Assessment of the Proportion of Cells with the Biomarker PD-L1 in Samples from Non-Small Cell Lung Cancer from the Phase III Study CA224-1093 (Relativity 1093)
Summary description of the study
The PD-L1 expression level is determined using the Ventana PD-L1 (SP263) CDx companion diagnostic to identify patients eligible for the Relativity 1093 drug study. This study will evaluate how well the experimental diagnostic can detect a specific level of the PD-L1 biomarker in individuals with lung cancer to treat them with the study medication of the Relativity 1093 drug study (Nivolumab + Relatlimab + platinum-based chemotherapy). For this purpose, tumor tissue samples will be sent to a central laboratory. If patients have already undergone a tumor biopsy within the last 10 months prior to study enrollment, the study physician will request these samples from the facility where the biopsy was performed. If no tumor tissue sample is available, a tumor biopsy must be performed to participate in this study. Participants with a positive result for PD-L1 expression may be included in the Relativity 1093 drug study. The outcome of this drug study will be used to determine how well the diagnostic can identify individuals who may benefit from the Relativity 1093 study medication.
(BASEC)
Intervention under investigation
Tumor samples will be sent to a laboratory for analysis. If patients have already undergone a tumor biopsy within the last 10 months prior to study enrollment, the study physician will request these samples from the facility where the biopsy was performed. If no tumor tissue sample is available, a tumor biopsy must be performed to participate in this study.
(BASEC)
Disease under investigation
Non-Small Cell Lung Cancer
(BASEC)
Patients with lung cancer who can provide a sufficient amount of tumor tissue for analysis and evaluation. (BASEC)
Exclusion criteria
Tumor tissue samples that are older than 12 months, or tumor tissue samples that have not been properly fixed or collected, or that contain decalcified bone material. (BASEC)
Trial sites
Basel, Bellinzona, Lausanne, Other
(BASEC)
Basel, Bellizona, Lausanne, Munsterlingen
(BASEC)
Sponsor
Carmen Lilla, Bristol-Myers Squibb SA
(BASEC)
Contact
Contact Person Switzerland
Dr Andreas Schmidt
+41612655074
andreasmichael.schmitt@clutterusb.chUniversity Hospital Basel
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
02.07.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
A Phase 3, Randomized, Open-label Study of Nivolumab + Relatlimab Fixed-dose Combination with Chemotherapy Ver-sus Pembrolizumab with Chemotherapy as First-line Treat-ment for Participants with Non-squamous (NSQ), Stage IV or Recurrent Non-small Cell Lung Cancer and with Tumor Cell PD-L1 Expression ≥ 1% (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
not available
Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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