jRCT2051240051招募中不适用
A randomized, multicenter, double-blind, Phase 3 study to investigate the safety and efficacy of belrestotug in combination with dostarlimab compared with placebo in combination with pembrolizumab in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1-selected non-small-cell lung cancer (GALAXIES LUNG-301) (GALAXIES LUNG-301 )
GlaxoSmithKline K.K.0 个研究点目标入组 1,000 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,000
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •1.Has a histologically or cytologically confirmed diagnosis of 1 of the following:
- •a. Locally advanced, unresectable NSCLC (not eligible for curative surgery
- •and/or definitive radiotherapy with or without chemotherapy), or
- •b. Metastatic NSCLC.
- •2.Has not received prior systemic therapy for their locally advanced or metastatic
- •3.Provides a tumor tissue sample obtained at the time of or after the initial diagnosis of
- •locally advanced or metastatic NSCLC.
- •4.Has measurable disease (at least 1 target lesion) based on RECIST 1.1, as determined
- •by the investigator.
- •5.Has a PD-L1-high (TC>-50%) tumor as determined by the assay at a central laboratory.
- •6.Has adequate organ function.
排除标准
- •1.Has NSCLC with a tumor that harbors any of the following molecular alterations:
- •a.EGFR mutations that are sensitive to available targeted inhibitor therapy.
- •b.ALK translocations that are sensitive to available targeted inhibitor therapy.
- •c.Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.
- •2.Has had major surgery within 4 weeks of the first dose of study intervention or has received lung radiation therapy of >30Gy within 6months of the first dose of study intervention.
- •3.Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, CTLA-4, TIGIT, or other checkpoint pathways.
- •4.Has never smoked, defined as smoking <100 tobacco cigarettes in a lifetime
- •5.Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years.
- •6.Has known symptomatic, untreated, or actively progressing brain metastases and/or leptomeningeal disease.
- •7.Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
- •8.Has symptomatic ascites or pleural effusion or pericardial effusion.
结局指标
主要结局
-
-PFS by BICR -OS
次要结局
未报告次要终点
研究者
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