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Cobolimab

Phase 3

Lung Cancer, Non-Small Cell | Monoclonal antibody | Oncology |GSK plc|Last Updated: Sep 26, 2025

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
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Trial Design
RandomizedACTIVE_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment758
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04655976Efficacy Comparison of Cobolimab + Dostarlimab + Docetaxel to Dostarlimab + Docetaxel to Docetaxel Alone in Participants With Advanced Non-small Cell Lung Cancer Who Have Progressed on Prior Anti-PD-(L)1 Therapy and ChemotherapyPHASE3 ACTIVE NOT_RECRUITING 758Dec 8, 2020Mar 30, 2027Sep 26, 2025163 United States, Argentina +22
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Study Endpoints
Primary Endpoints
Overall survival (OS) in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving docetaxel alone
Up to approximately 52 months

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

OS in participants receiving dostarlimab + docetaxel relative to participants receiving docetaxel alone
Up to approximately 52 months

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

Secondary Endpoints
OS in participants receiving cobolimab + dostarlimab + docetaxel relative to participants receiving dostarlimab + docetaxel
Up to approximately 52 months
Objective response rate (ORR)
Up to approximately 52 months
Progression free survival (PFS)
Up to approximately 52 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Participants receiving cobolimab+ dostarlimab+ docetaxelEXPERIMENTAL -
Participants receiving dostarlimab+ docetaxelEXPERIMENTAL -
Participants receiving docetaxelACTIVE_COMPARATOR -
Interventions
NameTypeDescription
CobolimabBIOLOGICALCobolimab will be administered.
DostarlimabBIOLOGICALDostarlimab will be administered.
DocetaxelDRUGDocetaxel will be administered.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites163

Inclusion Criteria: * Participant has histologically or cytologically proven advanced or metastatic NSCLC and only squamous or non-squamous cell carcinoma. * Participant has received no more than 2 prior lines of therapy for advanced or metastatic disease, which must only include a platinum based (...

Countries:United StatesArgentinaAustraliaBelgiumBrazilCanadaFinlandFranceGermanyGreeceItalyJapanMexicoNetherlandsPolandRomaniaRussiaSouth KoreaSpainSwedenTaiwanThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT04655976primaryCompletionDate: changed
LOWMay 24, 2026NCT04655976studyFirstPostDate: changed