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

Advanced Non Small Cell Lung Cancer Clinical Trial

— PREDICTION  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04886401
• Other study ID #: PREDICTION - 29BRC21.0115
• Status: Recruiting
• Start date: April 16, 2021
• Est. completion date: May 16, 2021

Study information

• Verified date: April 2021
• Source: University Hospital, Brest
• Contact: Margaux GEIER, MD
• Phone: 02 30 33 80 30
• Email: margaux.geier[@]chu-brest.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 16, 2021
• Est. primary completion date: May 16, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Non Small Cell Lung Cancer
• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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