A Phase III, Two- Arm, Parallel, Randomized, Multi-Center, Open‑Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) in Combination with Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients with Metastatic Non-Small Cell Lung Cancer (mNSCLC) (eVOLVE-Lung02)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 293
- 试验地点
- 99
- 主要终点
- Progression-Free Survival (PFS) in PD-L1 <1% (using BICR assessments according to RECIST 1.1); PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants where PD-L1 <1%.
研究概览
简要总结
The primary objective of the study is to determine whether volrustomig plus chemotherapy improves PFS and OS when compared with pembrolizumab plus chemotherapy in participants with mNSCLC where PD-L1 < 1%.
研究设计
- 分配方式
- Randomized
- 主要目的
- Follow up period
- 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
- 是
入选标准
- •Histologically or cytologically documented squamous or non-squamous NSCLC. Stage IV NSCLC (according to Version 8 of the IASLC Staging
- •Provision of tumor sample for prospective PD-L1 testing .
- •PD-L1 <50%.
- •Absence of sensitizing EGFR mutations (including, but not limited to, exon 19 deletion or exon 21 L858R, exon 21 L861Q, exon 18 G719X, or exon 20 S768I mutation) and ALK and ROS1 rearrangements.
- •Absence of documented tumor genomic alteration results from tests conducted as part of standard local practice in any other actionable driver oncogenes (eg, NTRK, BRAF, RET, MET, etc.) for which there are locally approved targeted first-line therapies.
排除标准
- •Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes (eg, NUT carcinoma, thoracic SMARCA4-deficient undifferentiated tumor, adenoid cystic carcinoma, epithelial-myoepithelial carcinoma) are excluded.
- •No prior exposure to immunotherapy.
- •No medical contraindication to platinum-based treatment.
- •Spinal cord compression.
- •Brain metastases unless asymptomatic, stable, and not requiring steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study enrollment.
- •History of another primary malignancy except for: (a) 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. (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease. (c) Adequately treated carcinoma in situ without evidence of disease.
- •As judged by the investigator, any condition that would interfere with evaluation of the study intervention or interpretation of participant safety or study results.
研究组 & 干预措施
volrustomig
Participants receiving volrustomig
干预措施: volrustomig (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) in PD-L1 <1% (using BICR assessments according to RECIST 1.1); PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants where PD-L1 <1%.
Progression-Free Survival (PFS) in PD-L1 <1% (using BICR assessments according to RECIST 1.1); PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants where PD-L1 <1%.
Overall Survival (OS) in PD-L1 <1%; OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants where PD-L1 < 1%.
Overall Survival (OS) in PD-L1 <1%; OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants where PD-L1 < 1%.
次要结局
- Overall survival in all randomized patients
- Progression Free Survival in all randomized participants.
研究者
AstraZeneca Clinical Study Information Center
Scientific
AstraZeneca AB