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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Small Cell Lung Carcinoma

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.

• Study Type: Observational
• Enrollment (Actual): 20

Contacts and Locations

Study Locations

• France
  • Brest, France, 29609
    • CHU de Brest

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Brest
• Investigators: Study Director: Margaux Geier, MD, Department of Medical Oncology, Brest University Hospital; Principal Investigator: Pierre Le Noac'h, MD, Department of Medical Oncology, Brest University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2021
• Primary Completion (Actual): October 1, 2021
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: August 9, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 14, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Biomarker; Immunotherapy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Small Cell Lung Carcinoma
• Other Study ID Numbers: 29BRC21.0110 - HYPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected data that underlie results in a publication
• IPD Sharing Time Frame: Data will be available after the publication of result and ending five years maximum following the last visit of the last patient
• IPD Sharing Access Criteria: Data access requests will be reviewed by the internal committee of Brest University Hospital. requestors will be required to sign and complete a data access agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No