NCT06561620招募中4 期
A Prospective Study of Befotertinib Adjuvant Therapy in Patients With Postoperative MRD-positive Non-small Cell Lung Cancer in Stage IA2-IB With High Risk Factors
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 592
- 试验地点
- 1
- 主要终点
- 3-year disease-free survival
研究概览
简要总结
To evaluate 3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC treated with adjuvant befortinib and under routine observation (3y-DFS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- •Age: 18-75 years old.
- •Gender: both men and women are acceptable, as balanced as possible.
- •Patients with lung adenocarcinoma who underwent R0 resection and were clinically confirmed as IA2-IB by histopathology and whose tumor size was (1-4cm), the surgical tissue samples tested positive for EGFR-sensitive mutations and positive for MRD after surgery.
- •Accompanied by arbitrary ≥ 2 high-risk factors; High risk factors such as pleural invasion, airway diffusion, vascular infiltration, low differentiation, pathological micropapillary composition ≥ 15%, complex glandular composition ≥ 20%, etc.
- •Achieve R0 resection: For CTR < 50% ground glass nodules, wedge resection is acceptable and the margin is negative, and 3 groups of lymph node biopsies are negative; for CTR ≥ 50% or pure solid nodules, at least segmental resection is undergone, and lymph node dissection is systematically performed; if there is no clear evidence of metastasis, if it cannot be judged, it can be determined by an independent review committee for pathological consultation.
- •The ECOG behavioral status score is 0 to 1, and the expected survival time is > 1 year.
- •Voluntary MRD screening and voluntary befortinib adjuvant therapy;
- •Have a certain organ system function, defined as follows, based on the researcher's experience A. Absolute neutrophil count (ANC) ≥ 1.5 x 109/L B. Platelets ≥ 100 x 109/L; C. Hemoglobin ≥ 9 g/dL (≥ 90 g/L) Note that in order to achieve the required hemoglobin level, blood transfusion is allowed; D. Total bilirubin ≤ 1.5 times the upper limit of normal (ULN); E. If there is no liver metastasis, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × ULN; if liver metastasis, ≤ 5 × ULN; F. Creatinine ≤ 1.5 x ULN. Patients are still eligible for inclusion if the creatinine clearance value calculated by the Cockcroft-Gault method is ≥ 50 mL/min (0.83 mL/s).
- •Female subjects of childbearing age must have a serum pregnancy test within 3 days before the start of the study drug, and the result is negative, and they are willing to use a medically approved high-efficacy contraceptive method (such as intrauterine devices, contraceptives or condoms) during the study period and within 3 months after the last administration of the study drug; for significant other male subjects who are women of childbearing age, they should be surgically sterilized, or agree to use effective methods of contraception during the study period and within 3 months after the last study dose.
- •Voluntary and capable of following the test and follow-up procedures.
- •Sign the informed consent form.
排除标准
- •There is any other treatment before the operation, and no informed consent is signed;
- •The patient has been diagnosed with cancer within 2 years;
- •Have a history of interstitial lung disease, drug-induced interstitial disease or any active interstitial lung disease with clinical evidence; CT scan at baseline revealed idiopathic pulmonary fibrosis.
- •Patients who are known to be allergic to any component of befortinib or similar drugs;
- •Pregnant or lactating women;
- •Situations considered unsuitable for inclusion by other researchers.
研究组 & 干预措施
Treatment
Active Comparator
干预措施: Befotertinib (Drug)
结局指标
主要结局
3-year disease-free survival
时间窗: 3 years
3-year disease-free survival after complete resection in patients with MRD-positive EGFR-sensitive mutations in Stage IA2-IB NSCLC
次要结局
未报告次要终点
研究者
Haiquan Chen
Chief of the MDT board of thoracic cancer
Fudan University
研究点 (1)
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