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

NCT04886401 | Recruiting

• 1 other identifier: 29BRC21.0115
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Non Small Cell Lung Cancer

Keywords

pembrolizumab; biomarkers; multiplex imaging

Outcome Measures

Primary Outcomes (1)

• Identifying predictive biomarkers of anti-PD-1 response

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

  1 year

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Auto-immune disease
• Prior exposure to immunotherapy
• First dose pembrolizumab administered after December 2019

Sponsors & Collaborators

• University Hospital, Brest: lead

Study Sites (1)

CHRU de Brest

Brest, 29609, France

RECRUITING

Study Officials

• Margaux GEIER, MD

  CHRU Brest

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaux GEIER, MD

CONTACT

02 30 33 80 30; margaux.geier@chu-brest.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2021
• First Posted: May 14, 2021
• Study Start: April 16, 2021
• Primary Completion: May 16, 2025
• Study Completion: May 16, 2025
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

FR (1)