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

StatusRecruiting
PhasePhase 3
Started2025-08-11
View on ClinicalTrials.gov ↗
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.

Amendment history 5 changes detected by DataLookout

2026-09-01
Trial sites expanded: 126 → 132 locations
2026-07-30
Trial sites expanded: 120 → 126 locations
2026-05-28
Trial sites expanded: 114 → 120 locations
2026-04-23
Primary endpoint(s) modified
WasObjective Response Rate (ORR), Overall Survival (OS)
NowOverall Survival (OS)
2026-04-23
Trial sites expanded: 102 → 114 locations
Trial Details
NCT Number NCT07099898
Lead Sponsor GlaxoSmithKline
Conditions Neoplasms, Lung
Enrollment 420 participants
Start Date 2025-08-11
Primary Completion 2027-11-05 (estimated)
Study Completion 2029-09-28 (estimated)
Updated on ClinicalTrials.gov 2026-08-31