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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT07099898
Registration number
NCT07099898
Ethics application status
Date submitted
30/07/2025
Date registered
1/08/2025
Date last updated
26/08/2025
Titles & IDs
Public title
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
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Scientific 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)
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Secondary ID [1]
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2025-521627-78
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Secondary ID [2]
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223674
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Neoplasms, Lung
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Condition category
Condition code
Cancer
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Lung - Mesothelioma
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Cancer
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Lung - Non small cell
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Cancer
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Lung - Small cell
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Other - GSK5764227
Treatment: Drugs - Topotecan
Experimental: GSK5764227 -
Active comparator: Topotecan -
Treatment: Other: GSK5764227
GSK5764227 will be administered
Treatment: Drugs: Topotecan
Topotecan will be administered
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Intervention code [1]
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Treatment: Other
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Intervention code [2]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Objective Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with a confirmed complete response (CR) or confirmed partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded independent central review (BICR) assessment
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Timepoint [1]
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Up to approximately 55 weeks
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Primary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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OS is defined as the time from the date of randomization to the date of death by any cause
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Timepoint [2]
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Up to approximately 55 weeks
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Secondary outcome [1]
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ORR by investigator assessment
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Assessment method [1]
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ORR is defined as the percentage of participants with a confirmed CR or confirmed PR per RECIST 1.1 by investigator assessment
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Timepoint [1]
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Up to approximately 161 weeks
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Secondary outcome [2]
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Duration of Response (DoR)
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Assessment method [2]
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DoR is defined as the time from the date of first documented objective response (CR or PR) per RECIST 1.1 by \[investigator/BICR\] assessment to the date of first documented PD per RECIST 1.1 by \[investigator/BICR\] assessment or death due to any cause, whichever comes first
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Timepoint [2]
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Up to approximately 161 weeks
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Secondary outcome [3]
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Progression-free survival (PFS)
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Assessment method [3]
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PFS is defined as the time from the date of randomization to the date of first documented Progressive disease (PD) per RECIST 1.1 by \[investigator/BICR\] assessment or death from any cause, whichever occurs first
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Timepoint [3]
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Up to approximately 161 weeks
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Secondary outcome [4]
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Disease control rate (DCR) 12
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Assessment method [4]
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DCR12 is defined as the percentage of participants who have a Best objective response (BOR) of confirmed CR, confirmed PR, or Stable Disease (SD) after the date of randomization, per RECIST 1.1 by \[investigator/BICR\] assessment
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Timepoint [4]
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Up to approximately 11 weeks
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Secondary outcome [5]
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Brain PFS
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Assessment method [5]
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Brain PFS is defined as the time from the date of randomization to the date of first documented PD per Response assessment in neuro-oncology (RANO-BM) by Response Evaluation Criteria in Solid Tumors by blinded independent central review (RANO-BICR) assessment or death from any cause, whichever occurs first in participants with a history of brain metastasis
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Timepoint [5]
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Up to approximately 161 weeks
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Secondary outcome [6]
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Brain DoR
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Assessment method [6]
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Brain DoR is defined as the time from the first documented objective response (CR/PR according to RANO-BM by RANO-BICR assessment) until the time of first documentation of disease progression or death, whichever occurs first, in participants with a history of brain metastasis
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Timepoint [6]
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Up to approximately 161 weeks
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Secondary outcome [7]
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Brain ORR
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Assessment method [7]
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Brain ORR is defined as the percentage of participants with confirmed brain CR or confirmed brain PR per RANO-BM by RANO-BICR assessment
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Timepoint [7]
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Up to approximately 161 weeks
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Secondary outcome [8]
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Brain DCR12
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Assessment method [8]
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Brain DCR12 is defined as the percentage of participants with an intracranial BOR of confirmed CR, confirmed PR or SD after the date of randomization, per RANO-BM by RANO-BICR assessment
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Timepoint [8]
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Up to approximately 11 weeks
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Secondary outcome [9]
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Time to brain progression
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Assessment method [9]
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Time to brain progression is defined as the time from the date of randomization to the date of first documented brain PD per RANO-BM by RANO-BICR assessment
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Timepoint [9]
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Up to approximately 161 weeks
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Secondary outcome [10]
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Number of participants with Adverse events (AEs), Serious Adverse Events (SAEs) and Adverse events of special interest (AESIs) by severity
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Assessment method [10]
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Timepoint [10]
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Up to approximately 161 weeks
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Secondary outcome [11]
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Number of participants with AEs leading to dose modifications or study intervention discontinuation
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Assessment method [11]
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Timepoint [11]
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Up to approximately 161 weeks
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Secondary outcome [12]
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Number of participants with a change from baseline in vital signs
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Assessment method [12]
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Number of participants will be assessed.
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Timepoint [12]
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Baseline (Day -1) and up to approximately 161 weeks
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Secondary outcome [13]
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Number of participants with a change from baseline in laboratory parameters (hematology and clinical chemistry)
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Assessment method [13]
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Number of participants will be assessed.
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Timepoint [13]
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Baseline (Day -1) and up to approximately 161 weeks
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Secondary outcome [14]
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Number of participants with a change from baseline in cardiac function [Electrocardiogram (ECG)
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Assessment method [14]
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Number of participants will be assessed.
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Timepoint [14]
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Baseline (Day -1) and up to approximately 161 weeks
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Secondary outcome [15]
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Number of participants with a change from baseline in Eastern Cooperative Oncology Group (ECOG) performance status
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Assessment method [15]
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Number of participants will be assessed.
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Timepoint [15]
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Baseline (Day -1) and up to approximately 161 weeks
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Secondary outcome [16]
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Observed PK concentrations of GSK5764227 (conjugated antibody and small molecule payload)
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Assessment method [16]
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Timepoint [16]
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Up to approximately 161 weeks
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Secondary outcome [17]
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Number of participants with Antidrug antibody (ADA) or Neutralizing Antibody (NAb)
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Assessment method [17]
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Timepoint [17]
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Up to approximately 161 weeks
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Secondary outcome [18]
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Titers of ADA against GSK5764227
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Assessment method [18]
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Timepoint [18]
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Up to approximately 161 weeks
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
11/08/2025
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
11/09/2028
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Actual
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Sample size
Target
300
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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GSK Investigational Site - Blacktown
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Recruitment hospital [2]
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GSK Investigational Site - St Leonards
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Recruitment postcode(s) [1]
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2148 - Blacktown
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Recruitment postcode(s) [2]
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2065 - St Leonards
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Recruitment outside Australia
Country [1]
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Argentina
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State/province [1]
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Buenos Aires
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Country [2]
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Argentina
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State/province [2]
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Ciudad Autonoma de Buenos Aire
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Country [3]
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Canada
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State/province [3]
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Ontario
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Country [4]
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Japan
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State/province [4]
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Fukuoka
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
GlaxoSmithKline
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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 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."
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Trial website
https://clinicaltrials.gov/study/NCT07099898
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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US GSK Clinical Trials Call Center
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Address
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Country
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Phone
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877-379-3718
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Informed consent form (ICF), Clinical study report (CSR)
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When will data be available (start and end dates)?
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or asset(s) with development terminated across all indications.
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Available to whom?
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months, but an extension may be granted, when justified, for up to 6 months.
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT07099898
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