SHR-A2009 Combined With Bevacizumab in the Treatment of Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer : a Randomized Controlled, Open, Multicenter Phase III Study
A Randomized, Open-label, Multicenter, Phase III Study of SHR-A2009 in Combination With Bevacizumab Versus Sacituzumab Tirumotecan in Advanced or Metastatic Non-small Cell Lung Cancer
The study is being conducted to evaluate the efficacy, and safety of SHR-A2009 combined bevacizumab versus Sacituzumab Tirumotecan in the treatment of locally advanced or metastatic non-squamous non-small cell lung cancer
研究概览
研究类型
注册 (估计的)
阶段
- 第三阶段
联系人和位置
学习联系方式
- 姓名:Yijing Chen
- 电话号码:0518-82342973
- 邮箱:yijing.chen.yc510@hengrui.com
学习地点
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-
Guangdong
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Guangzhou、Guangdong、中国、510080
- Guangdong Provincial People's Hospital
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首席研究员:
- Yilong Wu
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
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voluntarily participate in this clinical study, understand the research procedure and be able to sign the informed consent in writing ; the age at the time of signing the informed consent form is 18-75 years old ( including both ends ), both men and women can.
The ECOG score was 0 or 1.
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Participants with locally advanced or metastatic non-squamous non-small cell lung cancer confirmed by histology or cytology.
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Adequate bone marrow and organ function.
Exclusion Criteria:
- Anti-tumor therapy such as chemotherapy, biological therapy, targeted therapy, immunotherapy or other unlisted clinical research drugs or treatments were received within 4 weeks before the first medication.
- Untreated or active central nervous system tumor metastasis
- Imaging showed that the tumor invaded important organs or tumor surrounding / invasion of large blood vessels or there was obvious necrosis / cavity, which was judged by the researchers to have a risk of bleeding.
- History of interstitial pneumonia or participants who cannot rule out interstitial pneumonia ; or other moderate to severe lung diseases ; or received previous pneumonectomy surgery
- Participants with severe cardiovascular and cerebrovascular diseases
- Have a history of severe bleeding tendency or coagulation dysfunction ; bleeding symptoms with significant clinical significance occurred within 3 months before the first medication.
- Arterial and venous thrombosis events occurred within 6 months before the first administration ;
- HIV test positive
- Participants with active hepatitis B or C
- Severe infection occurred within 4 weeks before the first administration
- Allergy to any component of the treatment regimen
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的:SHR-A2009 + bevacizumab
|
SHR-A2009 + bevacizumab |
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有源比较器:Sacituzumab Tirumotecan
|
Sacituzumab Tirumotecan |
研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
PFS
大体时间:about 24 months
|
about 24 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
The incidence and grade of adverse events;
大体时间:about 24 months
|
about 24 months
|
|
OS
大体时间:about 24 months
|
about 24 months
|
|
ORR
大体时间:about 24 months
|
about 24 months
|
|
DoR
大体时间:about 24 months
|
about 24 months
|
|
DCR
大体时间:about 24 months
|
about 24 months
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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