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

August 14, 2024 updated by: University Hospital, Brest

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

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 3 year
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 Frame: 3 year
Time between treatment start and date of progression according to investigator, or death from any cause
3 year
Overall survival
Time Frame: 3 year
Time between treatment start and date of death from any cause
3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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