A Randomized, Double-blind, Multiregional Phase 3 Study of Ivonescimab Combined With Chemotherapy Versus Pembrolizumab Combined With Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer (HARMONi-3)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 1,600
- 试验地点
- 722
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a Phase 3 Randomized, double-blind, Multiregional Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Non-small Cell Lung Cancer. The primary endpoint is overall survival and progression free survival assessed by investigator. The key secondary endpoints include response and safety.
详细描述
This study consists of two distinct NSCLC histology cohorts: squamous (N=600) and non-squamous (N=1000), approximately 1600 patients in total. Within each cohort, subjects are randomized in a 1:1 ratio into one of two treatment groups, receiving either ivonescimab or pembrolizumab combined with platinum-doublet chemotherapy. The two histology cohorts will be analyzed independently
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years old at the time of enrollment
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Expected life expectancy ≥ 3 months
- •Metastatic (Stage IV) NSCLC
- •Histologically or cytologically confirmed squamous or non-squamous NSCLC
- •Recorded measurement of the Tumor Proportion Score (TPS) or Tumor Cells (TC) for PD-L1 expression, irrespective of the PD-L1 expression, prior to randomization
- •At least one measurable noncerebral lesion according to RECIST 1.1
- •No prior systemic treatment for metastatic NSCLC
排除标准
- •Histologic or cytopathologic evidence of the presence of small cell lung carcinoma
- •Known actionable genomic alterations (EGFR, ALK, ROS1, and BRAF V600E) or genes for which first-line approved therapies are available.
- •For non-squamous histology patients, actionable driver mutation testing results are required before randomization.
- •Has received any prior therapy for NSCLC in the metastatic setting
- •Tumor invasion, encasement of organs (e.g. pericardium, heart, trachea, esophagus, central bronchi), or major blood vessels (e.g aorta, central veins), if poses a significant increased risk of bleeding.
研究组 & 干预措施
Arm A - Ivonescimab and chemotherapy
Subject will receive ivonescimab and chemotherapy
干预措施: Ivonescimab Injection (Biological)
Arm B - Pembrolizumab and chemotherapy
Subject will receive pembrolizumab and chemotherapy
干预措施: Pembrolizumab Injection (Biological)
结局指标
主要结局
Overall Survival (OS)
时间窗: approximately 4 years
Overall Survival (OS) in the ITT population
Progression Free Survival (PFS)
时间窗: approximately 3 years
Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1
Overall Survival (OS)
时间窗: approximately 4 years
Overall Survival (OS) in the ITT population
Progression Free Survival (PFS)
时间窗: approximately 3 years
Progression Free Survival (PFS) assessed by investigator based on RECIST V1.1
次要结局
- Adverse Event (AE)(From the subject signs the ICF to 30 days (AE) and 90 days (SAE related to ivonescimab/pembrolizumab ) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first, up to 2 years.)