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NCT04886401Recruiting

Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients with NSCLC

Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients with Non Small Cell Lung Cancer Mass Tissue Imaging HyperIONTM

Source: ClinicalTrials.gov · Last updated 6 Feb 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Therapeutic antibodies that block the programmed death-ligand 1 (PD-L1)/programmed death-1 (PD-1) pathway have revolutionized immuno-oncology by inducing robust and durable responses in patients with various cancer including advanced non-small-cell lung cancer (NSCLC). However, these responses only occur in a subset of patients, even in case of PD-L1 overexpression. Elucidating the determinants of response and resistance but also of severe immune-mediated adverse events is key to improving outcomes and developing new treatment strategies. Biomarkers that predict immune checkpoint inhibitors efficacy and toxicity are urgently needed and could emerge from characterization of tumor microenvironment. The purpose of PREDICTION project is to elucidate response and toxicity predictive immunophenotypic signatures using a new in situ multiplexed strategy with imaging mass cytometry Hyperion. Patients treated with anti-PD-1 pembrolizumab will be selected on their response and toxicity profiles. Then, tumor samples will be analysed with Hyperion technology, allowing delineation of cell subpopulations and cell-cell interactions, highlighting tumor heterogeneity and to determine correlations between response and toxicity features. The number of co-analysable markers enables global vision on the same tissue section. A better understanding of the tumor microenvironment complex system will lead to discover new predictive biomarkers potentially transferable to current practice.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
10 May 2021
Start date
16 Apr 2021
Primary completion date
16 May 2025
Lead sponsor
University Hospital, Brest
NCT number
NCT04886401

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 16 Apr 2021 to the primary completion date, 16 May 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior exposure to immunotherapy

Other illness

  • Auto-immune disease

Other

  • First dose pembrolizumab administered after December 2019

Who the study is looking for

  • Adult patients
  • Advanced NSCLC with PD-L1 TPS of 50% or greater
  • Administration of first line pembrolizumab between January 2017 \& December 2019

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
CHRU de Brest
Coordinator of this site? Confirm its status
BrestFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.