Status:
RECRUITING
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
Lead Sponsor:
GlaxoSmithKline
Conditions:
Neoplasms, Lung
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 specifical...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 28 2029
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT07099898
Start Date
August 11 2025
End Date
September 28 2029
Last Update
March 6 2026
Active Locations (102)
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1
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina, 7600
2
GSK Investigational Site
Buenos Aires, Argentina, C1426ABP
3
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, C1012AAR
4
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE