To Investigate EGFR Exon20 Insertion Mutation Testing Methodologies, Clinicopathological Characteristics and Molecular Epidemiology in Chinese Patients With Advanced NSCLC: a Nationwide Multicentre Real-world Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC
研究概览
简要总结
The main aim of this study is to examine the percentage of people with lung cancer who carry a certain gene mutation (epidermal growth factor receptor exon 20 insertions - EGFR ex20ins) and their frequency in Chinese participants with Non-small cell lung cancer (NSCLC) after having been tested for the gene mutation.
Data from the participant's electronic medical records at the hospital will be collected.
详细描述
This is a non-interventional, retrospective, observational study of the Chinese participants with locally advanced or metastatic NSCLC with EGFR ex20ins mutation. The primary objective of this study is to explore the prevalence of EGFR ex20ins, subtypes of EGFR ex20ins and their frequency in Chinese participants with locally advanced or metastatic NSCLC.
The study will enroll approximately 10800 patients. Participants will be enrolled in the following two cohorts:
- Cohort 1: Participants With Positive EGFR ex20ins Detection
- Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection
The data will be collected retrospectively using the participant electronic medical records and next-generation gene sequencing (NGS)/polymerase chain reaction (PCR) kit instructions.
This multi-center trial will be conducted at 15 sites across China. The overall time to participate and data collection will be approximately 12 months.
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
- •Cohort 1 and 2:
- •Participants with a diagnosis of locally advanced or metastatic NSCLC, clinical staging of IIIB-IV.
- •Participants who have received NGS testing and have EGFR ex20ins positive result.
- •Participants who have received NGS testing
排除标准
- •Incomplete information, including key demographic characteristics, clinicopathological characteristics, and genetic testing information.
结局指标
主要结局
Cohort 2: Prevalence of EGFR ex20ins in Chinese Participants With Locally Advanced or Metastatic NSCLC
时间窗: Up to 3 years prior to leading site initiation
The prevalence of EGFR ex20ins will be reported for participants with locally advanced or metastatic NSCLC.
Cohort 1 and 2: Number of EGFR ex20ins Subtypes in Chinese Participants With Locally Advanced or Metastatic NSCLC
时间窗: Up to 3 years prior to leading site initiation
EGFR ex20ins subtype is defined by insertion or duplication mutation occurred in amino acids (AA) 761 to AA775 of EGFR gene. The number of EGFR ex20ins subtypes will be reported.
Cohort 1 and 2: Frequency of Each EGFR ex20ins Subtype in Chinese Participants With Locally Advanced or Metastatic NSCLC
时间窗: Up to 3 years prior to leading site initiation
The frequency of each EGFR ex20ins subtype will be reported.
次要结局
- Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Demographic Characteristics(Up to 3 years prior to leading site initiation)
- Cohort 1 and 2: Site of Metastasis at the Time of NGS Testing(Up to 3 years prior to leading site initiation)
- Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Cytology or Histology at the Time of NGS Testing(Up to 3 years prior to leading site initiation)
- Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Clinical Stages of Lung Cancer at the Time of NGS Testing(Up to 3 years prior to leading site initiation)
- Cohort 1 and 2: Percentage of Theoretically Underdiagnosed EGFR ex20ins Mutation by Different PCR Kits Based on NGS Real-world Database(Up to 3 years prior to leading site initiation)
- Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Demographic Characteristics(Up to 3 years prior to leading site initiation)
- Cohort 2: Site of Metastasis at the Time of NGS Testing(Up to 3 years prior to leading site initiation)
- Cohort 1 and 2: Number of EGFR ex20ins Positive Participants With Clinical Stages of Lung Cancer at the Time of NGS Testing(Up to 3 years prior to leading site initiation)
- Cohort 1 and 2: Number and Kinds of Co-occurring Mutations of EGFR ex20ins at Baseline in Positive Participants Detected by NGS Testing(Baseline (prior to NGS testing))
- Cohort 2: Number and Kinds of Co-occurring Mutations at Baseline in EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type Detected by NGS Testing(Baseline (prior to NGS testing))
- Cohort 2: Number of EGFR ex20ins Positive Participants, Participants With Common EGFR Mutations and Participants With EGFR Wild Type With Cytology or Histology at the Time of NGS Testing(Up to 3 years prior to leading site initiation)