NCT05468489进行中（未招募）3 期
A Randomized, Open-label Study of Serplulimab Plus Chemotherapy (Carboplatin-Etoposide) in Comparison With Atezolizumab Plus Chemotherapy in Previously Untreated US Patients With Extensive Stage Small Cell Lung Cancer (ES-SCLC) (ASTRIDE)
Shanghai Henlius Biotech67 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年11月18日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 67
- 主要终点
- OS
研究概览
简要总结
This is a randomized, open-label study of Serplulimab plus chemotherapy (Carboplatin-Etoposide) in comparison with Atezolizumab plus chemotherapy in previously untreated US patients with ES-SCLC.
Subjects in this study will be randomized to arm A or B at 1:1 ratio as follows:
- Arm A (Serplulimab): Serplulimab + chemotherapy (carboplatin-etoposide)
- Arm B (control): Atezolizumab + chemotherapy (carboplatin-etoposide)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation in clinical studies.
- •Male or female aged ≥ 18 years at the time of signing the ICF.
- •Histologically or cytologically diagnosed with ES-SCLC (according to the Veterans Administration Lung Study Group staging system).
- •No prior systemic therapy for ES-SCLC.
- •At least one measurable lesion as assessed according to RECIST 1.1 within 4 weeks prior to randomization.
- •Major organs are functioning well.
- •Every effort should be made to provide tumor tissues for the determination of PD-L1 expression.
- •An ECOG PS score of 0 or
- •An expected survival ≥ 12 weeks.
- •Subjects with prior denosumab use that can and agree to switch to bisphosphonate therapy for bone metastases starting prior to randomization and throughout treatment.
- •Participant must keep contraception.
排除标准
- •Histologically or cytologically confirmed mixed SCLC.
- •Known history of severe allergy to any monoclonal antibody.
- •Known hypersensitivity to carboplatin or etoposide.
- •Patients with myocardial infarction within half a year before the first dose of the study drug, poorly controlled arrhythmia.
- •Pregnant or breastfeeding females.
- •Patients with a known history of psychotropic drug abuse or drug addiction.
- •Patients who have other factors that could lead to the early termination of this study based on the investigator's judgment.
研究组 & 干预措施
Serplulimab + chemotherapy
Experimental
Serplulimab + chemotherapy (carboplatin-etoposide)
干预措施: Serplulimab + chemotherapy (carboplatin-etoposide) (Drug)
Atezolizumab + chemotherapy
Active Comparator
Atezolizumab + chemotherapy (carboplatin-etoposide)
干预措施: Atezolizumab + chemotherapy (carboplatin-etoposide) (Drug)
结局指标
主要结局
OS
时间窗: A period from randomization through death regardless of causality (approximately up to 24 months).
Overall assessment
次要结局
- Number of participants with treatment-related adverse events as assessed by CTCAE v5.0(approximately up to 24 months)
- Maximum Plasma Concentration (Cmax)(approximately up to 24 months)
- Minimum Plasma Concentration (Cmin)(approximately up to 24 months)
- PFS(approximately up to 24 months)
- Average Plasma Concentration (Cavg)(approximately up to 24 months)
- ORR(approximately up to 14 months)
研究者
研究点 (67)
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