🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in Ireland / NCT07099898
Recruiting Phase 3

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

NCT07099898 · tracked via the Priya Life Science Ireland tracker
Sponsor
GlaxoSmithKline
Phase
Phase 3
Started
2025-08-11
Last updated
2026-08-31

Condition(s) studied

Neoplasms, Lung

Investigational drug(s) / intervention(s)

Ris-RezTopotecan

Ris-Rez: Ris-Rez will be administered

Topotecan: Topotecan will be administered

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (132)

FacilityCityRegionStatus
GSK Investigational Site Los Angeles California Recruiting
GSK Investigational Site Wilson North Carolina Recruiting
GSK Investigational Site Mar del Plata Buenos Aires Recruiting
GSK Investigational Site Buenos Aires Argentina Recruiting
GSK Investigational Site Ciudad Autonoma de Buenos Aire Argentina Recruiting
GSK Investigational Site Ciudad Autonoma de Buenos Aire Argentina Recruiting
GSK Investigational Site Rosario Argentina Recruiting
GSK Investigational Site Vicente López Argentina Recruiting
GSK Investigational Site Blacktown New South Wales Recruiting
GSK Investigational Site St Leonards New South Wales Recruiting
GSK Investigational Site Nedlands Western Australia Withdrawn
GSK Investigational Site Barretos Brazil Recruiting
GSK Investigational Site CuritibaPR Brazil Recruiting
GSK Investigational Site Florianópolis Brazil Recruiting
GSK Investigational Site Porto Alegre Brazil Recruiting
GSK Investigational Site Porto Alegre Brazil Recruiting
GSK Investigational Site Rio de Janeiro Brazil Recruiting
GSK Investigational Site São Paulo Brazil Recruiting
GSK Investigational Site Pleven Bulgaria Recruiting
GSK Investigational Site Plovdiv Bulgaria Recruiting
GSK Investigational Site Rousse Bulgaria Recruiting
GSK Investigational Site Sofia Bulgaria Recruiting
GSK Investigational Site Sofia Bulgaria Recruiting
GSK Investigational Site Ottawa Ontario Recruiting
GSK Investigational Site Toronto Ontario Recruiting
GSK Investigational Site Montreal Quebec Recruiting
GSK Investigational Site Montreal Quebec Recruiting
GSK Investigational Site Vaasa Finland Recruiting
GSK Investigational Site Boulogne-Billancourt France Recruiting
GSK Investigational Site Grenoble France Recruiting
GSK Investigational Site Saint-Herblain France Recruiting
GSK Investigational Site Karlsruhe Baden-Wurttemberg Recruiting
GSK Investigational Site Augsburg Germany Recruiting
GSK Investigational Site Chemnitz Germany Recruiting
GSK Investigational Site Esslingen am Neckar Germany Recruiting
GSK Investigational Site Heidelberg Germany Recruiting
GSK Investigational Site Löwenstein Germany Recruiting
GSK Investigational Site Lübeck Germany Recruiting
GSK Investigational Site München Germany Recruiting
GSK Investigational Site Nuremberg Germany Recruiting

+ 92 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07099898 on ClinicalTrials.gov ↗ ← All trials in Ireland