NCT05701384尚未招募2 期
A Phase II Study for the Evaluation of the Feasibility of Lazertinib 160mg Per Day in Patients With EGFR T790M Mutant Non-small Cell Lung Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- The dose reduction or treatment discontinuation rate
研究概览
简要总结
The lazertinib is currently approved as 2nd line T790M mutation-positive NSCLC that failed from either 1st or 2nd generation EGFR TKI. The current recommended dosage is 240mg. Based on the promising clinical efficacy of the dose escalation study, this study is designed to evaluatee the clinical efficacy and safety of 160mg lazertinib.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed non-small cell lung cancer
- •Patients in a palliative setting who is not applicable for the curative treatment
- •EGFR mutation positive patients who received previous 1st or 2nd generation EGFR TKI
- •Confirmed EGFR T790M mutation after the previous EGFR TKI
- •Available to receive lazertinib either as po or vis levine tube
- •Willing to participate clinical trial
- •Age over or equal to 19
- •ECOG PS 0 to 2
排除标准
- •Previously received 3rd generation EGFR TKI
- •No clinical benefit is expected based on the investigator's decision
- •Uncontrolled symptomatic CNS metastases
- •Uncontrolled systemic disease
研究组 & 干预措施
Lazertinib 160mg arm
Experimental
干预措施: Lazertinib (Drug)
结局指标
主要结局
The dose reduction or treatment discontinuation rate
时间窗: Total 24 months of study period
Dose who received dosage below 160mg or discontinued due to the adverse event
次要结局
未报告次要终点
研究者
Jong-Mu Sun
Professor
Samsung Medical Center
研究点 (1)
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