Last updated: 05/22/2026 18:50:55

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

GSK study ID
223674
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
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 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.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Overall Survival (OS)

Timeframe: Up to approximately 113 weeks

Secondary outcomes:

Objective Response Rate (ORR)

Timeframe: Up to approximately 139 weeks

Duration of Response (DoR)

Timeframe: Up to approximately 139 weeks

Progression-free survival (PFS)

Timeframe: Up to approximately 139 weeks

Disease control rate (DCR) 12

Timeframe: Up to approximately 11 weeks

Brain PFS

Timeframe: Up to approximately 139 weeks

Brain DoR

Timeframe: Up to approximately 139 weeks

Brain ORR

Timeframe: Up to approximately 139 weeks

Brain DCR12

Timeframe: Up to approximately 11 weeks

Time to brain progression

Timeframe: Up to approximately 139 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 139 weeks

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

Timeframe: Up to approximately 139 weeks

Number of participants with a change from baseline in vital signs

Timeframe: Baseline (Day -1) and up to approximately 139 weeks

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

Timeframe: Baseline (Day -1) and up to approximately 139 weeks

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

Timeframe: Baseline (Day -1) and up to approximately 139 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 139 weeks

Observed PK concentrations of Ris-Rez (conjugated antibody and small molecule payload)

Timeframe: Up to approximately 139 weeks

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

Timeframe: Up to approximately 139 weeks

Titers of ADA against Ris-Rez

Timeframe: Up to approximately 139 weeks

Participant reported experience with study treatment

Timeframe: Up to approximately 139 weeks

Interventions:
Biological/vaccine: Ris-Rez
Drug: Topotecan
Enrollment:
420
Observational study model:
Not applicable
Primary completion date:
2027-05-11
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
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
Guadajalara, 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
Location
GSK Investigational Site
Timisoara, Romania, 300329
Status
Recruiting
Location
GSK Investigational Site
Lausanne, Switzerland, 1011
Status
Recruiting
Location
GSK Investigational Site
Almada, Portugal, 2805-267
Status
Recruiting
Location
GSK Investigational Site
Craiova, Romania, 200542
Status
Recruiting
Location
GSK Investigational Site
Ruse, Bulgaria, 7002
Status
Recruiting
Location
GSK Investigational Site
Plovdiv, Bulgaria
Status
Recruiting
Location
GSK Investigational Site
Floresti, Romania, 407280
Status
Recruiting
Location
GSK Investigational Site
Pisa, Italy, 57124
Status
Recruiting
Location
GSK Investigational Site
GRENOBLE CEDEX 9, France, 38043
Status
Recruiting
Location
GSK Investigational Site
Muenchen, Germany, 81377
Status
Recruiting
Location
GSK Investigational Site
Bergamo, Italy
Status
Recruiting
Location
GSK Investigational Site
Nuernberg, Germany, 90340
Status
Recruiting
Location
GSK Investigational Site
Saint Herblain, France, 44805
Status
Recruiting
Location
GSK Investigational Site
Miyagi, Japan, 980-8574
Status
Recruiting
Location
GSK Investigational Site
Karlsruhe, Baden-Wuerttemberg, Germany, 76137
Status
Recruiting
Location
GSK Investigational Site
Stuttgart, Germany, 70376
Status
Recruiting
Location
GSK Investigational Site
Augsburg, Germany, 86156
Status
Recruiting
Location
GSK Investigational Site
GuimarAes, Portugal, 4835-044
Status
Recruiting
Location
GSK Investigational Site
Cluj-Napoca, Romania, 400015
Status
Recruiting
Location
GSK Investigational Site
Orbassano, Italy, 10043
Status
Recruiting
Location
GSK Investigational Site
GyOngyOs, Hungary, 3200
Status
Recruiting
Location
GSK Investigational Site
KecskemEt, Hungary, 6000
Status
Recruiting
Location
GSK Investigational Site
TOrOkbAlint, Hungary, 2045
Status
Recruiting
Location
GSK Investigational Site
Esslingen, Germany, 73730
Status
Recruiting
Location
GSK Investigational Site
Budapest, Hungary, H-1121
Status
Recruiting
Location
GSK Investigational Site
Chemnitz, Germany, 09113
Status
Recruiting
Location
GSK Investigational Site
Farkasgyepű, Hungary, 8552
Status
Recruiting
Location
GSK Investigational Site
Sofia, Bulgaria, 1606
Status
Recruiting
Location
GSK Investigational Site
LODZ, Poland, 93-338
Status
Recruiting
Location
GSK Investigational Site
Tokyo, Japan, 104-0045
Status
Recruiting
Location
GSK Investigational Site
Nedlands, WA, Australia, 6009
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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