Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)

Trial Title: Searching for Predictive Biomarkers of Efficacy in Small Cell Lung Cancer Patients Treated With Chemotherapy-immunotherapy Combination Using Imaging Mass Cytometry (HYPE)

NCT ID: NCT06558903

Condition: Small Cell Lung Carcinoma

Conditions: Official terms:
Small Cell Lung Carcinoma

Conditions: Keywords:
Biomarker
Immunotherapy

Study type: Observational

Overall status: Active, not recruiting

Study design:

Time perspective: Retrospective

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.

Criteria for eligibility:

Study pop:
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

Sampling method: Probability Sample
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: CHU de Brest

Address:
City: Brest
Zip: 29609
Country: France

Start date: June 24, 2021

Completion date: January 1, 2025

Lead sponsor:
Agency: University Hospital, Brest
Agency class: Other

Source: University Hospital, Brest

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06558903