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Clinical Trials in the UK / NCT05565378
Active, not recruiting Phase 2

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

NCT05565378 · tracked via the Priya Life Science UK tracker
Sponsor
GlaxoSmithKline
Phase
Phase 2
Started
2022-10-14
Last updated
2026-06-15

Condition(s) studied

Lung Cancer, Non-Small Cell

Investigational drug(s) / intervention(s)

PembrolizumabDostarlimabBelrestotugNelistotug

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)

Trial sites (99)

FacilityCityRegionStatus
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.

Official registry record

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.

View NCT05565378 on ClinicalTrials.gov ↗ ← All trials in the UK