Un estudio de plataforma de fase 2, aleatorizado, abierto, que utiliza un protocolo maestro para evaluar combinaciones novedosas de inmunoterapia en participantes con cáncer de pulmón de células no pequeñas localmente avanzado/metastásico, no tratado previamente, seleccionado por el ligando de muerte programada 1

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT05565378Tipo: INTERVENTIONALInicio: 14 de oct de 2022Fin estimado: 26 de feb de 2027

Resumen

Este estudio monitoreará la seguridad de combinaciones novedosas de inmunoterapia en participantes con cáncer de pulmón de células no pequeñas (CPNCP) con expresión alta de PD-L1 (células tumorales [TC]/puntuación de proporción tumoral [TPS] >= 50%), no tratado previamente, irresecable, localmente avanzado o metastásico. Los nombres Belrestotug, GSK4428859A y EOS884448 son intercambiables y designan el mismo compuesto. En el resto del documento, el fármaco se denominará Belrestotug.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Histologically or cytologically confirmed diagnosis of locally advanced unresectable NSCLC not eligible for curative surgery and/or definitive radiotherapy with or without chemotherapy or metastatic NSCLC (squamous or non squamous)
No prior systemic therapy for their locally advanced or metastatic NSCLC
Provides a fresh tumor tissue sample or archival sample collected within 2 years prior to screening
PD-L1-high (TC/TPS \>= 50%) tumor
Measurable disease based on RECIST 1.1, as determined by the investigator
Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
Adequate Baseline organ function
Female participants of childbearing potential must use adequate contraception

Criterios de exclusión

Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFR and /or ALK translocations mutations that are sensitive to available targeted inhibitor therapy, Any other known genomic aberrations or oncogenic driver mutations for which a locally approved targeted therapy is available for first-line treatment of locally advanced or metastatic NSCLC.
Had major surgery within 4 weeks or lung radiation of \>30 Gy therapy within 6 months prior to the first dose of study intervention
Received prior therapy with any immune checkpoint inhibitors
Never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime
Has an invasive malignancy or history of invasive malignancy other than the disease under study within the last 5 years (clinical exceptions apply as per protocol)
Symptomatic, untreated, or actively progressing, brain metastases or any leptomeningeal disease (regardless of symptomatology, treatment status, or stability)
Autoimmune disease or syndrome that required systemic treatment within the past 2 years
Receiving systemic steroid therapy \<= 3 days prior to first dose of study intervention or any form of immunosuppressive medication
Received any live vaccine \<= 30 days prior to first dose of study intervention
Any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis
History or evidence of cardiac abnormalities
Current unstable liver or biliary disease
Severe infection within 4 weeks prior to the first dose of study intervention
Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or hepatitis C
Has advanced, symptomatic, or visceral spread and is considered to be at imminent risk of life-threatening complications (including, but not limited to, massive uncontrolled effusions \[e.g., pleural, pericardial, peritoneal\])
Is currently participating in or has participated in a study of an investigational therapy within 4 weeks prior to the first dose of study intervention
Has a history of allogeneic tissue/stem cell transplant or solid organ transplant

Intervenciones

drug

Pembrolizumab

Pembrolizumab will be administered.

drug

Dostarlimab

Dostarlimab will be administered

drug

Belrestotug

Belrestotug will be administered.

drug

Nelistotug

Nelistotug will be administered.

Ubicaciones

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Cipoletti Rio Negro, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Florida, Argentina

GSK Investigational Site

Mar del Plata, Argentina

GSK Investigational Site

San Juan, Argentina

GSK Investigational Site

Santa Fe, Argentina

Patrocinadores

PrincipalGlaxoSmithKline

ColaboradoriTeos Therapeutics

Aviso: La información de este ensayo proviene de fuentes públicas y tiene carácter exclusivamente informativo. No constituye asesoramiento médico, regulatorio ni de ningún otro tipo. Las traducciones son automatizadas y no poseen validez oficial. Consultá siempre con un profesional de la salud. Ver Términos de Uso.

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