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ACTIVE NOT RECRUITING

NCT06472076

PHASE3

A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to evaluate the safety and tolerability profile of dostarlimab in combination with belrestotug when compared with pembrolizumab and placebo in participants with previously untreated, unresectable, locally advanced or metastatic PD-L1 high NSCLC.

Official title: A Randomized, Multicenter, Double-blind, Phase 3 Study to Investigate the Safety and Efficacy of Belrestotug in Combination With Dostarlimab Compared With Placebo in Combination With Pembrolizumab in Participants With Previously Untreated, Unresectable, Locally Advanced or Metastatic PD-L1 Selected Non-small Cell Lung Cancer (GALAXIES Lung-301)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2024-06-10

Completion Date

2027-02-02

Last Updated

2025-09-10

Healthy Volunteers

Conditions

Lung Cancer, Non-Small Cell

Interventions

BIOLOGICAL

Dostarlimab

Dostarlimab will be administered.

BIOLOGICAL

Belrestotug

Belrestotug will be administered.

BIOLOGICAL

Pembrolizumab

Pembrolizumab will be administered.

DRUG

Placebo

Placebo will be administered.

Inclusion Criteria: * Has a 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 * Has not received prior systemic therapy for their locally advanced or metastatic NSCLC. * Provides a fresh tumor tissue sample obtained at the time of or after the initial diagnosis of locally advanced or metastatic NSCLC. * Has a PD-L1-high (Tumor cells \[TC\] ≥50%) tumor * Has measurable disease (at least 1 target lesion) based on RECIST 1.1 * Has an Eastern Cooperative Oncology Group (ECOG) Performance status (PS) score of 0 or 1. * Has adequate organ function Exclusion Criteria: * Has NSCLC with a tumor that harbors any of the following molecular alterations: 1. Epidermal growth factor receptor (EGFR) mutations that are sensitive to available targeted inhibitor therapy 2. Anaplastic lymphoma kinase (ALK) translocations that are sensitive to available targeted inhibitor therapy 3. 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. * Has had surgery within 4 weeks of the first dose of study intervention and has not recovered from AEs (i.e., has any ongoing surgery-related events ≥ Grade 1)/complications related to surgery or has received lung radiation therapy of \>30 gray (Gy) within 6 months * Has received prior therapy with any immune checkpoint inhibitors, including antibodies or drugs targeting PD-(L)1, Cytotoxic T-lymphocyte-associated protein 4 (CTLA-4), T cell immunoglobulin and ITIM domain (TIGIT), or other checkpoint pathways. * Has 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, with the exception of those with a negligible risk of metastasis or death and/or treated with expected curative outcome. * Has symptomatic, untreated, or actively progressin g brain metastases or leptomeningeal disease * Has autoimmune disease or syndrome (current or history thereof) that required systemic treatment within the past 2 years. * Has received any live vaccine within 30 days prior to first dose of study intervention. * Has any history of idiopathic pulmonary fibrosis, organizing pneumonia, drug induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis. * Has symptomatic ascites, pleural effusion, or pericardial effusion. * Has active inflammatory bowel disease * Has a history of significant acute or chronic cardiac diagnosis requiring intervention/treatment in the last 6 months. * Has severe infection or complication thereof 4 weeks prior to randomisation including active tuberculosis. * Has a history of allogeneic tissue/stem cell transplant or solid organ transplant.

Locations (134)

GSK Investigational Site

Ocala, Florida, United States

GSK Investigational Site

Honolulu, Hawaii, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Ann Arbor, Michigan, United States

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Omaha, Nebraska, United States

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Nashville, Tennessee, United States

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Fort Worth, Texas, United States

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Olympia, Washington, United States

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Buenos Aires, Argentina

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Cipoletti Rio Negro, Argentina

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Ciudad Autonoma de Buenos Aire, Argentina

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Ciudad Autonoma de Bueno, Argentina

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Córdoba, Argentina

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Florida, Argentina

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Mendoza, Argentina

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Rosario, Argentina

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Rosario, Argentina

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San Miguel de Tucumán, Argentina

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Hasselt, Belgium

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Mont Gaston, Belgium

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Barretos, Brazil

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Belém, Brazil

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CuritibaPR, Brazil

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Florianópolis, Brazil

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Fortaleza, Brazil

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Londrina, Brazil

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Porto VelhoRondOnia, Brazil

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Salvador, Brazil

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SAo JosE Do Rio PretoSP, Brazil

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São Paulo, Brazil

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Vitória, Brazil

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Haskovo, Bulgaria

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Plovdiv, Bulgaria

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Halifax, Nova Scotia, Canada

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Chengdu, China

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Hangzhou, China

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Hangzhou, China

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Hefei, China

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Nanjing, China

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Shanghai, China

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Kuopio, Finland

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Turku, Finland

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Angers, France

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Boulogne-Billancourt, France

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Limoges, France

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Lorient, France

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Pessac, France

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Rennes, France

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Hamburg, Germany

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Shatin, Hong Kong

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Gokul Shirgoan, Kolhapur, India

GSK Investigational Site

Ahmedabad-380016, India

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Apex Wellness Hospital, India

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Bangalore, India

GSK Investigational Site

Bangalore, India

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Belagavi, India

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Bhubaneswar, India

GSK Investigational Site

Bhubaneswar, India

GSK Investigational Site

Gūrgaon, India

GSK Investigational Site

Kolkata, India

GSK Investigational Site

New Delhi, India

GSK Investigational Site

Aichi, Japan

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Chiba, Japan

GSK Investigational Site

Ehime, Japan

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Ehime, Japan

GSK Investigational Site

Fukuoka, Japan

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Fukuoka, Japan

GSK Investigational Site

Gifu, Japan

GSK Investigational Site

Gunma, Japan

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Hiroshima, Japan

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Hokkaido, Japan

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Hyōgo, Japan

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Hyōgo, Japan

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Kanagawa, Japan

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Kyoto, Japan

GSK Investigational Site

Mie, Japan

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Miyagi, Japan

GSK Investigational Site

Miyagi, Japan

GSK Investigational Site

Nagasaki, Japan

GSK Investigational Site

Niigata, Japan

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Okayama, Japan

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Osaka, Japan

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Osaka, Japan

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Tochigi, Japan

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Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

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Tokyo, Japan

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Tottori, Japan

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Wakayama, Japan

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Guadajalara, Mexico

GSK Investigational Site

La Paz BCS, Mexico

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Mexico City, Mexico

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San Luis Potosí City, Mexico

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Alkmaar, Netherlands

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Enschede, Netherlands

GSK Investigational Site

Panama City, Panama

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Punta Pacifica Panama City Panama, Panama

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Daegu, South Korea

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Incheon, South Korea

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Seoul, South Korea

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Seoul, South Korea

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Seoul, South Korea

GSK Investigational Site

Seoul, South Korea

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Seoul, South Korea

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A Coruña, Spain

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Aravaca, Spain

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BaracaldoVizcaya, Spain

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Barcelona, Spain

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Cartagena Murcia, Spain

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Córdoba, Spain

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Jaén, Spain

GSK Investigational Site

Las Palmas de Gran Canar, Spain

GSK Investigational Site

Madrid, Spain

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Madrid, Spain

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Madrid, Spain

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Madrid, Spain

GSK Investigational Site

Málaga, Spain

GSK Investigational Site

Oviedo, Spain

GSK Investigational Site

Pamplona, Spain

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Salamanca, Spain

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Santander, Spain

GSK Investigational Site

Seville, Spain

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Valladolid, Spain

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Gävle, Sweden

GSK Investigational Site

Kaohsiung City, Taiwan

GSK Investigational Site

Taipei, Taiwan

GSK Investigational Site

Adana, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

Clinical Research Directory

A Study of Belrestotug Plus Dostarlimab Compared With Placebo Plus Pembrolizumab in Previously Untreated Participants With Programmed Death Ligand 1 (PD-L1) High Non-small-cell Lung Cancer (NSCLC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (134)