VENTANA PD-L1 SP263 GCT1046-06 V01
Research type
Research Study
Full title
Clinical Performance Study Protocol for Use of VENTANA PD-L1 (SP263) CDx Assay for Determining PD-L1 Status in Genmab Phase 3 Trial GCT1046-06.
IRAS ID
352976
Contact name
Manish Mani Subramaniam
Contact email
Sponsor organisation
Roche Diagnostics Solutions
Clinicaltrials.gov Identifier
PS-24-08-048656 , RD007098 Clinical Performance Study Eudamed Number
Duration of Study in the UK
2 years, 10 months, 4 days
Research summary
PD-L1, or programmed death ligand 1, is a protein detected in normal human immune cells (T lymphocytes) that prevents the immune system from attacking healthy cells. Cancer cells can express high levels of PD-L1, which can prevent T cells (T lymphocytes) from attacking the cancer. A PD-L1 test measures the percentage of tumour cells that express PD-L1 protein in human tissues. This test is performed using a laboratory technique called immunohistochemical (IHC) staining. Immunohistochemical staining or immunohistochemistry (IHC) is a laboratory technique that uses antibodies to identify antigens in tissue samples. In the PDL1 test, a specific PDL1 antibody will be applied to the human tumour tissues, in order to detect the PDL1 protein or PDL1 antigen in the tumour. High levels of PD-L1 protein in tumours can indicate that a patient may benefit from immunotherapy. Immunotherapy uses medicines called immune checkpoint inhibitors (ICIs) to prevent PD-L1 from stopping T cells from attacking cancer cells. Patients with advanced lung cancer, especially a type of lung cancer called non-small cell lung cancers (NSCLC) who have high levels of PD-L1 may benefit from ICIs. ICIs can help with survival of these patients. Several ICs such as nivolumab, pembrolizumab, atezolizumab, and durvalumab have been successfully used to treat NSCLC patients based on the estimation of PDL1 levels in tumour tissues by PDL1 test.
The PDL1 test is called as a “companion diagnostic test (CDx test). A CDx test is a medical test or device which helps determine if a patient is suitable for a specific drug or therapy. Therefore, PDL1 testing in human NSCLC tumour tissues helps in selecting the appropriate immunotherapy drug for the patient.
In this medical device evaluation study, PDL1 (SP263, the PDL1 antibody used to detect PDL1 protein in tumour tissue) test will be used to determine levels of expression of PDL1 in tumour tissues from patients with NSCLC screened for enrolment in the drug study (GCT 1046-06). The drug study is to test the efficacy and safety of the drug combination acasunlimab (GEN1046) and pembrolizumab in patients with PDL1 positive NSCLCs.A positive PDL1 test at 1%, which means tumour sample showing at least 1% of positive PDL1 expression is required for enrolment of the patient in the drug study. A positive PDL1 test between 1% and 49% levels and more than or equal to 50% level, which means tumour samples showing between 1 and 49% positive PDL1 expression and tumour samples showing more than or equal to 50% positive PDL1 expression are required for classifying patients in different treatment arms of the drug study.
Thus, in summary, in this medical device evaluation study, we aim to test the utility of the PDL1 (SP263) as a test to identify NSCLC patients who can benefit from the above mentioned drug combination in patients enrolled as part of the drug study.
REC name
North of Scotland Research Ethics Committee 1
REC reference
25/NS/0010
Date of REC Opinion
31 Jan 2025
REC opinion
Favourable Opinion