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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- 3-Year Disease-Free Survival Rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Patients with IA-stage (8th edition of AJCC staging) non-small cell lung cancer (NSCLC) confirmed by histopathology and with high-risk factors
- •EGFR mutation positive
- •No previous systemic anti-tumor treatment
- •Expected or already received surgical treatment
- •Intended to receive or already received third-generation EGFR-TKI adjuvant therapy after surgery.
排除标准
- •Small cell lung cancer
- •With other malignant tumors that require treatment
- •Pregnant or lactating women
- •Those who the researchers consider not suitable to participate in this clinical trial.
结局指标
主要结局
3-Year Disease-Free Survival Rate
时间窗: 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
次要结局
- 5-Year Disease-Free Survival rate(5 years after 3rd generation EGFR-TKIs adjuvant therapy)
- Disease-free Survival (DFS)(Approximately 5 years)
- 5-Year Overall Survival Rate(5 years after 3rd generation EGFR-TKIs adjuvant therapy)
- 3-Year Overall Survival Rate(3 years after 3rd generation EGFR-TKIs adjuvant therapy)
- Overall Survival（OS）(Approximately 5 years)
- Incidence of Adverse Events(From the start of adjuvant therapy to 28 days after the end of treatment)