RecruitingPhase 3NCT07099898

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

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)


Sponsor

GlaxoSmithKline

Enrollment

420 participants

Start Date

Aug 11, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez 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 Ris-Rez and the other receiving topotecan.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new drug called GSK5764227 for people with extensive-stage small cell lung cancer (a fast-growing type of lung cancer) that has come back after initial treatment with platinum-based chemotherapy and immunotherapy. GSK5764227 is an antibody-drug conjugate — a type of precision medicine that delivers a cancer-killing payload directly to tumor cells. **You may be eligible if...** - You are 18 or older - You have confirmed extensive-stage small cell lung cancer - You have already received at least one prior treatment combining a platinum-based chemotherapy with a PD-(L)1 immunotherapy drug - You have measurable disease on scans - Your daily functioning is good (ECOG 0 or 1) **You may NOT be eligible if...** - You have previously received an antibody-drug conjugate (ADC) that targets a protein called B7-H3 or uses a Topoisomerase-1 payload - You have active brain metastases or cancer spreading to the membrane around the brain - You have active hepatitis B or C - You have known HIV - You have significant active bleeding or severe heart disease - You have interstitial lung disease or prior serious pneumonitis Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALRis-Rez

Ris-Rez will be administered

DRUGTopotecan

Topotecan will be administered


Locations(114)

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

Saint-Herblain, France

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Germany

GSK Investigational Site

Esslingen am Neckar, Germany

GSK Investigational Site

Lübeck, Germany

GSK Investigational Site

München, Germany

GSK Investigational Site

Nuremberg, Germany

GSK Investigational Site

Stuttgart, 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

Gyöngyös, Hungary

GSK Investigational Site

Kecskemét, Hungary

GSK Investigational Site

Törökbálint, Hungary

GSK Investigational Site

Dublin, Ireland

GSK Investigational Site

Jerusalem, Israel

GSK Investigational Site

Tel Aviv, Israel

GSK Investigational Site

Bergamo, Italy

GSK Investigational Site

Orbassano, 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

Miyagi, 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

Guimarães, Portugal

GSK Investigational Site

Craiova Dolj, Dolj, Romania

GSK Investigational Site

Cluj-Napoca, 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

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NCT07099898


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