drugset / Trial / NCT07099898

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

NCT07099898

Phase 3 Recruiting 420 enrolled GlaxoSmithKline
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2025-08-11
Primary completion
2027-11-05
Completion
2029-09-28

Drugs

EvaluationDrugModalityDoseRoute
Subject HS-20093 Other / unclassified
Comparator Topotecan Small molecule

Indications