Prospective External Control Cohort In Patients With Newly Diagnosed Advanced or Metastatic EGFR Mutant Non-Small Cell Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 130
- 试验地点
- 10
- 主要终点
- Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
研究概览
简要总结
The objective of this study is to build a prospective cohort in patients with locally advanced or metastatic NSCLC with common EGFR mutations. In NPM-002, there will be standardized data collection at baseline, on-treatment and at discontinuation of therapy. Patients who enroll prior to initiation of osimertinib treatment (~30%) will undergo imaging with standardized intervals.
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
- 否
入选标准
- •Be ≥18 years of age at the time of informed consent
- •Evidence of a confirmed diagnosis of EGFR mutant (EGFR exon 19del or EGFR exon 21 L858R) locally advanced or metastatic NSCLC diagnosed on Jan 1st 2024 or later.
排除标准
- •ECOG≥2 at diagnosis of advanced or metastatic NSCLC
- •Evidence of prior treatment with osimertinib, amivantamab or lazertinib. For the planned selection and analysis of external controls, further eligibility criteria will be applied according to the COPERNICUS SAP.
研究组 & 干预措施
Osimertinib plus chemo, or other regimens
Osimertinib plus chemo, or other regimens in the metastatic setting initiated on or after January 1, 2024
Osimertinib monotherapy
Osimertinib monotherapy for newly diagnosed mNSCLC
结局指标
主要结局
Assess real world progression-free survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib
时间窗: From the index date (date of initiation of first line treatment for metastatic disease) until date of progression or date of death whichever comes first, assessed up to 100 months)
次要结局
- Assess overall survival in patients with locally advanced or metastatic NSCLC treated with first line osimertinib(From the index date (date of initiation of first line treatment for metastatic disease) until death, as assessed up to 100 months)
- Assess time to treatment discontinuation in patients with locally advanced or metastatic NSCLC treated with first line osimertinib(From the index date (date of initiation of first line treatment for metastatic disease) until treatment discontinuation, as assessed up to 100 months)