Estudio de fase 3, aleatorizado, abierto, de nivolumab + relatlimab en combinación de dosis fija con quimioterapia versus pembrolizumab con quimioterapia como tratamiento de primera línea en participantes con cáncer de pulmón de células no pequeñas (CPCNP) no escamoso (NSQ), estadio IV o recurrente, con expresión de PD-L1 en células tumorales ≥ 1%

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06561386Tipo: INTERVENTIONALInicio: 7 de oct de 2024Fin estimado: 4 de ago de 2032

Resumen

El propósito de este estudio es comparar la eficacia de nivolumab y relatlimab en combinación con quimioterapia frente a pembrolizumab con quimioterapia en participantes con cáncer de pulmón de células no pequeñas no escamoso, estadio IV o recurrente, con expresión de PD-L1 ≥ 1%.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Participants must have histologically confirmed Stage IV or recurrent Non-small Cell Lung Cancer (NSCLC) of non-squamous (NSQ) histology with no prior systemic anti-cancer therapy given as primary therapy for advanced or metastatic disease.
Participants must have measurable PD-L1 ≥ 1% Tumor Cell (TC) score by the investigational PD-L1 immunohistochemistry (IHC) assay VENTANA PD-L1 (SP263) CDx Assay conducted by central laboratory during the screening period prior to randomization.
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 a life expectancy of at least 3 months at the time of randomization.

Criterios de exclusión

Participants must not be pregnant and/or breastfeeding.
Participants with epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), or ROS-1 mutations that are sensitive to available targeted inhibitor therapy. Participants with unknown EGFR, ALK, or ROS-1 status are excluded.
Participants with known BRAFV600E mutations, that are sensitive to available targeted inhibitor therapy; participants with known activating rearranged during transfection (RET) mutations or neurotrophic tyrosine receptor kinase (NTRK) fusion gene alterations are excluded. Participants with unknown or indeterminate BRAF mutation, activating RET mutations or NTRK fusion gene alterations are eligible.
Participants must not have untreated central nervous system (CNS) metastases.
Participants must not have leptomeningeal metastases (carcinomatous meningitis).
Participants must not have concurrent malignancy requiring treatment.
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 to assist with management.
Participants must not have a history of myocarditis.
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.