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A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) | Clinical Trials | Clareo Health

RECRUITINGPHASE3

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)

NCT07099898•GlaxoSmithKline

View on ClinicalTrials.gov

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."

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 with at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression
•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 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.
•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 documented Hepatitis B or Hepatitis C

Locations (102)

GSK Investigational Site

Mar del Plata, Buenos Aires, Argentina

GSK Investigational Site

Buenos Aires, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Ciudad Autonoma de Buenos Aire, Argentina

GSK Investigational Site

Rosario, Argentina

GSK Investigational Site

Vicente López, Argentina

GSK Investigational Site

Blacktown, New South Wales, Australia

GSK Investigational Site

St Leonards, New South Wales, Australia

GSK Investigational Site

Nedlands, Western Australia, Australia

GSK Investigational Site

Barretos, Brazil

Key Dates

Start Date

August 11, 2025

Primary Completion Date

October 29, 2027

Completion Date

September 28, 2029

Last Updated

March 6, 2026

Enrollment

420

ESTIMATED participants

Conditions

Neoplasms, Lung

Interventions

GSK5764227

BIOLOGICAL

Topotecan

DRUG

Contacts

US GSK Clinical Trials Call Center

CONTACT

877-379-3718 GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center

CONTACT

+44 (0) 20 89904466 GSKClinicalSupportHD@gsk.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 6, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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