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

Last updated: November 8, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

2

Condition

N/A

Treatment

Dostarlimab

Belrestotug

GSK6097608

Clinical Study ID

NCT05565378
213824
2021-005115-32
GALAXIES LUNG-201
  • Ages > 18
  • All Genders

Study Summary

This study will evaluate the efficacy, safety, pharmacokinetics (PK), and pharmacodynamics (PDy) of novel immunotherapy combinations compared with immunotherapy monotherapy 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically or cytologically confirmed diagnosis of locally advanced unresectableNSCLC not eligible for curative surgery and/or definitive radiotherapy with orwithout 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 yearsprior 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

Exclusion Criteria:

  • Presence of Epidermal growth factor receptor (EGFR) mutations, Anaplastic lymphomakinase (ALK) translocations, or other known genomic aberrations or oncogenic drivermutations for which a locally approved targeted therapy is available.

  • Has NSCLC with a tumor that harbors any of the following molecular alterations: EGFRand /or ALK translocations mutations that are sensitive to available targetedinhibitor therapy, Any other known genomic aberrations or oncogenic driver mutationsfor which a locally approved targeted therapy is available for first-line treatmentof locally advanced or metastatic NSCLC.

  • Had major surgery within 4 weeks or lung radiation of >30 Gy therapy within 6 monthsprior 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 diseaseunder study within the last 5 years (clinical exceptions apply as per protocol)

  • Symptomatic, untreated, or actively progressing, brain metastases or anyleptomeningeal disease (regardless of symptomatology, treatment status, orstability)

  • Autoimmune disease or syndrome that required systemic treatment within the past 2years

  • Receiving systemic steroid therapy <= 3 days prior to first dose of studyintervention 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 inducedpneumonitis, 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 Bsurface antigen, or hepatitis C

  • Has advanced, symptomatic, or visceral spread and is considered to be at imminentrisk of life-threatening complications (including, but not limited to, massiveuncontrolled effusions [e.g., pleural, pericardial, peritoneal])

  • Is currently participating in or has participated in a study of an investigationaltherapy within 4 weeks prior to the first dose of study intervention

  • Has a history of allogeneic tissue/stem cell transplant or solid organ transplant

Study Design

Total Participants: 340
Treatment Group(s): 6
Primary Treatment: Dostarlimab
Phase: 2
Study Start date:
October 14, 2022
Estimated Completion Date:
October 02, 2028

Connect with a study center

  • GSK Investigational Site

    Ciudad Autonoma Buenos Aires, Buenos Aires C1430EGF
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aires, Buenos Aires 1425
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autónoma de Buenos Aires, Buenos Aires C1426ABP
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cipoletti, Rio Negro, Río Negro R8324CVE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1426AGE
    Argentina

    Site Not Available

  • GSK Investigational Site

    Cipoletti Rio Negro, R8324CVE
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad AutOnoma de Buenos Aire, C1426ABP
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, 1414
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Florida, 1602
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mar del Plata, 7600
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    San Juan, J5402DIL
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Santa Fe, 3000
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Edegem, 2650
    Belgium

    Site Not Available

  • GSK Investigational Site

    Wilrijk, 2650
    Belgium

    Active - Recruiting

  • GSK Investigational Site

    Vitória, Espírito Santo 29043-260
    Brazil

    Site Not Available

  • GSK Investigational Site

    Bela Vista, São Paulo 01323-001
    Brazil

    Site Not Available

  • GSK Investigational Site

    Barretos, 14784-400
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Porto Alegre, 90610-000
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Sao Paulo, 01246-000
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    São Paulo, 01246-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    VitOria, 29043-260
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Oulu, 90029
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Tampere, 33520
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Turku, 20520
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Vaasa, 65130
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Bordeaux, 33076
    France

    Active - Recruiting

  • GSK Investigational Site

    Bordeaux Cedex, 33076
    France

    Site Not Available

  • GSK Investigational Site

    Caen Cedex 9, 14033
    France

    Active - Recruiting

  • GSK Investigational Site

    Marseille, 13009
    France

    Active - Recruiting

  • GSK Investigational Site

    Montpellier Cedex, 34298
    France

    Site Not Available

  • GSK Investigational Site

    Quimper cedex, 29107
    France

    Active - Recruiting

  • GSK Investigational Site

    Strasbourg, 67091
    France

    Active - Recruiting

  • GSK Investigational Site

    Strasbourg Cedex, 67091
    France

    Site Not Available

  • GSK Investigational Site

    Dresden, Sachsen 01307
    Germany

    Site Not Available

  • GSK Investigational Site

    Berlin, 13125
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Essen, 45147
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Grosshansdorf, 22927
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Heidelberg, 69126
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Jena, 07747
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Athens, 11528
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Haidari - Athens, 12462
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Larisa, 41110
    Greece

    Site Not Available

  • GSK Investigational Site

    Larissa, 41110
    Greece

    Active - Recruiting

  • GSK Investigational Site

    PapagosAthens, 115 27
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Pylaia Thessaloniki, 57001
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Thessaloniki, 54645
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Budapest, H-1121
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    Farkasgyepű, 8552
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    GyOngyOs, 3200
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    Gyöngyös, 3200
    Hungary

    Site Not Available

  • GSK Investigational Site

    TOrOkbAlint, 2045
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    TatabAnya, 2800
    Hungary

    Active - Recruiting

  • GSK Investigational Site

    Tatabánya, 2800
    Hungary

    Site Not Available

  • GSK Investigational Site

    Törökbálint, 2045
    Hungary

    Site Not Available

  • GSK Investigational Site

    Roma, Lazio 00144
    Italy

    Site Not Available

  • GSK Investigational Site

    Livorno, Toscana 57124
    Italy

    Site Not Available

  • GSK Investigational Site

    Legnago (VR), Veneto 37045
    Italy

    Site Not Available

  • GSK Investigational Site

    Avellino, 83100
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Bergamo, 24125
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Campania, 83100
    Italy

    Site Not Available

  • GSK Investigational Site

    Firenze, 50134
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Genova, 16132
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Pisa, 57124
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Verona, 37045
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Chiba, 277-8577
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Hyogo, 673-8558
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kanagawa, 241-8515
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Osaka, 589-8511
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Saitama, 350-1298
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Incheon, 21565
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 03080
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442-723
    Korea, Republic of

    Active - Recruiting

  • GSK Investigational Site

    Suwon, Gyeonggi-do, 442-723
    Korea, Republic of

    Site Not Available

  • GSK Investigational Site

    Toluca de Lerdo, Estado De México 50120
    Mexico

    Site Not Available

  • GSK Investigational Site

    Estado de Mexico, 50120
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    Guadalajara, 44280
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    San Luis PotosI, 78209
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    San Luis Potosí, 78209
    Mexico

    Site Not Available

  • GSK Investigational Site

    Enschede, 7512 KZ
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Groningen, 9728 NZ
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Leeuwarden, 8934 AD
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Utrecht, 3543 AZ
    Netherlands

    Active - Recruiting

  • GSK Investigational Site

    Lublin, 20-954
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Olsztyn, 10-288
    Poland

    Site Not Available

  • GSK Investigational Site

    Prabuty, 82-550
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Siedlce, 08-110
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Wroclaw, 53-439
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Gaia, 4434-502
    Portugal

    Active - Recruiting

  • GSK Investigational Site

    GuimarAes, 4835-044
    Portugal

    Active - Recruiting

  • GSK Investigational Site

    Guimarães, 4835-044
    Portugal

    Site Not Available

  • GSK Investigational Site

    Lisboa, 1500-650
    Portugal

    Active - Recruiting

  • GSK Investigational Site

    Porto, 4200-072
    Portugal

    Active - Recruiting

  • GSK Investigational Site

    Vila Nova de Gaia, 4434-502
    Portugal

    Site Not Available

  • GSK Investigational Site

    Kraaifontein, Western Province 7570
    South Africa

    Site Not Available

  • GSK Investigational Site

    Cape Town, 7570
    South Africa

    Active - Recruiting

  • GSK Investigational Site

    Parktown, 2193
    South Africa

    Active - Recruiting

  • GSK Investigational Site

    Pretoria, 0001
    South Africa

    Site Not Available

  • GSK Investigational Site

    Badajoz, 06080
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Badalona, 08916
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Barcelona, 08907
    Spain

    Active - Recruiting

  • GSK Investigational Site

    L'Hospitalet de Llobregat, 08907
    Spain

    Site Not Available

  • GSK Investigational Site

    Las Palmas De Gran Canar, 35016
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Las Palmas De Gran Canaria, 35016
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28046
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Malaga, 29010
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Málaga, 29010
    Spain

    Site Not Available

  • GSK Investigational Site

    PamplonaNavarra, 28027
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Pozuelo De AlarcOn Madr, 28223
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Pozuelo De Alarcón. Madrid., 28223
    Spain

    Site Not Available

  • GSK Investigational Site

    Valencia, 46026
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Bangkok, 10210
    Thailand

    Active - Recruiting

  • GSK Investigational Site

    Chiangmai, 50200
    Thailand

    Active - Recruiting

  • GSK Investigational Site

    Khlong Luang, 12120
    Thailand

    Site Not Available

  • GSK Investigational Site

    Kho Hong Hat Yai, 90110
    Thailand

    Active - Recruiting

  • GSK Investigational Site

    Khon Kaen, 40002
    Thailand

    Active - Recruiting

  • GSK Investigational Site

    Pathumthani, 12120
    Thailand

    Active - Recruiting

  • GSK Investigational Site

    Songkla, 90110
    Thailand

    Site Not Available

  • GSK Investigational Site

    Samsun, Atakum 55200
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    Ankara, 06680
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    Antalya, 07070
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    Edirne, 22020
    Turkey

    Site Not Available

  • GSK Investigational Site

    Istanbul, 34214
    Turkey

    Active - Recruiting

  • GSK Investigational Site

    Abu Dhabi, 51900
    United Arab Emirates

    Active - Recruiting

  • GSK Investigational Site

    Abu-Dhabi, 51900
    United Arab Emirates

    Site Not Available

  • GSK Investigational Site

    Al-Ain,
    United Arab Emirates

    Site Not Available

  • GSK Investigational Site

    Dubai,
    United Arab Emirates

    Active - Recruiting

  • GSK Investigational Site

    Northwood, Middlesex HA6 2RN
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Middlesbrough, TS4 3BW
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Middlesex, HA6 2RN
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Wolverhampton, WV10 0QP
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Los Angeles, California 90017
    United States

    Site Not Available

  • GSK Investigational Site

    Plantation, Florida 33322
    United States

    Active - Recruiting

  • GSK Investigational Site

    Baltimore, Maryland 21215
    United States

    Active - Recruiting

  • GSK Investigational Site

    Boston, Massachusetts 02118-2905
    United States

    Active - Recruiting

  • GSK Investigational Site

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • GSK Investigational Site

    Albuquerque, New Mexico 87131
    United States

    Active - Recruiting

  • GSK Investigational Site

    Bryn Mawr, Pennsylvania 19010
    United States

    Site Not Available

  • GSK Investigational Site

    Media, Pennsylvania 19063
    United States

    Site Not Available

  • GSK Investigational Site

    Paoli, Pennsylvania 19301
    United States

    Active - Recruiting

  • GSK Investigational Site

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • GSK Investigational Site

    Wynnewood, Pennsylvania 19096
    United States

    Active - Recruiting

  • GSK Investigational Site

    Chattanooga, Tennessee 37404
    United States

    Active - Recruiting

  • GSK Investigational Site

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • GSK Investigational Site

    Morgantown, West Virginia 26506
    United States

    Active - Recruiting

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