A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ROS1-rearranged Non-squamous Non-small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study was designed to explore the efficacy and safety of Crizotinib as a first-line treatment for advanced NSCLC with ROS1 rearrangement positive mutation in the real world, explore the new drug resistance mechanism of ROS1 under Crizotinib treatment and the consistency of plasma and tissue detection driving genes, and finally evaluate the mutation spectrum of plasma dynamic detection driving genes. In predicting the risk of disease progression.
详细描述
This is a research project involving patients in Medical Oncology Department of Affiliated Cancer Hospital of Xiangya School of Medicine Central South University. Retrospective study of 40 patients with advanced non-squamous non-small cell lung cancer (NSCLC) using Crizotinib ROS1 rearrangement positive mutation was conducted to observe the efficacy and safety of Crizotinib regimen in the real world.Exploratory research contents are as follows: 1. Consistency between tissue gene test (NGS) and plasma gene test (NGS) at the initial diagnosis; 2. Consistency between NGS and plasma gene test (NGS) at the progression of clozotinib treatment; 3. Drug resistance mechanism of clozotinib in ROS1 rearrangement positive NSCLC; 4. Plasma drug resistance. Large panel dynamic driven gene mutation analysis was used to construct disease progression risk model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •≥18,Advanced Non-squamous Non-small Cell Lung Cancer Confirmed by Histopathology
- •ROS1 Arranged Positive
- •ROS1 Arranged Detection Method is NGS
- •First Diagnosis and Treatment
- •Treatment Plan is Kazolinib 250mg po bid
排除标准
- •Patients received antitumor treatment before
- •Patients with contraindication of chemotherapy
- •Pregnant or breast feeding women
研究组 & 干预措施
Cohorts 1
ROS1 fusion positive NSCLC patients who received crizotinib
干预措施: Crizotinib (Drug)
结局指标
主要结局
PFS
时间窗: may 2018- may 2019 (1 year)
progression survival time
次要结局
- ORR(may 2018- may 2019 (1 year))
- OS(may 2018- may 2019 (1 year))
研究者
Yongchang Zhang
Professor
Hunan Province Tumor Hospital
