NCT05675033尚未招募2 期
Serplulimab Combined With Anti-VEGF Antibody and Platinum-based Chemotherapy in Treat-naive EGFR/ALK-negative Advanced Lung Adenocarcinoma, a Single Arm Clinical Trail
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
- 50
- 主要终点
- PFS
研究概览
简要总结
In order to further evaluate the efficacy of immunotherapy combined with antivascular therapy in the real world, we used Serpluimab combined with Bevacizumab and platinum-based chemotherapy in previously untreated EGFR/ALK-negative advanced non-squamous NSCLC patients, to evaluate the efficacy and safety of this regimen.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fully understood this study and voluntarily signed the informed consent form (ICF);
- •≥ 18 years and ≤ 75 years old;
- •ECOG score 0-1;
- •Non-squamous NSCLC;
- •stage IV;
- •EGFR and ALK negative;
- •Treatment-naive;
- •According to RECIST1.1 criteria, there are measurable or evaluable lesions.
排除标准
- •Tumor histology or cytology confirmed that it was associated with squamous cell carcinoma or small cell lung cancer;
- •Patients with severe organ dysfunction were indicated by examination, Exclude subjects with any active, known or suspected autoimmune diseases;
- •The estimated survival time is less than 3 months.
研究组 & 干预措施
study arm
Other
This is a single arm study.
干预措施: Serplulimab and Bevacizumab injection (Drug)
结局指标
主要结局
PFS
时间窗: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
progression-free survival
次要结局
- ORR(up to 12 months)
- DCR(up to 12 months)
- Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability](up to 24 months)
研究者
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