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)
Résumé de l'étude
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 étudiée
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)
Maladie en cours d'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)
Critères d'exclusion
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)
Lieu de l’étude
Bâle, Bellinzona, Lausanne, Autre
(BASEC)
Basel, Bellizona, Lausanne, Munsterlingen
(BASEC)
Sponsor
Carmen Lilla, Bristol-Myers Squibb SA
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Dr Andreas Schmidt
+41612655074
andreasmichael.schmitt@clutterusb.chUniversity Hospital Basel
(BASEC)
Informations scientifiques
non disponible
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
02.07.2025
(BASEC)
Identifiant de l'essai ICTRP
non disponible
Titre officiel (approuvé par le comité d'éthique)
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)
Titre académique
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Titre public
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Maladie en cours d'investigation
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Intervention étudiée
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Type d'essai
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Plan de l'étude
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Critères d'inclusion/exclusion
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Critères d'évaluation principaux et secondaires
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Date d'enregistrement
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Inclusion du premier participant
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Sponsors secondaires
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Contacts supplémentaires
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ID secondaires
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Résultats-Données individuelles des participants
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Informations complémentaires sur l'essai
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Résultats de l'essai
Résumé des résultats
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Lien vers les résultats dans le registre primaire
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