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

StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Interventions modified
    • Study sites: 134 to 135
  2. Study sites: 132 to 134 Show 4 more changesShow less
    • Interventions: Ris-Rez (Biological), Topotecan (Drug) to Risvutatug rezetecan (Ris-Rez) (Biological), Topotecan (Drug)
    • Eligibility criteria expanded, about 17 words
    • Secondary endpoints: 19 to 23
    • Study title expanded, about 2 words
  3. Trial sites expanded: 126 → 132 locationsv12
  4. Trial sites expanded: 120 → 126 locationsv11
  5. Trial sites expanded: 114 → 120 locationsv10
  6. Primary endpoint(s) modifiedv9 Show 5 more changesShow less
    • Trial sites expanded: 102 → 114 locations
    • Primary completion date: Oct 29, 2027 to Nov 5, 2027
    • Interventions: GSK5764227 (Biological), Topotecan (Drug) to Ris-Rez (Biological), Topotecan (Drug)
    • Eligibility criteria expanded, about 40 words
    • Secondary endpoints: 18 to 19
  7. Enrollment target: 300 to 420
    • Study sites: 90 to 102
    v8
  8. Primary completion date: Sep 2, 2026 to Oct 29, 2027
    • Study sites: 59 to 90
    • Study completion date: Sep 11, 2028 to Sep 28, 2029
    v7
  9. Study sites: 42 to 59v6
  10. Study sites: 14 to 42v5
  11. Study sites: 6 to 14v4
  12. Study sites: 4 to 6v3
  13. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Study sites: 0 to 4
    • Primary completion date: Sep 8, 2026 to Sep 2, 2026
    • Study completion date: Sep 15, 2028 to Sep 11, 2028
    • Start date changed from estimate of Aug 15, 2025 to Aug 11, 2025
  14. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07099898
Lead Sponsor GlaxoSmithKline
Conditions
(from sponsor)		 Neoplasms, Lung
Related terms Lung Neoplasms, Small Cell Lung Carcinoma
Enrollment 420 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov