Device Protocol R2810-ONC-16113
Research type
Research Study
Full title
Clinical Performance Study Plan (CPSP) for the use of PD-L1 IHC 22C3 pharmDx Assay for a Randomized, Phase 3, Open- Label Study of Combinations of REGN2810 (Anti-PD-1 Antibody), Ipilimumab (Anti-CTLA-4 Antibody), and Platinum- Based Doublet Chemotherapy in First-Line Treatment of Patients with Advanced or Metastatic Non-Small Cell Lung Cancer with Tumors Expressing PD-L1 <50%
IRAS ID
254982
Contact name
Kristina McGuire
Contact email
Sponsor organisation
Regeneron Pharmaceuticals, Inc.
Eudract number
2017-001041-27
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
D50583/C47053, CPSP Document Number; 18/EM/0120, UK REC Reference 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 the cemiplimab and combination treatment (ipi and chemo) for NSCLC patients.
Eligible patients will be randomized 1:1:1 to one of the following treatment arms:
• Treatment Arm A: SOC chemotherapy of choice
• Treatment Arm B: REGN2810 plus chemotherapy of choice, referred as (REGN2810/chemo-f)
• Treatment Arm C: REGN2810 plus platinum-based doublet chemotherapy and ipilimumab, referred as (REGN2810/chemo-l/ipi)
The PD-L1 IHC 22C3 pharmDx assay will be used in the clinical trial R2810-ONC-16113 (UK REC Reference 18/EM/0120) 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 outcome of the trial.REC name
West Midlands - Black Country Research Ethics Committee
REC reference
18/WM/0381
Date of REC Opinion
11 Dec 2018
REC opinion
Unfavourable Opinion