2024-515008-38-00招募中3 期
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)
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 296
- 试验地点
- 71
- 主要终点
- Overall Survival (OS).
研究概览
简要总结
To demonstrate the efficacy of rilvegostomig plus chemotherapy relative to pembrolizumab plus chemotherapy by assessment of OS and PFS
研究设计
- 分配方式
- Na
- 主要目的
- Post-intervention
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically documented non-squamous NSCLC.
- •Stage IIIB/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, noncurative therapy received for NSCLC.
- •Prior treatment with an anti-PD-1 or anti-PD-L1 agent.
- •Any prior exposure to an anti-TIGIT therapy or any other anticancer therapy targeting immune-regulatory receptors or mechanisms.
- •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 or immunosuppressive drugs.
- •Active primary immunodeficiency/active infectious disease(s).
- •Active tuberculosis infection.
研究组 & 干预措施
KEYTRUDA 25 mg/mL concentrate for solution for infusion
Comparator
干预措施: KEYTRUDA 25 mg/mL concentrate for solution for infusion (Drug)
INFLIXIMAB
Auxiliary
干预措施: INFLIXIMAB (Drug)
PEMETREXED, PEMETREXED
Test
干预措施: PEMETREXED (Drug)
Rilvegostomig
Test
干预措施: Rilvegostomig (Drug)
CISPLATIN
Test
干预措施: CISPLATIN (Drug)
MYCOPHENOLATE MOFETIL
Auxiliary
干预措施: MYCOPHENOLATE MOFETIL (Drug)
CARBOPLATIN
Test
干预措施: CARBOPLATIN (Drug)
结局指标
主要结局
Overall Survival (OS).
Overall Survival (OS).
Progression-free survival (PFS).
Progression-free survival (PFS).
次要结局
- Landmark progression-free survival (PFS) rates
- Time to second progression or death (PFS2)
- Overall response rate (ORR)
- Duration of response (DoR)
- Concentration of rilvegostomig in serum.
- Presence of antidrug antibody (ADAs), titer and neutralizing antibodies for rilvegostomig.
- Proportion of participants with maintained or improved physical functioning.
- Time to deterioration (TTD) of global health status (GHS)/quality of life (QoL) and in pulmonary symptoms.
- Landmark overall survival (OS) rates
- Adverse events (AEs) (graded by CTCAE version 5.0), clinical laboratory assessments, vital signs, and Eastern Cooperative Oncology Group (ECOG) performance status.
研究者
Clinical Study Information Center
Scientific
AstraZeneca AB
研究点 (71)
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