A Retrospective, Non-interventional Study to Evaluate EGFR-Tyrosine Kinase Inhibitor Retreatment in Patients With Locally Advanced or Metastatic EGFR Mutated NSCLC Who Previously Treated With EGFR-TKI as First-line Therapy and Chemotherapy as Second-line Therapy - SEQUENCE Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
研究概览
简要总结
This is a retrospective, non-interventional, multicenter, observational chart review study to explore the clinical benefits of retreatment with TKI in the real world.
详细描述
This study is designed to retrospectively review the medical and chemotherapy records of 300 patients with EGFR mutation positive adenocarcinoma NSCLC. Eligible patients are as follows: histologically or cytologically confirmed NSCLC, undergone EGFR-TKI retreatment sometime after the failure of the initial EGFR-TKI. After initial treatment, patients had been treated with chemotherapy and subsequently re-treated with EGFR-TKI will be identified. The target population will be derived from multicentre in Taiwan. The study aim is to evaluate clinical effect in re-administration of EGFR-TKI using retrospectively collected data from these eligible patients to provide valuable information.
研究设计
- 研究类型
- Observational
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 20 Years 至 150 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with advanced adenocarcinoma or positive result of thyroid transcription factor 1 NSCLC
- •Positive Epidermal Growth Factor Receptor mutation result with sensitive mutation
- •Female or male aged ≧20 years
- •Patients treated with Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor and subsequently treated with chemotherapy before re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor.
排除标准
- •Patients with EGFR mutation status of positive exon 20 T790M mutation only.
- •Patients who are confirmed of squamous type NSCLC
结局指标
主要结局
The treatment duration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor re-administration
时间窗: From the start of re-administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.
The median duration of re-administration of Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor will be summarized by days or months, if applicable. The range of this treatment duration will also be presented. All analyses will be performed on all eligible patients in this study.
次要结局
- Assessment of overall survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.(From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.)
- Record treatment duration in the initial EGFR-TKI therapy and first time chemotherapy.(Between the initial EGFR-TKI therapy and first time chemotherapy.)
- Assessment of progression-free survival for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.(From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.)
- image peer review to evaluate tumour size retrospectively in different sequences of treatment((1) initial and re-administration of EGFR-TKI therapy, (2) first time chemotherapy ever used (second-line treatment) after initial EGFR-TKI treatment.)
- overall survival (OS), plasma CEA level and chemotherapy regimens ever used.(between first time chemotherapy and EGFR-TKI re-administration)
- The reason(s) for the treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review(Initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment) after peer review.)
- Assessment of response rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.(From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.)
- Assessment of disease control rate for initial, second EGFR-TKI treatment and chemotherapy between two Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor treatments.(From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.)
- Record the reason(s) for treatment change for initial and re-administration of EGFR-TKI therapy and first time chemotherapy (second-line treatment).(From the start of administration of EGFR-TKI to data cut-off date, assessed approximately up to 6 months.)
- Explore relationships between efficacy of EGFR-TKI initial and re-administration and patient characteristics or EGFR TKI treatment characteristics.(EGFR-TKI initial and re-administration)