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临床试验/NCT03646994
NCT03646994招募中不适用

A Real World Study to Evaluate the Efficacy and Safety of First Line Crizotinib in ROS1-rearranged 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 40 人开始时间: 2018年8月1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
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

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

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)

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