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RECRUITING Phase 3 ClinicalTrials.gov

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]

Sponsor: GlaxoSmithKline • ClinicalTrials.gov ID: NCT07099898

Registry updated: 2026-10-20
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Description

In this study researchers are testing Risvutatug rezetecan also known as (Ris-Rez) a new medicine that targets specific proteins (B7-H3) on cancer cells, thereby reducing the cancer's ability to grow and spread. This study specifically aims to evaluate how well Ris-Rez works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether Ris-Rez makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether Ris-Rez 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 Ris-Rez and the other receiving topotecan.

Interventions

  • Risvutatug rezetecan (Ris-Rez) (Biological)
    Ris-Rez will be administered
  • Topotecan (Drug)
    Topotecan will be administered

Eligibility criteria

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 for at least 2 cycles of therapy and a chemotherapy free-interval of \>30 days, with documented progression. Participants with prior tarlatamab treatment in either the first- or second-line ES-SCLC setting are eligible. * 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 adequate organ function and an ECOG performance status of 0 or 1 Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * Pathological diagnosis of complex SCLC or transformed SCLC. * Limited stage small cell lung cancer at diagnosis * 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 significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease), * Has active Hepatitis B or Hepatitis C

Conditions

Neoplasms, Lung

Locations

  • GSK Investigational Site — Los Angeles, California, United States
  • GSK Investigational Site — Miami, Florida, United States
  • GSK Investigational Site — Plantation, Florida, United States
  • GSK Investigational Site — Tamarac, Florida, United States
  • GSK Investigational Site — East Syracuse, New York, United States
  • GSK Investigational Site — Wilson, North Carolina, United States
  • GSK Investigational Site — Canton, Ohio, United States
  • 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 — Melbourne, Victoria, Australia
  • GSK Investigational Site — Nedlands, Western Australia, Australia
  • GSK Investigational Site — Florianópolis, Santa Catarina, Brazil
  • GSK Investigational Site — Barretos, Brazil
  • GSK Investigational Site — CuritibaPR, Brazil
  • GSK Investigational Site — Porto Alegre, Brazil
  • GSK Investigational Site — Porto Alegre, Brazil
  • GSK Investigational Site — Rio de Janeiro, Brazil
  • GSK Investigational Site — São Paulo, Brazil
  • GSK Investigational Site — Pleven, Bulgaria
  • GSK Investigational Site — Plovdiv, Bulgaria
  • GSK Investigational Site — Rousse, Bulgaria
  • GSK Investigational Site — Sofia, Bulgaria
  • GSK Investigational Site — Sofia, Bulgaria
  • GSK Investigational Site — Ottawa, Ontario, Canada
  • GSK Investigational Site — Toronto, Ontario, Canada
  • GSK Investigational Site — Montreal, Quebec, Canada
  • GSK Investigational Site — Montreal, Quebec, Canada
  • GSK Investigational Site — Vaasa, Finland
  • GSK Investigational Site — Boulogne-Billancourt, France
  • GSK Investigational Site — Grenoble, France
  • GSK Investigational Site — Saint-Herblain, France
  • GSK Investigational Site — Villejuif, France
  • GSK Investigational Site — Karlsruhe, Baden-Wurttemberg, Germany
  • GSK Investigational Site — Löwenstein, Baden-Wurttemberg, Germany
  • GSK Investigational Site — Stuttgart, Baden-Wurttemberg, Germany
  • GSK Investigational Site — Augsburg, Germany
  • GSK Investigational Site — Chemnitz, Germany
  • GSK Investigational Site — Esslingen am Neckar, Germany
  • GSK Investigational Site — Heidelberg, Germany
  • GSK Investigational Site — Immenhausen, Germany
  • GSK Investigational Site — Lübeck, Germany
  • GSK Investigational Site — München, Germany
  • GSK Investigational Site — Nuremberg, Germany
  • GSK Investigational Site — Heraklion, Crete, Greece
  • GSK Investigational Site — Athens, Greece
  • GSK Investigational Site — Athens, Greece
  • GSK Investigational Site — Athens, Greece
  • GSK Investigational Site — Pylaia Thessaloniki, Greece
  • GSK Investigational Site — Pylaia Thessaloniki, Greece
  • GSK Investigational Site — Budapest, Hungary
  • GSK Investigational Site — Farkasgyepű, Hungary
  • GSK Investigational Site — Gyöngyös, Hungary
  • GSK Investigational Site — Kecskemét, Hungary
  • GSK Investigational Site — Székesfehérvár, Hungary
  • GSK Investigational Site — Törökbálint, Hungary
  • GSK Investigational Site — Dublin, Ireland
  • GSK Investigational Site — Jerusalem, Israel
  • GSK Investigational Site — Tel Aviv, Israel
  • GSK Investigational Site — Milan, MI, Italy
  • GSK Investigational Site — Bergamo, Italy
  • GSK Investigational Site — Genova, Italy
  • GSK Investigational Site — Orbassano, Italy
  • GSK Investigational Site — Pisa, Italy
  • GSK Investigational Site — Roma, Italy
  • GSK Investigational Site — Siena, Italy
  • GSK Investigational Site — Verona, Italy
  • 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 — Kanagawa, Japan
  • GSK Investigational Site — Kochi, Japan
  • GSK Investigational Site — Kyoto, Japan
  • GSK Investigational Site — Mie, Japan
  • GSK Investigational Site — Miyagi, 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 — Tokyo, Japan
  • GSK Investigational Site — Toyama, Japan
  • GSK Investigational Site — San Pedro Garza García, Nuevo León, Mexico
  • GSK Investigational Site — Guadajalara, Mexico
  • GSK Investigational Site — Mexico City, Mexico
  • GSK Investigational Site — Mexico City, Mexico
  • GSK Investigational Site — Gliwice, Poland
  • GSK Investigational Site — Kielce, Poland
  • GSK Investigational Site — Lodz, Poland
  • GSK Investigational Site — Olsztyn, Poland
  • GSK Investigational Site — Otwock, Poland
  • GSK Investigational Site — Poznan, Poland
  • GSK Investigational Site — Przemyśl, Poland
  • GSK Investigational Site — Siedlce, Poland
  • GSK Investigational Site — Almada, Setúbal District, Portugal
  • GSK Investigational Site — Coimbra, Portugal
  • GSK Investigational Site — Guimarães, Portugal
  • GSK Investigational Site — Lisbon, Portugal
  • GSK Investigational Site — Craiova Dolj, Dolj, Romania
  • GSK Investigational Site — Cluj-Napoca, Romania
  • GSK Investigational Site — Craiova, Romania
  • GSK Investigational Site — Floreşti, Romania
  • GSK Investigational Site — Iași, Romania
  • GSK Investigational Site — Timișoara, Romania
  • 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 — Barcelona, Spain
  • GSK Investigational Site — Barcelona, Spain
  • GSK Investigational Site — Barcelona, Spain
  • GSK Investigational Site — L'Hospitalet de Llobrega, Spain
  • GSK Investigational Site — Las Palmas de Gran Canar, Spain
  • GSK Investigational Site — Madrid, Spain
  • GSK Investigational Site — Madrid, Spain
  • GSK Investigational Site — Madrid, Spain
  • GSK Investigational Site — Madrid, Spain
  • GSK Investigational Site — Santander, Spain
  • GSK Investigational Site — Stockholm, Sweden
  • GSK Investigational Site — Basel, Switzerland
  • GSK Investigational Site — Lausanne, 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
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record