A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab in Combination With Platinum-based Chemotherapy for the First-line Treatment of Patients With Locally Advanced or Metastatic Non-squamous Non-small Cell Lung Cancer Whose Tumors Express PD-L1 (ARTEMIDE-Lung03)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 1,160
- 试验地点
- 300
- 主要终点
- Overall survival (OS)
研究概览
简要总结
The purpose of ARTEMIDE-Lung03 is to evaluate the efficacy and safety of rilvegostomig compared to pembrolizumab, both in combination with platinum-based doublet chemotherapy, as a first-line treatment of patients with locally advanced or metastatic non-squamous NSCLC 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, both in combination with platinum-based doublet chemotherapy, as a 1L treatment for patients with locally advanced or metastatic non-squamous NSCLC whose tumors express PD-L1 (TC ≥ 1%).
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 non-squamous NSCLC.
- •Stage III B/C or IV NSCLC (based on the American Joint Committee on Cancer Edition 8) not amenable to curative treatment.
- •Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion and exon 21 L858R, exon 21 L861Q, exon 18 G719X, and exon 20 S768I mutations) and ALK and ROS1 rearrangements.
- •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 and available targeted 1L therapies.
- •Provision of acceptable tumor sample, to confirm tumor PD-L1 expression TC ≥ 1%.
- •At least one lesion not previously irradiated that qualifies as a RECIST 1.1 TL 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 or MRI and is suitable for accurate repeated measurements.
- •Adequate organ and bone marrow function
排除标准
- •Presence of small cell and neuroendocrine histology components.
- •Brain metastases unless asymptomatic, stable, and not requiring steroids or anticonvulsants for at least 7 days prior to randomization. A minimum of 2 weeks must have elapsed between the end of local therapy (brain radiotherapy or surgery) and randomization. Participants must have recovered from the acute toxic effect of radiotherapy (eg, dizziness and signs of increased intracranial pressure) or surgery prior to randomization.
- •Any prior systemic therapy received for NSCLC except in the neoadjuvant or adjuvant setting or definitive chemoradiotherapy with the intent to cure, provided that progression has occurred > 12 months after the end of systemic therapy treatment.
- •Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
- •Any prior treatment with an anti-PD-1 or anti-PD-L1 agent.
- •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.
- •Active or prior documented autoimmune or inflammatory disorders requiring chronic systemic treatment with the use of disease-modifying agents, corticosteroids, or immunosuppressive drugs.
- •Active primary immunodeficiency/active infectious disease(s).
- •Active tuberculosis infection.
研究组 & 干预措施
Arm A
Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
干预措施: Rilvegostomig (Drug)
Arm B
Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
干预措施: Carboplatin (Drug)
Arm B
Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
干预措施: Pemetrexed (Drug)
Arm A
Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
干预措施: Carboplatin (Drug)
Arm A
Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
干预措施: Cisplatin (Drug)
Arm A
Rilvegostomig in combination with platinum-based doublet chemotherapy followed by rilvegostomig monotherapy plus pemetrexed in maintenance.
干预措施: Pemetrexed (Drug)
Arm B
Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
干预措施: Pembrolizumab (Drug)
Arm B
Pembrolizumab in combination with platinum-based doublet chemotherapy followed by pembrolizumab monotherapy plus pemetrexed in maintenance.
干预措施: Cisplatin (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: Up to approximately 6 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 6 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 6 years)
- Landmark progression-free survival (PFS) rates(Up to approximately 6 years)
- Time to second progression or death (PFS2)(Up to approximately 6 years)
- Overall response rate (ORR)(Up to approximately 6 years)
- Duration of response (DoR)(Up to approximately 6 years)
- Pharmacokinetic (PK) of rilvegostomig(Up to approximately 6 years)
- Immunogenicity of rilvegostomig(Up to approximately 6 years)
- Patient-reported physical functioning(Up to approximately 6 years)
- Patient-reported global health status (GHS)/quality of life (QoL)(Up to approximately 6 years)
- Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC)(Up to approximately 6 years)