Life sciences · Phase 3 Trial
ClinicalTrials.gov · September 25, 2026
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Phase 3 Trial.
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Registry record from ClinicalTrials.gov (NCT07099898). This is a study registration, not published results. Lead sponsor: GlaxoSmithKline. Recruitment status: RECRUITING. Phase: PHASE3. Study type: INTERVENTIONAL. Enrollment: 420 participants (ESTIMATED). Conditions: Neoplasms, Lung. Interventions: BIOLOGICAL: Risvutatug rezetecan (Ris-Rez); DRUG: Topotecan. Primary outcome measures: Overall Survival (OS) , Up to approximately 113 weeks. Brief summary: 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.