NCT06736561尚未招募不适用
A Multicenter Real-world Clinical Study on the Efficacy and Safety of Ensartinib As Neoadjuvant Treatment for Anaplastic Lymphoma Kinase (ALK) Positive Non-small Cell Lung Cancer (NSCLC) Patients.
Harbin Medical University0 个研究点目标入组 100 人开始时间: 2025年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 主要终点
- MPR
研究概览
简要总结
Explore the efficacy and safety of Ensartinib in neoadjuvant treatment for ALK-positive non-small cell lung cancer in the real world.This is a real-world study of patients receiving enshatinib-based neoadjuvant therapy with R0 resection, divided into retrospective cohort 1, prospective cohort 2, and prospective cohort 3. The dose, duration, and whether to combine or sequentially treat enshatinib were clinical decisions made by the investigator on a patient-specific basis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Cohort 1: Female or male aged >=18 years;
- •Cohort 1: Received neoadjuvant treatment with Ensartinib before the project started;
- •Cohort 1: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
- •Cohort 1: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy.
- •Cohort 2: Female or male aged >=18 years;
- •Cohort 2: Intended to receive Ensartinib monotherapy as neoadjuvant treatment for 6-12 weeks;
- •Cohort 2: Diagnosed with clinical stage II-III resectable or potentially resectable (T1-4 N2 M0) ALK-positive NSCLC before neoadjuvant treatment;
- •Cohort 2: Confirmed ALK positive by immunohistochemistry (IFL), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
- •Cohort 2: Signed informed consent form;
- •Cohort 3: Female or male aged >=18 years;
- •Cohort 3: Intended to receive neoadjuvant treatment including Ensartinib, but not meeting the inclusion criteria for Cohort 2;
- •Cohort 3: Diagnosed with clinical stage II-III resectable or potentially resectable ALK-positive NSCLC before neoadjuvant treatment;
- •Cohort 3: Confirmed ALK positive by immunohistochemistry (IHC), fluorescence in situ hybridization (FISH), next-generation sequencing (NGS), or other non-specific sequencing methods before receiving ALK inhibitor therapy;
- •Cohort 3: Signed informed consent form.
排除标准
- •Cohort 1: Patients who have received treatment with Ensartinib after the project has started;
- •Cohort 1: Patients who have received Ensartinib treatment but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
- •Cohort 1: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
- •Cohort 1: Patients who are participating in other clinical studies outside of this research;
- •Cohort 1: Other circumstances deemed unsuitable for enrollment by the researchers.
- •Cohort 2: Patients who have received Ensartinib treatment before the study started;
- •Cohort 2: Patients who have received other systemic treatments besides Ensartinib;
- •Cohort 2: Neoadjuvant treatment cycles less than 6 weeks or more than 12 weeks;
- •Cohort 2: Patients who have received Ensartinib monotherapy but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
- •Cohort 2: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
- •Cohort 2: Patients who are participating in other clinical studies outside of this research;
- •Cohort 2: Other circumstances deemed unsuitable for enrollment by the researchers.
- •Cohort 3: Patients who have received neoadjuvant treatment containing Ensartinib but meet the enrollment criteria for Cohort 2;
- •Cohort 3: Patients who have received treatment containing Ensartinib but have not completed the objective efficacy evaluation according to the follow-up cycle specified by the clinical physician;
- •Cohort 3: History of hypersensitivity reactions to active or inactive excipients of Ensartinib or to drugs with similar chemical structures or categories as Ensartinib;
- •Cohort 3: Patients who are participating in other clinical studies outside of this research;
- •Cohort 3: Other circumstances deemed unsuitable for enrollment by the researchers.
结局指标
主要结局
MPR
时间窗: 6month
Main pathological remission rate
次要结局
- pCR(6month)
- 2-year disease-free survival rate(2year)
- ORR(1year)
研究者
Jianqun Ma
archiater
Harbin Medical University
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