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NCT07099898PHASE3Recruiting

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]

GlaxoSmithKline

Start Date

8/11/2025

Completion Date

9/28/2029

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 Criteria

Age Range: 18 years to No maximum

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 for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible. * 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 adequate organ function and 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. * Limited stage small cell lung cancer at diagnosis * 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 significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease), * Has active Hepatitis B or Hepatitis C

Interventions

BIOLOGICAL

Risvutatug rezetecan (Ris-Rez)

DRUG

Topotecan

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Conditions

Neoplasms, Lung

Locations

GSK Investigational Site

Los Angeles, California 90027

United States

GSK Investigational Site

East Syracuse, New York 13057

United States

GSK Investigational Site

Wilson, North Carolina 27893-3484

United States

GSK Investigational Site

Canton, Ohio 44718

United States

GSK Investigational Site

Mar del Plata, Buenos Aires 7600

Argentina

GSK Investigational Site

Buenos Aires, C1426ABP

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1012AAR

Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, C1426AGE

Argentina

GSK Investigational Site

Rosario, S2000 DEJ

Argentina

GSK Investigational Site

Vicente López, 1602

Argentina

GSK Investigational Site

Blacktown, New South Wales 2148

Australia

GSK Investigational Site

St Leonards, New South Wales 2065

Australia

GSK Investigational Site

Nedlands, Western Australia 6009

Australia

GSK Investigational Site

Florianópolis, Santa Catarina 88020-210

Brazil

GSK Investigational Site

Barretos, 14784-400

Brazil

GSK Investigational Site

CuritibaPR, 80810-050

Brazil

GSK Investigational Site

Porto Alegre, 90020-090

Brazil

GSK Investigational Site

Porto Alegre, 90610-000

Brazil

GSK Investigational Site

Rio de Janeiro, 22250-905

Brazil

GSK Investigational Site

São Paulo, 04312903

Brazil

GSK Investigational Site

Pleven, 5800

Bulgaria

GSK Investigational Site

Plovdiv,

Bulgaria

GSK Investigational Site

Rousse, 7002

Bulgaria

GSK Investigational Site

Sofia, 1606

Bulgaria

GSK Investigational Site

Sofia, 1632

Bulgaria

GSK Investigational Site

Ottawa, Ontario K1H 8L6

Canada

GSK Investigational Site

Toronto, Ontario M5G 1Z5

Canada

GSK Investigational Site

Montreal, Quebec H3T 1E2

Canada

GSK Investigational Site

Montreal, Quebec H4J 1C5

Canada

GSK Investigational Site

Vaasa, 65130

Finland

GSK Investigational Site

Boulogne-Billancourt, 92100

France

GSK Investigational Site

Grenoble, 38043

France

GSK Investigational Site

Saint-Herblain, 44805

France

GSK Investigational Site

Villejuif, 94805

France

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg 76137

Germany

GSK Investigational Site

Löwenstein, Baden-Wurttemberg 74245

Germany

GSK Investigational Site

Stuttgart, Baden-Wurttemberg 70376

Germany

GSK Investigational Site

Augsburg, 86156

Germany

GSK Investigational Site

Chemnitz, 09113

Germany

GSK Investigational Site

Esslingen am Neckar, 73730

Germany

GSK Investigational Site

Heidelberg, 69126

Germany

GSK Investigational Site

Lübeck, 23562

Germany

GSK Investigational Site

München, 81377

Germany

GSK Investigational Site

Nuremberg, 90340

Germany

GSK Investigational Site

Heraklion, Crete 700 13

Greece

GSK Investigational Site

Athens, 115 22

Greece

GSK Investigational Site

Athens, 11526

Greece

GSK Investigational Site

Athens, 12462

Greece

GSK Investigational Site

Pylaia Thessaloniki, 570 01

Greece

GSK Investigational Site

Pylaia Thessaloniki, 57001

Greece

GSK Investigational Site

Budapest, H-1121

Hungary

GSK Investigational Site

Farkasgyepű, 8552

Hungary

GSK Investigational Site

Gyöngyös, 3200

Hungary

GSK Investigational Site

Kecskemét, 6000

Hungary

GSK Investigational Site

Székesfehérvár, 8000

Hungary

GSK Investigational Site

Törökbálint, 2045

Hungary

GSK Investigational Site

Dublin, D09 V2N0

Ireland

GSK Investigational Site

Jerusalem, 9112001

Israel

GSK Investigational Site

Tel Aviv, 6423906

Israel

GSK Investigational Site

Milan, MI 20141

Italy

GSK Investigational Site

Bergamo,

Italy

GSK Investigational Site

Genova, 16132

Italy

GSK Investigational Site

Orbassano, 10043

Italy

GSK Investigational Site

Pisa, 57124

Italy

GSK Investigational Site

Siena, 53100

Italy

GSK Investigational Site

Verona, 37134

Italy

GSK Investigational Site

Fukuoka, 812-8582

Japan

GSK Investigational Site

Hokkaido, 060-8648

Japan

GSK Investigational Site

Ishikawa, 920-8530

Japan

GSK Investigational Site

Kagoshima, 890-8520

Japan

GSK Investigational Site

Kanagawa, 241-8515

Japan

GSK Investigational Site

Kanagawa, 252-0375

Japan

GSK Investigational Site

Kochi, 783-8505

Japan

GSK Investigational Site

Kyoto, 612-8555

Japan

GSK Investigational Site

Mie, 515-8544

Japan

GSK Investigational Site

Miyagi, 980-8574

Japan

GSK Investigational Site

Osaka, 541-8567

Japan

GSK Investigational Site

Osaka, 573-1191

Japan

GSK Investigational Site

Osaka, 594-0073

Japan

GSK Investigational Site

Tokyo, 104-0045

Japan

GSK Investigational Site

Tokyo, 113-8603

Japan

GSK Investigational Site

Tokyo, 113-8677

Japan

GSK Investigational Site

Toyama, 930-8550

Japan

GSK Investigational Site

San Pedro Garza García, Nuevo León 66260

Mexico

GSK Investigational Site

Guadajalara, 44280

Mexico

GSK Investigational Site

Mexico City, 06700

Mexico

GSK Investigational Site

Mexico City, 06760

Mexico

GSK Investigational Site

Gliwice, 44-102

Poland

GSK Investigational Site

Kielce, 25-640

Poland

GSK Investigational Site

Lodz, 93-338

Poland

GSK Investigational Site

Otwock, 05-400

Poland

GSK Investigational Site

Poznan, 60-569

Poland

GSK Investigational Site

Siedlce, 08-110

Poland

GSK Investigational Site

Almada, Setúbal District 2805-267

Portugal

GSK Investigational Site

Guimarães, 4835-044

Portugal

GSK Investigational Site

Lisbon, 1400-038

Portugal

GSK Investigational Site

Craiova Dolj, Dolj 200535

Romania

GSK Investigational Site

Cluj-Napoca, 400015

Romania

GSK Investigational Site

Craiova, 200542

Romania

GSK Investigational Site

Floreşti, 407280

Romania

GSK Investigational Site

Iași, 700451

Romania

GSK Investigational Site

Timișoara, 300329

Romania

GSK Investigational Site

Changwon, 51472

South Korea

GSK Investigational Site

Cheongju Chungcheongbuk-do, 28644

South Korea

GSK Investigational Site

Daegu, 41404

South Korea

GSK Investigational Site

Gyeonggi-do, 10408

South Korea

GSK Investigational Site

Seongnam-si Gyeonggi-do, 13620

South Korea

GSK Investigational Site

Seoul, 03722

South Korea

GSK Investigational Site

Suwon Gyeonggi-do, 442723

South Korea

GSK Investigational Site

Ulsan, 44033

South Korea

GSK Investigational Site

Barcelona, 08003

Spain

GSK Investigational Site

Barcelona, 08035

Spain

GSK Investigational Site

Barcelona, 8036

Spain

GSK Investigational Site

L'Hospitalet de Llobrega, 08908

Spain

GSK Investigational Site

Las Palmas de Gran Canar, 35016

Spain

GSK Investigational Site

Madrid, 28007

Spain

GSK Investigational Site

Madrid, 28034

Spain

GSK Investigational Site

Madrid, 28041

Spain

GSK Investigational Site

Madrid, 28046

Spain

GSK Investigational Site

Santander, 39011

Spain

GSK Investigational Site

Stockholm, 171 64

Sweden

GSK Investigational Site

Basel, 4031

Switzerland

GSK Investigational Site

Lausanne, 1011

Switzerland

GSK Investigational Site

Adana, Adana 01140

Turkey (Türkiye)

GSK Investigational Site

Samsun, Atakum 55200

Turkey (Türkiye)

GSK Investigational Site

Ankara, 06010

Turkey (Türkiye)

GSK Investigational Site

Ankara, 06520

Turkey (Türkiye)

GSK Investigational Site

Ankara, 6230

Turkey (Türkiye)

GSK Investigational Site

Diyarbakır, 21280

Turkey (Türkiye)

GSK Investigational Site

Istanbul, 34010

Turkey (Türkiye)

GSK Investigational Site

Izmir, 35110

Turkey (Türkiye)

GSK Investigational Site

Izmir, 35340

Turkey (Türkiye)

GSK Investigational Site

London, W1G 6AD

United Kingdom

GSK Investigational Site

Portsmouth, PO6 3LY

United Kingdom

GSK Investigational Site

Truro, TR1 3LJ

United Kingdom