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临床试验/NCT05933044
NCT05933044已完成不适用

A Retrospective Observational, Multi-Centre, Cohort Study to Understand Real-World Treatment Patterns and Clinical Outcomes of Adult Patients With Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III) in Canada

AstraZeneca5 个研究点 分布在 1 个国家目标入组 662 人开始时间: 2021年11月19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
发起方
AstraZeneca
入组人数
662
试验地点
5
主要终点
Overall survival

研究概览

简要总结

In the RELEVANCE study, we will develop a scalable electronic medical report data capture platform to collect and analyse real-world data in the stage III NSCLC population in Canada across several Canadian cancer centres. Subsequent analyses will examine treatment patterns and clinical outcomes, including overall survival, for these patients, stratified by durvalumab regimen or non-durvalumab regimen during the time of the PACIFIC Patient Support Program.

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 130 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male or female aged 18 years or older
  • Patients must have histologically or cytologically documented diagnosis of NSCLC with a locally advanced, or locally recurrent (stage III) disease between November 1, 2017 and December 31, 2019 at the centre (Note: durvalumab uptake rate requires a secondary index date, such as initiation of CRT before availability of durvalumab in May 2018)

排除标准

  • Patients treated with durvalumab in clinical studies prior to the start date
  • Clinical trial patients where treatments received are blinded in the patient medical records

研究组 & 干预措施

Durvalumab cohort

All stage III non-small cell lung cancer (NSCLC) patients who received durvalumab

干预措施: Durvalumab (Drug)

结局指标

主要结局

Overall survival

时间窗: November 1, 2017 to August 31, 2022

次要结局

  • Proportion of PACIFIC regimen initiation and uptake in patients who received CRT(November 1, 2017 to August 31, 2022)
  • Reasons for treatment discontinuation(November 1, 2017 to August 31, 2022)
  • Time-to-treatment discontinuation(November 1, 2017 to August 31, 2022)
  • Rate and type of resection(November 1, 2017 to August 31, 2022)
  • Treatments received including rates of concurrent chemoradiotherapy (cCRT) and sequential chemoradiotherapy (sCRT) use in unresectable disease(November 1, 2017 to August 31, 2022)
  • Time to durvalumab initiation following CRT(November 1, 2017 to August 31, 2022)
  • Rate and type of adverse events of special interest in the durvalumab cohort(November 1, 2017 to August 31, 2022)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (5)

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