NCT05445310招募中2 期
Adjuvant Furmonertinib in Stage IA With High Risk Factors and Stage IB Non-small Cell Lung Cancer: a Prospective Single-arm Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Disease-free survival rate at 3 years
研究概览
简要总结
This is a prospective, single arm study to investigate the efficacy and safety furmonertinib 80mg/d as adjuvant treatment for 3 years post surgery of stage IA with high-risk factors and stage IB non-small cell lung cancer. A total of 114 patients would be enrolled. The primary endpoint is the disease-free survival rate at 3 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Received radical resection of non-small cell lung cancer without prior anti-tumor therapies including radiotherapy, chemotherapy, target therapy and immunotherapy.
- •Histologically diagnosed Non-small cell lung cancer based on the judgement of at least 2 pathologists.
- •Stage IA with high risk factors including micropapillae or solid components, vascular invasion, spread through air spaces, low differentiation, tumor budding and insufficient lymph node dissection; Stage IB with or without high-risk factors. The pathological stage is based on the 8th edition of AJCC lung cancer staging.
- •EGFR mutation positive according to NGS testing by tissue, including deletions in exon 19, L858R, S768I, G719X, L861Q, T790M mutations et al.
- •ECOG performance status 0-
- •Sufficient organ function in liver, renal, kidney and hematology.
- •With written signed informed consent form, ability to report adverse events, and good adherence to clinical study.
排除标准
- •Lung cancer with small cell or neuroendocrine cancer cell.
- •EGFR exon 20 insertion positive.
- •Concurrent with other diver mutations including alterations in ALK, ROS1, MET et al.
- •Women who are pregnant or breastfeeding.
- •Use of CYP3A4 strong depressant within 7 days or CYP3A4 strong inducer within 21 days prior to initial administration, use of other anti-tumor treatment including traditional Chinese medicine within 14 days before enrollment.
- •Concurrent with other malignancies excluding carcinoma in situ.
- •With uncontrolled systematic diseases such as active bleeding, unstable angina, heart infarction within 1 year, chronic heart failure and uncontrolled hypertension and diabetes mellitus; with active infection of HBV, HCV or HIV, or other infections requiring injection of antibiotics.
- •Gastrointestinal disorders which may affect drug taking or absorption.
- •With history of QT prolongation or relative risk factors including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome et al.
- •With history of interstitial lung disease or relative risk.
- •Allergic to any component of furmonertinib tablet.
- •Mental illness or drug abuse.
- •Live vaccination within 30 days before enrollment.
- •Other situation judged by investigator such as failure to follow the rules of study.
- •Attending another study of investigational drug, or received other study drugs or medical devices with 4 weeks before enrollment.
研究组 & 干预措施
Furmonertinib
Experimental
Patients will receive furmonertinib 80mg/d for 3 years or until disease recurrence or treatment cessation for other reasons.
干预措施: Furmonertinib (Drug)
结局指标
主要结局
Disease-free survival rate at 3 years
时间窗: 3 years following the first dose of study drug
The rate of survival patients without disease recurrence at 3 years
次要结局
- Median disease-free survival(Approximately 3 years following the first dose of study drugs)
- Overall survival rate at 3 years(3 years following the first dose of study drug)
- Median overall survival(Approximately 5 years following the first dose of study drugs)
- Adverse events(Approximately 3 years following the first dose of study drugs)
研究者
研究点 (1)
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