Tests Ris-Rez versus topotecan in people with relapsed small cell lung cancer
Compares a new B7-H3-targeting drug with topotecan in relapsed small cell lung cancer.
Plain-language title generated from the registry record
Registry title: A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]
Key facts
- Where
- Athens, Heraklion, and Pylaia Thessaloniki, GreeceSee the 3 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Has your cancer come back or got worse during or after treatment with platinum chemotherapy?
- Has the cancer spread to other parts of the body, or is it too advanced to be removed by surgery?
- Has your cancer spread to the brain?
- Has your cancer spread to the lining around the brain or spinal cord?
Source: NCT07099898, who can take part
Where in Greece
- AthensAthens, GreeceTaking people
- HeraklionHeraklion, GreeceTaking people
- Pylaia ThessalonikiPylaia Thessaloniki, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT07099898
- Record updated
- 10 November 2026
- Original 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.Read full original descriptionShow less
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)
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: 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: Has received any prior therapy with an Antibody-drug conjugate (ADC) with a Topoisomerase-1 (TOPO1)-inhibitor payload or treatments targeting B7-H3; Has clinically significant bleeding symptoms or significant bleeding tendency within 1 month prior to the first dose; 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; Limited stage small cell lung cancer at diagnosis; 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; Known active infectious diseases requiring systemic treatment or known Human immunodeficiency virus (HIV); Has significant pulmonary disease or respiratory impairment (e.g., uncontrolled asthma/COPD, restrictive lung disease),; Has active Hepatitis B or Hepatitis C; Participants are excluded from the study if any of the following criteria apply:; Pathological diagnosis of complex SCLC or transformed SCLC.