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Clinical Trials in France / NCT04886401
Recruiting Observational

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

NCT04886401 · tracked via the Priya Life Science France tracker
Phase
Observational
Started
2021-04-16
Last updated
2025-02-06

Condition(s) studied

Advanced Non Small Cell Lung Cancer

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients * Advanced NSCLC with PD-L1 TPS of 50% or greater * Administration of first line pembrolizumab between January 2017 \& December 2019 Exclusion Criteria: * Auto-immune disease * Prior exposure to immunotherapy * First dose pembrolizumab administered after December 2019

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
CHRU de Brest Brest France Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04886401 on ClinicalTrials.gov ↗ ← All trials in France