NCT05565378Active, not recruitingPhase 2
A Platform Study of Novel Immunotherapy Combinations in Participants With Previously Untreated, Advanced/Metastatic Non-Small-Cell Lung Cancer
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
Source: ClinicalTrials.gov · Last updated 15 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 351 (actual)
- First submitted
- 30 Sept 2022
- Start date
- 14 Oct 2022
- Primary completion date
- 9 Nov 2026
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Lung cancer
- NCT number
- NCT05565378
- EU CT number
- 2023-505057-40-00
- EudraCT number
- 2021-005115-32
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 351
- From 14 Oct 2022 to the primary completion date, 9 Nov 2026
- 86 sites in 22 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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
- Severe infection within 4 weeks prior to the first dose of study intervention
- 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
Other illness
- 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
- 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
- Positive for tuberculosis, human immunodeficiency virus (HIV) infection, hepatitis B surface antigen, or hepatitis C
- Has a history of allogeneic tissue/stem cell transplant or solid organ transplant
Lab values
- 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.
Other
- Never smoked, defined as smoking \<100 tobacco cigarettes in a lifetime
- 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 \[e.g., pleural, pericardial, peritoneal\])
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (86)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Abu Dhabi | United Arab Emirates | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cipoletti Rio Negro | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ciudad Autonoma de Buenos Aire | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Florida | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Mar del Plata | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | San Juan | Argentina | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Santa Fe | Argentina | Unknown status |
| University Of Antwerp Coordinator of this site? Confirm its status | Edegem | Belgium | Completed |
| GSK Investigational Site Coordinator of this site? Confirm its status | Barretos | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Porto Alegre | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Vitória | Brazil | Unknown status |
| Evangelische Lungenklinik Berlin Krankenhausbetriebs gGmbH Coordinator of this site? Confirm its status | Berlin | Germany | Active, not recruiting |
| Technische Universitaet Dresden Coordinator of this site? Confirm its status | Dresden | Germany | Active, not recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Active, not recruiting |
| LungenClinic Grosshansdorf GmbH Coordinator of this site? Confirm its status | Grosshansdorf | Germany | Active, not recruiting |
| Thoraxklinik Heidelberg gGmbH Coordinator of this site? Confirm its status | Heidelberg | Germany | Active, not recruiting |
| Institut Catala d'Oncologia Coordinator of this site? Confirm its status | Badalona | Spain | Active, not recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Complejo Hospitalario Universitario Insular Materno Infantil Coordinator of this site? Confirm its status | Las Palmas de Gran Canaria | Spain | Active, not recruiting |
| Institut Catala D'oncologia Coordinator of this site? Confirm its status | L'Hospitalet de Llobregat | Spain | Active, not recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Active, not recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Active, not recruiting |
| Fundación Instituto Valenciano de Oncología Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Active, not recruiting |
| Oulu University Hospital Coordinator of this site? Confirm its status | Oulu | Finland | Completed |
| Pirkanmaan hyvinvointialue Coordinator of this site? Confirm its status | Tampere | Finland | Completed |
| Turku University Hospital Coordinator of this site? Confirm its status | Turku | Finland | Completed |
| Vaasa Central Hospital Coordinator of this site? Confirm its status | Vaasa | Finland | Completed |
| Institut Bergonie Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Active, not recruiting |
| Institut Paoli-Calmettes Coordinator of this site? Confirm its status | Marseille | France | Active, not recruiting |
| Centre Hospitalier Intercommunal De Cornouaille Coordinator of this site? Confirm its status | Quimper Cedex | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex | France | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Middlesbrough | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Middlesex | United Kingdom | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Wolverhampton | United Kingdom | Unknown status |
| University General Hospital Attikon Coordinator of this site? Confirm its status | Athens | Greece | Active, not recruiting |
| Geniko Nosokomeio Thessalonikis George Papanikolaou Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| St. Luke's Hospital S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Athens Medical Center S.A. Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Koranyi National Institute For Pulmonology Coordinator of this site? Confirm its status | Budapest XII | Hungary | Completed |
| Farkasgyepui Tudogyogyintezet Coordinator of this site? Confirm its status | Farkasgyepű | Hungary | Completed |
| Matrai Gyogyintezet Coordinator of this site? Confirm its status | Gyöngyös | Hungary | Completed |
| Komarom-Esztergom Varmegyei Szent Borbala Korhaz Coordinator of this site? Confirm its status | Tatabánya | Hungary | Completed |
| Református Pulmonológiai Centrum Coordinator of this site? Confirm its status | Törökbálint | Hungary | Completed |
| Cliniche Gavazzeni S.p.A. Coordinator of this site? Confirm its status | Bergamo | Italy | Active, not recruiting |
| Azienda Unita' Sanitaria Locale Toscana Nord Ovest Coordinator of this site? Confirm its status | Leghorn | Italy | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chiba | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fukuoka | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hyōgo | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kanagawa | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Osaka | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Saitama | Japan | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Incheon | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Suwon Gyeonggi-do | South Korea | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Guadajalara | Mexico | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | San Luis Potosí City | Mexico | Unknown status |
| Frisius MC Coordinator of this site? Confirm its status | Leeuwarden | Netherlands | Completed |
| St Antonius Ziekenhuis Coordinator of this site? Confirm its status | Utrecht | Netherlands | Completed |
| Uniwersytecki Szpital Kliniczny nr 4 w Lublinie Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Szpital Specjalistyczny w Prabutach Sp. z o.o. Coordinator of this site? Confirm its status | Prabuty | Poland | Active, not recruiting |
| Mazowiecki Szpital Wojewodzki Im. Sw. Jana Pawła II W Siedlcach Sp. z o.o. Coordinator of this site? Confirm its status | Siedlce | Poland | Active, not recruiting |
| Dolnośląskie Centrum Onkologii, Pulmonologii i Hematologii Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| Unidade Local De Saude Do Alto Ave E.P.E. Coordinator of this site? Confirm its status | Guimaraes | Portugal | Active, not recruiting |
| Hospital Cuf Descobertas S.A. Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Hospital da Luz, S.A Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Instituto Portugues de Oncologia do Porto Francisco Gentil, E.P.E. Coordinator of this site? Confirm its status | Porto | Portugal | Active, not recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Active, not recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Bangkok | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chiang Mai | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Kho Hong Hat Yai | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Khon Kaen | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Pathum Thani | Thailand | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Albuquerque | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Chattanooga | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Cape Town | South Africa | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Parktown | South Africa | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Ankara | Turkey (Türkiye) | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Antalya | Turkey (Türkiye) | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Istanbul | Turkey (Türkiye) | Unknown status |
| GSK Investigational Site Coordinator of this site? Confirm its status | Samsun | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.