NCT06558799终止2 期
LUNAR-4: Pilot, Single Arm, Open-Label, Multinational Study of Tumor Treating Fields (TTFields, 150 kHz) Concomitant With Pembrolizumab for the Treatment of Metastatic Non-Small Cell Lung Cancer (NSCLC) Previously Treated With a PD-1/PD-L1 Inhibitor and Platinum-Based Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 31
- 试验地点
- 40
- 主要终点
- Overall Survival
研究概览
简要总结
The purpose of the study is to test the effectiveness and safety of TTFields therapy, delivered using the NovoTTF-200T device, concomitant with pembrolizumab in subjects with metastatic NSCLC previously treated with a PD-1/PD-L1 inhibitor and platinum-based chemotherapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •≥18 years of age
- •Histologically or cytologically confirmed diagnosis of NSCLC.
- •Documented positive tumor PD-L1 expression (TPS≥1%).
- •Eastern Cooperative Oncology Group (ECOG) Score of 0-
- •Diagnosis of radiological progression while on or after first platinum-based systemic therapy administered for advanced or metastatic disease.
- •Subjects must have received one line of PD-1/PD-L1 inhibitor therapy for advanced or metastatic NSCLC. PD-1/PD-L1 inhibitor may have been given alone or in combination with other therapy.
- •Subjects who received PD-1/PD-L1 inhibitor for advanced disease, must have had a best response on PD-1/PD-L1 inhibitor of stable disease (SD), partial response (PR) or complete response (CR).
- •Subjects must have experienced disease progression more than 84 days following Cycle 1 Day 1 (C1D1) of their most recent PD-1/PD-L1 inhibitor therapy.
排除标准
- •All individuals meeting any of the following exclusion criteria will be excluded from study participation:
- •Mixed small cell and NSCLC histology.
- •Subject must not have leptomeningeal disease or spinal cord compression.
- •Subject must not have untreated, symptomatic brain metastases, or residual neurological dysfunction.
- •Subjects must not have received more than one line of PD-1/PD-L1 inhibitor for advanced disease.
- •Subjects with a known sensitizing mutation for which the Food and Drug Administration (FDA)-approved targeted therapy for NSCLC exists (e.g., EGFR, ALK, ROS1) are excluded unless previously received at least one of the approved therapy(ies).
- •Subjects with more than 2 lines of therapy in the advanced setting.
- •Pregnant or breastfeeding.
- •Implantable electronic medical devices (e.g. pacemaker, defibrillator) in the upper torso.
- •Known allergies to medical adhesives or hydrogel.
研究组 & 干预措施
NovoTTF-200T + Pembrolizumab
Experimental
干预措施: NovoTTF-200T (Device)
NovoTTF-200T + Pembrolizumab
Experimental
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Overall Survival
时间窗: 16
To compare OS in subjects treated with TTFields concomitant with pembrolizumab compared to OS of subjects who were treated with docetaxel alone in the LUNAR/ EF-24 study (superiority analysis)
次要结局
未报告次要终点
研究者
研究点 (40)
Loading locations...
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