NCT07117890招募中2 期
a Study of Sunvozertinib Treatment in Untreated Advanced NSCLC With EGFR Uncommon Mutations
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Objective Response Rate(ORR)
研究概览
简要总结
This study is a single arm study to access the anti-tumor efficacy and safety of sunvozertinib in untreated advanced NSCLC patients with EGFR uncommon mutations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years old
- •histologically or cytologically confirmed non-squamous NSCLC with documented EGFR uncommon mutations from a local laoratory. at least one EGFR uncommon mutation (excluding EGFR 19del/l858r/T790m/Ex 20ins ) or compund mutations with EGFR uncommon mutations.
- •predicted life expectancy ≥ 12 weeks.
- •patient must have measurable disease according to RECIST 1.1
排除标准
- •previos systemic anti-tumor therapy
- •a history of malignant tumors within 2years
- •any severa or poorly controlled systemic disease per investigator's judgement
- •active infections
研究组 & 干预措施
Sunvozertinib 300mg
Experimental
sunvozertinib monotherapy, 300mg QD
干预措施: sunvozertinib 300mg (Drug)
sunvozertinib 200mg
Experimental
sunvozertinib monotherapy, 200mg QD
干预措施: sunvozertinib 200mg (Drug)
结局指标
主要结局
Objective Response Rate(ORR)
时间窗: from first dose to last dose ,up to 24 months
次要结局
- Progression-free survival (PFS)(from first dose to first documented disease progression assessed by investigator or death due to any cause up to 48 months ,up to 18 months)
- Duration of Response (DoR)(for subject with PR or CR defined as the time from the first dose documentd CR or PR to disease progression or death up to 18 months)
研究者
Jialei Wang
Chief physician
Fudan University
研究点 (1)
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