NCT07798947尚未招募2 期
A Multicenter, Open-label, Phase Ⅱ Clinical Study of SHR-7787 Injection Combined With Adebrelimab in Patients With Limited Stage Small Cell Lung Cancer
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
- 120
- 试验地点
- 1
- 主要终点
- Incidence and severity of serious adverse events (SAEs)
研究概览
简要总结
This study is an open-label, multicenter, phase II clinical study designed to evaluate the preliminary efficacy, safety, and tolerability of SHR-7787 in combination with Adebrelimab in patients with limited-stage small cell lung cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •Voluntarily participate in this clinical study, understand the study procedures, and be able to sign the informed consent form (ICF) in writing.
- •Aged 18 to 75 years (inclusive), of any gender.
- •Histologically or cytologically confirmed unresectable limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based chemotherapy and radiation therapy.
- •ECOG performance status score of 0 or
- •Estimated survival time of more than 3 months.
- •Have adequate bone marrow and organ function.
- •Female trial participants of childbearing potential must agree to use highly effective contraception from the time of signing the informed consent form until 6 months after the last dose of the investigational drug, and avoid donating eggs.
排除标准
- •Combined small cell lung cancer or any transformed small cell lung cancer.
- •History of other malignancies within 5 years prior to the first dose of the study drug.
- •Severe cardiovascular or cerebrovascular diseases.
- •Bleeding symptoms of significant clinical relevance within 3 months prior to the first dose of the study drug.
- •Malignant pleural effusion or malignant pericardial effusion.
- •Severe infection within 4 weeks prior to the initiation of study treatment.
- •Active tuberculosis infection within 1 year prior to enrollment, identified by medical history or imaging examination.
- •History of immunodeficiency.
- •Active, known, or suspected autoimmune disease, or a history of autoimmune disease.
- •Prior treatment with immune checkpoint inhibitors (ICIs).
- •Undergone major organ surgery within 4 weeks prior to the first dose of the study drug.
- •Any other factors that, in the judgment of the investigator, may affect the study results or force premature termination of the study.
研究组 & 干预措施
SHR-7787 (Dose 1) + SHR-1316 group
Experimental
干预措施: SHR-1316 (Drug)
SHR-7787 (Dose 1) + SHR-1316 group
Experimental
干预措施: SHR-7787 Injection (Drug)
SHR-7787 (Dose 2) + SHR-1316 group
Experimental
干预措施: SHR-7787 Injection (Drug)
SHR-7787 (Dose 2) + SHR-1316 group
Experimental
干预措施: SHR-1316 (Drug)
结局指标
主要结局
Incidence and severity of serious adverse events (SAEs)
时间窗: Approximately 3 weeks
The dose expansion part of Phase 1
Incidence and severity of adverse events (AEs)
时间窗: Approximately 3 weeks
The dose expansion part of Phase 1
Progression-Free Survival (PFS)
时间窗: Approximately 16 months
The dose expansion part of Phase 1
次要结局
- Overall Survival (OS)(Approximately 16 months)
- Objective Response Rate (ORR)(Approximately 16 months)
- Duration of Response (DoR)(Approximately 16 months)
- Anti-Drug Antibody (ADA) of SHR-7787(Approximately 16 months)
- Disease Control Rate (DCR)(Approximately 16 months)
- Incidence and severity of adverse events (AEs)(Approximately 16 months)
- Incidence and severity of serious adverse events (SAEs)(Approximately 16 months)
研究者
研究点 (1)
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