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临床试验/NCT02392455
NCT02392455已完成不适用

Vargatef in 2nd-line Therapy of Advanced or Metastatic Adenocarcinoma of the Lung

Boehringer Ingelheim0 个研究点目标入组 817 人开始时间: 2015年3月23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
已完成
入组人数
817
主要终点
Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)

研究概览

简要总结

This observational study will investigate the efficacy and tolerability of Vargatef (Nintedanib) plus docetaxel in daily routine second-line treatment in patients with locally advanced, metastatic or locally recurrent NSCLC. Treatment with Vargatef in eligible NSCLC patients, for whom the treating physician has decided to initiate treatment with Vargatef in second line according to the local label, will be observed for up to 24 months. Survial follow-up will be done until the end of the study.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

A

干预措施: treatment (Drug)

结局指标

主要结局

Percentage of patients alive one year after start of therapy with Vargatef and Docetaxel (1-year survival rate)

时间窗: up to 24 months

次要结局

  • Tumour control rate (complete response, partial response, stable disease)(up to 24 months)
  • Incidence of side effects(up to 24 months)
  • One year survival rate of patients with first line progression within 9 months after start of first line therapy(up to 24 months)
  • Progression-free survival of patients with first line progression within 9 months after start of first line therapy(up to 24 months)
  • Median overall survival(up to 24 months)
  • Progression-free survival(up to 24 months)

研究者

申办方类型
Industry
责任方
Sponsor

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