NCT05862194已完成不适用
Retrospective, External Comparator Study to Assess the Real-World Effectiveness of Lazertinib as the Second-Line Treatment Versus Platinum-based Chemotherapy in Patients With EGFR Mutation+ Locally Advanced or Metastatic NSCLC
Yuhan Corporation0 个研究点目标入组 534 人开始时间: 2015年6月1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
- 入组人数
- 534
- 主要终点
- Comparative evaluation of (real-world:rw) Progression-free survival (PFS) between patients receiving Lazertinib versus Platinum-based Chemotherapy
研究概览
简要总结
This retrospective, external comparator study for Lazertinib aims to assess the real-world effectiveness of Lazertinib as the second-line treatment versus platinum-based chemotherapy in patients with epidermal growth receptor sensitizing mutation-positive, locally advanced or metastatic Non-small Lung cancer.
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
- 否
入选标准
- •Target and Period: Patients aged 18 or older
- •Target Conditions:
- •Lazertinib:
- •Patients diagnosed with locally progressive or metastatic non-small cell lung cancer, who previously received first or second-generation EGFR-TKI treatment, and who started administrating Lazertinib during the index period
- •Patients with T790M mutation positive
- •Patients with an ECOG PS score of 0 to 1 at the time of initial drug administration
- •Platinum-based Chemotherapy
- •Patients who were diagnosed with locally advanced or metastatic non-small cell lung cancer, and previously received first or second-generation EGFR-TKI treatment during the baseline period
- •Patient who started administering platinum-based chemotherapy after prior first or second-generation EGFR-TKI treatment during the index period
- •Patients who were confirmed positive for active EGFR mutations (L858R, Exon19Del, G719X, L861Q) during the baseline period
- •Patients with an ECOG PS score of 0 to 1 at the time of initial drug administration
排除标准
- •Patients with carcinoma besides NSCLC requiring treatment
- •Any unstable brain metastasis with symptomatic and/or requiring emergency treatment
研究组 & 干预措施
Lazertinib
干预措施: Lazertinib (Drug)
Platinum-based Chemotherapy
干预措施: Platinum-based Chemotherapy (Drug)
结局指标
主要结局
Comparative evaluation of (real-world:rw) Progression-free survival (PFS) between patients receiving Lazertinib versus Platinum-based Chemotherapy
时间窗: Up to 64 months
(rw) PFS, is defined as the time from the first administrating date of treatment (Lazertinib or Platinum-based Chemotherapy) to clinician-assessed progression disease or death from any cause, whichever occurs first.
次要结局
- Comparative evaluation between patients receiving Lazertinib versus Platinum-based Chemotherapy of (rw) Overall survival (OS)(Up to 64 months)
- Comparative evaluation of (rw) Investigator-assessed objective response rate (ORR) between patients receiving Lazertinib versus Platinum-based Chemotherapy(Up to 64 months)
- Comparative evaluation of (rw) Time to treatment discontinuation (TTD) between patients receiving Lazertinib versus Platinum-based Chemotherapy(Up to 64 months)
研究者
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