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RECRUITING

NCT07099898

PHASE3

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Sponsor: GlaxoSmithKline

View on ClinicalTrials.gov

Summary

"In this study researchers are testing GSK5764227, a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancers ability to grow and spread. This study specifically aims to evaluate how well GSK5764227 works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether GSK5764227 makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether GSK576227 is safe and tolerated well by participants compared to topotecan and provide a better understanding of the main side effects of both drugs. Participants with relapsed SCLC will be randomly divided into two groups: one group receiving GSK5764227 and the other receiving topotecan."

Official title: Phase 3, Multicenter, Randomized, Open-label Clinical Study of GSK5764227, a B7-H3 Antibody Drug Conjugate (ADC), Compared With Topotecan in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2025-08-11

Completion Date

2029-09-28

Last Updated

2026-03-06

Healthy Volunteers

Conditions

Neoplasms, Lung

Interventions

BIOLOGICAL

GSK5764227

GSK5764227 will be administered

DRUG

Topotecan

Topotecan will be administered

Inclusion Criteria: Participants are eligible to be included in the study only if all of the following criteria apply: * Adults \>18 or the minimum legal adult age at the time the informed consent form is signed * Has histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC). * Has received 1 prior platinum-based systemic therapy with a PD- (L)1 inhibitor with at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression * Has at least 1 target lesion per RECIST 1.1, as determined by the investigator. * Is capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the ICF and in the protocol. * Has an ECOG performance status of 0 or 1 Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Pathological diagnosis of complex SCLC or transformed SCLC. * Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3. * Has known sensitivity to study intervention components or excipients or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study. * Has severe, uncontrolled or active cardiovascular disorders. * Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose. * Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV). * Has symptomatic brain metastases or untreated progression exclusively due to brain metastasis during or after the last treatment prior to screening, evidence of leptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases. * Has any evidence of current interstitial lung disease or pneumonitis or a prior history of ILD or non-infectious pneumonitis requiring high dose steroids. * Has documented Hepatitis B or Hepatitis C

Locations (102)

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Vicente López, Argentina

GSK Investigational Site

Blacktown, New South Wales, Australia

GSK Investigational Site

St Leonards, New South Wales, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Barretos, Brazil

GSK Investigational Site

CuritibaPR, Brazil

GSK Investigational Site

Florianópolis, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Porto Alegre, Brazil

GSK Investigational Site

Rio de Janeiro, Brazil

GSK Investigational Site

São Paulo, Brazil

GSK Investigational Site

Pleven, Bulgaria

GSK Investigational Site

Plovdiv, Bulgaria

GSK Investigational Site

Rousse, Bulgaria

GSK Investigational Site

Ottawa, Ontario, Canada

GSK Investigational Site

Toronto, Ontario, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Montreal, Quebec, Canada

GSK Investigational Site

Vaasa, Finland

GSK Investigational Site

Boulogne-Billancourt, France

GSK Investigational Site

Grenoble, France

GSK Investigational Site

Lübeck, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Nuremberg, Germany

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Athens, Greece

GSK Investigational Site

Heraklion Crete, Greece

GSK Investigational Site

Pylaia Thessaloniki, Greece

GSK Investigational Site

Pylaia Thessaloniki, Greece

GSK Investigational Site

Dublin, Ireland

GSK Investigational Site

Jerusalem, Israel

GSK Investigational Site

Tel Aviv, Israel

GSK Investigational Site

Bergamo, Italy

GSK Investigational Site

Pisa, Italy

GSK Investigational Site

Fukuoka, Japan

GSK Investigational Site

Hokkaido, Japan

GSK Investigational Site

Ishikawa, Japan

GSK Investigational Site

Kagoshima, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kanagawa, Japan

GSK Investigational Site

Kochi, Japan

GSK Investigational Site

Kyoto, Japan

GSK Investigational Site

Mie, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Osaka, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Tokyo, Japan

GSK Investigational Site

Toyama, Japan

GSK Investigational Site

Guadalajara, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Mexico City, Mexico

GSK Investigational Site

Monterrey, Mexico

GSK Investigational Site

Kielce, Poland

GSK Investigational Site

Otwock, Poland

GSK Investigational Site

Poznan, Poland

GSK Investigational Site

Siedlce, Poland

GSK Investigational Site

Almada, Portugal

GSK Investigational Site

Craiova Dolj, Dolj, Romania

GSK Investigational Site

Craiova, Romania

GSK Investigational Site

Floreşti, Romania

GSK Investigational Site

Iași, Romania

GSK Investigational Site

Timișoara, Romania

GSK Investigational Site

Changwon, South Korea

GSK Investigational Site

Cheongju Chungcheongbuk-do, South Korea

GSK Investigational Site

Daegu, South Korea

GSK Investigational Site

Gyeonggi-do, South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea

GSK Investigational Site

Seoul, South Korea

GSK Investigational Site

Suwon Gyeonggi-do, South Korea

GSK Investigational Site

Ulsan, South Korea

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

Barcelona, Spain

GSK Investigational Site

L'Hospitalet de Llobrega, Spain

GSK Investigational Site

Las Palmas de Gran Canar, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Madrid, Spain

GSK Investigational Site

Santander, Spain

GSK Investigational Site

Stockholm, Sweden

GSK Investigational Site

Basel, Switzerland

GSK Investigational Site

Lausanne, Switzerland

GSK Investigational Site

Adana, Adana, Turkey (Türkiye)

GSK Investigational Site

Samsun, Atakum, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Ankara, Turkey (Türkiye)

GSK Investigational Site

Diyarbakır, Turkey (Türkiye)

GSK Investigational Site

Istanbul, Turkey (Türkiye)

GSK Investigational Site

Izmir, Turkey (Türkiye)

GSK Investigational Site

Izmir, Turkey (Türkiye)

GSK Investigational Site

London, United Kingdom

GSK Investigational Site

Portsmouth, United Kingdom

GSK Investigational Site

Truro, United Kingdom

Clinical Research Directory

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (102)