A Phase 2, Randomized, Active-Controlled, Open-Label Study to Evaluate the Efficacy and Safety of LBL-007 in Combination With Tislelizumab Plus Chemotherapy as First-Line Treatment in Patients With Unresectable Locally Advanced or Metastatic Esophageal Squamous Cell Carcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 66
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
This is a randomized, open-label study to compare how well LBL-007 works in combination with tislelizumab and chemotherapy versus tislelizumab and chemotherapy when given as the first-line treatment in participants with inoperable locally advanced or metastatic esophageal squamous cell carcinoma (ESCC).
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
- •Able to provide written informed consent and can agree to comply with the study requirements.
- •Participants with metastatic ESCC or unresectable, locally advanced ESCC.
- •Histologically confirmed diagnosis of ESCC.
- •Can provide a tumor sample.
- •At least 1 measurable lesion as defined by RECIST v1.
- •Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.
排除标准
- •Prior treatment for advanced or metastatic ESCC within the past 6 months
- •Locally advanced ESCC that is either resectable or potentially curable with definitive chemoradiation treatment per local investigator
- •Palliative radiation treatment for ESCC within the past 4 weeks
- •Participants with an esophageal/bronchial or esophageal/aorta fistula
- •Prior treatment with programmed cell death protein-1 (PD-1) or other immune-oncological drugs
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
LBL-007
LBL-007 in combination with tislelizumab plus chemotherapy doublet.
干预措施: Chemotherapy Doublet (Drug)
LBL-007
LBL-007 in combination with tislelizumab plus chemotherapy doublet.
干预措施: LBL-007 (Drug)
LBL-007
LBL-007 in combination with tislelizumab plus chemotherapy doublet.
干预措施: Tislelizumab (Drug)
Tislelizumab and Chemotherapy
Tislelizumab plus chemotherapy doublet.
干预措施: Chemotherapy Doublet (Drug)
Tislelizumab and Chemotherapy
Tislelizumab plus chemotherapy doublet.
干预措施: Tislelizumab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: Approximately 10 months
Percentage of participants whose best overall response (BOR) is complete response (CR) or partial response (PR) as assessed by the investigator per Response Evaluation Criteria for Solid Tumors (RECIST) v1.1.
次要结局
- Progression Free Survival (PFS)(Approximately 18 months)
- Duration of Response (DOR)(Approximately 18 months)
- Number of Participants with Adverse Events (AEs)(Approximately 18 months)
- Disease Control Rate (DCR)(Approximately 18 months)