A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
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)
- Neoplasms, Lung
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- GlaxoSmithKline
- Enrolment target
- 420
- Started
- 11 August 2025
- Main results due
- 5 November 2027
- Study sites
- 135
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(135)
GSK Investigational Site
Los Angeles, California, United States
Recruiting
GSK Investigational Site
East Syracuse, New York, United States
Recruiting
GSK Investigational Site
Wilson, North Carolina, United States
Recruiting
GSK Investigational Site
Canton, Ohio, United States
Recruiting
GSK Investigational Site
Mar del Plata, Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Buenos Aires, Argentina
Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina
Recruiting
GSK Investigational Site
Ciudad Autonoma de Buenos Aire, Argentina
Recruiting
GSK Investigational Site
Rosario, Argentina
Recruiting
GSK Investigational Site
Vicente López, Argentina
Recruiting
GSK Investigational Site
Blacktown, New South Wales, Australia
Recruiting
GSK Investigational Site
St Leonards, New South Wales, Australia
Recruiting
GSK Investigational Site
Nedlands, Western Australia, Australia
Withdrawn
GSK Investigational Site
Florianópolis, Santa Catarina, Brazil
Recruiting
GSK Investigational Site
Barretos, Brazil
Recruiting
GSK Investigational Site
CuritibaPR, Brazil
Recruiting
GSK Investigational Site
Porto Alegre, Brazil
Recruiting
GSK Investigational Site
Porto Alegre, Brazil
Recruiting
GSK Investigational Site
Rio de Janeiro, Brazil
Recruiting
GSK Investigational Site
São Paulo, Brazil
Recruiting
GSK Investigational Site
Pleven, Bulgaria
Recruiting
GSK Investigational Site
Plovdiv, Bulgaria
Recruiting
GSK Investigational Site
Rousse, Bulgaria
Recruiting
GSK Investigational Site
Sofia, Bulgaria
Withdrawn
GSK Investigational Site
Sofia, Bulgaria
Recruiting
GSK Investigational Site
Ottawa, Ontario, Canada
Recruiting
GSK Investigational Site
Toronto, Ontario, Canada
Recruiting
GSK Investigational Site
Montreal, Quebec, Canada
Recruiting
GSK Investigational Site
Montreal, Quebec, Canada
Recruiting
GSK Investigational Site
Vaasa, Finland
Recruiting
GSK Investigational Site
Boulogne-Billancourt, France
Recruiting
GSK Investigational Site
Grenoble, France
Recruiting
GSK Investigational Site
Saint-Herblain, France
Recruiting
GSK Investigational Site
Villejuif, France
Recruiting
GSK Investigational Site
Karlsruhe, Baden-Wurttemberg, Germany
Recruiting
GSK Investigational Site
Löwenstein, Baden-Wurttemberg, Germany
Recruiting
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, Germany
Recruiting
GSK Investigational Site
Augsburg, Germany
Recruiting
GSK Investigational Site
Chemnitz, Germany
Recruiting
GSK Investigational Site
Esslingen am Neckar, Germany
Recruiting
GSK Investigational Site
Heidelberg, Germany
Recruiting
GSK Investigational Site
Lübeck, Germany
Recruiting
GSK Investigational Site
München, Germany
Recruiting
GSK Investigational Site
Nuremberg, Germany
Recruiting
GSK Investigational Site
Heraklion, Crete, Greece
Recruiting
GSK Investigational Site
Athens, Greece
Recruiting
GSK Investigational Site
Athens, Greece
Recruiting
GSK Investigational Site
Athens, Greece
Recruiting
GSK Investigational Site
Pylaia Thessaloniki, Greece
Recruiting
GSK Investigational Site
Pylaia Thessaloniki, Greece
Recruiting
GSK Investigational Site
Budapest, Hungary
Recruiting
GSK Investigational Site
Farkasgyepű, Hungary
Recruiting
GSK Investigational Site
Gyöngyös, Hungary
Recruiting
GSK Investigational Site
Kecskemét, Hungary
Recruiting
GSK Investigational Site
Székesfehérvár, Hungary
Recruiting
GSK Investigational Site
Törökbálint, Hungary
Recruiting
GSK Investigational Site
Dublin, Ireland
Recruiting
GSK Investigational Site
Jerusalem, Israel
Recruiting
GSK Investigational Site
Tel Aviv, Israel
Recruiting
GSK Investigational Site
Milan, MI, Italy
Recruiting
Showing 60 of 135 sites — filter to narrow it down. 132 of the 135 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07099898. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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