A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)
NCT ID: NCT07099898
Last Updated: 2026-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
300 participants
INTERVENTIONAL
2025-08-11
2028-09-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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GSK5764227
GSK5764227
GSK5764227 will be administered
Topotecan
Topotecan
Topotecan will be administered
Interventions
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GSK5764227
GSK5764227 will be administered
Topotecan
Topotecan will be administered
Eligibility Criteria
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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
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
18 Years
ALL
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Locations
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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
CuritibaPR, , Brazil
GSK Investigational Site
Porto Alegre, , Brazil
GSK Investigational Site
São Paulo, , Brazil
GSK Investigational Site
Ottawa, Ontario, Canada
GSK Investigational Site
Toronto, Ontario, Canada
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Vaasa, , Finland
GSK Investigational Site
Athens, , Greece
GSK Investigational Site
Pylaia Thessaloniki, , Greece
GSK Investigational Site
Jerusalem, , Israel
GSK Investigational Site
Fukuoka, , Japan
GSK Investigational Site
Hokkaido, , Japan
GSK Investigational Site
Ishikawa, , Japan
GSK Investigational Site
Kagoshima, , Japan
GSK Investigational Site
Kanagawa, , Japan
GSK Investigational Site
Kochi, , Japan
GSK Investigational Site
Kyoto, , Japan
GSK Investigational Site
Mie, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Osaka, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Tokyo, , Japan
GSK Investigational Site
Toyama, , Japan
GSK Investigational Site
Guadalajara, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Mexico City, , Mexico
GSK Investigational Site
Monterrey, , Mexico
GSK Investigational Site
Changwon, , South Korea
GSK Investigational Site
Cheongju Chungcheongbuk-do, , South Korea
GSK Investigational Site
Daegu, , South Korea
GSK Investigational Site
Gyeonggi-do, , South Korea
GSK Investigational Site
Seongnam-si Gyeonggi-do, , South Korea
GSK Investigational Site
Seoul, , South Korea
GSK Investigational Site
Suwon Gyeonggi-do, , South Korea
GSK Investigational Site
Ulsan, , South Korea
GSK Investigational Site
Stockholm, , Sweden
GSK Investigational Site
Basel, , Switzerland
GSK Investigational Site
Adana, Adana, Turkey (Türkiye)
GSK Investigational Site
Samsun, Atakum, Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Ankara, , Turkey (Türkiye)
GSK Investigational Site
Diyarbakır, , Turkey (Türkiye)
GSK Investigational Site
Istanbul, , Turkey (Türkiye)
GSK Investigational Site
Izmir, , Turkey (Türkiye)
GSK Investigational Site
Izmir, , Turkey (Türkiye)
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Portsmouth, , United Kingdom
GSK Investigational Site
Truro, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2025-521627-78
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
223674
Identifier Type: -
Identifier Source: org_study_id
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