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BMS-986012

Phase 2

Extensive-stage Small Cell Lung Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Apr 29, 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
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment135
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04702880A Study of BMS-986012 in Combination With Carboplatin, Etoposide, and Nivolumab as First-line Therapy in Extensive-stage Small Cell Lung CancerPHASE2 COMPLETED 135 — — Mar 17, 2021Nov 28, 2025Apr 29, 202639 United States, Australia +9
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AEs)
Up to 2 years and 100 days
Incidence of serious adverse events (SAEs)
Up to 2 years and 128 days
Incidence of AEs leading to discontinuation
Up to 2 years and 128 days
Incidence of deaths
Up to 2 years and 128 days
Progression-free survival (PFS) by blinded independent central review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria
Up to 2 years
Secondary Endpoints
Progression-free survival rate (PFSR)
6 and 12 months
PFS by investigator based on RECIST v1.1 criteria
Up to 2 years
PFSR
6 and 12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: Carboplatin + Etoposide + Nivolumab + BMS-986012EXPERIMENTAL -
Arm B: Carboplatin + Etoposide + NivolumabEXPERIMENTAL -
Interventions
NameTypeDescription
BMS-986012BIOLOGICALSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
EtoposideDRUGSpecified dose on specified days
NivolumabBIOLOGICALSpecified dose on specified days
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites39

Inclusion Criteria: * Histologically or cytologically documented extensive-stage small cell lung cancer (ES-SCLC) and extensive-stage disease (American Joint Committee on Cancer, 8th edition, Stage IV \[T any, N any, M1a, M1b, or M1c\], or T3-4 due to multiple lung nodules that are too extensive or...

Countries:United StatesAustraliaBelgiumCanadaGreeceItalyJapanNetherlandsPolandRomaniaSpain
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Recent Changes (Last 90 Days)
MEDIUMMay 30, 2026NCT04702880TRIAL_REMOVED: changed
MEDIUMMay 30, 2026NCT04702880TRIAL_REMOVED: changed
MEDIUMMay 30, 2026NCT04702880TRIAL_REMOVED: changed
MEDIUMMay 30, 2026NCT04702880TRIAL_REMOVED: changed
HIGHMay 26, 2026NCT04702880Status: ACTIVE_NOT_RECRUITING → COMPLETED
LOWMay 24, 2026NCT04702880studyFirstPostDate: changed