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临床试验/NCT02777658
NCT02777658已完成不适用

PANORAMA - Real World Molecular Testing, Treatment Patterns, and Clinical Outcomes in Patients With EGFR Mutation-Positive Locally Advanced or Advanced NSCLC

AstraZeneca1 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2016年5月26日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
AstraZeneca
入组人数
169
试验地点
1
主要终点
To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC

研究概览

简要总结

The objectives of this study are to assess molecular testing, treatment patterns, and associated outcomes among patients with EGFR (Epidermal Growth Factor Receptor) mutation-positive locally advanced or advanced NSCLC (Non-Small Cell Lung Cancer) who have progressed on or after EGFR-TKI (EGFR-Tyrosine Kinase Inhibitor) therapy post availability of a third-generation TKI (primary study cohort). Additionally, molecular testing and treatment patterns will be assessed among a secondary cohort of patients which will include patients diagnosed with de-novo EGFR T790M mutation-positive locally advanced or advanced NSCLC.

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

结局指标

主要结局

To assess treatment patterns and associated clinical outcomes among patients with EGFR mutation-positive locally advanced or advanced NSCLC

时间窗: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months

Treatment patterns and associated clinical outcomes including: Overall survival measured from: date of initial diagnosis to date of death from any cause (for primary and secondary cohorts), date of progression to date of death from any cause (for primary cohort only); Time to initiation of new therapy defined as the time from start date of current therapy to start date of subsequent therapy; Treatment(s) received post diagnosis and post progression including chemotherapy, radiation, surgery, targeted therapy, immunotherapy; Treatment sequence patterns, line(s) of therapy, treatment regimen(s), treatment duration, number of cycles;

To evaluate molecular testing patterns among patients with EGFR mutation-positive locally advanced or advanced NSCLC

时间窗: Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months

Molecular testing patterns including: Molecular testing rate defined as the number of patients identified as having received molecular testing divided by the number of patients in the primary study cohort (applicable to patients in the primary study cohort); Change in testing rates over time - testing rate over time will be described; Molecular testing details including sample type, method of biopsy, testing turnaround time, test type, reason for testing, testing laboratory type, reason for not performing a test; Molecular testing results including mutation status and type, test outcome, histologic/phenotypic transformation;

次要结局

  • To assess treatment related complications(Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months)
  • To document rate of central nervous system (CNS) metastases(Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months)
  • To assess health care utilization patterns(Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months)
  • To assess biopsy related complications(Date of enrollment in the study until end of follow-up or death if this occurs before, assessed approximately up to 36 months)
  • Assessment of health-related quality of life (HRQoL)(Date of first visit to last visit. HRQoL are collected every 6 months (plus or minus 1.5 months) up to 36 months)

研究者

发起方
AstraZeneca
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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