Phase 3 Study of GSK5764227 in Participants with Relapsed Small Cell Lung Cancer
Research type
Research Study
Full 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)
IRAS ID
1012080
Contact name
Lise Albrieux
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Research summary
GSK 223674 trial - Phase 3, multicentre, randomised, open-label clinical study of GSK5764227, a B7-H3 antibody drug conjugate (ADC), compared with topotecan in patients with relapsed small cell lung cancer (SCLC) aims to evaluate the efficacy and safety of GSK5764227 versus topotecan in treating relapsed SCLC.
Small Cell Lung Cancer (SCLC) is a rapidly spreading cancer that is difficult to treat. Current treatments like chemotherapy provide only minor improvements, and there is a need for better treatments for relapsed SCLC. GSK5764227 is an investigational medicine that targets the B7-H3 protein on cancer cells, delivering a toxin directly to the cancer cells to inhibit their growth and spread.
The study's primary objective is to compare the effectiveness of GSK5764227 and topotecan in preventing or inhibiting cancer growth. Secondary objectives include evaluating the efficacy of GSK5764227 in treating brain metastases, its safety, processing in the body, tolerance, effects on the immune system, and impact on participant symptoms and quality of life.
Patients will be randomly assigned to either the experimental group (receiving GSK5764227) or the control group (receiving topotecan). Both treatments will be administered as intravenous infusions. Inclusion criteria include being 18 years or older, having a confirmed diagnosis of extensive stage-small cell lung cancer (ES-SCLC), and having completed a first round of platinum-based chemotherapy combined with or without immunotherapy. Exclusion criteria include having complex lung cancer, prior B7-H3 targeted treatment, another unrelated cancer, or recent major surgery.
The study will be run at UK hospitals. Patients will remain in the study until their cancer progresses or they experience unacceptable side effects. Adverse effects will be closely monitored by study doctors.REC name
Wales REC 1
REC reference
25/WA/0114
Date of REC Opinion
30 Jul 2025
REC opinion
Further Information Favourable Opinion