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

February 4, 2025 updated by: University Hospital, Brest

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

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

Study Contact

Study Locations

  • France
      • Brest, France, 29609
        • Recruiting
        • CHRU de Brest
        • Contact:
          • Margaux GEIER

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All-comer adults with advanced NSCLC and a PD-L1 TPS of 50% or greater, measured via IHC assays on a tumor biopsy sample, and treated with first-line pembrolizumab. Anti-PD-1 monotherapy was infused every three weeks until disease progression (according to RECIST criteria v1.1) or unacceptable toxicity, according to the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) v4.0. Exclusion criteria were prior exposure to immunotherapy/chemotherapy without recent biopsy before starting pembrolizumab or unavailable/insufficient tumor tissue.

Description

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

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
Identifying predictive biomarkers of anti-PD-1 response
Time Frame: 1 year
Identifying predictive biomarkers of anti-PD-1 response by highlighting discriminant cell profiles between responder and non-responder patients
1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Brest

Investigators

  • Principal Investigator: Margaux GEIER, MD, CHRU Brest

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)

April 16, 2021

Primary Completion (Estimated)

May 16, 2025

Study Completion (Estimated)

May 16, 2025

Study Registration Dates

First Submitted

May 10, 2021

First Submitted That Met QC Criteria

May 10, 2021

First Posted (Actual)

May 14, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 4, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29BRC21.0115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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