Evaluation of PD-L1 Expression Levels in Lung Cancer Samples from the ARTEMIDE-Lung04 Study
Summary description of the study
This diagnostic study with an experimental test, called the VENTANA PD-L1 (SP263) companion diagnostic test, is conducted in conjunction with the ARTEMIDE-Lung04 pharmaceutical study. Tumor samples from patients screened for the ARTEMIDE-Lung 04 study will be analyzed using the PD-L1 test to determine the expression level of the protein known as programmed death-ligand 1 (PD-L1). A high level of PD-L1 protein expression in the tumor sample as determined by the test is required to be eligible for inclusion in the pharmaceutical study. The diagnostic study evaluates the effectiveness of the PD-L1 test in identifying metastatic NSCLC patients who are most likely to benefit from treatment with the experimental therapy of the pharmaceutical study.
(BASEC)
Intervention under investigation
A tumor sample recently collected as part of the diagnosis or a sample collected during the selection period for the pharmaceutical study of the ARTEMIDE Lung 04 study will be analyzed. The PD-L1 test will detect and stain the PD-L1 protein in the tumor tissue, which will be examined under a microscope by a pathologist in a laboratory. The percentage of tumor cells stained for PD-L1 will be noted by the pathologist. The results will be used to determine if the requirements for participation in the ARTEMIDE-Lung 04 study are met.
Tumor samples will be analyzed in a central laboratory in the United States.
(BASEC)
Disease under investigation
Lung Cancer
(BASEC)
Tumor samples must meet certain criteria to be eligible for testing with the PD-L1 test, e.g., they must be fixed in formalin and contain sufficient tumor cells. (BASEC)
Exclusion criteria
A sample will be excluded from the diagnostic study if certain criteria apply, for example, if it has been fixed in alcohol. (BASEC)
Trial sites
Lausanne
(BASEC)
Sponsor
Ventana Medical Systems, Inc. (Roche Tissue Diagnostics,RTD) Roche Diagnostics International Ltd.
(BASEC)
Contact
Contact Person Switzerland
Dr. Karim Abdelhamid
+41 79 5560440
karim.abdelhamid@clutterchuv.chCHUV Centre hospitalier universitaire vaudois
(BASEC)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Vaud
(BASEC)
Date of authorisation
28.08.2025
(BASEC)
ICTRP Trial ID
NCT06868277 (ICTRP)
Official title (approved by ethics committee)
Clinical Performance Study Protocol for Use of the VENTANA PD-L1 (SP263) CDx Assay: Evaluation of PD-L1 Expression Levels in Non-small Cell Lung Cancer Specimens from Phase III Study D702GC00001 (ARTEMIDE-Lung04) (BASEC)
Academic title
A Phase III, Randomized, Double-blind, Multicenter, Global Study of Rilvegostomig or Pembrolizumab Monotherapy for the First-line Treatment of Patients With PD-L1-high Metastatic Non-small Cell Lung Cancer (ARTEMIDE-Lung04) (ICTRP)
Public title
A Global Phase III Study of Rilvegostomig or Pembrolizumab Monotherapy for First-Line Treatment of PD-L1-high Metastatic Non-small Cell Lung Cancer (ICTRP)
Disease under investigation
Carcinoma, Non-Small Cell Lung (ICTRP)
Intervention under investigation
Biological: RilvegostomigBiological: Pembrolizumab (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Inclusion Criteria:
- Histologically or cytologically documented NSCLC (non small lung cancer), including
all histological subtypes.
- Stage IV mNSCLC (metastatic non-small cell lung cancer) (based on the American Joint
Committee on Cancer Edition 8) not amenable to curative treatment.
- Absence of sensitizing EGFR (epidermal growth factor) mutations and ALK (anaplastic
lymphoma kinase) and ROS1 (c-ros oncogene 1) rearrangements. Negative assay result
is required for all non-squamous histology subtypes.
- Absence of documented tumor genomic mutation results from tests conducted as part of
standard local practice in any other actionable driver oncogenes for which there are
locally approved targeted 1L (first line) therapies.
- WHO (World Health Organization)/ECOG (Eastern Cooperative Oncology Group)
performance status of 0 or 1, with no deterioration over the previous 2 weeks prior
to baseline at screening and prior to randomization.
- Minimum life expectancy of 12 weeks.
- Provision of acceptable tumor sample for the central testing prior to randomization.
- At least one lesion not previously irradiated that qualifies as a RECIST 1.1
(Response Evaluation Criteria in Solid Tumors, Version 1.1) TL (target lesion) at
baseline and can be accurately measured at baseline as >= 10 mm in the longest
diameter (except lymph nodes, which must have short axis >= 15 mm) with CT (computed
tomography) or MRI (magnetic resonance imaging) and is suitable for accurate
repeated measurements.
- Adequate organ and bone marrow function
Exclusion Criteria:
- As judged by the investigator, any severe or uncontrolled systemic diseases, makes
it undesirable for the participant to participate in the study or that would
jeopardize compliance with the protocol.
- History of organ transplant.
- Active or prior documented autoimmune or inflammatory disorders requiring chronic
treatment with steroids or other immunosuppressive treatment.
- History of another primary malignancy except for malignancy treated with curative
intent with no known active disease >= 2 years before the first dose of study
intervention and of low potential risk for recurrence.
- Presence of small cell and neuroendocrine histology components.
- Brain metastases unless asymptomatic, stable, and not requiring steroids or
anticonvulsants for at least 4 weeks prior to start of study intervention.
- Active primary immunodeficiency/active infectious disease(s)
- Active tuberculosis infection
- Any prior systemic therapy received for advanced or mNSCLC (metastatic non-small
cell lung cancer).
- Any prior exposure to an anti-TIGIT (T-cell immunoglobulin and immunoreceptor
tyrosine-based inhibitory motif domain) therapy or any other anticancer therapy
targeting immune-regulatory receptors or mechanisms.
- Any prior treatment with an anti-PD-1 (programmed cell death protein 1) or
anti-PD-L1 (anti-programmed death-ligand 1) agent. (ICTRP)
not available
Primary and secondary end points
Overall Survival (OS);Progression-Free Survival (PFS) (ICTRP)
Landmark Overall Survival (OS) rates;Landmark Progression-Free Survival (PFS) rates;Objective Response Rate (ORR);Duration of Response (DoR);Time to second progression or death (PFS2);Pharmakokinetics (PK) of rilvegostomig;Immunogenicity of rilvegostomig;Patient-reported physical functioning;Patient-reported global health status (GHS)/quality of life (QoL);Patient-reported lung cancer symptoms of non-small cell lung cancer (NSCLC) (ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
AstraZeneca Clinical Study Information Center, information.center@astrazeneca.com, 1-877-240-9479 (ICTRP)
Secondary trial IDs
2024-517780-24-00, D702GC00001 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/study/NCT06868277 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available