STRIVE: A Single-arm Phase 2 Study on Treatment of Lung Squamous Cell Carcinoma by Tiragolumab Plus Ivonescimab for Patients Who Progressed on Platinum Doublets and Anti-PD-1/PD-L1
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 48
- 主要终点
- Safety and adverse events (AEs).
研究概览
简要总结
To learn if the drug combination of tiragolumab and ivonescimab can help to control LSCC that got worse after standard treatment with platinum doublets and anti-PD-1/PD-L1 therapy.
详细描述
Primary Objectives To determine the objective response rate (ORR) of metastatic LSCC patients who progressed on platinum doublets and anti-PD1/PD-L1 treated with Tiragolumab/Ivonescimab.
Secondary Objectives To evaluate the investigator assessed progression-free survival (PFS) and overall survival (OS) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 of tiragolumab in combination with ivonescimab To evaluate the duration of response (DoR) of tiragolumab in combination with ivonescimab, as assessed by investigator, based on RECIST v1.1 To evaluate the safety and tolerability of tiragolumab in combination with ivonescimab
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Single Arm
Treatment with Tiragolumab + Ivonescimab
干预措施: Tiragolumab (Drug)
Single Arm
Treatment with Tiragolumab + Ivonescimab
干预措施: Ivonescimab (Drug)
结局指标
主要结局
Safety and adverse events (AEs).
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点