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Adagrasib

Phase 3

Carcinoma, Non-Small-Cell Lung | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jun 2, 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
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment630
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06875310A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)PHASE3 RECRUITING 630Apr 24, 2025Apr 30, 2032Jun 2, 2026353 United States, Argentina +33
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Study Endpoints
Primary Endpoints
Progression Free Survival (PFS) as Assessed per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Blinded Independent Central Review (BICR)
Up to 7 years
Overall Survival (OS)
Up to 7 years
Secondary Endpoints
Overall Response (OR) as Assessed per RECIST v1.1 by BICR
Up to 7 years
Duration of Response (DOR) as Assessed per RECIST 1.1 by BICR
Up to 7 years
PFS as Assessed per RECIST v1.1 by Investigator
Up to 7 years
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
AdagrasibEXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
AdagrasibDRUGSpecified dose on specified days
PembrolizumabDRUGSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
PemetrexedDRUGSpecified dose on specified days
PlaceboDRUGSpecified dose on specified days
CisplatinDRUGSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites353

Inclusion Criteria: * Histologically or cytologically confirmed diagnosis of non-squamous NSCLC with evidence of KRAS G12C mutation via tumor sample and/or circulating tumor deoxyribonucleic acid (ctDNA). * Locally advanced or metastatic disease. * Measurable disease via computed tomography (CT) or...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilBulgariaCanadaChileChinaColombiaCroatiaFranceGermanyGreeceHong KongHungaryIndiaIrelandIsraelItalyJapanMexicoNetherlandsPolandPortugalRomaniaSaudi ArabiaSouth KoreaSpainSwitzerlandTaiwanThailandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT06875310lastUpdatePostDate: changed
LOWJun 2, 2026NCT06875310lastUpdatePostDate: changed
LOWJun 2, 2026NCT06875310lastUpdatePostDate: changed
LOWMay 26, 2026NCT06875310primaryCompletionDate: changed
LOWMay 24, 2026NCT06875310studyFirstPostDate: changed