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临床试验/NCT04105153
NCT04105153已完成不适用

Real-world Analysis of Workup at Disease Progression and Implementation of Osimertinib for EGFR+ NSCLC

Thoraxklinik-Heidelberg gGmbH1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2019年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
400
试验地点
1
主要终点
Fraction of EGFR+ NSCLC patients with sequential TKI treatment

研究概览

简要总结

Tyrosine kinase inhibitors (TKI) have greatly improved prognosis of epidermal growth factor receptor (EGFR)-positive non-small cell lung cancer (NSCLC), with tumor responses in the majority of cases and a median overall survival currently exceeding 2.5 years. However, clinical courses vary widely and eventual treatment failure is inevitable. The most common resistance mechanism against first- and second-generation EGFR inhibitors is the EGFR T790M mutation, which emerges in about 50% of cases and is amenable to next-line treatment with the third-generation compound osimertinib. However, experience in everyday clinical practice shows that implementation of EGFR TKI sequencing is often problematic, for example because a considerable number of EGFR+ NSCLC patients failing first- and second-generation EGFR inhibitors do not undergo T790M mutation testing at the time of disease progression. This study will use patient records to analyze the clinical course of EGFR+ NSCLC patients treated with first- and second-generation EGFR inhibitors at the Thoraxklinik Heidelberg (Germany) during the past years. The main aim is to analyze the diagnostic and therapeutic measures, including implementation of osimertinib, taken at the time of disease progression as well as their effect on patient outcome in a real-world, routine clinical setting.

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

  • histologically confirmed locally advanced (stage III) and not suitable for definitive local treatment, or metastatic (stage IV) NSCLC
  • activating EGFR mutation confirmed
  • treatment with EGFR TKI

排除标准

  • 未提供

结局指标

主要结局

Fraction of EGFR+ NSCLC patients with sequential TKI treatment

时间窗: assessment will performed retrospectively for all study patients from September 2019 until June 2020

* the rate of rebiopsy and molecular workup (especially T790M testing) at disease progression under treatment with first-/second-generation EGFR inhibitors * the frequency of T790M mutations in the molecular workup of patients with disease progression under first-/second-generation EGFR inhibitors * the actual rate of osimertinib implementation after failure of first-/second-generation EGFR inhibitors in the "real-world" setting.

次要结局

  • Progression-free survival (PFS)(assessment will performed retrospectively for all study patients from September 2019 until June 2020)
  • Time-to-next-treatment (TNT)(assessment will performed retrospectively for all study patients from September 2019 until June 2020)
  • Time-to-chemotherapy (TTC)(assessment will performed retrospectively for all study patients from September 2019 until June 2020)
  • Overall survival (OS)(assessment will performed retrospectively for all study patients from September 2019 until June 2020)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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