A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
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
Interventions
Risvutatug rezetecan (Ris-Rez)
Topotecan
Conditions
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
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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
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Pylaia Thessaloniki, 570 01
Greece
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Pylaia Thessaloniki, 57001
Greece
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Budapest, H-1121
Hungary
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Farkasgyepű, 8552
Hungary
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Gyöngyös, 3200
Hungary
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Kecskemét, 6000
Hungary
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Székesfehérvár, 8000
Hungary
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Törökbálint, 2045
Hungary
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Dublin, D09 V2N0
Ireland
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Jerusalem, 9112001
Israel
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Tel Aviv, 6423906
Israel
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Milan, MI 20141
Italy
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Bergamo,
Italy
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Genova, 16132
Italy
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Orbassano, 10043
Italy
GSK Investigational Site
Pisa, 57124
Italy
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Siena, 53100
Italy
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Verona, 37134
Italy
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Fukuoka, 812-8582
Japan
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Hokkaido, 060-8648
Japan
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Ishikawa, 920-8530
Japan
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Kagoshima, 890-8520
Japan
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Kanagawa, 241-8515
Japan
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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
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Timișoara, 300329
Romania
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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
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Barcelona, 8036
Spain
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L'Hospitalet de Llobrega, 08908
Spain
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Las Palmas de Gran Canar, 35016
Spain
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Madrid, 28007
Spain
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Madrid, 28034
Spain
GSK Investigational Site
Madrid, 28041
Spain
GSK Investigational Site
Madrid, 28046
Spain
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Santander, 39011
Spain
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Stockholm, 171 64
Sweden
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Basel, 4031
Switzerland
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Lausanne, 1011
Switzerland
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Adana, Adana 01140
Turkey (Türkiye)
GSK Investigational Site
Samsun, Atakum 55200
Turkey (Türkiye)
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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)
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Izmir, 35110
Turkey (Türkiye)
GSK Investigational Site
Izmir, 35340
Turkey (Türkiye)
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London, W1G 6AD
United Kingdom
GSK Investigational Site
Portsmouth, PO6 3LY
United Kingdom
GSK Investigational Site
Truro, TR1 3LJ
United Kingdom