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临床试验/NCT03571360
NCT03571360Unknown2 期

Expression/DNA Methylation of Cancer Testis Antigens May Predict Response to Pembrolizumab in Non-small Cell Lung Cancer Patients

Medical University of Vienna2 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2020年2月10日最近更新:
适应症

试验速览

阶段
2 期
入组人数
42
试验地点
2
主要终点
Response rate

研究概览

简要总结

Pembrolizumab is a potent and highly selective humanized monoclonal antibody (mAb) of the IgG4/kappa isotype designed to directly block the interaction between PD-1 and its ligands, PD-L1 and PD-L2. KeytrudaTM (pembrolizumab) has been approved by the FDA and the EMA for the therapy of with chemotherapy pretreated NSCLC patients with PD-L1 expression (TPS ≥ 1%) on tumor cells. In addition, pembrolizumab was approved for the first line treatment of metastatic NSCLC patients with high PD-L1 expression (TPS ≥ 50%) on tumor cells. Pembrolizumab will be given in a flat dose of 200 mg i.v. every 3 weeks until disease progression, toxicity or patient withdrawal for a maximum of 2 years. Patients with untreated advanced stage lung adenocarcinoma, without an EGFR mutation or ALK translocation, will be included.

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 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Response rate

时间窗: 6 months after start of treatment

Complete and partial remission, stable disease; measured by computertomography; RECIST 1.1 criteria

PFS

时间窗: Time from start of treatment to radiologically confirmed progressive disease or death due to any cause, whichever came first, assessed up to 24 months.

Distribution of PFS of patients

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Gerwin Heller

Principal Investigator

Medical University of Vienna

研究点 (2)

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