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Immunological Markers Predictive of Response and Toxicity to Checkpoint Inhibitors in Non-small Cell Lung Cancer (IMMUNO-PREDICT)

2021年6月2日 更新者：University Hospital, Brest

Immunological Markers Predictive of Response and Toxicity to Checkpoint in Metastatic Non-Small-cell Lung Cancers

A prospective, observational, single-center study to determine the proportion of patients who have or will develop changes in biological markers of immunity during immunotherapy treatment.

研究概览

地位

招聘中

条件

详细说明

The study will run for 12 months with a 6-month follow-up at the inclusion of the last patient.

Patients will be included from the initiation of immunotherapy treatment regardless of the line.The routine immunological workup will be performed before the first immunotherapy infusion in order to analyze a certain number of immunological markers (autoantibodies, RF, LDH, complement (C3 C4), anti-tissue antibodies, lymphocyte immunophenotyping). This assessment will then be performed at progression, at the appearance of side effects requiring the immunotherapy to be stopped, or at 6 months of follow-up in case of continuation of the immunotherapy.

The investigators will evaluate the response to the treatment, the progression via re-evaluation assessments performed in standard practice (every 3 to 4 courses depending on the type of immunotherapy) as well as the appearance of side effects throughout the follow-up will be evaluate.

研究类型

观察性的

注册 (预期的)

150

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients with metastatic non-small cell lung cancer receiving immunotherapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUMAB) regardless of the line of treatment in daily practice

描述

Inclusion Criteria:

  • Major patient
  • Metastatic non-small cell lung cancer
  • Initiation of anti PDL1 therapy (NIVOLUMAB, PEMBROLIZUMAB or ATEZOLIZUAMB) in daily practice
  • No objection made

Exclusion Criteria:

  • Autoimmune disease diagnosed prior to initiation of immune checkpoint inhibitor therapy.
  • Previous immune-modulating therapy (including corticosteroid therapy greater than 10 mg/day)
  • Patient with prior checkpoint inhibitor therapy
  • Patient with a contraindication to immunotherapy
  • Patient under legal protection
  • Refusal to participate

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change of biological markers of immunity under immunotherapy at 6 months
大体时间：Day 0 and month 6 (M6)
Determine the proportion of patients who have or will develop a change in biological markers of immunity under immunotherapy at 6 months or, failing that, at the end of the immunotherapy (FAN and/or RF and/or anti-tissue and/or decrease in acquired complement verified on the difference between 6 months and inclusion, lymphocyte immunophenotyping)
Day 0 and month 6 (M6)

次要结果测量

结果测量
措施说明
大体时间
Impact on Overall Survival (OS) and Progression Free Survival (PFS)
大体时间：Day 0 and Six month after (M6)
Determine if the presence of biological markers of autoimmunity at initiation or during anti-PD1/PDL1 immunotherapy influences overall survival or progression-free survival.
Day 0 and Six month after (M6)
Impact on autoimmune toxicity
大体时间：Day 0 and month 6 (M6)

Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade).

Determine if the presence of biological markers of autoimmunity (at inclusion, at 6 months or at progression) is associated with autoimmune toxicity (any clinical or biological autoimmune event regardless of its grade).
Day 0 and month 6 (M6)
Impact of complement
大体时间：Day 0 and month 6 (M6)
Determine if the decrease in complement at 6 months is associated with autoimmune toxicity.
Day 0 and month 6 (M6)
Impact of autoimmune toxicity on OS
大体时间：Day 0 and month 6 (M6)
Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's overall survival.
Day 0 and month 6 (M6)
Impact of autoimmune toxicity on PFS
大体时间：Day 0 and month 6 (M6)
Determine if the occurrence of autoimmune toxicity during anti-PD1/PDL1 immunotherapy for non-small cell lung cancer influences the patient's progression-free survival.
Day 0 and month 6 (M6)
Impact of clinical factors
大体时间：Day 0 and month 6 (M6)
Determine if clinical factors (undernutrition, tumor mass, general condition) at initiation or during anti-PD1/PDL1 immunotherapy influence patient's overall survival and progression-free survival
Day 0 and month 6 (M6)
Study the clinical factors influencing the immune profile
大体时间：Day 0 and month 6 (M6)
Study the clinical factors influencing the immune profile
Day 0 and month 6 (M6)
Impact of CRP and lymphopenia
大体时间：Day 0 and month 6 (M6)
Determine if CRP and the presence of initial lymphopenia influence the presence or induction of an immunological abnormality
Day 0 and month 6 (M6)

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University Hospital, Brest

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年4月8日

初级完成 (预期的)

2021年10月8日

研究完成 (预期的)

2022年10月8日

研究注册日期

首次提交

2021年5月27日

首先提交符合 QC 标准的

2021年6月2日

首次发布 (实际的)

2021年6月9日

研究记录更新

最后更新发布 (实际的)

2021年6月9日

上次提交的符合 QC 标准的更新

2021年6月2日

最后验证

2021年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Immuno-PREDICT ( 29BRC21.0021)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

All collected data that underlie results in a publication

IPD 共享时间框架

Data will be available beginning 18 months and ending five years following the publication

IPD 共享访问标准

Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

IPD 共享支持信息类型

  • 研究方案

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

CROs by country

CROs in Malta

条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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