Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT07099898

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

Led by GlaxoSmithKline · Updated on 2026-04-22

420

Participants Needed

114

Research Sites

215 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older or minimum legal adult age at consent
  • Histologically or cytologically confirmed extensive-stage small cell lung cancer (ES-SCLC)
  • Received 1 prior platinum-based systemic therapy with a PD-(L)1 inhibitor for at least 2 cycles and chemotherapy free interval greater than 30 days with documented progression
  • Prior tarlatamab treatment in first- or second-line ES-SCLC setting is allowed
  • At least 1 target lesion per RECIST 1.1 as determined by investigator
  • Capable of giving signed informed consent and complying with study requirements
  • Adequate organ function and ECOG performance status of 0 or 1
Not Eligible

You will not qualify if you...

  • Pathological diagnosis of complex SCLC or transformed SCLC
  • Limited stage small cell lung cancer at diagnosis
  • Prior therapy with an antibody-drug conjugate (ADC) containing Topoisomerase-1 inhibitor payload or treatments targeting B7-H3
  • Known sensitivity or allergy contraindicating study participation
  • Severe, uncontrolled or active cardiovascular disorders
  • Clinically significant bleeding or bleeding tendency within 1 month prior to first dose
  • Known active infectious diseases requiring systemic treatment or known HIV
  • Symptomatic brain metastases or untreated progression due to brain metastases, leptomeningeal/brainstem/spinal cord metastases
  • Evidence or history of interstitial lung disease or pneumonitis requiring high-dose steroids
  • Significant pulmonary disease or respiratory impairment such as uncontrolled asthma, COPD, or restrictive lung disease
  • Active Hepatitis B or Hepatitis C

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 114 locations

1

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina, 7600

Actively Recruiting

2

GSK Investigational Site

Buenos Aires, Argentina, C1426ABP

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3

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR

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4

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE

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5

GSK Investigational Site

Rosario, Argentina, S2000 DEJ

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6

GSK Investigational Site

Vicente López, Argentina, 1602

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7

GSK Investigational Site

Blacktown, New South Wales, Australia, 2148

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8

GSK Investigational Site

St Leonards, New South Wales, Australia, 2065

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9

GSK Investigational Site

Nedlands, Western Australia, Australia, 6009

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10

GSK Investigational Site

Barretos, Brazil, 14784-400

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11

GSK Investigational Site

CuritibaPR, Brazil, 80810-050

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12

GSK Investigational Site

Florianópolis, Brazil, 88020-210

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13

GSK Investigational Site

Porto Alegre, Brazil, 90020-090

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14

GSK Investigational Site

Porto Alegre, Brazil, 90610-000

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15

GSK Investigational Site

Rio de Janeiro, Brazil, 22250-905

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16

GSK Investigational Site

São Paulo, Brazil, 04312903

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17

GSK Investigational Site

Pleven, Bulgaria, 5800

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18

GSK Investigational Site

Plovdiv, Bulgaria

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19

GSK Investigational Site

Rousse, Bulgaria, 7002

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20

GSK Investigational Site

Ottawa, Ontario, Canada, K1H 8L6

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21

GSK Investigational Site

Toronto, Ontario, Canada, M5G 1Z5

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22

GSK Investigational Site

Montreal, Quebec, Canada, H3T 1E2

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23

GSK Investigational Site

Montreal, Quebec, Canada, H4J 1C5

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24

GSK Investigational Site

Vaasa, Finland, 65130

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25

GSK Investigational Site

Boulogne-Billancourt, France, 92100

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26

GSK Investigational Site

Grenoble, France, 38043

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27

GSK Investigational Site

Saint-Herblain, France, 44805

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28

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany, 76137

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29

GSK Investigational Site

Augsburg, Germany, 86156

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30

GSK Investigational Site

Esslingen am Neckar, Germany, 73730

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31

GSK Investigational Site

Lübeck, Germany, 23562

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32

GSK Investigational Site

München, Germany, 81377

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33

GSK Investigational Site

Nuremberg, Germany, 90340

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34

GSK Investigational Site

Stuttgart, Germany, 70376

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35

GSK Investigational Site

Athens, Greece, 115 22

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36

GSK Investigational Site

Athens, Greece, 11526

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37

GSK Investigational Site

Athens, Greece, 12462

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38

GSK Investigational Site

Heraklion Crete, Greece, 71110

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39

GSK Investigational Site

Pylaia Thessaloniki, Greece, 570 01

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40

GSK Investigational Site

Pylaia Thessaloniki, Greece, 57001

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41

GSK Investigational Site

Gyöngyös, Hungary, 3200

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42

GSK Investigational Site

Kecskemét, Hungary, 6000

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43

GSK Investigational Site

Törökbálint, Hungary, 2045

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44

GSK Investigational Site

Dublin, Ireland, D09 V2N0

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45

GSK Investigational Site

Jerusalem, Israel, 9112001

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46

GSK Investigational Site

Tel Aviv, Israel, 6423906

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47

GSK Investigational Site

Bergamo, Italy

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48

GSK Investigational Site

Orbassano, Italy, 10043

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49

GSK Investigational Site

Pisa, Italy, 57124

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50

GSK Investigational Site

Fukuoka, Japan, 812-8582

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51

GSK Investigational Site

Hokkaido, Japan, 060-8648

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52

GSK Investigational Site

Ishikawa, Japan, 920-8530

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53

GSK Investigational Site

Kagoshima, Japan, 890-8520

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54

GSK Investigational Site

Kanagawa, Japan, 241-8515

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55

GSK Investigational Site

Kanagawa, Japan, 252-0375

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56

GSK Investigational Site

Kochi, Japan, 783-8505

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57

GSK Investigational Site

Kyoto, Japan, 612-8555

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58

GSK Investigational Site

Mie, Japan, 515-8544

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59

GSK Investigational Site

Miyagi, Japan, 980-8574

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60

GSK Investigational Site

Osaka, Japan, 541-8567

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61

GSK Investigational Site

Osaka, Japan, 573-1191

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62

GSK Investigational Site

Osaka, Japan, 594-0073

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63

GSK Investigational Site

Tokyo, Japan, 113-8603

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64

GSK Investigational Site

Tokyo, Japan, 113-8677

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65

GSK Investigational Site

Toyama, Japan, 930-8550

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66

GSK Investigational Site

Guadalajara, Mexico, 44280

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67

GSK Investigational Site

Mexico City, Mexico, 06700

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68

GSK Investigational Site

Mexico City, Mexico, 06760

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69

GSK Investigational Site

Monterrey, Mexico, 66260

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70

GSK Investigational Site

Kielce, Poland, 25-640

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71

GSK Investigational Site

Otwock, Poland, 05-400

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72

GSK Investigational Site

Poznan, Poland, 60-569

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73

GSK Investigational Site

Siedlce, Poland, 08-110

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74

GSK Investigational Site

Almada, Portugal, 2805-267

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75

GSK Investigational Site

Guimarães, Portugal, 4835-044

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76

GSK Investigational Site

Craiova Dolj, Dolj, Romania, 200535

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77

GSK Investigational Site

Cluj-Napoca, Romania, 400015

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78

GSK Investigational Site

Craiova, Romania, 200542

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79

GSK Investigational Site

Floreşti, Romania, 407280

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80

GSK Investigational Site

Iași, Romania, 700451

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81

GSK Investigational Site

Timișoara, Romania, 300329

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82

GSK Investigational Site

Changwon, South Korea, 51472

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83

GSK Investigational Site

Cheongju Chungcheongbuk-do, South Korea, 28644

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84

GSK Investigational Site

Daegu, South Korea, 41404

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85

GSK Investigational Site

Gyeonggi-do, South Korea, 10408

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86

GSK Investigational Site

Seongnam-si Gyeonggi-do, South Korea, 13620

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87

GSK Investigational Site

Seoul, South Korea, 03722

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88

GSK Investigational Site

Suwon Gyeonggi-do, South Korea, 442723

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89

GSK Investigational Site

Ulsan, South Korea, 44033

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90

GSK Investigational Site

Barcelona, Spain, 08035

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91

GSK Investigational Site

Barcelona, Spain, 8017

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92

GSK Investigational Site

Barcelona, Spain, 8036

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93

GSK Investigational Site

L'Hospitalet de Llobrega, Spain, 08908

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94

GSK Investigational Site

Las Palmas de Gran Canar, Spain, 35016

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95

GSK Investigational Site

Madrid, Spain, 28007

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96

GSK Investigational Site

Madrid, Spain, 28034

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97

GSK Investigational Site

Madrid, Spain, 28041

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98

GSK Investigational Site

Madrid, Spain, 28046

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99

GSK Investigational Site

Santander, Spain, 39011

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100

GSK Investigational Site

Stockholm, Sweden, 171 64

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101

GSK Investigational Site

Basel, Switzerland, 4031

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102

GSK Investigational Site

Lausanne, Switzerland, 1011

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103

GSK Investigational Site

Adana, Adana, Turkey (Türkiye), 01140

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104

GSK Investigational Site

Samsun, Atakum, Turkey (Türkiye), 55200

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105

GSK Investigational Site

Ankara, Turkey (Türkiye), 06010

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106

GSK Investigational Site

Ankara, Turkey (Türkiye), 06100

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107

GSK Investigational Site

Ankara, Turkey (Türkiye), 06520

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108

GSK Investigational Site

Diyarbakır, Turkey (Türkiye), 21280

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109

GSK Investigational Site

Istanbul, Turkey (Türkiye), 34010

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110

GSK Investigational Site

Izmir, Turkey (Türkiye), 35110

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111

GSK Investigational Site

Izmir, Turkey (Türkiye), 35340

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112

GSK Investigational Site

London, United Kingdom, W1G 6AD

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113

GSK Investigational Site

Portsmouth, United Kingdom, PO6 3LY

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114

GSK Investigational Site

Truro, United Kingdom, TR1 3LJ

Actively Recruiting

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Research Team

U

US GSK Clinical Trials Call Center

CONTACT

E

EU GSK Clinical Trials Call Center

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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