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

NCT ID: NCT04886401

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2025-05-16

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Brest

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaux GEIER, MD

Role: PRINCIPAL_INVESTIGATOR

CHRU Brest

Locations

CHRU de Brest

Brest, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Margaux GEIER, MD

Role: CONTACT

margaux.geier@chu-brest.fr

02 30 33 80 30

Facility Contacts

Margaux GEIER

Role: primary

Other Identifiers

29BRC21.0115

Identifier Type: -

Identifier Source: org_study_id