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

Last updated: March 5, 2026
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

3

Condition

Small Cell Lung Cancer

Lung Cancer

Treatment

Topotecan

GSK5764227

Clinical Study ID

NCT07099898
223674
2025-521627-78
  • Ages > 18
  • All Genders

Study 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."

Eligibility Criteria

Inclusion

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 issigned

  • 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 withat least 2 cycles of therapy and a chemotherapy free-interval of >30 days, withdocumented 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 therequirements and restrictions listed in the ICF and in the protocol.

  • Has an ECOG performance status of 0 or 1

Exclusion

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 aTopoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3.

  • Has known sensitivity to study intervention components or excipients or otherallergy that, in the opinion of the investigator or medical monitor, contraindicatesparticipation 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 Humanimmunodeficiency virus (HIV).

  • Has symptomatic brain metastases or untreated progression exclusively due to brainmetastasis during or after the last treatment prior to screening, evidence ofleptomeningeal/meningeal/brainstem metastasis or evidence of spinal cord metastases.

  • Has any evidence of current interstitial lung disease or pneumonitis or a priorhistory of ILD or non-infectious pneumonitis requiring high dose steroids.

  • Has documented Hepatitis B or Hepatitis C

Study Design

Total Participants: 420
Treatment Group(s): 2
Primary Treatment: Topotecan
Phase: 3
Study Start date:
August 11, 2025
Estimated Completion Date:
September 28, 2029

Connect with a study center

  • GSK Investigational Site

    Mar del Plata, Buenos Aires 7600
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Mar del Plata 3430863, Buenos Aires 3435907 7600
    Argentina

    Site Not Available

  • GSK Investigational Site

    Buenos Aires, C1426ABP
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Buenos Aires 3435910, C1426ABP
    Argentina

    Site Not Available

  • GSK Investigational Site

    Ciudad Autonoma de Buenos Aire, C1426AGE
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario, S2000 DEJ
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Rosario 3838583, S2000 DEJ
    Argentina

    Site Not Available

  • GSK Investigational Site

    Vicente López, 1602
    Argentina

    Active - Recruiting

  • GSK Investigational Site

    Vicente López 3427505, 1602
    Argentina

    Site Not Available

  • GSK Investigational Site

    Blacktown, New South Wales 2148
    Australia

    Active - Recruiting

  • GSK Investigational Site

    St Leonards, New South Wales 2065
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Blacktown 2175411, New South Wales 2155400 2148
    Australia

    Site Not Available

  • GSK Investigational Site

    St Leonards 8029783, New South Wales 2155400 2065
    Australia

    Site Not Available

  • GSK Investigational Site

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

  • GSK Investigational Site

    Nedlands 2064874, Western Australia 2058645 6009
    Australia

    Site Not Available

  • GSK Investigational Site

    Barretos, 14784-400
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Barretos 3470451, 14784-400
    Brazil

    Site Not Available

  • GSK Investigational Site

    CuritibaPR, 80810-050
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Florianópolis, 88020-210
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Florianópolis 3463237, 88020-210
    Brazil

    Site Not Available

  • GSK Investigational Site

    Porto Alegre, 90020-090
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Porto Alegre 3452925, 90610-000
    Brazil

    Site Not Available

  • GSK Investigational Site

    Rio de Janeiro, 22250-905
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    Rio de Janeiro 3451190, 22250-905
    Brazil

    Site Not Available

  • GSK Investigational Site

    São Paulo, 04312903
    Brazil

    Active - Recruiting

  • GSK Investigational Site

    São Paulo 3448439, 04312903
    Brazil

    Site Not Available

  • GSK Investigational Site

    Pleven, 5800
    Bulgaria

    Active - Recruiting

  • GSK Investigational Site

    Pleven 728203, 5800
    Bulgaria

    Site Not Available

  • GSK Investigational Site

    Plovdiv,
    Bulgaria

    Active - Recruiting

  • GSK Investigational Site

    Rousse, 7002
    Bulgaria

    Active - Recruiting

  • GSK Investigational Site

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Toronto, Ontario M5G 1Z5
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Ottawa 6094817, Ontario 6093943 K1H 8L6
    Canada

    Site Not Available

  • GSK Investigational Site

    Toronto 6167865, Ontario 6093943 M5G 1Z5
    Canada

    Site Not Available

  • GSK Investigational Site

    Montreal, Quebec H3T 1E2
    Canada

    Active - Recruiting

  • GSK Investigational Site

    Montreal 6077243, Quebec 6115047 H4J 1C5
    Canada

    Site Not Available

  • GSK Investigational Site

    Vaasa, 65130
    Finland

    Active - Recruiting

  • GSK Investigational Site

    Vaasa 632978, 65130
    Finland

    Site Not Available

  • GSK Investigational Site

    Boulogne-Billancourt, 92100
    France

    Active - Recruiting

  • GSK Investigational Site

    Boulogne-Billancourt 3031137, 92100
    France

    Site Not Available

  • GSK Investigational Site

    Grenoble, 38043
    France

    Active - Recruiting

  • GSK Investigational Site

    Lübeck, 23562
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Lübeck 2875601, 23562
    Germany

    Site Not Available

  • GSK Investigational Site

    München, 81377
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Nuremberg, 90340
    Germany

    Active - Recruiting

  • GSK Investigational Site

    Athens, 12462
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Athens 264371, 11526
    Greece

    Site Not Available

  • GSK Investigational Site

    Heraklion Crete, 71110
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Pylaia Thessaloniki, 57001
    Greece

    Active - Recruiting

  • GSK Investigational Site

    Dublin, D09 V2N0
    Ireland

    Active - Recruiting

  • GSK Investigational Site

    Dublin 2964574, D09 V2N0
    Ireland

    Site Not Available

  • GSK Investigational Site

    Jerusalem, 9112001
    Israel

    Active - Recruiting

  • GSK Investigational Site

    Jerusalem 281184, 9112001
    Israel

    Site Not Available

  • GSK Investigational Site

    Tel Aviv, 6423906
    Israel

    Active - Recruiting

  • GSK Investigational Site

    Tel Aviv 293397, 6423906
    Israel

    Site Not Available

  • GSK Investigational Site

    Bergamo,
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Pisa, 57124
    Italy

    Active - Recruiting

  • GSK Investigational Site

    Fukuoka, 812-8582
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Fukuoka 1863967, 812-8582
    Japan

    Site Not Available

  • GSK Investigational Site

    Hokkaido, 060-8648
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Ishikawa, 920-8530
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Ishikawa 1861393, 920-8530
    Japan

    Site Not Available

  • GSK Investigational Site

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kagoshima 1860827, 890-8520
    Japan

    Site Not Available

  • GSK Investigational Site

    Kanagawa, 241-8515
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kanagawa 1860292, 241-8515
    Japan

    Site Not Available

  • GSK Investigational Site

    Kochi, 783-8505
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kochi 1859146, 783-8505
    Japan

    Site Not Available

  • GSK Investigational Site

    Kyoto, 612-8555
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Kyoto 1857910, 612-8555
    Japan

    Site Not Available

  • GSK Investigational Site

    Mie, 515-8544
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Mie 1857357, 515-8544
    Japan

    Site Not Available

  • GSK Investigational Site

    Osaka, 594-0073
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Osaka 1853909, 541-8567
    Japan

    Site Not Available

  • GSK Investigational Site

    Tokyo, 113-8603
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Tokyo 1850147, 113-8603
    Japan

    Site Not Available

  • GSK Investigational Site

    Toyama, 930-8550
    Japan

    Active - Recruiting

  • GSK Investigational Site

    Toyama 1849876, 930-8550
    Japan

    Site Not Available

  • GSK Investigational Site

    Guadalajara, 44280
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    Guadalajara 4005539, 44280
    Mexico

    Site Not Available

  • GSK Investigational Site

    Mexico City, 06700
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    Mexico City 3530597, 06760
    Mexico

    Site Not Available

  • GSK Investigational Site

    Monterrey, 66260
    Mexico

    Active - Recruiting

  • GSK Investigational Site

    Monterrey 3995465, 66260
    Mexico

    Site Not Available

  • GSK Investigational Site

    Kielce, 25-640
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Kielce 769250, 25-640
    Poland

    Site Not Available

  • GSK Investigational Site

    Otwock, 05-400
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Otwock 762788, 05-400
    Poland

    Site Not Available

  • GSK Investigational Site

    Poznan, 60-569
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Poznan 3088171, 60-569
    Poland

    Site Not Available

  • GSK Investigational Site

    Siedlce, 08-110
    Poland

    Active - Recruiting

  • GSK Investigational Site

    Siedlce 759412, 08-110
    Poland

    Site Not Available

  • GSK Investigational Site

    Almada, 2805-267
    Portugal

    Active - Recruiting

  • GSK Investigational Site

    Craiova Dolj, Dolj 200535
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Craiova, 200542
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Floreşti, 407280
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Iași, 700451
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Iași 675810, 700451
    Romania

    Site Not Available

  • GSK Investigational Site

    Timișoara, 300329
    Romania

    Active - Recruiting

  • GSK Investigational Site

    Changwon, 51472
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Changwon 1846326, 51472
    South Korea

    Site Not Available

  • GSK Investigational Site

    Cheongju Chungcheongbuk-do, 28644
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Daegu, 41404
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Daegu 1835329, 41404
    South Korea

    Site Not Available

  • GSK Investigational Site

    Gyeonggi-do, 10408
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Gyeonggi-do 6363696, 10408
    South Korea

    Site Not Available

  • GSK Investigational Site

    Seongnam-si Gyeonggi-do, 13620
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Seoul, 03722
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • GSK Investigational Site

    Suwon Gyeonggi-do, 442723
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Ulsan, 44033
    South Korea

    Active - Recruiting

  • GSK Investigational Site

    Ulsan 1833747, 44033
    South Korea

    Site Not Available

  • GSK Investigational Site

    Barcelona, 8017
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Barcelona 3128760, 8017
    Spain

    Site Not Available

  • GSK Investigational Site

    L'Hospitalet de Llobrega, 08908
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Las Palmas de Gran Canar, 35016
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid, 28041
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • GSK Investigational Site

    Santander, 39011
    Spain

    Active - Recruiting

  • GSK Investigational Site

    Santander 3109718, 39011
    Spain

    Site Not Available

  • GSK Investigational Site

    Stockholm, 171 64
    Sweden

    Active - Recruiting

  • GSK Investigational Site

    Stockholm 2673730, 171 64
    Sweden

    Site Not Available

  • GSK Investigational Site

    Basel, 4031
    Switzerland

    Active - Recruiting

  • GSK Investigational Site

    Basel 2661604, 4031
    Switzerland

    Site Not Available

  • GSK Investigational Site

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • GSK Investigational Site

    Adana, Adana 01140
    Turkey (Türkiye)

    Active - Recruiting

  • GSK Investigational Site

    Adana 325363, Adana 325361 01140
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Samsun, Atakum 55200
    Turkey (Türkiye)

    Active - Recruiting

  • GSK Investigational Site

    Samsun 740264, Atakum 55200
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Ankara, 06100
    Turkey (Türkiye)

    Active - Recruiting

  • GSK Investigational Site

    Ankara 323786, 06520
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Diyarbakır, 21280
    Turkey (Türkiye)

    Active - Recruiting

  • GSK Investigational Site

    Diyarbakır 316541, 21280
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Istanbul, 34010
    Turkey (Türkiye)

    Active - Recruiting

  • GSK Investigational Site

    Istanbul 745044, 34010
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    Izmir, 35110
    Turkey (Türkiye)

    Active - Recruiting

  • GSK Investigational Site

    Izmir 311046, 35110
    Turkey (Türkiye)

    Site Not Available

  • GSK Investigational Site

    London, W1G 6AD
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    London 2643743, W1G 6AD
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Portsmouth, PO6 3LY
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Portsmouth 2639996, PO6 3LY
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Truro, TR1 3LJ
    United Kingdom

    Active - Recruiting

  • GSK Investigational Site

    Truro 2635412, TR1 3LJ
    United Kingdom

    Site Not Available

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