Risvutatug rezetecan for Relapsed Small Cell Lung Cancer

A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC) [EMBOLD SCLC-301]

Recruiting Phase 3 Interventional Study
Neoplasms, Lung
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
420 (estimated)
Sponsor
GlaxoSmithKline · Industry
Who this trial is looking for

This trial is looking for adults with relapsed small cell lung cancer. Participants will either receive a new medicine called Risvutatug rezetecan or the standard treatment, topotecan, to see which is more effective and safer.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am an adult over 18 years old.
  • I have extensive-stage small cell lung cancer.
  • I have received 1 prior platinum-based therapy with a PD-1 or PD-L1 inhibitor.
  • I have at least 1 tumor that can be measured.
  • I can provide signed consent.
  • I have adequate organ function.
  • I have an ECOG performance status of 0 or 1.

You may not be able to join if

  • I have complex small cell lung cancer or transformed small cell lung cancer.
  • I had limited stage small cell lung cancer at diagnosis.
  • I have received treatment with an antibody-drug conjugate targeting B7-H3.
  • I have severe, uncontrolled cardiovascular disorders.
  • I have had significant bleeding symptoms in the past month.
  • I have an active infectious disease requiring treatment.
  • I have untreated brain metastases or spinal cord metastases.
  • I have significant lung disease or respiratory issues.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial
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 dis…
Trial Locations
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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…
Contacts

US GSK Clinical Trials Call Center

877-379-3718

GSKClinicalSupportHD@gsk.com

CONTACT

EU GSK Clinical Trials Call Center

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

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