Study of Predictive Biomarkers of Response to Carboplatin Etoposide Atezolizumab Combination in Patients With Small Cell Lung Cancer, Exploratory Study by HYPErionTM Tissue Mass Imaging
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients
研究概览
简要总结
The goal of this retrospective study is to identify predictive biomarkers of efficacy in tumor samples of small cell lung cancer patients treated with chemotherapy-immunotherapy combination using imaging mass cytometry. The main question it aims to answer is: is there any feature in the tumour microenvironment that can discriminate responders from non responders before treatment? Participants will provide consent for the collection of their clinical data and the study of their tumor samples
详细描述
Small cell lung cancer patients treated with first-line atezolizumab plus platinum-etoposide regimen with available formalin fixed paraffin embedded (FFPE) biopsies at baseline will be identified from Brest University Hospital medical records and their samples will be retrieved from Brest University Hospital Pathology Laboratory for imaging mass cytometry analyses.
Clinical data will be collected for each patient, including progression-free survival (defined as the time between treatment start and date of progression according to investigator, or death from any cause) and overall survival (defined as the time between treatment start and date of death from any cause).
For imaging mass cytometry analyses, a panel of 39 metal-tagged antibodies will be used to characterize the cell composition of lung tumors at baseline (inflammatory, tumor and stromal cells).
Statistical analyses will be performed to correlate the composition of the tumor microenvironment at baseline and the survival data.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with extensive or metastatic small cell lung cancer
- •Patients who started a first line treatment with atezolizumab plus carboplatin and etoposide in routine practice before February 2021
- •Patients with available tumor sample before treatment start
- •No objection from living patients
排除标准
- •Patients who started first line treatment with atezolizumab plus carboplatin and etoposide in routine practice after February 2021
- •Patients having received immunotherapy in a clinical trial
- •Patients with auto-immune disorder
- •Patients under legal protection (guardianship, curatorship)
- •Patients refusing to participate to the study
结局指标
主要结局
Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients
时间窗: 3 year
Features in the tumour microenvironment that can discriminate patients responding to anti-PD-L1 from non responders
次要结局
- Overall survival(3 year)
- Progression-free survival(3 year)