NCT06767514招募中3 期
A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 780
- 试验地点
- 285
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
Clinical study of ivonescimab for first-line treatment of metastatic NSCLC patients with high PD-L1. Evaluating overall survival and progression free survival.
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 - 1
- •Expected life expectancy ≥ 3 months
- •Metastatic (Stage IV) NSCLC
- •Histologically or cytologically confirmed squamous or non-squamous NSCLC
- •Tumor demonstrates high PD-L1 expression ( TPS>50%) based on a 22C3 immunohistochemistry ( IHC) clinical assay approved / cleared by local health authorities.
- •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 for which first-line approved therapies are indicated. For patients with non-squamous histology, actionable driver mutation testing results are required before randomization.
- •Has received any prior therapy for NSCLC in the metastatic setting.
- •Concurrent enrollment in another clinical study, unless patient is enrolled in a non-interventional clinical study or is completing survival follow -up.
- •Known actionable genomic alterations for which first-line approved therapies are indicated
- •Symptomatic CNS metastases, CNS metastasis ≥ 1.5 cm, CNS radiation within 7 days prior to randomization, potential need for CNS radiation within the first cycle, or leptomeningeal disease
- •Other prior malignancy (including previously treated NSCLC) unless the patient has undergone curative therapy with no evidence of recurrence of the disease for 3 years prior to randomization
- •Active autoimmune or lung disease requiring systemic therapy
- •Has pre-existing peripheral neuropathy that is ≥ Grade 2 by CTCAE version 5
- •Severe infection within 4 weeks prior to randomization
- •Major surgical procedures or serious trauma within 4 weeks prior to randomization
- •History of noninfectious pneumonia requiring systemic corticosteroids, or current interstitial lung disease
研究组 & 干预措施
Arm A - Ivonescimab
Experimental
Subject will receive ivonescimab as an IV injection
干预措施: Ivonescimab Injection (Biological)
Arm B - Pembrolizumab
Active Comparator
Subject will receive pembrolizumab as an IV injection
干预措施: Pembrolizumab Injection (Biological)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 36 months
Progression free survival (PFS)
时间窗: Up to approximately 36 months
次要结局
- Objective response rate (ORR)(Up to approximately 36 months)
- Disease control rate ( DCR)(Up to approximately 36 months)
- Duration of response (DoR)(Up to approximately 36 months)
- Adverse Events (AE): incidence and severity of adverse events (AEs) and clinically significant abnormal laboratory test results([Time Frame: 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 approximately 24 months.)
研究者
研究点 (285)
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