Last updated: 09/25/2025 11:10:12
A Study of GSK5764227 in Participants with Relapsed Small Cell Lung Cancer (SCLC)
GSK study ID
223674
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official 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)
Trial description: "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."
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Objective Response Rate (ORR)
Timeframe: Up to approximately 55 weeks
Overall Survival (OS)
Timeframe: Up to approximately 55 weeks
Secondary outcomes:
ORR by investigator assessment
Timeframe: Up to approximately 161 weeks
Duration of Response (DoR)
Timeframe: Up to approximately 161 weeks
Progression-free survival (PFS)
Timeframe: Up to approximately 161 weeks
Disease control rate (DCR) 12
Timeframe: Up to approximately 11 weeks
Brain PFS
Timeframe: Up to approximately 161 weeks
Brain DoR
Timeframe: Up to approximately 161 weeks
Brain ORR
Timeframe: Up to approximately 161 weeks
Brain DCR12
Timeframe: Up to approximately 11 weeks
Time to brain progression
Timeframe: Up to approximately 161 weeks
Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity
Timeframe: Up to approximately 161 weeks
Number of participants with AEs leading to dose modifications or study intervention discontinuation
Timeframe: Up to approximately 161 weeks
Number of participants with a change from baseline in vital signs
Timeframe: Baseline (Day -1) and up to approximately 161 weeks
Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)
Timeframe: Baseline (Day -1) and up to approximately 161 weeks
Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)
Timeframe: Baseline (Day -1) and up to approximately 161 weeks
Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
Timeframe: Baseline (Day -1) and up to approximately 161 weeks
Observed PK concentrations of GSK5764227 (conjugated antibody and small molecule payload)
Timeframe: Up to approximately 161 weeks
Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
Timeframe: Up to approximately 161 weeks
Titers of ADA against GSK5764227
Timeframe: Up to approximately 161 weeks
Interventions:
Enrollment:
300
Primary completion date:
2026-02-09
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Lung
Product
Not applicable
Collaborators
Not applicable
Study date(s)
August 2025 to September 2028
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- 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
- Participants are excluded from the study if any of the following criteria apply:
- Pathological diagnosis of complex SCLC or transformed SCLC.
Inclusion and exclusion criteria
Inclusion criteria:
- 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
Participants are eligible to be included in the study only if all of the following criteria apply:
Exclusion criteria:
- 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
Participants are excluded from the study if any of the following criteria apply:
Trial location(s)
Location
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina, C1426AGE
Status
Recruiting
Showing 1 - 6 of 13 Results
Study documents
No study documents available.
Results overview
Study Results yet to be posted
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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