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NCT Number: NCT06558903

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Brest

Brest, 29609, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. Progression-free survival

    Time frame: 3 year

    Time between treatment start and date of progression according to investigator, or death from any cause

  2. Overall survival

    Time frame: 3 year

    Time between treatment start and date of death from any cause

Sponsors and collaborators

Lead sponsor

University Hospital, Brest

Other

Registry information

Official study 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

Acronym: HYPE

Important dates

Study start
2021
Primary completion
2021
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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