Patient Characteristics, Treatment Patterns and Outcomes of Advanced Non-small Cell Lung Cancer Patients With EGFR Exon 20 Insertion Mutations: A Non-interventional Retrospective Medical Chart Review in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 15
- 主要终点
- Percentage of Participants Based on Type of EGFR Mutation
研究概览
简要总结
The main aim is to evaluate sociodemographic and clinical characteristics of advanced Non-Small Cell Lung Cancer (NSCLC) in adults participants with epidermal growth factor receptor (EGFR) exon 20 insertions mutations during the 5 years before data extraction date (from 1-Jan-2017 to 1-Jan-2022).
Participants will not receive any drug. This study will only collect the data from the medical records via chart review.
详细描述
This is an observational, non-interventional, retrospective study in participants with NSCLC with EGFR exon 20 insertions mutations. This study will assess the sociodemographic and clinical characteristics of advanced NSCLC participants.
The study will enroll approximately 60 participants. Participants who were evaluated and treated at the participating sites between 01 January 2017 and 30 September 2021 will be included. The data will be collected from the medical record of participants via medical chart review. All the participants will be assigned to a single observational cohort:
• Participants With Advanced NSCLC with EGFR Exon 20 Insertions Mutations
This multi-center trial will be conducted in Spain. The overall duration of the study will be approximately 27 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
- •Participants with a pathologically and/or cytologically confirmed diagnosis of advanced stage NSCLC (International Classification of Disease, 10th revision [ICD-10] C34.x), either primary, advanced or after relapse of initial non-metastatic disease, evaluated and treated during the last five years prior data extraction date from 1-Jan-2017 to 1-Jan-
- •Participants with detection of an EGFR exon 20 insertion mutation, at any point.
- •Has documentation available for at least 2 visits since the initiation of the last treatment within the last five years (1-January-2017 to 1-January-2022).
排除标准
- •Participants do not meet any of the inclusion criteria.
结局指标
主要结局
Percentage of Participants Based on Type of EGFR Mutation
时间窗: From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022)
Percentage of participants will be reported based on type of EGFR mutation and its variant: EGFR exon 20 insertion or compound mutations.
次要结局
- Overall Response Rate (ORR)(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Time-to-treatment Failure (TTF)(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Number of Participants who Experience at Least one Treatment-related AE(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Disease Control Rate (DCR)(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Progression-free Survival (PFS)(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Health Care Resources Utilization(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Percentage of Participants With Grade 3 or Higher Treatment-related Adverse Events (AEs)(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Percentage of Participants Based on Method of Molecular Testing for EGFR Mutation(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Overall Survival (OS)(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))
- Percentage of Participants who Experience at Least one AEs Leading to Treatment Discontinuation(From the treatment start date till the data extraction date (1-Jan-2017 to 1-Jan-2022))