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

May 22, 2026 updated by: GlaxoSmithKline

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426ABP
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christian Fuentes
      • Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nicolas Minatta
      • Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Martin Paskevicius
      • Rosario, Argentina, S2000 DEJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriel Garbaos
      • Vicente López, Argentina, 1602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gustavo Lopez
    • Buenos Aires
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ignacio Casarini
  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Emma Boys
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Malinda Itchins
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adnan Khattak
  • Brazil
      • Barretos, Brazil, 14784-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Flavio Augusto Ferreira da Silva
      • CuritibaPR, Brazil, 80810-050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Karina Costa Maia Vianna
      • Florianópolis, Brazil, 88020-210
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fabricio Grando
      • Porto Alegre, Brazil, 90610-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Gelatti
      • Porto Alegre, Brazil, 90020-090
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Katsuki Tiscoski
        • Contact:
        • Contact:
      • Rio de Janeiro, Brazil, 22250-905
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tatiane Montella
      • São Paulo, Brazil, 04312903
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Gilberto De Castro Junior
        • Contact:
        • Contact:
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yordan Ignatov
      • Plovdiv, Bulgaria
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Vladimir Kanarev
        • Contact:
        • Contact:
      • Rousse, Bulgaria, 7002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nikolay Nikolaev
      • Sofia, Bulgaria, 1606
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhasmina Mihaylova
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul Wheatley-Price
      • Toronto, Ontario, Canada, M5G 1Z5
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Natasha Leighl
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer Friedmann
      • Montreal, Quebec, Canada, H4J 1C5
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kevin Jao
  • Finland
      • Vaasa, Finland, 65130
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ravichandra Ravi
  • France
      • Boulogne-Billancourt, France, 92100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Etienne Giroux Leprieur
      • Grenoble, France, 38043
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Denis Moro-Sibilot
        • Contact:
        • Contact:
      • Saint-Herblain, France, 44805
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sandrine Hiret
        • Contact:
        • Contact:
  • Germany
      • Augsburg, Germany, 86156
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bjoern Hackanson
      • Chemnitz, Germany, 09113
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stefan Hammerschmidt
      • Esslingen am Neckar, Germany, 73730
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Martin Faehling
      • Lübeck, Germany, 23562
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jens Kisro
        • Contact:
        • Contact:
      • München, Germany, 81377
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diego Kauffmann-Guerrero
      • Nuremberg, Germany, 90340
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Markus Horneber
      • Stuttgart, Germany, 70376
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Perihan Canoglu
    • Baden-Wurttemberg
      • Karlsruhe, Baden-Wurttemberg, Germany, 76137
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Christian Meyer zum Bueschenfelde
        • Contact:
        • Contact:
  • Greece
      • Athens, Greece, 11526
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • IOANNIS MOUNTZIOS
        • Contact:
        • Contact:
      • Athens, Greece, 12462
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Amanda Psyrri
      • Athens, Greece, 115 22
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • ANASTASIOS GRIVAS
      • Heraklion Crete, Greece, 71110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofia Agelaki
      • Pylaia Thessaloniki, Greece, 57001
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ippokratis Korantzis
        • Contact:
        • Contact:
      • Pylaia Thessaloniki, Greece, 570 01
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofia Baka
  • Hungary
      • Budapest, Hungary, H-1121
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriella Temesi
      • Farkasgyepű, Hungary, 8552
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zsolt Kiraly
      • Gyöngyös, Hungary, 3200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • István Albert
      • Kecskemét, Hungary, 6000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zsuzsanna Kelemen
      • Törökbálint, Hungary, 2045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriella Gálffy
  • Ireland
      • Dublin, Ireland, D09 V2N0
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jarushka Naidoo
  • Israel
      • Jerusalem, Israel, 9112001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yakir Rottenberg
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • ido wolf
  • Italy
      • Bergamo, Italy
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chiara Catania
      • Orbassano, Italy, 10043
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Passiglia
      • Pisa, Italy, 57124
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giacomo Allegrini
  • Japan
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Isamu Okamoto
        • Contact:
        • Contact:
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yasuyuki Ikezawa
      • Ishikawa, Japan, 920-8530
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Sone
      • Kagoshima, Japan, 890-8520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shunsuke Misono
      • Kanagawa, Japan, 241-8515
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shuji Murakami
      • Kanagawa, Japan, 252-0375
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katsuhiko Naoki
      • Kochi, Japan, 783-8505
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Toshiyuki Kozuki
        • Contact:
      • Kyoto, Japan, 612-8555
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kohei Fujita
      • Mie, Japan, 515-8544
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Osamu Hataji
      • Miyagi, Japan, 980-8574
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Eisaku Miyauchi
        • Contact:
      • Osaka, Japan, 541-8567
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • takako inoue
      • Osaka, Japan, 573-1191
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takayasu Kurata
      • Osaka, Japan, 594-0073
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takafumi Okabe
      • Tokyo, Japan, 113-8603
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kazuo Kasahara
      • Tokyo, Japan, 104-0045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yasushi Goto
      • Tokyo, Japan, 113-8677
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yukio Hosomi
      • Toyama, Japan, 930-8550
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Hirokazu Taniguchi
        • Contact:
        • Contact:
  • Mexico
      • Guadajalara, Mexico, 44280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Carlos Vazquez Limon
      • Mexico City, Mexico, 06760
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raul Rogelio Trejo-Rosales
      • Mexico City, Mexico, 06700
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Eleazar Omar Macedo-Perez
        • Contact:
        • Contact:
      • Monterrey, Mexico, 66260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hector Marcelino Diaz-Perez
  • Poland
      • Kielce, Poland, 25-640
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tomasz Kucharczyk
      • Lodz, Poland, 93-338
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ewa Kalinka
        • Contact:
        • Contact:
      • Otwock, Poland, 05-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aleksandra Szczesna
      • Poznan, Poland, 60-569
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katarzyna Stencel
      • Siedlce, Poland, 08-110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lubomir Bodnar
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Lopes
      • Guimarães, Portugal, 4835-044
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Brito
  • Romania
      • Cluj-Napoca, Romania, 400015
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Cristina Ligia Cebotaru
        • Contact:
        • Contact:
      • Craiova, Romania, 200542
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Schenker
      • Floreşti, Romania, 407280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrei Ungureanu
      • Iași, Romania, 700451
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Teodora Alexa-Stratulat
      • Timișoara, Romania, 300329
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • DANIELA SIRBU
    • Dolj
      • Craiova Dolj, Dolj, Romania, 200535
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristian Lungulescu
  • South Korea
      • Changwon, South Korea, 51472
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Junho Ji
      • Cheongju Chungcheongbuk-do, South Korea, 28644
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ki Hyeong Lee
        • Contact:
        • Contact:
      • Daegu, South Korea, 41404
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Seung Soo Yoo
      • Gyeonggi-do, South Korea, 10408
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Young Joo Lee
      • Seongnam-si Gyeonggi-do, South Korea, 13620
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yu Jung Kim
      • Seoul, South Korea, 03722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hye Ryun Kim
      • Suwon Gyeonggi-do, South Korea, 442723
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Byoung Yong Shim
      • Ulsan, South Korea, 44033
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cheol Kyung Sin
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pedro Rocha
      • Barcelona, Spain, 8017
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Edurne Arriola Aperribay
        • Contact:
        • Contact:
      • Barcelona, Spain, 8036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Noemi Reguart Aransay
        • Contact:
        • Contact:
      • L'Hospitalet de Llobrega, Spain, 08908
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miguel Ángel Mosteiro Lamas
      • Las Palmas de Gran Canar, Spain, 35016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Delvys Rodriguez-Abreu
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Javier Francisco De Castro Carpeño
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Eugenia Olmedo García
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Luis Paz-Ares
        • Contact:
        • Contact:
      • Madrid, Spain, 28007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rosa Alvarez Alvarez
        • Contact:
        • Contact:
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marta Lopez-Brea Piqueras
        • Contact:
        • Contact:
  • Sweden
      • Stockholm, Sweden, 171 64
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hannah Björn Andtback
  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Schmitt
      • Lausanne, Switzerland, 1011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nuria Neisy Mederos Alfonso
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ismail Erturk
      • Ankara, Turkey (Türkiye), 06100
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mustafa Erman
        • Contact:
        • Contact:
      • Ankara, Turkey (Türkiye), 06520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Umut Demirci
      • Diyarbakır, Turkey (Türkiye), 21280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Muhammet kaplan
      • Istanbul, Turkey (Türkiye), 34010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Seyda Gunduz
        • Contact:
        • Contact:
      • Izmir, Turkey (Türkiye), 35110
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sema Erturk
      • Izmir, Turkey (Türkiye), 35340
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elif Atag
    • Adana
      • Adana, Adana, Turkey (Türkiye), 01140
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ahmet Sumbul
    • Atakum
      • Samsun, Atakum, Turkey (Türkiye), 55200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dilek Erdem
  • United Kingdom
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Anja Williams
        • Contact:
        • Contact:
      • Portsmouth, United Kingdom, PO6 3LY
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Giuseppe Luigi Banna
      • Truro, United Kingdom, TR1 3LJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Grant Stewart

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Topotecan
Drug: Topotecan
Topotecan will be administered
Experimental: Ris-Rez
Biological: Ris-Rez
Ris-Rez will be administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival (OS)
Time Frame: Up to approximately 113 weeks
OS is defined as the time from the date of randomization to the date of death by any cause
Up to approximately 113 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 139 weeks
ORR is defined as the percentage of participants with a confirmed complete (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by investigator/Blinded Independent Central Review (BICR) assessment
Up to approximately 139 weeks
Duration of Response (DoR)
Time Frame: Up to approximately 139 weeks
DoR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by investigator/BICR assessment to the date of first documented PD per RECIST 1.1 by investigator/BICR assessment or death due to any cause, whichever comes first
Up to approximately 139 weeks
Progression-free survival (PFS)
Time Frame: Up to approximately 139 weeks
PFS is defined as the time from the date of randomization to the date of first documented Progressive disease (PD) per RECIST 1.1 by investigator/BICR assessment or death from any cause, whichever occurs first
Up to approximately 139 weeks
Disease control rate (DCR) 12
Time Frame: Up to approximately 11 weeks
DCR12 is defined as the percentage of participants who have a Best objective response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD) for a duration of at least 11 weeks, per RECIST 1.1 by investigator/BICR assessment
Up to approximately 11 weeks
Brain PFS
Time Frame: Up to approximately 139 weeks
Brain PFS is defined as the time from the date of randomization to the date of first documented PD per modified Response assessment in neuro-oncology (RANO-BM) by BICR assessment or death from any cause, whichever occurs first in participants with history of brain metastasis or presence of brain metastasis at baseline
Up to approximately 139 weeks
Brain DoR
Time Frame: Up to approximately 139 weeks
Brain DoR is defined as the time from the first documented objective response (CR/PR according to modified RANO-BM BICR assessment) until the time of first documentation of disease progression or death, whichever occurs first, in participants with a history of brain metastasis or presence of brain metastasis at baseline
Up to approximately 139 weeks
Brain ORR
Time Frame: Up to approximately 139 weeks
Brain ORR is defined as the percentage of participants with confirmed brain CR or confirmed brain PR per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline
Up to approximately 139 weeks
Brain DCR12
Time Frame: Up to approximately 11 weeks
Brain DCR12 is defined as the percentage of participants with an intracranial BOR of confirmed CR, confirmed PR or SD after the date of randomization, per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline
Up to approximately 11 weeks
Time to brain progression
Time Frame: Up to approximately 139 weeks
Time to brain progression is defined as the time from the date of randomization to the date of first documented brain PD per modified RANO-BM BICR assessment in participants with a history of brain metastasis or presence of brain metastasis at baseline.
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
Time Frame: Up to approximately 139 weeks
Up to approximately 139 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Time Frame: Up to approximately 139 weeks
Up to approximately 139 weeks
Number of participants with a change from baseline in vital signs
Time Frame: Baseline (Day -1) and up to approximately 139 weeks
Number of participants will be assessed.
Baseline (Day -1) and up to approximately 139 weeks
Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)
Time Frame: Baseline (Day -1) and up to approximately 139 weeks
Number of participants will be assessed.
Baseline (Day -1) and up to approximately 139 weeks
Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)
Time Frame: Baseline (Day -1) and up to approximately 139 weeks
Number of participants will be assessed.
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
Time Frame: Baseline (Day -1) and up to approximately 139 weeks
Number of participants will be assessed.
Baseline (Day -1) and up to approximately 139 weeks
Observed PK concentrations of Ris-Rez (conjugated antibody and small molecule payload)
Time Frame: Up to approximately 139 weeks
Up to approximately 139 weeks
Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
Time Frame: Up to approximately 139 weeks
Up to approximately 139 weeks
Titers of ADA against Ris-Rez
Time Frame: Up to approximately 139 weeks
Up to approximately 139 weeks
Participant reported experience with study treatment
Time Frame: Up to approximately 139 weeks
Participant reported outcomes assessing symptoms, daily functioning, and overall health status during study treatment will be measured using validated questionnaires
Up to approximately 139 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 11, 2025

Primary Completion (Estimated)

November 5, 2027

Study Completion (Estimated)

September 28, 2029

Study Registration Dates

First Submitted

July 30, 2025

First Submitted That Met QC Criteria

July 30, 2025

First Posted (Actual)

August 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 27, 2026

Last Update Submitted That Met QC Criteria

May 22, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 223674
  • 2025-521627-78-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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