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Recruiting NCT07099898

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

Phase III Interventional Neoplasms, Lung

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ris-Rez, Topotecan.
Who it may be relevant to
Registry conditions: Neoplasms, Lung. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Argentina, Australia, Brazil, Bulgaria, Canada +19
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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)

Overview

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.

Interventions

  • Biological Ris-Rez
    Ris-Rez will be administered
  • Drug Topotecan
    Topotecan will be administered

Primary outcome measures

  • Overall Survival (OS) [Time frame: Up to approximately 113 weeks]
Secondary outcome measures (12)
  • Objective Response Rate (ORR) [Time frame: Up to approximately 139 weeks]
  • Duration of Response (DoR) [Time frame: Up to approximately 139 weeks]
  • Progression-free survival (PFS) [Time frame: Up to approximately 139 weeks]
  • Disease control rate (DCR) 12 [Time frame: Up to approximately 11 weeks]
  • Brain PFS [Time frame: Up to approximately 139 weeks]
  • Brain DoR [Time frame: Up to approximately 139 weeks]
  • Brain ORR [Time frame: Up to approximately 139 weeks]
  • Brain DCR12 [Time frame: Up to approximately 11 weeks]
  • Time to brain progression [Time frame: 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]
  • Number of participants with AEs leading to dose modifications or study intervention discontinuation [Time frame: 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Japan · 17 centers
  • GSK Investigational Site — Fukuoka
  • GSK Investigational Site — Hokkaido
  • GSK Investigational Site — Ishikawa
  • GSK Investigational Site — Kagoshima
  • GSK Investigational Site — Kanagawa
  • GSK Investigational Site — Kanagawa
  • GSK Investigational Site — Kochi
  • GSK Investigational Site — Kyoto
  • … and 9 more centers
Spain · 10 centers

Center list to be confirmed — check the primary protocol.

Germany · 9 centers
  • GSK Investigational Site — Karlsruhe
  • GSK Investigational Site — Augsburg
  • GSK Investigational Site — Chemnitz
  • GSK Investigational Site — Esslingen am Neckar
  • GSK Investigational Site — Löwenstein
  • GSK Investigational Site — Lübeck
  • GSK Investigational Site — München
  • GSK Investigational Site — Nuremberg
  • … and 1 more center
Turkey (Türkiye) · 9 centers

Center list to be confirmed — check the primary protocol.

South Korea · 8 centers

Center list to be confirmed — check the primary protocol.

Brazil · 7 centers
  • GSK Investigational Site — Barretos
  • GSK Investigational Site — CuritibaPR
  • GSK Investigational Site — Florianópolis
  • GSK Investigational Site — Porto Alegre
  • GSK Investigational Site — Porto Alegre
  • GSK Investigational Site — Rio de Janeiro
  • GSK Investigational Site — São Paulo
Argentina · 6 centers
  • GSK Investigational Site — Mar del Plata
  • GSK Investigational Site — Buenos Aires
  • GSK Investigational Site — Ciudad Autonoma de Buenos Aire
  • GSK Investigational Site — Ciudad Autonoma de Buenos Aire
  • GSK Investigational Site — Rosario
  • GSK Investigational Site — Vicente López
Greece · 6 centers
  • GSK Investigational Site — Athens
  • GSK Investigational Site — Athens
  • GSK Investigational Site — Athens
  • GSK Investigational Site — Heraklion
  • GSK Investigational Site — Pylaia Thessaloniki
  • GSK Investigational Site — Pylaia Thessaloniki
Hungary · 6 centers
  • GSK Investigational Site — Budapest
  • GSK Investigational Site — Farkasgyepű
  • GSK Investigational Site — Gyöngyös
  • GSK Investigational Site — Kecskemét
  • GSK Investigational Site — Székesfehérvár
  • GSK Investigational Site — Törökbálint
Italy · 6 centers
  • GSK Investigational Site — Bergamo
  • GSK Investigational Site — Milan
  • GSK Investigational Site — Orbassano
  • GSK Investigational Site — Pisa
  • GSK Investigational Site — Siena
  • GSK Investigational Site — Verona
Romania · 6 centers

Center list to be confirmed — check the primary protocol.

Bulgaria · 5 centers
  • GSK Investigational Site — Pleven
  • GSK Investigational Site — Plovdiv
  • GSK Investigational Site — Rousse
  • GSK Investigational Site — Sofia
  • GSK Investigational Site — Sofia
Poland · 5 centers

Center list to be confirmed — check the primary protocol.

Canada · 4 centers
  • GSK Investigational Site — Ottawa
  • GSK Investigational Site — Toronto
  • GSK Investigational Site — Montreal
  • GSK Investigational Site — Montreal
Mexico · 4 centers
  • GSK Investigational Site — Guadajalara
  • GSK Investigational Site — Mexico City
  • GSK Investigational Site — Mexico City
  • GSK Investigational Site — San Pedro Garza García
Australia · 3 centers
  • GSK Investigational Site — Blacktown
  • GSK Investigational Site — St Leonards
  • GSK Investigational Site — Nedlands
France · 3 centers
  • GSK Investigational Site — Boulogne-Billancourt
  • GSK Investigational Site — Grenoble
  • GSK Investigational Site — Saint-Herblain
United Kingdom · 3 centers

Center list to be confirmed — check the primary protocol.

Israel · 2 centers
  • GSK Investigational Site — Jerusalem
  • GSK Investigational Site — Tel Aviv
Portugal · 2 centers

Center list to be confirmed — check the primary protocol.

Switzerland · 2 centers

Center list to be confirmed — check the primary protocol.

Finland · 1 center
  • GSK Investigational Site — Vaasa
Ireland · 1 center
  • GSK Investigational Site — Dublin
Sweden · 1 center

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07099898 · 223674 · 2025-521627-78-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗