助治疗存在 EGFR 罕见突变 II-IIIA 期非小细胞肺癌患者完全切除术后的安全性和耐受性：包括不良事件（AE）和严重不良事件（SAE）的发生率，AE/SAE 导致治疗终止的发生率。  

Objectives of Study：

Primary Objective: ? To evaluate the efficacy of Limertinib as adjuvant therapy in patients with stage II-IIIA non-small cell lung cancer harboring EGFR uncommon mutations after complete resection. Secondary Objectives: ? To evaluate the safety and tolerability of Limertinib as adjuvant therapy in the aforementioned patient population: including the incidence of adverse events (AEs) and serious adverse events (SAEs), and the incidence of treatment discontinuation due to AEs/SAEs.

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. 在实施任何试验相关流程之前，签署书面知情同意； 2. 年龄≥18周岁； 3. 组织学或细胞学证实的非鳞状非小细胞肺癌； 4. 术后病理分期为II-IIIA (AJCC 8th版) 5. 组织学检测存在少见EGFR敏感突变 （EGFR G719X、L861Q、S768I和EGFR 20ins）； 6. NSCLC原发灶完全切除； 7. 受试者手术完全康复并且已完成术后标准治疗； 8. ECOG评分0-1分； 9. 预期生存时间>3个月； 10. 足够器官功能，受试者需满足如下实验室指标： 1) 近14天未使用粒细胞集落刺激因子的情况下，中性粒细胞绝对值（ANC）≥1.5x10^9/L； 2) 近14天未输血的情况下，血小板≥100×10^9/L； 3) 近14天内无输血或使用促红细胞生成素的情况下，血红蛋白>9g/dL； 4) 总胆红素≤1.5×正常值上限（ULN）； 5) 天门冬氨酸转氨酶（AST）、丙氨酸转氨酶（ALT）在≤2.5×ULN（有肝转移的受试者允许ALT 或AST ≤5×ULN）； 6) 血肌酐≤1.5×ULN并且肌酐清除率（采用Cockcroft-Gault 公式计算）≥60 ml/min； 7) 凝血功能良好，定义为国际标准化比值（INR）或凝血酶原时间（PT）≤1.5倍ULN； 8) 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) 心肌酶谱在正常范围内（如研究者综合判断为不具有临床意义的单纯实验室异常也允许入组）； 11. 对于育龄期女性受试者，应在接受首次研究药物给药（第1周期第1天）之前的3天内接受尿液或血清妊娠试验且结果为阴性。如果尿液妊娠试验结果无法确认为阴性，则要求进行血液妊娠试验。非育龄期女性定义为绝经后至少１年，或进行过手术绝育或子宫切除术； 12. 如存在受孕风险，所有受试者（不论男性或女性）均需在整个治疗期间直至治疗末次研究药物给药后120天（或末次研究药物给药后180天）内采用年失败率低于1%的避孕措施。

Inclusion criteria

1. Provide written informed consent prior to participation in any study-related procedures. 2. Age >= 18 years. 3. Histologically or cytologically confirmed non-squamous non-small cell lung cancer (NSCLC). 4. Postoperative pathological stage II-IIIA (AJCC 8th edition). 5. Histological testing confirming the presence of an uncommon EGFR sensitizing mutation (EGFR G719X, L861Q, S768I, or EGFR exon 20 insertion). 6. Complete resection of the primary NSCLC lesion (R0 resection). 7. Full recovery from surgery and completion of standard postoperative therapy (if applicable). 8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1. 9. Life expectancy > 3 months. 10. Adequate organ function, defined as the following laboratory values within 14 days prior to the first dose of study drug: 1) Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (without granulocyte colony-stimulating factor support within 14 days). 2) Platelet count >= 100 x 10^9/L (without transfusion within 14 days). 3) Hemoglobin > 9.0 g/dL (without transfusion or erythropoietin use within 14 days). 4) Total bilirubin <= 1.5 x upper limit of normal (ULN). 5) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) <= 2.5 x ULN (<= 5 x ULN is acceptable for subjects with documented liver metastasis). 6) Serum creatinine <= 1.5 x ULN and? calculated creatinine clearance (using the Cockcroft-Gault formula) >= 60 mL/min. 7) Adequate coagulation, defined as International Normalized Ratio (INR) or prothrombin time (PT) <= 1.5 x ULN. 8) Normal thyroid function, defined as Thyroid-Stimulating Hormone (TSH) within the normal range. If baseline TSH is outside the normal range, subjects may be enrolled if both Total T3 (or Free T3) and Free T4 are within normal limits. i) Normal myocardial enzyme profile (isolated laboratory abnormalities judged by the Investigator as clinically insignificant are acceptable). 11. For women of childbearing potential (WOCBP), a negative urine or serum pregnancy test must be confirmed within 3 days prior to receiving the first dose of study drug (Cycle 1, Day 1). A serum pregnancy test is required if the urine test result is inconclusive. Non-childbearing potential is defined as being post-menopausal for at least 1 year, or having undergone surgical sterilization (bilateral oophorectomy, salpingectomy, or hysterectomy). 12. For subjects with childbearing potential, effective contraception with a method associated with a failure rate of <1% per year must be used by both male and female subjects during the treatment period and for at least 120 days (or 180 days, consult protocol) after the last dose of study drug.

排除标准：

1. 病理为小细胞肺癌（SCLC），包括SCLC与NSCLC混合的肺癌； 2. 接受过以下治疗： ? 当前肺癌的术前、术后或计划性放射治疗； ? 术前（新辅助）含铂或其他化疗方案； ? 除标准含铂双药术后辅助化疗外，任何既往针对NSCLC的抗肿瘤治疗（包括试验性治疗）； ? 曾接受新辅助或辅助EGFR-TKI治疗； ? 首次研究药物给药前4周内接受过大手术（包括原发肿瘤手术，血管通路置入除外）； ? 当前使用或无法在首次给药前停用强效CYP3A4诱导剂（需至少停药3周）； ? 已知化合物半衰期5倍时间内使用过试验性药物或其相关物质。 3. 仅接受肺段切除术或楔形切除术的患者需排除，因手术范围不足可能影响疗效评估 4. 其他恶性肿瘤病史，例外情况：已治愈的非黑色素瘤皮肤癌、原位癌，或治疗后超过5年无复发证据的其他实体瘤（需研究者评估复发风险低） 5. 研究治疗开始时，既往治疗导致的毒性需≤CTCAE 1级（脱发及既往铂类相关2级神经病变除外） 6. 未控制的高血压、活动性出血性疾病、需要静脉治疗的感染（乙肝、丙肝、HIV感染等），研究者判断可能影响试验安全性或方案依从性 7. 难治性恶心呕吐、慢性胃肠道疾病、吞咽困难或可能影响利厄替尼正常吸收的重大肠切除史 8. 心脏功能标准： ? QT间期延长：平均静息校正QTc>470毫秒（基于3次心电图）； ? 心电图异常：完全性左束支传导阻滞、III度房室传导阻滞等； ? 心律失常风险因素：低钾血症、先天性长QT综合征、家族史等。 9. 既往间质性肺病（ILD）病史、需激素治疗的放射性肺炎或活动性ILD 10. 实验室指标异常 ? 骨髓抑制：中性粒细胞<1.5×10?/L，血小板<100×10?/L，血红蛋白<90 g/L； ? 肝功能不全：ALT/AST>2.5×ULN，总胆红素>1.5×ULN（Gilbert综合征>3×ULN）； ? 肾功能不全：肌酐>1.5×ULN且肌酐清除率<50 mL/min； 11. 妊娠或哺乳期妇女； 12. 对利厄替尼成分或类似结构药物过敏者； 13. 有可能干扰试验结果、妨碍受试者全程参与研究的病史或疾病证据、治疗或实验室检查值异常，或研究者认为其他不适合入组的情况研究者认为存在其他潜在风险不适合参加本研究。

Exclusion criteria：

1. Pathological diagnosis of small cell lung cancer (SCLC), including combined SCLC and NSCLC. 2. Prior treatment as follows: Preoperative, postoperative, or planned radiotherapy for the current lung cancer. Preoperative (neoadjuvant) platinum-based or other chemotherapy regimens. Any prior antineoplastic therapy for NSCLC (including investigational therapy), except for standard adjuvant platinum-doublet chemotherapy. Prior neoadjuvant or adjuvant EGFR-TKI therapy. Major surgery (including primary tumor surgery, excluding vascular access placement) within 4 weeks prior to the first dose of study drug. Current use of or inability to discontinue strong CYP3A4 inducers (requires a washout period of at least 3 weeks) prior to the first dose. Use of an investigational drug or related material within 5 half-lives of the known compound. 3. Patients who underwent only segmentectomy or wedge resection are excluded, as the limited surgical extent may impact efficacy evaluation. 4. History of other malignancies, except for: cured non-melanoma skin cancer, carcinoma in situ, or other solid tumors treated and with no evidence of recurrence for >5 years (investigator must assess as low risk of recurrence). 5. At the start of study treatment, toxicities from prior therapy must have recovered to ≤ Grade 1 per CTCAE (except alopecia and Grade 2 neuropathy related to prior platinum therapy, which are allowed). 6. Uncontrolled hypertension, active bleeding disorders, or active infections requiring intravenous therapy (e.g., hepatitis B, hepatitis C, HIV), or other conditions that, in the investigator's judgment, may compromise safety or protocol compliance. 7. Refractory nausea/vomiting, chronic gastrointestinal diseases, dysphagia, or prior significant bowel resection that may interfere with the normal absorption of limertinib. 8. Cardiac function criteria: Prolonged QTc interval: average resting corrected QTc >470 msec (based on 3 ECGs). Significant ECG abnormalities: e.g., complete left bundle branch block, third-degree atrioventricular block. Risk factors for arrhythmia: hypokalemia, congenital long QT syndrome, family history of long QT syndrome, etc. 9. History of interstitial lung disease (ILD), radiation pneumonitis requiring steroid treatment, or active ILD. 10. Clinically significant laboratory abnormalities: Myelosuppression: Neutrophil count <1.5 x 10?/L, platelet count <100 x 10?/L, hemoglobin <90 g/L. Hepatic impairment: ALT/AST >2.5 x ULN, total bilirubin >1.5 x ULN (>3 x ULN for Gilbert's syndrome). Renal impairment: Serum creatinine >1.5 x ULN and? calculated creatinine clearance <50 mL/min. 11. Pregnant or lactating women. 12. Known hypersensitivity to limertinib, its components, or drugs with a similar chemical structure. 13. Any other condition, including medical history, concurrent disease, treatment, or laboratory abnormality, that, in the investigator's judgment, could interfere with the interpretation of study results, prevent the subject from completing the study, or poses an undue risk, making the subject unsuitable for participation. 3. Patients who underwent only segmentectomy or wedge resection are excluded, as the limited surgical extent may impact efficacy evaluation. 4. History of other malignancies, except for: cured non-melanoma skin cancer, carcinoma in situ, or other solid tumors treated and with no evidence of recurrence for >5 years (investigator must assess as low risk of recurrence). 5. At the start of study treatment, toxicities from prior therapy must have recovered to ≤ Grade 1 per CTCAE (except alopecia and Grade 2 neuropathy related to prior platinum therapy, which are allowed). 6. Uncontrolled hypertension, active bleeding disorders, or active infections requiring intravenous therapy (e.g., hepatitis B, hepatitis C, HIV), or other conditions that, in the investigator's judgment, may compromise safety or protocol compliance. 7. Refractory nausea/vomiting, chronic gastrointestinal diseases, dysphagia, or prior significant bowel resection that may interfere with the normal absorption of limertinib. 8. Cardiac function criteria: Prolonged QTc interval: average resting corrected QTc >470 msec (based on 3 ECGs). Significant ECG abnormalities: e.g., complete left bundle branch block, third-degree atrioventricular block. Risk factors for arrhythmia: hypokalemia, congenital long QT syndrome, family history of long QT syndrome, etc. 9. History of interstitial lung disease (ILD), radiation pneumonitis requiring steroid treatment, or active ILD. 10. Clinically significant laboratory abnormalities: Myelosuppression: Neutrophil count <1.5 x 10?/L, platelet count <100 x 10?/L, hemoglobin <90 g/L. Hepatic impairment: ALT/AST >2.5 x ULN, total bilirubin >1.5 x ULN (>3 x ULN for Gilbert's syndrome). Renal impairment: Serum creatinine >1.5 x ULN and? calculated creatinine clearance <50 mL/min. 11. Pregnant or lactating women. 12. Known hypersensitivity to limertinib, its components, or drugs with a similar chemical structure. 13. Any other condition, including medical history, concurrent disease, treatment, or laboratory abnormality, that, in the investigator's judgment, could interfere with the interpretation of study results, prevent the subject from completing the study, or poses an undue risk, making the subject unsuitable for participation.

研究实施时间：

Study execute time：

从 From 2026-05-11 00:00:00至 To 2029-05-10 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-05-11 00:00:00 至 To 2027-05-11 00:00:00  

干预措施：

Interventions：

组别：

试验组

样本量：

18

Group：

Test group

Sample size：

干预措施：

利厄替尼

干预措施代码：

Intervention：

Limertinib

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北省 

市(区县)：

  

Country：

Chin 

Province：

Hebei 

City：

 

单位(医院)：

河北医科大学第四医院 

单位级别：

三甲 

Institution
hospital：

The Fourth Hospital of Hebei Medical University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

2年无复发生存率

指标类型：

主要指标

Outcome：

2-year DFS 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：

3年无复发生存率

指标类型：

次要指标

Outcome：

3-year DFS 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：

无复发生存

指标类型：

次要指标

Outcome：

Disease-free survival (DFS)

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：

指标中文名：

安全性

指标类型：

次要指标

Outcome：

Safety

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

 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 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）：

不涉及

Randomization Procedure (please state who generates the random number sequence and by what method)：

not involve

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：

Blinding：

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）：

不涉及

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

not involve

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：

电子病例收集表

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

eCRF

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：

  2026-04-08 14:30:37