NCT07099898

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

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)

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

"In this study researchers are testing GSK5764227, a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancers ability to grow and spread. This study specifically aims to evaluate how well GSK5764227 works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether GSK5764227 makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether GSK576227 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 GSK5764227 and the other receiving topotecan."

Conditions

• Neoplasms, Lung

Interventions

Type	Name	Description
BIOLOGICAL	GSK5764227	GSK5764227 will be administered
DRUG	Topotecan	Topotecan will be administered

Timeline

• Start date: 2025-08-11
• Primary completion: 2027-10-29
• Completion: 2029-09-28
• First posted: 2025-08-01
• Last updated: 2026-03-06

Locations

102 sites across 23 countries: Argentina, Australia, Brazil, Bulgaria, Canada, Finland, France, Germany, Greece, Ireland, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, South Korea, Spain, Sweden, Switzerland, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study