VENTANA PD-LA (SP263) - R3767-ONC-2236
Research type
Research Study
Full title
Diagnostic Protocol for VENTANA PD-L1 (SP263) CDx Assay in Regeneron Pharmaceuticals Study R3767-ONC-2236
IRAS ID
330419
Contact name
Kathrina Alexander
Contact email
Sponsor organisation
Ventana Medical Systems
Clinicaltrials.gov Identifier
2022-501577-40-00, Regeneron's pharmaceutical study R3767-ONC-2236 EU CTA Number; 163869, Regeneron's pharmaceutical study R3767-ONC-2236 IND
Duration of Study in the UK
2 years, 7 months, 1 days
Research summary
The Dx protocol is being conducted in support of Regeneron Study R3767-ONC-2236 to identify the PD-L1 expression level of tumor specimens at screening, for patient enrollment and stratification in Regeneron Study R3767-ONC-2236. Exploratory biomarker-related efficacy analysis from Study R3767-ONC-2236 may also serve to evaluate the clinical performance of VENTANA PD-L1 (SP263) CDx Assay in terms of its ability to identify NSCLC patients who may benefit from treatment with fianlimab in combination with cemiplimab and chemotherapy.
As part of a co-development paradigm including both an investigational therapy and an investigational diagnostic, RTD will be responsible for certain aspects of the investigational IVD device use within the Study R3767-ONC-2236. As such, this Dx protocol supports the Study R3767-ONC2236 by describing the procedures for how the patient tumor samples collected as part of Study R3767-ONC-2236 should be tested with VENTANA PD-L1 (SP263) CDx Assay at the Dx testing sites.
Exploratory biomarker-related clinical efficacy analysis from Study R3767-ONC-2236 may be used to evaluate the clinical performance of VENTANA PD-L1 (SP263) CDx Assay as a CDx device for fianlimab in combination with cemiplimab and chemotherapy relative to cemiplimab in combination with chemotherapy in advanced treatment-naïve NSCLC patients with squamous or non-squamous NSCLC.
Enrollment for patients with squamous NSCLC will be capped at ≤50% of the total sample size. At least 30% but no more than 40% of patients enrolled must have tumors that express PD-L1 in ≥50% of tumor cells. Enrollment of patients whose tumors express PD-L1 in <1% of tumor cells will be capped at 30% of the total sample size. Enrollment of patients with PD-L1 expression <50% of tumor cells will be capped at 70%.
Additionally, PD-L1 expression results from testing that occurred under this CDx protocol RD006664 (D191469) for patients with PD-L1 expression ≥50% TC may be considered for other RTD NSCLC studies being conducted in collaboration with Regeneron, at the discretion of the patient’s physician if the patient has given the proper informed consent. It is anticipated that tumor specimens from approximately 2200 patients undergoing screening to participate in Study R3767-ONC-2236 will be tested with VENTANA PD-L1 (SP263) CDx Assay at Dx testing sites.
Stained slides from each case will be interpreted by qualified pathologists who will assign a PDL1 expression level. PD-L1 expression level in TC (<1%, 1% to 49%, ≥50% to <75%, and ≥75%) will be one of the stratification factors used for randomization of patients into the treatment arms. Performance of VENTANA PD-L1 (SP263) CDx Assay will be evaluated per the endpoints and acceptance criteria defined in this protocol.REC name
North of Scotland Research Ethics Committee 1
REC reference
23/NS/0074
Date of REC Opinion
28 Jul 2023
REC opinion
Favourable Opinion