Brief Summary
“In this study researchers are testing GSK5764227, a new medicine that targets specific proteins (B7-H3) on cancera disease where abnormal cells split without control and spread to other nearby body tissue and/or organs cellsthe basic structural and functional unit of all living things, thereby reducing the cancers ability to grow and spread. This study specifically aims to evaluate how well GSK5764227 works in treating relapsed SCLC compared to standard treatment topotecan, by checking whether GSK5764227 makes cancers smaller or disappear completely and if it helps participants live longer. The study is also assessing whether GSK576227 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 GSK5764227 and the other receiving topotecan.”
Intervention / Treatment
- Biological: GSK5764227
- Drug: 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 consenta process in which a patient receives detailed information about a procedure or treatment, including its potential risks, benefits, and alternatives. The patient then has the opportunity to understand the information and voluntarily agree to the procedure or treatment. 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 with at least 2 cycles of therapy and a chemotherapya cancer treatment that uses drugs to kill or slow the growth of cancer cells, while minimising damage to healthy cells free-interval of >30 days, with documented progression
- 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 an ECOG performance status of 0 or 1