A Phase II Study of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The objective response rate of the tumor (ORR)
研究概览
简要总结
Efficacy and Safety Evaluation of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients With EGFRm+/MET+ Locally Advanced or Metastatic NSCLC.
详细描述
A Multicenter,Randomized,open-label,Phase II Study to Evaluate the Efficacy and Safety of Vebreltinib Plus PLB1004 as the First-line Therapy for Patients with EGFRm+(exon 19 deletion or exon 21 L858R)/MET+ Locally Advanced or Metastatic Non-small Cell Lung Cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Ability to understand and willingness to sign a written informed consent document.
- •Aged at least 18 years old.
- •Histologically or cytologically confirmed locally advanced or metastatic NSCLC (stage IIIB~IV).
- •Patients with previously untreated, EGFRm-positive (exon 19 deletion or L858R) and MET overexpression (IHC 3+) .
- •At least one measurable lesion as defined by RECIST V1.
- •ECOG performance status 0 to 1.
排除标准
- •There are mutations of ALK or ROS
- •Have symptomatic and neurologically unstable central nervous system (CNS) metastases or CNS disease that requires increased steroid doses for control.
- •Pregnant or nursing women.
研究组 & 干预措施
Vebreltinib 150mg BID+PLB1004 80mg QD
Subjects will receive Vebreltinib 150mg orally twice per day (BID) + PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
干预措施: Vebreltinib (Drug)
Vebreltinib 150mg BID+PLB1004 80mg QD
Subjects will receive Vebreltinib 150mg orally twice per day (BID) + PLB1004 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
干预措施: PLB1004 (Drug)
Osimertinib 80mg QD
Subjects will receive Osimertinib 80mg orally once per day (QD),21day cycles until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
干预措施: Osimertinib (Drug)
结局指标
主要结局
The objective response rate of the tumor (ORR)
时间窗: 2 Years
The incidence of confirmed complete response or partial response.
次要结局
- Time to Response (TTR)(2 Years)
- Duration of Response (DoR)(2 Years)
- The disease control rate (DCR)(2 Years)
- Progression-free survival (PFS)(2 Years)
- Incidence of Treatment-Emergent Adverse Events(2 Years)