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A Non-interventional, Real-world Study on the Adjuvant Treatment of Chinese EGFR-positive Stage IA NSCLC Patients With High-risk Factors Using Third-generation EGFR-TKIs.

2026年6月30日 更新者：First Affiliated Hospital of Guangxi Medical University

A Non-interventional, Real-World Study of Third-Generation EGFR-TKI Adjuvant Therapy in Chinese EGFR-Positive Stage IA Non-Small Cell Lung Cancer Patients With High-Risk Factors

This study aims to evaluate the real-world effectiveness and safety of third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors (TKIs)-such as osimertinib, aumolertinib, and furmonertinib-as adjuvant therapy for patients with early-stage non-small cell lung cancer (NSCLC) in China.

Approximately 500 eligible patients are planned to be enrolled. All participants must have been diagnosed with Stage IA NSCLC (according to the 8th edition of the AJCC staging system) following surgical resection, harboring EGFR-sensitive mutations, and presenting with high-risk recurrence factors (e.g., poor differentiation, lymphovascular invasion, and spread through air spaces).

This is a non-interventional, real-world study that does not alter physicians' original prescribing habits or clinical management strategies. Patients will receive standard treatment with third-generation EGFR-TKIs according to routine clinical practice (typically for a duration of three years). The research team will periodically collect follow-up data, with a primary focus on postoperative disease-free survival (DFS) and drug safety profiles.

Through this investigation, we seek to determine whether this specific population of high-risk early-stage patients can derive clinical benefit from postoperative targeted therapy. The findings are expected to provide evidence to support the development of future clinical guidelines.

研究概览

地位

尚未招聘

条件

干预/治疗

研究类型

观察性的

注册 (估计的)

500

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

学习地点

  • 中国
    • Guangxi
      • Nanning、Guangxi、中国、530021
        • The First Affiliated Hospital of Guangxi Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

This is a prospective, non-interventional, real-world study. The study population consists of 500 Chinese patients with stage IA NSCLC with high-risk factors and EGFR mutations. All participants have undergone or are planned to undergo surgical resection and are receiving or planned to receive third-generation EGFR-TKI adjuvant therapy according to the standard of care and the approved registration study protocol. Treatment duration is planned for up to 3 years until disease recurrence/progression, intolerable toxicity, withdrawal of consent, or completion of the 3-year treatment period. The study aims to collect data for final analysis without interfering with the patients' routine clinical treatment decisions.

描述

Inclusion Criteria:

  1. Age ≥ 18 years old
  2. Patients with IA-stage (8th edition of AJCC staging) non-small cell lung cancer (NSCLC) confirmed by histopathology and with high-risk factors
  3. EGFR mutation positive
  4. No previous systemic anti-tumor treatment
  5. Expected or already received surgical treatment
  6. Intended to receive or already received third-generation EGFR-TKI adjuvant therapy after surgery.

Exclusion Criteria:

  1. Small cell lung cancer
  2. With other malignant tumors that require treatment
  3. Pregnant or lactating women
  4. Those who the researchers consider not suitable to participate in this clinical trial.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

队列和干预

团体/队列
干预/治疗
Observational Group
Third-generation EGFR-TKI adjuvant therapy for Chinese patients with stage IA EGFR-positive NSCLC who have high-risk factors
药品：Third-generation EGFR-TKI
This is an observational, non-interventional study. The interventions listed herein refer to routine standard adjuvant therapies administered entirely at the discretion and implementation of the attending physicians, without any interference from the study protocol. The research team is solely responsible for observing and collecting data, and does not participate in or influence patients' treatment decisions.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
3-Year Disease-Free Survival Rate
大体时间：3 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
3 years after 3rd generation EGFR-TKIs adjuvant therapy

次要结果测量

结果测量
措施说明
大体时间
5-Year Disease-Free Survival rate
大体时间：5 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients who did not PD or all-cause death after 3-years 3rd generation EGFR-TKIs adjuvant therapy
5 years after 3rd generation EGFR-TKIs adjuvant therapy
Disease-free Survival (DFS)
大体时间：Approximately 5 years
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of disease recurrence or death (by any cause in the absence of recurrence).
Approximately 5 years
5-Year Overall Survival Rate
大体时间：5 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients alive at 5 years
5 years after 3rd generation EGFR-TKIs adjuvant therapy
3-Year Overall Survival Rate
大体时间：3 years after 3rd generation EGFR-TKIs adjuvant therapy
The proportion of patients alive at 3 years
3 years after 3rd generation EGFR-TKIs adjuvant therapy
Overall Survival（OS）
大体时间：Approximately 5 years
From date of 3rd generation EGFR-TKIs adjuvant therapy started until date of death (by any cause in the absence of recurrence).
Approximately 5 years
Incidence of Adverse Events
大体时间：From the start of adjuvant therapy to 28 days after the end of treatment
The type, frequency and severity of adverse events during treatment (TEAE) and treatment-related adverse events (TRAE)
From the start of adjuvant therapy to 28 days after the end of treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

First Affiliated Hospital of Guangxi Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2031年9月1日

研究完成 (估计的)

2032年12月31日

研究注册日期

首次提交

2026年6月30日

首先提交符合 QC 标准的

2026年6月30日

首次发布 (实际的)

2026年7月7日

研究记录更新

最后更新发布 (实际的)

2026年7月7日

上次提交的符合 QC 标准的更新

2026年6月30日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 2026-K0033

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

IPD 计划说明

This is a single-center retrospective observational study. Due to practical limitations in data management infrastructure and the lack of specific funding allocated for data sharing activities, the research team does not plan to share individual participant data.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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