A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 895
- 试验地点
- 259
- 主要终点
- Overall Survival (OS), in PD-L1-negative participants.
研究概览
简要总结
The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety of volrustomig in combination with chemotherapy compared with pembrolizumab in combination with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.
详细描述
Adult patients with a histologically or cytologically documented metastatic NSCLC, with tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment. Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig + chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until disease progression as efficacy assessment. All patients will be followed for survival until the end of the study. An data monitoring committee (DMC) composed of independent experts will be convened to confirm the safety and tolerability of the proposed dose and schedule.
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
- None
盲法说明
None (Open Label)
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 squamous or non-squamous NSCLC.
- •Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic Oncology 2016), not amenable to curative surgery or radiation.
- •Absence of sensitizing EGFR mutations 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 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 are excluded.
- •Spinal cord compression.
- •Symptomatic brain metastases. Brain metastases may be treated or untreated, but participants must be asymptomatic and off steroids for at least 14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed between the end of brain radiotherapy and study enrollment.
- •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.
- •Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
- •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
Arm 2
Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Pembrolizumab (Drug)
Arm 2
Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Carboplatin (Drug)
Arm 2
Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Pemetrexed (Drug)
Arm 1
Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Volrustomig (Drug)
Arm 1
Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Paclitaxel (Drug)
Arm 1
Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Carboplatin (Drug)
Arm 1
Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Pemetrexed (Drug)
Arm 2
Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
干预措施: Paclitaxel (Drug)
结局指标
主要结局
Overall Survival (OS), in PD-L1-negative participants.
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, in PD-L1-negative participants.
Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
时间窗: Up to approximately 6 years
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), in PD-L1-negative participants.
次要结局
- PFS (using BICR assessments according to RECIST 1.1)(Up to approximately 6 years)
- OS(Up to approximately 6 years)
- Presence of ADAs against volrustomig in serum(Up to approximately 6 years)
- TTD of lung cancer symptoms(Up to approximately 6 years)
- Overall Response Rate (ORR)(Up to approximately 6 years)
- Duration of Response (DoR)(Up to approximately 6 years)
- PFS (using Investigator assessments according to RECIST 1.1)(Up to approximately 6 years)
- PFS2(Up to approximately 6 years)
- Concentration of volrustomig in serum and PK parameters(Up to approximately 6 years)
- Time-To-Deterioration (TTD) in physical functioning(Up to approximately 6 years)