Device Protocol R2810-ONC-1763
Research type
Research Study
Full title
Clinical Performance Study Plan (CPSP) for the use of PD-L1 IHC 22C3 pharmDx Assay for A Randomized, Open-Label Study of Combinations of Standard and High Dose REGN2810 (Cemiplimab; Anti-PD-1 Antibody) and Ipilimumab (Anti-CTLA-4 Antibody) in the Second-Line Treatment of Patients with Advanced Non-Small Cell Lung Cancer
IRAS ID
254315
Contact name
Kristina McGuire
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2017-003684-35
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
18/YH/0165, REC reference for Clinical Trial; D50581/C46998, CPSP Document Number
Duration of Study in the UK
3 years, 10 months, 5 days
Research summary
The PD-L1 IHC 22C3 pharmDx IVD device is co-developed as a companion diagnostic for treatment of cemiplimab (Anti-PD-1 Antibody) in NSCLC patients.
Eligible patients will be randomized 1:1:1 to one of the following treatment arms: Treatment Arm A: Cemiplimab 350 mg every 3 weeks (Q3W) for 108 weeks (referred to as “SDREGN2810”)
Treatment Arm B: Cemiplimab 350 mg Q3W for 108 weeks plus ipilimumab 50 mg every 6 weeks (Q6W) for up to 4 doses (“SDREGN2810/ipi”)
Treatment Arm C: Cemiplimab 1050 mg Q3W for 108 weeks (“HDREGN2810”)
The PD-L1 IHC 22C3 pharmDx assay will be used in clinical trial R2810-ONC-1763 (REC Reference 18/YH/0165) to screen NSCLC patients for PD-L1 biomarker expression to test the clinical performance of PD-L1 IHC 22C3 pharmDx as a companion diagnostic. The clinical performance of PD-L1 IHC 22C3 pharmDx as an IVD for cemiplimab for NSCLC patients will be evaluated by analyzing the clinical outcome of the trial.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
18/WM/0382
Date of REC Opinion
11 Dec 2018
REC opinion
Unfavourable Opinion