Real World Treatment Patterns, Clinical Outcomes and EGFR / T790M Testing Practices in EGFR-Mutated Advanced Non-Small Cell Lung Cancer Patients Receiving First-Line TKI Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 896
- 试验地点
- 1
- 主要终点
- First- or second-generation EGFR TKI used in first-line therapy
研究概览
简要总结
Multinational, multi-center medical record review to describe the treatment patterns, clinical outcomes, and EGFR / T790M testing practices in EGFR-mutated advanced NSCLC patients receiving first-line EGFR TKI therapy in Europe.
详细描述
The aim is to generate real-life data on treatment patterns of the EGFR-mutated advanced NSCLC patients receiving first- or second-generation EGFR TKI in first line of therapy as provided per routine practice in eight countries. An approximate number of 820 patients will take part in the REFLECT study.
It is anticipated that data, generated from the proposed large cohort across centers in Europe, will facilitate a better understanding of unmet medical needs in first line of treatment and will provide a platform for improving patients' management.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of locally advanced unresectable or metastatic NSCLC;
- •Aged at least 18 years at first diagnosis of locally advanced/metastatic NSCLC;
- •Lab-confirmed EGFR mutation;
- •Received a first- or second-generation EGFR TKI as first-line treatment for advanced/metastatic disease;
- •First-line EGFR TKI (afatinib, gefitinib, erlotinib) initiated between January 1, 2015 and June 30, 2018;
- •Patients may be alive or deceased at the time of medical record review.
排除标准
- •Patients enrolled at any time in an interventional clinical trial for an experimental treatment related to EGFR-mutated NSCLC;
- •Patients receiving any systemic therapy for locally advanced or metastatic NSCLC prior to first-line EGFR TKI treatment in the locally advanced/metastatic setting;
- •Missing or unknown data on any of the following key study dates:
- •Date of initial NSCLC diagnosis;
- •Date of first diagnosis of or progression to advanced/metastatic NSCLC;
- •Date of first-line EGFR TKI initiation for advanced/metastatic disease;
- •Date of death or last available follow-up.
结局指标
主要结局
First- or second-generation EGFR TKI used in first-line therapy
时间窗: From date of initiating EGFR TKI in first line until the end of available follow-up or death, if this occurs before; assessed up to 60 months
Frequency distribution of first-line EGFR TKI of first- or second generation prescribed: erlotinib, gefitinib, or afatinib
Proportion of patients progressing on first line EGFR TKI therapy and describe the time to progression
时间窗: From date of initiating EGFR TKI in first line until the earliest of progression, death or end of available follow-up, whichever occur first; assessed up to 60 months
Proportion of patients with a progression event during first-line EGFR TKI therapy or other evidence recorded in the patient's medical records deemed by the clinician to be indicative of progression; Time to progression, defined as time from EGFR TKI therapy initiation in the first-line locally advanced or metastatic setting until the earliest of progression death, or end of available follow-up (i.e., progression-free survival); Proportion of patients discontinuing first-line EGFR therapy for reasons other than progression event or death
Proportion of patients receiving second-line therapy and type of second-line therapy among patients progressing on first line EGFR TKI therapy
时间窗: From date of initiating EGFR TKI in first line until date of starting second-line therapy; assessed up to 60 months
Proportion of patients prescribed second-line therapy, as well as time to second-line therapy initiation, as defined by time from first-line EGFR TKI discontinuation until the earliest of second-line initiation, death, or end of available follow-up; Frequency distribution of the second-line therapy regimen (chemotherapy, osimertinib, other EGFR TKI, I/O therapy, or other therapy) among patients initiating second-line therapy.
次要结局
- How the proportion of patients receiving second-line therapy differs between patients tested for T790M mutation and patients not tested for T790M mutations(From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 55 months)
- Proportion of patients receiving third- or later-line therapy and type of this therapy and to explore whether the proportion receiving third-/later-line therapies varies by the second-line therapy category received(From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 50 months)
- Overall survival (OS) expectation for all patients from first diagnosis of locally advanced or metastatic disease and from start of first-line EGFR TKI therapy(From date of metastatic disease diagnostic or start of first-line EGFR TKI therapy until the end of available follow-up or death, if this occurs before; assessed up to 60 months)
- Incidence of other mutations, in case additional molecular testing was performed either at the time of initial EGFR testing or at the time of T790M testing(From date of metastatic disease diagnostic until end of available follow-up or death, if this occurs before; assessed up to 60 months)
- Patients' demographic and baseline disease characteristics(From date of initial diagnosis of NSCLC or metastatic disease, whichever is diagnosed first until the end of available follow-up or death, if this occurs before; assessed up to 60 months)
- Type of sample & test used to determine the EGFR mutation and type of EGFR mutation identified(From date of metastatic disease diagnostic until the end of available follow-up or death, if this occurs before; assessed up to 60 months)
- Proportion of patients with brain metastases (BM) among metastatic patients and the overall survival (OS) expectation in the group of patients with BM(From date of metastatic disease diagnostic until the first BM diagnosis; From first BM diagnosis to the start of first-line EGFR TKI therapy, end of available follow-up or death, if this occurs before; all assessed up to 60 months)
- Proportion of patients with leptomeningeal disease (LM) among metastatic patients and the overall survival (OS)(From date of metastatic disease diagnostic until the LM diagnosis; From LM diagnosis to the start of first-line EGFR TKI therapy, end of available follow-up or death, if this occurs before; all assessed up to 60 months)
- Proportion of patients where the first-line therapy with first- or second-generation EGFR TKI is associated with any other systemic therapy, including the type of systemic therapy(From date of initiating EGFR TKI in first line until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 60 months)
- Proportion of patients tested for T790M mutation and the proportion of patients with positive mutation among patients progressing on first-line EGFR TKI therapy(From date of initiating EGFR TKI in first line until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 60 months)
- Proportion of patients receiving second-line therapy and type of second line therapy received among patients progressing on first-line EGFR TKI therapy and tested for T790M mutation(From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 55 months)
- Proportion of patients receiving second-line therapy and type of second line therapy received among patients progressing on first-line EGFR TKI therapy and not tested for T790M(From date of initiating second-line therapy until the earliest of progression, death or end of available follow-up, whichever occurs first; assessed up to 55 months)