Estudio de fase 3, aleatorizado, multicéntrico y doble ciego para investigar la seguridad y la eficacia de belrestotug en combinación con dostarlimab comparado con placebo en combinación con pembrolizumab en participantes con cáncer de pulmón de células no pequeñas PD-L1 seleccionado, localmente avanzado irresecable o metastásico, sin tratamiento previo (GALAXIES Lung-301)

Activo, no reclutaFase 3ClinicalTrials.gov

ID: NCT06472076Tipo: INTERVENTIONALInicio: 10 de jun de 2024Fin estimado: 2 de feb de 2027

Resumen

El objetivo de este ensayo clínico es evaluar el perfil de seguridad y tolerabilidad de dostarlimab en combinación con belrestotug en comparación con pembrolizumab y placebo en participantes con CPNCP PD-L1 alto, localmente avanzado irresecable o metastásico, sin tratamiento sistémico previo.

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

Has a 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
Has not received prior systemic therapy for their locally advanced or metastatic NSCLC.
Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC.
Has a PD-L1-high (Tumor cells \[TC\] ≥50%) tumor
Has measurable disease (at least 1 target lesion) based on RECIST 1.1
Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0 or 1.
Has adequate organ function

Criterios de exclusión

Has NSCLC with a tumor that harbors any of the following molecular alterations:
Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy
Anaplastic lymphoma kinase (ALK) translocations 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.
Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of \>30 gray (Gy) within 6 months
Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways.
Has 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, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome.
Has symptomatic, untreated, or actively progressin g brain metastases or leptomeningeal disease
Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years.
Has received any live vaccine within 30 days prior to first dose of study intervention.
Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis.
Has symptomatic ascites, pleural effusion, or pericardial effusion.
Has active inflammatory bowel disease
Has a history of significant acute or chronic cardiac diagnosis requiring intervention/treatment in the last 6 months.
Has severe infection or complication thereof 4 weeks prior to randomisation including active tuberculosis.
Has a history of allogeneic tissue/stem cell transplant or solid organ transplant.

Intervenciones

biological

Dostarlimab

Dostarlimab will be administered.

biological

Belrestotug

Belrestotug will be administered.

biological

Pembrolizumab

Pembrolizumab will be administered.

drug

Placebo

Placebo 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 Bueno, Argentina

GSK Investigational Site

Córdoba, Argentina

GSK Investigational Site

Florida, Argentina

GSK Investigational Site

Mendoza, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

San Miguel de Tucumán, 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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