Clinical trial NCT06558903: Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)
Official title: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Small Cell Lung Carcinoma
Keywords: Biomarker
Immunotherapy
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2024-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who started a first line treatment with atezolizumab plus carboplatin and etoposide at Brest University Hospital before February 2021 with available tumor sample before treatment start

Brief summary: 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

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients
timeFrame: 3 year
Secondary outcomes:
measure: Progression-free survival
timeFrame: 3 year
measure: Overall survival
timeFrame: 3 year
Other outcomes:
Locations:
city: Brest
country: France
facility: CHU de Brest
Study officials:
affiliation: Department of Medical Oncology, Brest University Hospital
name: Margaux Geier, MD
role: STUDY_DIRECTOR
affiliation: Department of Medical Oncology, Brest University Hospital
name: Pierre Le Noac'h, MD
role: PRINCIPAL_INVESTIGATOR
References: