Clinical Research Directory

Browse clinical research sites, groups, and studies.

Sites Groups Studies

Back to Studies

ACTIVE NOT RECRUITING

NCT05565378

PHASE2

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

351

Start Date

2022-10-14

Completion Date

2027-02-26

Last Updated

2026-01-08

Healthy Volunteers

Conditions

Lung Cancer, Non-Small Cell

Interventions

DRUG

Pembrolizumab

Pembrolizumab will be administered.

DRUG

Dostarlimab

Dostarlimab will be administered

DRUG

Belrestotug

Belrestotug will be administered.

DRUG

Nelistotug

Nelistotug will be administered.

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

Locations (99)

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

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

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

Clinical Research Directory

A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (99)