Impact of Lazertinib Dose Modification on Effectiveness and Safety in EGFR T790M-Positive Advanced Lung Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 试验地点
- 11
- 主要终点
- Progression Free Survival(PFS)
研究概览
简要总结
The primary objective is to evaluate Progression Free Survival (PFS) of the group (160 mg group) in which dose reduction was performed for 12 weeks after the first administration of Lazertinib.
The Secondary objectives of this study are as follows.
- To evaluate Progression-free survival (PFS) of the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib
- In the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, Time-to-Treatment Discontinuation(TTD), Objective Response Rate(ORR), Disease Control Rate(DCR), Tumor shrinkage and Overall Survival(OS) is evaluated.
- In the group maintaining the same dose (240mg group) and the group in which dose reduction was performed (160mg group) for 12 weeks after the first administration of Lazertinib, specific reasons (adverse event name, grade, etc.) according to Lazertinib dose adjustment is evaluated.
- To evaluate the treatment profile of Lazertinib including duration of treatment, dose adjustment, and reason for discontinuation of treatment.
- To evaluate the safety of Lazertinib in the 240 mg and 160 mg groups
详细描述
This study is a prospective multi-center observational study, and 11 institutions will participate to enroll 200 subjects competitively. We will evaluate the efficacy and safety of Lazertinib according to maintenance of the 240mg dose and reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib in non-small cell lung cancer patients confirmed to be T790M mutation-positive after treatment failure with first- or second-generation EGFR-TKIs. The study period is up to 3 years from the date of IRB approval. Follow-up is 2 years from the last subject enrollment, and data will be collected through periodic medical record review during Lazertinib administration for enrolled subjects.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who agreed in writing to participate in this study
- •Adult men and women over 20 years of age
- •Patients with locally advanced or metastatic, recurrent non-small cell lung cancer with EGFR mutation (based on AJCC 8th edition)
- •Patients with confirmed disease progression after 1st or 2nd generation EGFR-TKI treatment
- •Patients scheduled to receive Lazertinib after T790M mutation was confirmed positive in tissue or plasma
排除标准
- •Patients who are receiving or have already completed Lazertinib
- •Patients whose life expectancy is less than 12 weeks
研究组 & 干预措施
240mg group
Maintenance of the 240mg dose for 12 weeks after the first administration of Lazertinib
干预措施: Lazertinib (Drug)
160mg group
Reduction of the 160mg dose for 12 weeks after the first administration of Lazertinib
干预措施: Lazertinib (Drug)
结局指标
主要结局
Progression Free Survival(PFS)
时间窗: Up to approximately 3 years
Progression-free survival is defined as the period from the start of Lazertinib administration to the time when objective disease progression is confirmed or death from any cause during treatment, whichever occurs first.
次要结局
- Time-to-Treatment Discontinuation (TTD)(Up to approximately 3 years)
- Disease Control Rate (DCR)(Up to approximately 3 years)
- Objective Response Rate(ORR)(Up to approximately 3 years)
- Tumor shrinkage(Up to approximately 3 years)
- Overall Survival (OS)(Up to approximately 3 years)
研究者
Min Ki Lee
Professor
Pusan National University Hospital