NCT07099898RecruitingPhase 3
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)
Source: ClinicalTrials.gov · Last updated 20 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 420 (estimated)
- First submitted
- 30 Jul 2025
- Start date
- 11 Aug 2025
- Primary completion date
- 5 Nov 2027
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Lung cancer
- NCT number
- NCT07099898
- EU CT number
- 2025-521627-78-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 420
- From 11 Aug 2025 to the primary completion date, 5 Nov 2027
- 123 sites in 25 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Participants are excluded from the study if any of the following criteria apply:
- Pathological diagnosis of complex SCLC or transformed SCLC.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (123)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.