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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04886401
Acronym
PREDICTION
Enrollment
50
Registered
2021-05-14
Start date
2021-04-16
Completion date
2025-05-16
Last updated
2025-02-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Non Small Cell Lung Cancer

Keywords

pembrolizumab, biomarkers, multiplex imaging

Brief 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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
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

Design outcomes

Primary

MeasureTime frameDescription
Identifying predictive biomarkers of anti-PD-1 response1 yearIdentifying predictive biomarkers of anti-PD-1 response by highlighting discriminant cell profiles between responder and non-responder patients

Countries

France

Contacts

Primary ContactMargaux GEIER, MD
margaux.geier@chu-brest.fr02 30 33 80 30

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026