A Phase 3 Study of GSK5764227 in Participants with Relapsed Small Cell Lung Cancer (SCLC)
Summary description of the study
This study investigates the efficacy and safety of the drug GSK5764227 in participants with a relapse of small cell lung cancer (SCLC) compared to the approved standard medication Topotecan. GSK5764227 belongs to the class of antibody-drug conjugates (ADC). It is a specially designed antibody that recognizes the B7-H3 protein on the surface of cancer cells and can specifically destroy them. Participants whose SCLC has returned after initial platinum-based chemotherapy will be randomly assigned (in a 2:1 ratio) to two groups: - Experimental group: receives GSK5764227 (approximately 200 participants). The investigational drug is administered as an infusion every three weeks at a dosage of 8.0 mg/kg. - Control group: receives Topotecan (approximately 100 participants). Topotecan is administered intravenously for five consecutive days in a 21-day cycle. Both the participant and the investigator know which study drug is being administered (so-called open-label study). The study treatment will continue as long as it is deemed safe for the participant by the investigator, or until the disease worsens. Approximately 300 participants worldwide will be studied in this Phase 3 trial to gain new insights into the treatment of small cell lung cancer and to improve the currently limited therapies.
(BASEC)
Intervention under investigation
The investigational drug GSK5764227 belongs to the class of antibody-drug conjugates (ADC). An antibody is a protein that specifically recognizes certain molecules – here the B7-H3 protein, which is found on cancer cells but rarely in healthy tissue. The antibody binds to B7-H3 and releases a drug that attacks and kills the cancer cells.
(BASEC)
Disease under investigation
Small Cell Lung Cancer (SCLC)
(BASEC)
1. The person must be at least 18 years old. 2. There must be a confirmed diagnosis of advanced small cell lung cancer (extensive stage small cell lung cancer, ES-SCLC). 3. The person must have received platinum-based chemotherapy consisting of at least 2 cycles and combined with immunotherapy (PD-(L)1 inhibitor), unless there were medical reasons against immunotherapy. At least 30 days must have passed between the last chemotherapy and the new treatment. 4. It must be documented that the cancer has continued to grow after the last treatment, and there must be at least one visible, measurable tumor site outside the brain. 5. The person has adequate organ function as required by laboratory tests. (BASEC)
Exclusion criteria
1. Individuals with a diagnosis of complex small cell lung cancer (e.g., mixed small cell and non-small cell lung cancer) or transformed small cell lung cancer cannot participate. 2. Individuals with cancer that has spread to the brain (brain metastases) are excluded unless certain conditions are simultaneously met (discuss this with the investigator). All participants must undergo an MRI or CT scan of the brain before the study begins. 3. Individuals with an additional cancer diagnosis or a previous cancer diagnosis cannot participate, except for certain cancer types that have been completely and successfully treated (for at least 5 years). 4. Individuals who have had major surgery (such as brain, chest, or abdominal surgery) within the last 4 weeks before the first dose of the study are excluded. 5. Individuals who have already received another type of B7H3-targeted treatment. (BASEC)
Trial sites
Basel, Lausanne
(BASEC)
Sponsor
GlaxoSmithKline AG
(BASEC)
Contact
Contact Person Switzerland
Dr. Andreas Michael Schmitt
+41 61 265 50 74
andreasmichael.schmitt@clutterusb.chUniversitätsspital Basel Medzinische Onkologie
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
14.11.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
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) (BASEC)
Academic title
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Public title
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Disease under investigation
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Intervention under investigation
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Type of trial
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Trial design
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Inclusion/Exclusion criteria
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Primary and secondary end points
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Registration date
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Incorporation of the first participant
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Secondary sponsors
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Additional contacts
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Secondary trial IDs
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Results-Individual Participant Data (IPD)
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Further information on the trial
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Results of the trial
Results summary
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Link to the results in the primary register
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