NCT06755684招募中2 期
Neoadjuvant Befotertinib Combined Bevacizumab or Platinum-based Double Chemotherapy for Resectable Locally-advanced EGFR Mutation-positive Non-Small Cell Lung Cancer: a Single-center, Randomized Controlled Trial
Peng Zhang1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年11月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Major pathologic response (MPR)
研究概览
简要总结
This study targeted patients with resectable stage II-IIIA non-small cell lung cancer with EGFR mutation
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC patient with EGFR sensitive mutation as confirmed by needle biopsy;
- •At stage II-IIIA (TNM Staging, Version 8) as identified by chest CT, PET-CT or/and EBUS;
- •No systemic metastasis (confirmed by head MRI, whole body bone scan, PET-CT, liver and adrenal CT, etc.);
- •With the feasibility to receive radical surgery ;
- •Good lung function that could tolerate surgical treatment;
- •Aged 18-75 years;
- •At least one measurable tumor foci (the longest diameter measured by CT shall be > 10 mm);
- •Other major organs shall function well (liver, kidney, blood system, etc.):
- •ECOG PS score shall be 0-1;
- •The child-bearing female must undergo pregnancy test within 7 days before starting the treatment and the result shall be negative. Reliable contraceptive measures, such as intrauterine device, contraceptive pill and condom, shall be adopted during the trial and within 30 days after completion of the trial. The child-bearing male shall use condom for contraception during the trial and within 30 days after completion of the trial;
- •The patient shall sign the Informed Consent Form.
排除标准
- •The patient has undergone any systemic anti-cancer treatment for NSCLC, including surgical treatment, local radiotherapy, cytotoxic drug treatment, targeted drug treatment and experimental treatment, etc.;
- •The patient suffers from any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina pectoris, angina pectoris that starts to attack within the last 3 months, congestive heart failure [≥ Grade II specified by New York Heart Association (NYHA)], cardiac infarction (6 months before enrollment), severe arrhythmia and liver, kidney or metabolic diseases that requires drug treatment;
- •The patient is a carrier of HIV;
- •The patient has had or is currently suffering from interstitial lung disease;
- •The patient had undergone other major systemic operations or suffered from severe trauma within 3 months before the trial;
- •The patient is allergic to befotertinib or its any excipients;
- •The patient is allergic to bevacizumab or its any excipients;
- •The patient is allergic to platinum-based double chemotherapy or its any excipients;
- •The female patient is in pregnancy or lactation period;
- •There are any conditions under which the investigator considers the patient is not suitable to be enrolled.
研究组 & 干预措施
Befotertinib combined Bevacizumab
Experimental
Befotertinib combined Bevacizumab
干预措施: Befotertinib combined Bevacizumab (Drug)
Befotertinib combined platinum-based double chemotherapy
Experimental
Befotertinib combined platinum-based double chemotherapy
干预措施: Befotertinib combined platinum-based double chemotherapy (Drug)
结局指标
主要结局
Major pathologic response (MPR)
时间窗: up to 4 months
MPR is defined as the proportion of participants who have achieved major pathologic response (on routine hematoxylin and eosin staining, tumors with no more than 10% viable tumor cells) in all participants who have completed the neoadjuvant therapy before surgery
次要结局
- Objective response rate (ORR)(Up to 4 months)
- Progression-free survival (PFS)(up to 60 months)
- Event-free survival (EFS)(Up to 60 months)
- Overall survival (OS)(up to 60 months)
- Disease-free survival (DFS)(up to 60 months)
- R0 rate(up to 4 months)
- adverse event (AE) rate(up to 4 months)
- Complete Pathological response (CPR)(Up to 4 months)
研究者
Peng Zhang
Archiater
Shanghai Pulmonary Hospital, Shanghai, China
研究点 (1)
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