NCT05132218招募中不适用
Prospective Exploratory Real World Study of Ensatinib in alK-positive Patients Undergoing Initial Treatment for Advanced Non-small Cell Lung Cancer
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年10月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- progression-free survival
研究概览
简要总结
The experimental design is exploratory, single-arm, multi-center, real-world research.
Ensatinib 225mg qd A prospective and exploratory real-world study of Ensatinib for ALK-positive advanced non-small cell lung cancer patients Test purposes Exploring the real world, Ensatinib is effective for the newly treated ALK+ advanced NSCLC
- Efficacy and safety;
- The relationship between molecular mechanism and curative effect;
- Ensatinib resistance mechanism;
详细描述
Enrolled patients:
- stage IIIB or stage IV NSCLC
- Each center confirmed ALK+ by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
- Without any ALK-TKI treatment; Study endpoint
Primary endpoint:
According to the RECIST1.1 standard, the progression-free survival (PFS) assessed by the investigator;
Secondary endpoint:
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
- •stage IIIB or stage IV NSCLC by histology or cytology;
- •All centers confirmed ALK positive by tissue samples (Abbott FISH, VENTANA ALK D5F3, NGS method confirmation);
- •Without any ALK-TKI treatment;
- •Voluntarily and capable of following the trial and follow-up procedures;
- •Able to understand the nature of the trial, and be able to complete the signing of a written informed consent form.
排除标准
- •Pereceived any ALK-TKI treatment ;
- •Received any chemotherapy within 4 weeks, or underwent major surgery or radiotherapy within the last 14 days;
- •The investigator believes that the patient is not suitable for Ensatinib treatment.
- •Had a stem cell or organ transplant.
- •Having serious cardiovascular disease, including but not limited to: 5.Sino - QTcF interval ≥450 ms or other significant ECG abnormalities. According to the study, researchers either ruled that hypertension was poorly controlled (systolic blood pressure >160 mmHg or diastolic blood pressure >100mmHg).
- •Dysphagia, active gastrointestinal disease, or other disease that significantly affects drug absorption, distribution, metabolism, and excretion.
- •Previous history of interstitial lung disease, drug-induced interstitial lung disease, radioactive pneumonia requiring steroid treatment, or any indication of clinically active interstitial lung disease.
研究组 & 干预措施
Ensatinib for treated patients with ALK-positive advanced non-small cell lung cancer
Ensatinib 225mg QD Until the disease progresses or intolerance
干预措施: Ensatinib (Drug)
结局指标
主要结局
progression-free survival
时间窗: 2021.09.27-2024.12.30
次要结局
- overall survival(2021.09.27-2024.12.30)
- Time-to-TreatmentFailure(2021.09.27-2024.12.30)
研究者
Jun Zhao
Professor
Peking University Cancer Hospital & Institute
研究点 (1)
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