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临床试验/NCT04144569
NCT04144569招募中2 期

the Effectiveness and Safety Study on PD-1 Combined With Pyrotinib for First-line Chemotherapy Failed HER2 Insertion Mutation Advanced Non-small Cell Lung Cancer

Yongchang Zhang1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年1月30日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
PFS

研究概览

简要总结

The purpose of this study is to assess the safety and effectiveness of PD-1 Combined With Pyrotinib for First-line chemotherapy failed HER2 Insertion Mutation Positive Advanced Non-small Cell Lung Cancer

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Advanced non-small cell lung cancer confirmed by histology or cytology
  • HER2 insertion mutation-positive
  • Failure with first-line standard chemotherapy
  • with measurable lesions.

排除标准

  • no measurable tumor lesions
  • Patients received PD-1 or Pyrotinib before

研究组 & 干预措施

PD-1 Combined With Pyrotinib

Experimental

PD-1 combined With pyrotinib used fo first-line chemotherapy failedr HER2 Insertion mutation positive advanced NSCLC

干预措施: PD-1 Combined With Pyrotinib (Drug)

结局指标

主要结局

PFS

时间窗: Approximately 1 years

Progression free survival

次要结局

  • ORR(Approximately 1 years)
  • OS(Approximately 1 years)

研究者

发起方
Yongchang Zhang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yongchang Zhang

Professor

Hunan Province Tumor Hospital

研究点 (1)

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