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临床试验/NCT03658460
NCT03658460已完成不适用

Immune Checkpoint Inhibitors in Advanced Non-Small Cell Lung Cancer and Discovery of New Biomarkers

Aalborg University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年8月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Predictive, prognostic and resistance signatures

研究概览

简要总结

Lung cancer patients have a poor prognosis and only around 20 % is alive after 5 years. However, for advanced non-small cell lung cancer immunotherapy has become a cornerstone of treatment.

Two immunotherapeutic drugs for lung cancer have been approved in the last two years. Immunotherapy blocks the capability of cancer cells to inactivate the patient´s immune system, thus re-enabling eradication of cancer cells. In clinical trials, immunotherapy has shown superior survival and less toxicity compared to standard chemotherapy.

Whether the patients are candidates for immunotherapy or not is currently based on an unprecise biomarker that poorly predicts the patients who may benefit from immunotherapy. Immunotherapy can cause severe adverse effects and is expensive. Consequently, novel biomarkers are urgently needed from a patient perspective as well as a socioeconomic perspective.

The objective of the project is to investigate changes in genes and other signals in tissue and blood samples from immunotherapy treated lung cancer patients. The investigators expect to identify new biomarkers that can predict with high precision, which patients may benefit from immunotherapy. On-treatment, the investigators also aim to identify biomarkers that predict the treatment response and reveal the underlying mechanisms when cancer cells become resistant to the treatment.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Biopsy verified NSCLC
  • ≥ 18 years
  • WHO/ECOG performance status ≤ 2
  • Measurable disease according to RECIST 1.1
  • Candidate for immunotherapy treatment
  • Understand and accept oral and written information
  • Written informed consent

排除标准

  • Candidate for surgical and/or oncological treatment with curative intention
  • Other synchronous cancer

结局指标

主要结局

Predictive, prognostic and resistance signatures

时间窗: Until progression or 1 year after immunotherapy start date

Next Generation Sequencing and gene expression analysis with NanoString PanCancer IO 360 panel in tissue samples at baseline and 1) at progression or 2) one year after immunotherapy start and no progression.

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

Andreas Carus

Principal Investigator

Aalborg University Hospital

研究点 (1)

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