跳至主要内容
临床试验/NCT03647111
NCT03647111招募中不适用

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

Hunan Province Tumor Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2018年1月1日最近更新:
适应症
干预措施
相关药物

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

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

发起方
Hunan Province Tumor Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yongchang Zhang

Professor

Hunan Province Tumor Hospital

研究点 (1)

Loading locations...

相似试验