A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ALK Rearranged Advanced 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
- 120
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
This study aims to explore the efficacy and safety of Crizotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world.
详细描述
According to the study of P11014 and P1029, Crizotinib is a first-line therapy for advanced non squamous non small cell lung cancer with positive ALK rearrangement.This study aims to explore the efficacy and safety of clozotinib as a first-line therapy for advanced non-squamous non-small cell lung cancer with ALK-positive mutations in the real world. Among them, ALK positive was based on NGS test results, exploring the new drug resistance mechanism of ALK under clozotinib treatment mode and consistency between plasma and tissue detection driving genes, and finally assessing the role of plasma dynamic detection driving gene mutation spectrum in predicting disease progression risk. A retrospective study of 120 patients with advanced NSCLC using clozotinib ALK positive mutation was conducted to observe the efficacy and safety of clozotinib regimen in the real world.
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
- 否
入选标准
- •≥18,Pathologically proven ALK positive mutation in advanced non squamous non small cell lung cancer
- •ALK rearrangement detection method is NGS and Ventana
- •Primary treatment of first diagnosis
- •The treatment was Crizotinib 250mg po bid Exclusion Criteria
- •Patients received antitumor treatment before
- •Patients with contraindication of chemotherapy
- •Pregnant or breast feeding women
排除标准
- 未提供
研究组 & 干预措施
Cohorts 1
干预措施: Crizotinib (Drug)
结局指标
主要结局
PFS
时间窗: Approximately 1 years
Progression free survival
次要结局
- OS(Approximately 1 years)
研究者
Yongchang Zhang
Professor
Hunan Province Tumor Hospital
