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)
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
Non-Small Cell Lung Cancer
(BASEC)
Patients with lung cancer who can provide a sufficient amount of tumor tissue for analysis and evaluation. (BASEC)
Criteri di esclusione
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)
Luogo dello studio
Basilea, Bellinzona, Losanna, Altro
(BASEC)
Basel, Bellizona, Lausanne, Munsterlingen
(BASEC)
Sponsor
Carmen Lilla, Bristol-Myers Squibb SA
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr Andreas Schmidt
+41612655074
andreasmichael.schmitt@clutterusb.chUniversity Hospital Basel
(BASEC)
Informazioni scientifiche
non disponibile
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
02.07.2025
(BASEC)
ID di studio ICTRP
non disponibile
Titolo ufficiale (approvato dal comitato etico)
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)
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