NCT04886401 Retrospective Observational Study on Prediction of Response to PD-1 Immunotherapy in Patients with NSCLC
| NCT ID | NCT04886401 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Brest |
| Condition | Advanced Non Small Cell Lung Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2021-04-16 |
| Primary Completion | 2025-05-16 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2021-04-16 with a primary completion date of 2025-05-16.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Margaux GEIER, MD
PRINCIPAL INVESTIGATOR
CHRU BREST
Frequently Asked Questions
Who can join the NCT04886401 clinical trial?
This trial is open to participants of all sexes, studying Advanced Non Small Cell Lung Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04886401 currently recruiting?
Yes, NCT04886401 is actively recruiting participants. Contact the research team at margaux.geier@chu-brest.fr for enrollment information.
Where is the NCT04886401 trial being conducted?
This trial is being conducted at Brest, France.
Who is sponsoring the NCT04886401 clinical trial?
NCT04886401 is sponsored by University Hospital, Brest. The principal investigator is Margaux GEIER, MD at CHRU BREST. The trial plans to enroll 50 participants.
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