Last updated: 02/13/2026 08:40:27

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

GSK study ID
223674
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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)
Trial description: "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."
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Objective Response Rate (ORR)

Timeframe: Up to approximately 55 weeks

Overall Survival (OS)

Timeframe: Up to approximately 55 weeks

Secondary outcomes:

ORR by investigator assessment

Timeframe: Up to approximately 161 weeks

Duration of Response (DoR)

Timeframe: Up to approximately 161 weeks

Progression-free survival (PFS)

Timeframe: Up to approximately 161 weeks

Disease control rate (DCR) 12

Timeframe: Up to approximately 11 weeks

Brain PFS

Timeframe: Up to approximately 161 weeks

Brain DoR

Timeframe: Up to approximately 161 weeks

Brain ORR

Timeframe: Up to approximately 161 weeks

Brain DCR12

Timeframe: Up to approximately 11 weeks

Time to brain progression

Timeframe: Up to approximately 161 weeks

Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity

Timeframe: Up to approximately 161 weeks

Number of participants with AEs leading to dose modifications or study intervention discontinuation

Timeframe: Up to approximately 161 weeks

Number of participants with a change from baseline in vital signs

Timeframe: Baseline (Day -1) and up to approximately 161 weeks

Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)

Timeframe: Baseline (Day -1) and up to approximately 161 weeks

Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)

Timeframe: Baseline (Day -1) and up to approximately 161 weeks

Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status

Timeframe: Baseline (Day -1) and up to approximately 161 weeks

Observed PK concentrations of GSK5764227 (conjugated antibody and small molecule payload)

Timeframe: Up to approximately 161 weeks

Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)

Timeframe: Up to approximately 161 weeks

Titers of ADA against GSK5764227

Timeframe: Up to approximately 161 weeks

Interventions:
  • Biological/vaccine: GSK5764227
  • Drug: Topotecan
  • Enrollment:
    300
    Primary completion date:
    2027-29-10
    Observational study model:
    Not applicable
    Time perspective:
    Not applicable
    Clinical publications:
    Not applicable
    Medical condition
    Neoplasms, Lung
    Product
    Not applicable
    Collaborators
    Not applicable
    Study date(s)
    August 2025 to September 2029
    Type
    Interventional
    Phase
    3

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • 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
    • Participants are excluded from the study if any of the following criteria apply:
    • Pathological diagnosis of complex SCLC or transformed SCLC.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE
    Status
    Recruiting
    Location
    GSK Investigational Site
    St Leonards, NSW, Australia, 2065
    Status
    Recruiting
    Location
    GSK Investigational Site
    Fukuoka, Japan, 812-8582
    Status
    Recruiting
    Location
    GSK Investigational Site
    Blacktown, NSW, Australia, 2148
    Status
    Recruiting
    Location
    GSK Investigational Site
    BUENOS AIRES, Argentina, C1426ABP
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ottawa, ON, Canada, K1H 8L6
    Status
    Recruiting
    Location
    GSK Investigational Site
    Changwon, Unmapped, 51472
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ulsan, Unmapped, 44033
    Status
    Recruiting
    Location
    GSK Investigational Site
    Osaka, Japan, 594-0073
    Status
    Recruiting
    Location
    GSK Investigational Site
    Seongnam-si Gyeonggi-do, Unmapped, 13620
    Status
    Recruiting
    Location
    GSK Investigational Site
    Gyeonggi-do, Unmapped, 10408
    Status
    Recruiting
    Location
    GSK Investigational Site
    Rosario, Argentina, S2000 DEJ
    Status
    Recruiting
    Location
    GSK Investigational Site
    Nedlands, WA, Australia, 6009
    Status
    Recruiting
    Location
    GSK Investigational Site
    Hokkaido, Japan, 060-8648
    Status
    Recruiting
    Location
    GSK Investigational Site
    Kyoto, Japan, 612-8555
    Status
    Recruiting
    Location
    GSK Investigational Site
    Daegu, Unmapped, 41404
    Status
    Recruiting
    Location
    GSK Investigational Site
    London, Unmapped, W1G 6AD
    Status
    Recruiting
    Location
    GSK Investigational Site
    Suwon Gyeonggi-do, Unmapped, 442723
    Status
    Recruiting
    Location
    GSK Investigational Site
    Mie, Japan, 515-8544
    Status
    Recruiting
    Location
    GSK Investigational Site
    Toronto, ON, Canada, M5G 1Z5
    Status
    Recruiting
    Location
    GSK Investigational Site
    Kagoshima, Japan, 890-8520
    Status
    Recruiting
    Location
    GSK Investigational Site
    Seoul, Unmapped, 03722
    Status
    Recruiting
    Location
    GSK Investigational Site
    Tokyo, Japan, 113-8677
    Status
    Recruiting
    Location
    GSK Investigational Site
    Cheongju Chungcheongbuk-do, Unmapped, 28644
    Status
    Recruiting
    Location
    GSK Investigational Site
    Vicente Lopez, Argentina, 1602
    Status
    Recruiting
    Location
    GSK Investigational Site
    CuritibaPR, Brazil, 80810-050
    Status
    Recruiting
    Location
    GSK Investigational Site
    Truro, Unmapped, TR1 3LJ
    Status
    Recruiting
    Location
    GSK Investigational Site
    Kochi, Japan, 783-8505
    Status
    Recruiting
    Location
    GSK Investigational Site
    Porto Alegre, Brazil, 90020-090
    Status
    Recruiting
    Location
    GSK Investigational Site
    Istanbul, Turkey, 34010
    Status
    Recruiting
    Location
    GSK Investigational Site
    Mexico City, Mexico, 06700
    Status
    Recruiting
    Location
    GSK Investigational Site
    Osaka, Japan, 573-1191
    Status
    Recruiting
    Location
    GSK Investigational Site
    Tokyo, Japan, 113-8603
    Status
    Recruiting
    Location
    GSK Investigational Site
    Toyama, Japan, 930-8550
    Status
    Recruiting
    Location
    GSK Investigational Site
    Adana, Seyhan, Turkey, 01140
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ankara, Turkey, 06010
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ankara, Turkey, 06100
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ankara, Turkey, 06520
    Status
    Recruiting
    Location
    GSK Investigational Site
    Diyarbakir, Turkey, 21280
    Status
    Recruiting
    Location
    GSK Investigational Site
    Samsun, Atakum, Turkey, 55200
    Status
    Recruiting
    Location
    GSK Investigational Site
    Montreal, QC, Canada, H3T 1E2
    Status
    Recruiting
    Location
    GSK Investigational Site
    CIUDAD DE MEXICO, Mexico, 06760
    Status
    Recruiting
    Location
    GSK Investigational Site
    Sao Paulo, Brazil, 04312903
    Status
    Recruiting
    Location
    GSK Investigational Site
    Guadalajara, Mexico, 44280
    Status
    Recruiting
    Location
    GSK Investigational Site
    Izmir, Turkey, 35110
    Status
    Recruiting
    Location
    GSK Investigational Site
    Portsmouth, Unmapped, PO6 3LY
    Status
    Recruiting
    Location
    GSK Investigational Site
    Monterrey, Mexico, 66260
    Status
    Recruiting
    Location
    GSK Investigational Site
    Basel, Switzerland, 4031
    Status
    Recruiting
    Location
    GSK Investigational Site
    Mar del Plata, Buenos Aires, Argentina, 7600
    Status
    Recruiting
    Location
    GSK Investigational Site
    Kanagawa, Japan, 252-0375
    Status
    Recruiting
    Location
    GSK Investigational Site
    Osaka, Japan, 541-8567
    Status
    Recruiting
    Location
    GSK Investigational Site
    Izmir, Turkey, 35340
    Status
    Recruiting
    Location
    GSK Investigational Site
    Ishikawa, Japan, 920-8530
    Status
    Recruiting
    Location
    GSK Investigational Site
    Jerusalem, Israel, 9112001
    Status
    Recruiting
    Location
    GSK Investigational Site
    Pylaia Thessaloniki, Greece, 570 01
    Status
    Recruiting
    Location
    GSK Investigational Site
    STOCKHOLM, Sweden, 171 64
    Status
    Recruiting
    Location
    GSK Investigational Site
    Athens, Greece, 115 22
    Status
    Recruiting
    Location
    GSK Investigational Site
    Vaasa, Finland, 65130
    Status
    Recruiting
    Location
    GSK Investigational Site
    Madrid, Spain, 28041
    Status
    Recruiting
    Location
    GSK Investigational Site
    Montreal, QC, Canada, H4J 1C5
    Status
    Recruiting
    Location
    GSK Investigational Site
    Madrid, Spain, 28034
    Status
    Recruiting
    Location
    GSK Investigational Site
    Madrid, Spain, 28007
    Status
    Recruiting
    Location
    GSK Investigational Site
    Barcelona, Spain, 8017
    Status
    Recruiting
    Location
    GSK Investigational Site
    Athens, Greece, 12462
    Status
    Recruiting
    Location
    GSK Investigational Site
    Florianopolis, Brazil, 88020-210
    Status
    Recruiting
    Location
    GSK Investigational Site
    Rio de Janeiro, Brazil, 22250-905
    Status
    Recruiting
    Location
    GSK Investigational Site
    Barcelona, Spain, 08035
    Status
    Recruiting
    Location
    GSK Investigational Site
    Porto Alegre, Brazil, 90610-000
    Status
    Recruiting
    Location
    GSK Investigational Site
    Dublin 9, Ireland, D09 V2N0
    Status
    Recruiting
    Location
    GSK Investigational Site
    Tel Aviv, Israel, 6423906
    Status
    Recruiting
    Location
    GSK Investigational Site
    Kielce, Poland, 25-640
    Status
    Recruiting
    Location
    GSK Investigational Site
    Boulogne Billancourt, France, 92100
    Status
    Recruiting
    Location
    GSK Investigational Site
    Athens, Greece, 11526
    Status
    Recruiting
    Location
    GSK Investigational Site
    Poznan, Poland, 60-569
    Status
    Recruiting
    Location
    GSK Investigational Site
    Craiova Dolj, Dolj, Romania, 200535
    Status
    Recruiting
    Location
    GSK Investigational Site
    Santander, Spain, 39011
    Status
    Recruiting
    Location
    GSK Investigational Site
    Pleven, Bulgaria, 5800
    Status
    Recruiting
    Location
    GSK Investigational Site
    Luebeck, Germany, 23562
    Status
    Recruiting
    Location
    GSK Investigational Site
    Barretos, Brazil, 14784-400
    Status
    Recruiting
    Location
    GSK Investigational Site
    L'Hospitalet de Llobrega, Spain, 08908
    Status
    Recruiting
    Location
    GSK Investigational Site
    Madrid, Spain, 28046
    Status
    Recruiting
    Location
    GSK Investigational Site
    Las Palmas De Gran Canar, Spain, 35016
    Status
    Recruiting
    Location
    GSK Investigational Site
    Otwock, Poland, 05-400
    Status
    Recruiting
    Location
    GSK Investigational Site
    Siedlce, Poland, 08-110
    Status
    Recruiting
    Location
    GSK Investigational Site
    Heraklion Crete, Greece, 71110
    Status
    Recruiting
    Location
    GSK Investigational Site
    Iasi, Romania, 700451
    Status
    Recruiting
    Location
    GSK Investigational Site
    Barcelona, Spain, 8036
    Status
    Recruiting
    Location
    GSK Investigational Site
    Kanagawa, Japan, 241-8515
    Status
    Recruiting

    Study documents

    No study documents available.

    Results overview

    Study Results yet to be posted

    Recruitment status
    Recruiting
    Actual primary completion date
    Not applicable
    Actual study completion date
    Not applicable

    Plain language summaries

    Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

    Additional information about the trial

    Additional information
    Not applicable
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