NCT06868277招募中3 期
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 830
- 试验地点
- 304
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of ARTEMIDE-Lung04 is to assess the efficacy and safety of rilvegostomig compared with pembrolizumab monotherapy as 1L treatment in participants with mNSCLC and whose tumors express PD-L1.
详细描述
This is a Phase III, two-arm, randomized, double-blind, global, multicenter study assessing the efficacy and safety of rilvegostomig compared to pembrolizumab as a 1L treatment for patients with mNSCLC whose tumors express PD-L1.
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)
盲法说明
Double blind masking
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
- •Histologically or cytologically documented NSCLC (non small lung cancer), including all histological subtypes.
- •Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
- •Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result is required for all non-squamous histology subtypes.
- •Absence of documented tumor genomic mutation results from tests conducted as part of standard local practice in any other actionable driver oncogenes for which there are locally approved targeted 1L (first line) therapies.
- •WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group) performance status of 0 or 1, with no deterioration over the previous 2 weeks prior to baseline at screening and prior to randomization.
- •Minimum life expectancy of 12 weeks.
- •Provision of acceptable tumor sample for the central testing prior to randomization.
- •At least one lesion not previously irradiated that qualifies as a RECIST 1.1 (Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at baseline and can be accurately measured at baseline as ≥ 10 mm in the longest diameter (except lymph nodes, which must have short axis ≥ 15 mm) with CT (computed tomography) or MRI (magnetic resonance imaging) and is suitable for accurate repeated measurements.
- •Adequate organ and bone marrow function
排除标准
- •As judged by the investigator, any severe or uncontrolled systemic diseases, makes it undesirable for the participant to participate in the study or that would jeopardize compliance with the protocol.
- •History of organ transplant.
- •Active or prior documented autoimmune or inflammatory disorders requiring chronic treatment with steroids or other immunosuppressive treatment.
- •History of another primary malignancy except for malignancy treated with curative intent with no known active disease ≥ 2 years before the first dose of study intervention and of low potential risk for recurrence.
- •Presence of small cell and neuroendocrine histology components.
- •Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 4 weeks prior to start of study intervention.
- •Active primary immunodeficiency/active infectious disease(s)
- •Active tuberculosis infection
- •Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small cell lung cancer).
- •Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
- •Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or anti-PD-L1 (anti-programmed death-ligand 1) agent.
研究组 & 干预措施
Arm B
Active Comparator
Drug: Pembrolizumab
干预措施: Pembrolizumab (Biological)
Arm A
Experimental
Drug: rilvegostomig
干预措施: Rilvegostomig (Biological)
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to approximately 5 years
OS is defined as the time from randomization until the date of death due to any cause.
Progression-Free Survival (PFS)
时间窗: Up to approximately 5 years
PFS is defined as the time from randomization until radiological progression per RECIST 1.1 or death due to any cause (in the absence of progression).
次要结局
- Landmark Overall Survival (OS) rates(Up to approximately 5 years)
- Landmark Progression-Free Survival (PFS) rates(Up to approximately 5 years)
- Objective Response Rate (ORR)(Up to approximately 5 years)
- Duration of Response (DoR)(Up to approximately 5 years)
- Time to second progression or death (PFS2)(Up to approximately 5 years)
- Pharmakokinetics (PK) of rilvegostomig(Up to approximately 5 years)
- Immunogenicity of rilvegostomig(Up to approximately 5 years)
- Patient-reported physical functioning(Up to approximately 5 years)
- Patient-reported global health status (GHS)/quality of life (QoL)(Up to approximately 5 years)
- Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)(Up to approximately 5 years)
研究者
研究点 (304)
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