: Identification of a Predictive Metabolic Signature of Response to Immune Checkpoint Inhibitors in Non-Small Cell Lung Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Identification of the change from baseline Metabolic signature as predictive factor of the ICI response at 6 months or at the tumoral progression
研究概览
简要总结
Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment. To date, no powerful predictive biomarker of response has been found.
The investigators hypothesize that metabolomics profile could represent a potent biomarker of response to ICI
详细描述
Immune checkpoints inhibitors (ICI) are becoming new standards of care for Non-Small Cell Lung Carcinoma (NSCLC) treatment, both as first and second line of treatment. To date, no powerful predictive biomarker of response has been found. It has been recently shown that microbiota composition could dictate the ability of patients to respond to ICI. Since, the microbiota produces circulating metabolites that will subsequently act on immune system, the investigators hypothesized that metabolic signature, reflecting microbiota function, could represent a predictive biomarker of response to ICI.
Primary objective is to identify baseline metabolic signature (metabolomics analysis by Mass spectrometry) associated to ICI response. Secondary objectives are to link metabolic signature with microbiota composition (metagenomics analysis RNA 16S) and immune profile, and altogether with clinic response to ICI. Profile evolution (metabolic, metagenomics and immune) will be also analyzed at 2-month post ICI initiation and at tumor progression, if any.
In order to do so, the investigators thus plan to enroll 60 NSCLC patients treated by ICI as 1st, 2nd or 3rd line of treatment in CHUGA in 18 months. Blood as well feces will be collected prior to, and at 2 month following ICI treatment initiation as well as at progression. Will be excluded from this study, patients that have received antibiotic or corticotherapy 2 or 4 weeks before ICI initiation, respectively.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NSCLC diagnosis
- •Patient treated by a ICI in first, second or third line of treatment, or by the combination of chemotherapy and IPCI in first line of treatment
- •Patient with at least one measurable lesion as defined by RECIST
排除标准
- •Patient treated with antibiotic treatment within 2 weeks before the start of ICI or corticosteroids (>20 mg per day) within 4 weeks before the start of ICI
结局指标
主要结局
Identification of the change from baseline Metabolic signature as predictive factor of the ICI response at 6 months or at the tumoral progression
时间窗: baseline, 6 months or tumoral progression
To identify the link of the change from baseline of Metabolic signature in serum (metabolomics analysis performed using a Mass spectrometry) and the ICI response at 6 months or at the tumoral progression
次要结局
- Description of the profile change of Meta-genomic signature(2 months or tumoral progression)
- Identification of change of immune signature and the ICI response at 2 months or at the tumoral progression(Baseline and (2 months or tumoral progression))
- Description of the profile change of Immune signature at 2 months or at the tumoral progression(Baseline and 2 months or tumoral progression)
- Description of the survival without progression under ICI at 6 months or at the tumoral progression(6 months or tumoral progression)
- Identification of the link between the Meta-genomic and immune signatures and the metabolic signature at 6 months or at the tumoral progression(6 months or tumoral progression)
- Identification of the link between the profile change of meta-genomic signature and the ICI response at 2 months or at the tumoral progression(Baseline and (2 months or tumoral progression))
- Identification of the link between the Meta-genomic and immune signatures and ICI response at 6 months or at the tumoral progression(6 months or tumoral progression)
- Description of overall survival under ICI at 6 months or at the tumoral progression(6 months or tumoral progression)