A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)

Part of paid clinical trials in Los Angeles, California.

Sponsor
GlaxoSmithKline
Study ID
NCT07099898
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Neoplasms, Lung

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ris-Rez — BIOLOGICAL
    Ris-Rez will be administered
  • Topotecan — DRUG
    Topotecan will be administered

Study Details

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.

Key Dates

First listed
Aug 1, 2025
Start date
Aug 11, 2025
Status verified
Aug 2026
Primary completion
Nov 5, 2027
Completion
Sep 28, 2029

Study Design

Enrollment
420 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ris-Rez
  • Active Comparator: Topotecan

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: Up to approximately 113 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteLos AngelesCalifornia90027
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Ghassan Al-Jazayrly (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteWilsonNorth Carolina27893
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Keith Lerro (PRINCIPAL_INVESTIGATOR)

Find similar trials in Los Angeles, CA

By research site
GSK Investigational Site· Los Angeles, CAGSK Investigational Site· Wilson, NC

Related Studies