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

NCT05565378 | Active Not Recruiting Phase 2 FDA Drug

• 3 other identifiers: 2138242021-005115-32GALAXIES LUNG-201
• Study Type: interventional
• Target: 351
• Locations: 22 countries
• Sites: 99

Brief 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.

Conditions

Lung Cancer, Non-Small Cell

Keywords

Belrestotug; Dostarlimab; EOS884448; GSK6097608; GSK4428859A; Nelistotug; Non-small-cell lung cancer; Pembrolizumab; Programmed death ligand 1; Programmed death protein 1 Inhibitor; Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Number of Participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

  Up to 228 weeks

• Number of Participants with TEAEs or SAEs leading to dose modifications or treatment discontinuation

  Up to 228 weeks

Study Arms (6)

Pembrolizumab Monotherapy

ACTIVE COMPARATOR

Participants will be administered with pembrolizumab as monotherapy in a fixed dose.

Drug: Pembrolizumab

Dostarlimab Monotherapy

EXPERIMENTAL

Participants will be administered with dostarlimab as monotherapy in a fixed dose.

Drug: Dostarlimab

Substudy 1A

EXPERIMENTAL

Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose A).

Drug: Dostarlimab; Drug: Belrestotug

Substudy 1B

EXPERIMENTAL

Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose B).

Drug: Dostarlimab; Drug: Belrestotug

Substudy 1C

EXPERIMENTAL

Participants will be administered with dostarlimab in a fixed dose followed by belrestotug in a fixed dose (Dose C).

Drug: Dostarlimab; Drug: Belrestotug

Substudy 2A

EXPERIMENTAL

Participants will be administered with dostarlimab, fixed dose belrestotug, and fixed dose nelistotug

Drug: Dostarlimab; Drug: Belrestotug; Drug: Nelistotug

Interventions

Pembrolizumab DRUG

Pembrolizumab will be administered.

Pembrolizumab Monotherapy

Dostarlimab DRUG

Dostarlimab will be administered

Also known as: GSK4057190

Dostarlimab Monotherapy; Substudy 1A; Substudy 1B; Substudy 1C; Substudy 2A

Belrestotug DRUG

Belrestotug will be administered.

Also known as: EOS884448, GSK4428859A

Substudy 1A; Substudy 1B; Substudy 1C; Substudy 2A

Nelistotug DRUG

Nelistotug will be administered.

Also known as: GSK6097608

Substudy 2A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 \[e.g., pleural, pericardial, peritoneal\])

Sponsors & Collaborators

• GlaxoSmithKline: lead
• iTeos Therapeutics: collaborator

Study Sites (99)

GSK Investigational Site

Plantation, Florida, 33322, United States

Location

GSK Investigational Site

Albuquerque, New Mexico, 87131, United States

Location

GSK Investigational Site

Chattanooga, Tennessee, 37404, United States

Location

GSK Investigational Site

Morgantown, West Virginia, 26506, United States

Location

GSK Investigational Site

Buenos Aires, C1426ABP, Argentina

Location

GSK Investigational Site

Cipoletti Rio Negro, R8324CVE, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, 1414, Argentina

Location

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1426AGE, Argentina

Location

GSK Investigational Site

Florida, 1602, Argentina

Location

GSK Investigational Site

Mar del Plata, 7600, Argentina

Location

GSK Investigational Site

San Juan, J5402DIL, Argentina

Location

GSK Investigational Site

Santa Fe, 3000, Argentina

Location

GSK Investigational Site

Wilrijk, 2650, Belgium

Location

GSK Investigational Site

Barretos, 14784-400, Brazil

Location

GSK Investigational Site

Porto Alegre, 90610-000, Brazil

Location

GSK Investigational Site

São Paulo, 01246-000, Brazil

Location

GSK Investigational Site

Vitória, 29043-260, Brazil

Location

GSK Investigational Site

Oulu, 90220, Finland

Location

GSK Investigational Site

Tampere, 33520, Finland

Location

GSK Investigational Site

Turku, 20520, Finland

Location

GSK Investigational Site

Vaasa, 65130, Finland

Location

GSK Investigational Site

Bordeaux, 33076, France

Location

GSK Investigational Site

Caen, 14033, France

Location

GSK Investigational Site

Marseille, 13009, France

Location

GSK Investigational Site

Quimper, 29107, France

Location

GSK Investigational Site

Strasbourg, 67091, France

Location

GSK Investigational Site

Berlin, 13125, Germany

Location

GSK Investigational Site

Essen, 45147, Germany

Location

GSK Investigational Site

Großhansdorf, 22927, Germany

Location

GSK Investigational Site

Heidelberg, 69126, Germany

Location

GSK Investigational Site

Jena, 07747, Germany

Location

GSK Investigational Site

Athens, 11528, Greece

Location

GSK Investigational Site

Haidari - Athens, 12462, Greece

Location

GSK Investigational Site

Larissa, 41110, Greece

Location

GSK Investigational Site

PapagosAthens, 115 27, Greece

Location

GSK Investigational Site

Pylaia Thessaloniki, 57001, Greece

Location

GSK Investigational Site

Thessaloniki, 54645, Greece

Location

GSK Investigational Site

Thessaloniki, 57010, Greece

Location

GSK Investigational Site

Budapest, H-1121, Hungary

Location

GSK Investigational Site

Gyöngyös, 3200, Hungary

Location

GSK Investigational Site

Tatabánya, 2800, Hungary

Location

GSK Investigational Site

Avellino, 83100, Italy

Location

GSK Investigational Site

Bergamo, 24125, Italy

Location

GSK Investigational Site

Genova, 16132, Italy

Location

GSK Investigational Site

Pisa, 57124, Italy

Location

GSK Investigational Site

Verona, 37045, Italy

Location

GSK Investigational Site

Chiba, 277-8577, Japan

Location

GSK Investigational Site

Fukuoka, 812-8582, Japan

Location

GSK Investigational Site

Hyōgo, 673-8558, Japan

Location

GSK Investigational Site

Kanagawa, 241-8515, Japan

Location

GSK Investigational Site

Osaka, 590-0197, Japan

Location

GSK Investigational Site

Saitama, 350-1298, Japan

Location

GSK Investigational Site

Guadalajara, 44280, Mexico

Location

GSK Investigational Site

San Luis Potosí City, 78209, Mexico

Location

GSK Investigational Site

Enschede, 7512 KZ, Netherlands

Location

GSK Investigational Site

Groningen, 9728 NZ, Netherlands

Location

GSK Investigational Site

Leeuwarden, 8934 AD, Netherlands

Location

GSK Investigational Site

Utrecht, 3543 AZ, Netherlands

Location

GSK Investigational Site

Lublin, 20-954, Poland

Location

GSK Investigational Site

Prabuty, 82-550, Poland

Location

GSK Investigational Site

Siedlce, 08-110, Poland

Location

GSK Investigational Site

Gaia, 4434-502, Portugal

Location

GSK Investigational Site

Guimarães, 4835-044, Portugal

Location

GSK Investigational Site

Lisbon, 1500-650, Portugal

Location

GSK Investigational Site

Lisbon, 1998-018, Portugal

Location

GSK Investigational Site

Porto, 4200-072, Portugal

Location

GSK Investigational Site

Cape Town, 7570, South Africa

Location

GSK Investigational Site

Parktown, 2193, South Africa

Location

GSK Investigational Site

Incheon, 21565, South Korea

Location

GSK Investigational Site

Seoul, 03080, South Korea

Location

GSK Investigational Site

Seoul, 03722, South Korea

Location

GSK Investigational Site

Suwon Gyeonggi-do, 442-723, South Korea

Location

GSK Investigational Site

Badajoz, 06080, Spain

Location

GSK Investigational Site

Badalona, 08916, Spain

Location

GSK Investigational Site

Barcelona, 08035, Spain

Location

GSK Investigational Site

Barcelona, 08907, Spain

Location

GSK Investigational Site

Las Palmas de Gran Canar, 35016, Spain

Location

GSK Investigational Site

Madrid, 28027, Spain

Location

GSK Investigational Site

Madrid, 28041, Spain

Location

GSK Investigational Site

Madrid, 28046, Spain

Location

GSK Investigational Site

Málaga, 29010, Spain

Location

GSK Investigational Site

PamplonaNavarra, 28027, Spain

Location

GSK Investigational Site

Valencia, 46009, Spain

Location

GSK Investigational Site

Valencia, 46026, Spain

Location

GSK Investigational Site

Bangkok, 10210, Thailand

Location

GSK Investigational Site

Chiang Mai, 50200, Thailand

Location

GSK Investigational Site

Kho Hong Hat Yai, 90110, Thailand

Location

GSK Investigational Site

Khon Kaen, 40002, Thailand

Location

GSK Investigational Site

Pathum Thani, 12120, Thailand

Location

GSK Investigational Site

Samsun, Atakum, 55200, Turkey (Türkiye)

Location

GSK Investigational Site

Ankara, 06680, Turkey (Türkiye)

Location

GSK Investigational Site

Ankara, 06800, Turkey (Türkiye)

Location

GSK Investigational Site

Antalya, 07070, Turkey (Türkiye)

Location

GSK Investigational Site

Istanbul, 34214, Turkey (Türkiye)

Location

GSK Investigational Site

Abu Dhabi, 51900, United Arab Emirates

Location

GSK Investigational Site

Abu Dhabi, United Arab Emirates

Location

GSK Investigational Site

Middlesbrough, TS4 3BW, United Kingdom

Location

GSK Investigational Site

Middlesex, HA6 2RN, United Kingdom

Location

GSK Investigational Site

Wolverhampton, WV10 0QP, United Kingdom

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

pembrolizumab; dostarlimab

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 30, 2022
• First Posted: October 4, 2022
• Study Start: October 14, 2022
• Primary Completion (Estimated): February 26, 2027
• Study Completion (Estimated): February 26, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

TU (5); ME (2); NL (4); BR (4); HU (3); PT (5); GR (7); IT (5); PL (3); DE (5); ES (12); TH (5); FI (4); FR (5); KR (4); AR (8); JP (6); AE (2); ZA (2); GB (3); US (4); BE (1)