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Ris-Rez

Phase 3

Neoplasms, Lung | Monoclonal antibody | Oncology |GSK plc|Last Updated: May 27, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
Premium
Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment420
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07099898A Study of GSK5764227 in Participants With Relapsed Small Cell Lung Cancer (SCLC)PHASE3 RECRUITING 420Aug 11, 2025Sep 28, 2029May 27, 2026120 Argentina, Australia +22
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Study Endpoints
Primary Endpoints
Overall Survival (OS)
Up to approximately 113 weeks

OS is defined as the time from the date of randomization to the date of death by any cause

Secondary Endpoints
Objective Response Rate (ORR)
Up to approximately 139 weeks
Duration of Response (DoR)
Up to approximately 139 weeks
Progression-free survival (PFS)
Up to approximately 139 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Ris-RezEXPERIMENTAL -
TopotecanACTIVE_COMPARATOR -
Interventions
NameTypeDescription
Ris-RezBIOLOGICALRis-Rez will be administered
TopotecanDRUGTopotecan will be administered
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites120

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...

Countries:ArgentinaAustraliaBrazilBulgariaCanadaFinlandFranceGermanyGreeceHungaryIrelandIsraelItalyJapanMexicoPolandPortugalRomaniaSouth KoreaSpainSwedenSwitzerlandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 28, 2026NCT07099898lastUpdatePostDate: changed
LOWMay 28, 2026NCT07099898lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07099898primaryCompletionDate: changed
LOWMay 24, 2026NCT07099898studyFirstPostDate: changed