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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06558903

Acronym

HYPE

Enrollment

Registered

2024-08-19

Start date

2021-06-24

Completion date

2025-01-01

Last updated

2024-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Small Cell Lung Carcinoma

Keywords

Biomarker, Immunotherapy

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Identification of predictive biomarkers of anti-PD-L1 efficacy in the tumor of small cell lung cancer patients	3 year	Features in the tumour microenvironment that can discriminate patients responding to anti-PD-L1 from non responders

Secondary

Measure	Time frame	Description
Progression-free survival	3 year	Time between treatment start and date of progression according to investigator, or death from any cause
Overall survival	3 year	Time between treatment start and date of death from any cause

Countries

France

Outcome results