NCT07099898Recruiting
A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
Summary
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Countries
- Switzerland, France, Germany, Italy, United States, Argentina, Australia, Brazil, Bulgaria, Canada, Finland, Greece, Hungary, Ireland, Israel, Japan, Mexico, Poland, Portugal, Romania, South Korea, Spain, Sweden, Turkey (Türkiye), United Kingdom
- Sponsor
- GlaxoSmithKline(Industry)
- Protocol no.
- 223674
- Conditions
- Neoplasms, Lung
- Interventions
- Biological, Drug
Treatments studied
- Risvutatug rezetecan (Ris-Rez)
- Topotecan
Locations · 141
- Basel, SwitzerlandGSK Investigational SiteRecruiting at this site
- Lausanne, SwitzerlandGSK Investigational SiteRecruiting at this site
- Boulogne-Billancourt, FranceGSK Investigational SiteRecruiting at this site
- Grenoble, FranceGSK Investigational SiteRecruiting at this site
- Saint-Herblain, FranceGSK Investigational SiteRecruiting at this site
- Villejuif, FranceGSK Investigational SiteRecruiting at this site
- Karlsruhe, GermanyGSK Investigational SiteRecruiting at this site
- Löwenstein, GermanyGSK Investigational SiteRecruiting at this site
- Stuttgart, GermanyGSK Investigational SiteRecruiting at this site
- Augsburg, GermanyGSK Investigational SiteRecruiting at this site
- Chemnitz, GermanyGSK Investigational SiteRecruiting at this site
- Esslingen am Neckar, GermanyGSK Investigational SiteRecruiting at this site
- Heidelberg, GermanyGSK Investigational SiteRecruiting at this site
- Immenhausen, GermanyGSK Investigational SiteRecruiting at this site
- Lübeck, GermanyGSK Investigational SiteRecruiting at this site
- München, GermanyGSK Investigational SiteRecruiting at this site
- Nuremberg, GermanyGSK Investigational SiteRecruiting at this site
- Milan, ItalyGSK Investigational SiteRecruiting at this site
- Bergamo, ItalyGSK Investigational SiteRecruiting at this site
- Genova, ItalyGSK Investigational SiteRecruiting at this site
- Orbassano, ItalyGSK Investigational SiteRecruiting at this site
- Pisa, ItalyGSK Investigational SiteRecruiting at this site
- Roma, ItalyGSK Investigational SiteRecruiting at this site
- Siena, ItalyGSK Investigational SiteRecruiting at this site
- Verona, ItalyGSK Investigational SiteRecruiting at this site
- Los Angeles, United StatesGSK Investigational SiteRecruiting at this site
- Miami, United StatesGSK Investigational SiteRecruiting at this site
- Plantation, United StatesGSK Investigational SiteRecruiting at this site
- Tamarac, United StatesGSK Investigational SiteRecruiting at this site
- East Syracuse, United StatesGSK Investigational SiteRecruiting at this site
In total, worldwide, 141 of the 144 sites listed in the registry are recruiting; the other 3 are not currently recruiting.
Site status per the ClinicalTrials.gov registry (last update posted: October 20, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
+ 111 more locations
Other identifiers
- 2025-521627-78-00 · CTIS number
- 2025 · NIH grant
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.