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RecruitingPhase 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)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests Risvutatug rezetecan (Ris-Rez) for adults whose small cell lung cancer has come back or worsened after treatment. Researchers will compare it with topotecan to see if it shrinks cancer, helps people live longer, and is safe. Participants are placed by chance into one of the two treatment groups.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be older than 18, or meet the minimum legal adult age, when signing the consent form.
  • Have small cell lung cancer that has spread widely, confirmed by a tissue or cell test.
  • Have had one prior platinum-based chemotherapy treatment with a PD-(L)1 inhibitor, a drug that helps the immune system fight cancer, for at least 2 treatment cycles.
  • Have cancer that has worsened and have been off chemotherapy for more than 30 days. Prior tarlatamab treatment as the first or second treatment is allowed.
  • Have at least one tumor that the study doctor can measure using study rules.
  • Be able to sign the consent form and follow study rules.
  • Have organs that work well enough. Be fully active or able to do light work, with limits only on hard physical activity.

Who can't join

  • Have cancer diagnosed as complex or transformed small cell lung cancer, or have had limited-stage disease when first diagnosed.
  • Have had a drug that links an antibody to a TOPO1-blocking cancer drug, or any treatment that targets B7-H3.
  • Have an allergy to study drug ingredients or another allergy that makes joining unsafe.
  • Have severe, uncontrolled, or active heart or blood vessel disease, or serious bleeding or a strong tendency to bleed within 1 month before the first dose.
  • Have an active infection needing treatment throughout the body, known HIV, or active hepatitis B or C.
  • Have cancer in the brain that causes symptoms, or untreated cancer worsening only in the brain during or after the last treatment. Cancer in the brain's coverings, brainstem, or spinal cord also rules out joining.
  • Have current lung tissue disease or lung inflammation, or a history of these problems needing high-dose steroids when not caused by infection.
  • Have serious lung disease or breathing problems, such as uncontrolled asthma or COPD, or disease that keeps the lungs from expanding fully.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (7)

CA

FL

NC

NY

OH