NCT07489716
尚未招募
2 期
A Phase II Clinical Study on the Efficacy, Safety, and Pharmacokinetics of SHR-1826 for Injection in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer
概览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- ORR assessed by IRC according to RECIST v1.1 s）
概览
简要总结
This study is a single-arm, open-label, multicenter phase II clinical trial aimed at evaluating the efficacy, safety, and pharmacokinetics of SHR-1826 in treating locally advanced or metastatic non-small cell lung cancer . The recommended dose of SHR-1826 was administered via intravenous infusion once every 3 weeks (Q3W), with each treatment cycle lasting 21 days until meeting protocol-defined treatment discontinuation criteria.
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
- •Aged 18-75 years
- •ECOG performance status score of 0 or 1;
- •Histopathologically confirmed advanced or metastatic non-small cell lung cancer;
- •Participants must provide archived or fresh tumor tissue;
- •Participants must have experienced disease progression or intolerance after systemic anti-tumor therapy for advanced or metastatic disease;
- •At least one measurable lesion according to RECIST v1.1 criteria;
- •Expected survival ≥3 months;
- •Adequate organ function;
排除标准
- •Central nervous system metastasis or meningeal metastasis with clinical symptoms
- •History of or concurrent other malignancies;
- •Untreated spinal cord compression ;
- •Uncontrolled tumor-related pain;
- •Adverse events (AEs) from prior therapy not recovered to CTCAE Grade ≤1;
- •History of interstitial lung disease;
- •Severe cardiovascular/cerebrovascular diseases;
结局指标
主要结局
ORR assessed by IRC according to RECIST v1.1 s）
时间窗: once every 6 weeks, estimated 2 years
次要结局
- Disease Control Rate (DCR) assessed by the IRC and investigator according to RECIST v1.1;(once every 6 weeks, estimated 2 years)
- Objective Response Rate (ORR) assessed by the investigator according to RECIST v1.1;(once every 6 weeks, estimated 2 years)
- Duration of Response (DoR) assessed by the IRC and investigator according to RECIST v1.1;(once every 6 weeks, estimated 2 years)
- Progression-Free Survival (PFS) assessed by the IRC and investigator according to RECIST v1.1;(Estimated 2 years)
- Overall Survival (OS).(Estimated 2 years)
研究者
研究点 (1)
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