A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
NCT ID: NCT05565378
Last Updated: 2026-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE2
351 participants
INTERVENTIONAL
2022-10-14
2027-02-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab Monotherapy
Participants will be administered with pembrolizumab as monotherapy in a fixed dose.
Pembrolizumab
Pembrolizumab will be administered.
Dostarlimab Monotherapy
Participants will be administered with dostarlimab as monotherapy in a fixed dose.
Dostarlimab
Dostarlimab will be administered
Substudy 1A
Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A).
Dostarlimab
Dostarlimab will be administered
Belrestotug
Belrestotug will be administered.
Substudy 1B
Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B).
Dostarlimab
Dostarlimab will be administered
Belrestotug
Belrestotug will be administered.
Substudy 1C
Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C).
Dostarlimab
Dostarlimab will be administered
Belrestotug
Belrestotug will be administered.
Substudy 2A
Participants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug
Dostarlimab
Dostarlimab will be administered
Belrestotug
Belrestotug will be administered.
Nelistotug
Nelistotug will be administered.
Interventions
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Pembrolizumab
Pembrolizumab will be administered.
Dostarlimab
Dostarlimab will be administered
Belrestotug
Belrestotug will be administered.
Nelistotug
Nelistotug will be administered.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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iTeos Therapeutics
INDUSTRY
GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Plantation, Florida, United States
GSK Investigational Site
Albuquerque, New Mexico, United States
GSK Investigational Site
Chattanooga, Tennessee, United States
GSK Investigational Site
Morgantown, West Virginia, United States
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
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Marseille, , France
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Quimper, , France
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Strasbourg, , France
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Essen, , Germany
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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
GSK Investigational Site
Tatabánya, , Hungary
GSK Investigational Site
Avellino, , Italy
GSK Investigational Site
Bergamo, , Italy
GSK Investigational Site
Genova, , Italy
GSK Investigational Site
Pisa, , Italy
GSK Investigational Site
Verona, , Italy
GSK Investigational Site
Chiba, , Japan
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Hyōgo, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Saitama, , Japan
GSK Investigational Site
Guadalajara, , Mexico
GSK Investigational Site
San Luis Potosí City, , Mexico
GSK Investigational Site
Enschede, , Netherlands
GSK Investigational Site
Groningen, , Netherlands
GSK Investigational Site
Leeuwarden, , Netherlands
GSK Investigational Site
Utrecht, , Netherlands
GSK Investigational Site
Lublin, , Poland
GSK Investigational Site
Prabuty, , Poland
GSK Investigational Site
Siedlce, , Poland
GSK Investigational Site
Gaia, , Portugal
GSK Investigational Site
Guimarães, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Lisbon, , Portugal
GSK Investigational Site
Porto, , Portugal
GSK Investigational Site
Cape Town, , South Africa
GSK Investigational Site
Parktown, , South Africa
GSK Investigational Site
Incheon, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Suwon Gyeonggi-do, , South Korea
GSK Investigational Site
Badajoz, , Spain
GSK Investigational Site
Badalona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Las Palmas de Gran Canar, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Málaga, , Spain
GSK Investigational Site
PamplonaNavarra, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Valencia, , Spain
GSK Investigational Site
Bangkok, , Thailand
GSK Investigational Site
Chiang Mai, , Thailand
GSK Investigational Site
Kho Hong Hat Yai, , Thailand
GSK Investigational Site
Khon Kaen, , Thailand
GSK Investigational Site
Pathum Thani, , Thailand
GSK Investigational Site
Samsun, Atakum, Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Antalya, , Turkey (Türkiye)
GSK Investigational Site
Istanbul, , Turkey (Türkiye)
GSK Investigational Site
Abu Dhabi, , United Arab Emirates
GSK Investigational Site
Abu Dhabi, , United Arab Emirates
GSK Investigational Site
Middlesbrough, , United Kingdom
GSK Investigational Site
Middlesex, , United Kingdom
GSK Investigational Site
Wolverhampton, , United Kingdom
Countries
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Other Identifiers
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2021-005115-32
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GALAXIES LUNG-201
Identifier Type: OTHER
Identifier Source: secondary_id
213824
Identifier Type: -
Identifier Source: org_study_id
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