A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy with Pembrolizumab Plus Chemotherapy in Patients with Non-Squamous, Non-Small Cell Lung Cancer Stage IV/Recurrence with PD-L1 Expression ≥ 1 %
Descrizione riassuntiva dello studio
The aim of this study is to compare the efficacy of Nivolumab and Relatlimab in combination with chemotherapy with Pembrolizumab in combination with chemotherapy in participants with non-squamous, non-small cell lung cancer in stage IV or recurrence with a PD-L1 expression of ≥ 1%.
(BASEC)
Intervento studiato
Experimental Arm A:
Drug Nivolumab
Fixed dose on specified days
Drug Relatlimab
Fixed dose on specified days
Drug Carboplatin
Fixed dose on specified days
Drug Pemetrexed
Fixed dose on specified days
Drug Cisplatin
Fixed dose on specified days
Active Comparator: Arm B
Drug Pembrolizumab
Fixed dose on specified days
Drug: Carboplatin
Fixed dose on specified days
Drug Pemetrexed
Fixed dose on specified days
Drug Cisplatin
Fixed dose on specified days
(BASEC)
Malattie studiate
Non-Small Cell Lung Cancer
(BASEC)
- Participants must have a histologically confirmed non-small cell lung cancer (NSCLC) in stage IV or recurrence with non-squamous histology, for which no prior systemic cancer therapy has been administered as primary treatment for advanced or metastatic disease. - Participants must have measurable disease as assessed by computed tomography (CT) or magnetic resonance imaging (MRI) according to RECIST v1.1 criteria. - Participants must have an ECOG performance status (Eastern Cooperative Oncology Group) of ≤ 1 at screening, which must be confirmed prior to randomization. - Participants must have a life expectancy of at least 3 months at the time of randomization. - Participants must have a measurable PD-L1 value of ≥ 1% tumor cells (TC) in the tested immunohistochemistry test VENTANA PD-L1 (SP263) CDx Assay for the detection of PD-L1 expression. This test is performed by a central laboratory during the screening prior to randomization. (BASEC)
Criteri di esclusione
- Participants must not have untreated metastases in the central nervous system (CNS). - Participants must not have a concurrent malignancy requiring treatment. - Participants must not have an active autoimmune disease. - Participants must not have a history of interstitial lung disease or pneumonitis that requires oral or intravenous (IV) glucocorticoid treatment to support therapy. - Participants must not have a history of myocarditis. - Participants must not have received prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody or any other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. - Additional inclusion and exclusion criteria defined in the study protocol apply. - Female participants must not be pregnant or breastfeeding. - Participants must not have leptomeningeal metastases (carcinomatous meningitis). (BASEC)
Luogo dello studio
Basilea, Bellinzona, Losanna, Altro
(BASEC)
Münsterlingen
(BASEC)
Sponsor
Bristol-Myers Squibb SA, Steinhausen
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Andreas Schmitt
+41612655074
andreasmichael.schmitt@clutterusb.chUniversitätsspital 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 Versus Pembrolizumab with Chemotherapy as First-line Treatment 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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Tipo di studio
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Criteri di inclusione/esclusione
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Endpoint primari e secondari
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Inclusione del primo partecipante
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Contatti aggiuntivi
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Risultati-Dati individuali dei partecipanti
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Ulteriori informazioni sullo studio
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Risultati dello studio
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Link ai risultati nel registro primario
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