Pembrolizumab: Pembrolizumab will be administered.
Dostarlimab: Dostarlimab will be administered
Belrestotug: Belrestotug will be administered.
Nelistotug: Nelistotug will be administered.
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Primary outcome measure(s)
Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) — Up to 228 weeks
Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation — Up to 228 weeks
Trial sites (99)
Facility
City
Region
Status
GSK Investigational Site
Plantation
Florida
GSK Investigational Site
Albuquerque
New Mexico
GSK Investigational Site
Chattanooga
Tennessee
GSK Investigational Site
Morgantown
West Virginia
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
GSK Investigational Site
Wilrijk
Belgium
GSK Investigational Site
Barretos
Brazil
GSK Investigational Site
Porto Alegre
Brazil
GSK Investigational Site
São Paulo
Brazil
GSK Investigational Site
Vitória
Brazil
GSK Investigational Site
Oulu
Finland
GSK Investigational Site
Tampere
Finland
GSK Investigational Site
Turku
Finland
GSK Investigational Site
Vaasa
Finland
GSK Investigational Site
Bordeaux
France
GSK Investigational Site
Caen
France
GSK Investigational Site
Marseille
France
GSK Investigational Site
Quimper
France
GSK Investigational Site
Strasbourg
France
GSK Investigational Site
Berlin
Germany
GSK Investigational Site
Essen
Germany
GSK Investigational Site
Großhansdorf
Germany
GSK Investigational Site
Heidelberg
Germany
GSK Investigational Site
Jena
Germany
GSK Investigational Site
Athens
Greece
GSK Investigational Site
Haidari - Athens
Greece
GSK Investigational Site
Larissa
Greece
GSK Investigational Site
PapagosAthens
Greece
GSK Investigational Site
Pylaia Thessaloniki
Greece
GSK Investigational Site
Thessaloniki
Greece
GSK Investigational Site
Thessaloniki
Greece
GSK Investigational Site
Budapest
Hungary
GSK Investigational Site
Gyöngyös
Hungary
+ 59 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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