NCT06928389招募中3 期
A Randomized, Double-blind, Multicenter Phase 3 Clinical Trial of Ivonescimab Versus Placebo, Combined With Docetaxel in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) That Has Progressed on or After PD-(L)1 Inhibitor-based Therapy
Akeso1 个研究点 分布在 1 个国家目标入组 536 人开始时间: 2025年7月8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
- 招募中
- 发起方
- 入组人数
- 536
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a Phase 3 Randomized, double-blind, Multicenter Study of Ivonescimab Combined with Docetaxel Versus Placebo Combined with Docetaxel in Patients with Locally advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed on or after PD-(L)1 inhibitor-based therapy. The purpose of this study is to evaluate the efficacy and safety of ivonescimab versus placebo, combined with docetaxel in patients with advanced NSCLC.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide written informed consent and to comply with all requirements of study participation (including all study procedures).
- •Age ≥ 18 years old and ≤ 75 years old at the time of randomization.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or
- •Expected life expectancy of at least 3 months.
- •Histologically or cytologically confirmed diagnosis of NSCLC.
- •Locally advanced or metastatic NSCLC (American Joint Committee on Cancer [AJCC] 8th edition).
- •Previously received systemic platinum-based chemotherapy and PD-1/L1 inhibitors.
- •At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.
- •Adequate organ function.
排除标准
- •Histologic or cytopathologic evidence of the presence of small cell lung carcinoma.
- •Other malignancies within 3 years prior to randomization.
- •Known actionable genomic alterations.
- •Prior administration of any immunotherapy targeting immune mechanisms other than PD-1/PD-L1 inhibitors.
- •Previous treatment with docetaxel.
- •History of severe bleeding tendency or coagulation dysfunction.
- •Active autoimmune disease requiring systemic therapy within 2 years prior to randomization.
- •History of myocarditis, cardiomyopathy, and malignant arrhythmia.
研究组 & 干预措施
Ivonescimab and docetaxel
Experimental
干预措施: Ivonescimab, docetaxel (Drug)
Placebo and docetaxel
Active Comparator
干预措施: Placebo, docetaxel (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: approximately 5 years
Overall Survival (OS) in the FAS population
次要结局
- Progression Free Survival (PFS)(approximately 3 years)
- Adverse Event (AE)(From the patient signs the ICF to 30 days (AE) and 90 days (SAE) after the last dose of study treatment or initiation of other anticancer therapy, whichever occurs first)
研究者
研究点 (1)
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