NCT06844474招募中2 期
A Phase II, Multicenter, Open-Label Clinical Study to Evaluate the Safety, Tolerability and Efficacy of SHR-1826 for Injection in Patients With NSCLC
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)
研究概览
简要总结
This study is an open-label, multicenter Phase II clinical trial to evaluate the safety, tolerability and efficacy of SHR-1826 for injection in patients with NSCLC.
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
- •Subjects must voluntarily agree to participate in the trial and sign a written informed consent form.
- •ECOG performance score of 0-
- •Life expectancy ≥ 3 months.
- •Have at least one measurable tumor lesion per RECIST v1.
- •Subjects with histologically confirmed locally advanced or metastatic NSCLC.
- •Good level of organ function.
- •Provide archived or fresh tumor tissue for vendor test.
排除标准
- •Subjects with active central nervous system metastases or meningeal metastases;
- •History of serious cardiovascular and cerebrovascular diseases;
- •Subjects with a history of interstitial pneumonitis or imaging at screening suggestive of suspected interstitial pneumonitis;
- •Severe infection within 4 weeks prior to the first dose;
- •Ongoing or previous anti-tumor therapies within 4 weeks prior to the first dose of study drug;
- •Subjects with uncontrolled tumor-related pain;
- •Received >30 Gy of non-thoracic radical radiation therapy within 4 weeks prior to the first administration of study drug;
- •Concomitant other malignancies ≤ 5 years prior to first dose of study drug;
- •Unresolved toxicities from previous anti-tumor therapy to ≤ Grade 1 (based on NCI CTCAE v5.0);
- •History of immunodeficiency, including a positive HIV test;
- •Per the investigator's judgment, there are any other circumstances that may increase the risk of participating in the study, interfere with the study results, or make participation in the study inappropriate.
研究组 & 干预措施
Arm A
Experimental
SHR-1826 for injection in combination with Adebrelimab injection and SHR-8068 with or without Bevacizumab injection
干预措施: SHR-1826；Adebrelimab；SHR-8068；Bevacizumab (Drug)
结局指标
主要结局
Incidence and severity of adverse events (AEs) /serious adverse events(SAEs)
时间窗: approximately 2 years
Overall response rate (ORR)
时间窗: approximately to 2 years
次要结局
- Duration of response (DoR)(approximately to 2 years)
- Disease control rate (DCR)(approximately to 2 years)
- Progression-free survival (PFS)(approximately to 2 years)
- Overall survival (OS)(approximately to 5 years after last subject enrolled)
研究者
研究点 (2)
Loading locations...
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