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Recruiting

A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 1-49% - CA224-1093

Actualizado: 29 octubre, 2024   |   ClinicalTrials.gov

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Detalles del ensayo

  • Phase 3

    Fase

  • Sexo(s)

  • 18+

    Intervalo de edad

  • 100

    Lugar(es)

  • Recruiting

Opciones de tratamiento

Ramas de tratamiento del estudio
INTERVENCIÓN ASIGNADA
Experimental: Arm A
Drug: Nivolumab, Relatlimab, Carboplatin, Pemetrexed, Cisplatin
Active Comparator: Arm B
Drug: Pembrolizumab, Carboplatin, Pemetrexed, Cisplatin

Principales criterios de selección

Inclusion Criteria - Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with tumor cell PD-L1 expression 1% to 49% as determined by a central laboratory - Participants must have measurable disease by computed tomography (CT) or magnetic resonance imaging (MRI) per RECIST v1.1 criteria. - Participants must have an Easter Cooperative Oncology Group (ECOG) performance status of ≤ 1 at screening. - Participants must have no prior systemic anti-cancer treatment given as primary therapy for advanced or metastatic disease. Exclusion Criteria - Participants must not have epidermal growth factor receptor (EGFR) mutations, anaplastic lymphoma kinase (ALK) translocations, ROS-1 translocations and known BRAFV600E, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations and neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations. - Participants must not have untreated central nervous system (CNS) metastases. - Participants must not have concurrent malignancy requiring treatment or history of prior malignancy active within 2 years prior to randomization. - Participants must not have an active autoimmune disease. - Participants must not have history of interstitial lung disease or pneumonitis that required oral or intravenous (IV) glucocorticoids. - Participants must not have a history of myocarditis, regardless of etiology. - Participants must not have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, or anti-CTLA-4 antibody, or other antibody or drug targeting T-cell co-stimulation or checkpoint pathways. - Other protocol-defined Inclusion/Exclusion criteria apply.

Recomendamos encarecidamente que se comunique con BMS para informar de los efectos secundarios (eventos adversos)
Los efectos secundarios (eventos adversos) y otros eventos reportables se definen aquí
Informe de efectos secundarios (eventos adversos) o quejas sobre la calidad del producto: información médica

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Llame 900-150-160 o Escríbanos