Resumen

This study will monitor the safety of novel immunotherapy combinations in participants with Programmed death ligand-1 (PD L-1) high (Tumor cells \[TC\]/ Tumor proportion score \[TPS\] \>= 50%), previously untreated, unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC). Drug name mentioned as Belrestotug, GSK4428859A, and EOS884448 are all interchangeable for the same compound. In the rest of the document, the drug will be referred to as 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

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

A Phase 2, Randomized, Open-label, Platform Study Utilizing a Master Protocol to Evaluate Novel Immunotherapy Combinations in Participants With Previously Untreated, Locally Advanced/Metastatic, Programmed Death Ligand 1-Selected Non-Small-Cell Lung Cancer

Resumen

Elegibilidad

Criterios de inclusión

Criterios de exclusión

Intervenciones

Pembrolizumab

Dostarlimab

Belrestotug

Nelistotug

Ubicaciones

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

GSK Investigational Site

Patrocinadores