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BMS-986489

Phase 3

Extensive-Stage Small Cell Lung Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Trials Updated: Oct 13, 2026

BMS-986489 development status

Highest phase Phase 3
Registered trials 2 across 2 sponsors since Jan 2025

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC
Total Trials3
Total Enrollment790

FDA Designations

No designations recorded

BMS-986489 clinical trials

BMS-986489 · 3 trials · 3 indications

Phase 3 1Phase 2 1Phase 1 1
NCT06646276A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).Extensive-Stage Small Cell Lung Cancer
RECRUITING530 Analytics
PHASE3RECRUITING
A Study to Compare the Efficacy and Safety of BMS-986489 (Atigotatug+ Nivolumab Fixed Dose Combination) in Combination With Carboplatin Plus Etoposide to That of Atezolizumab With Carboplatin Plus Etoposide as First-Line Therapy in Participants With Extensive-Stage Small Cell Lung Cancer (TIGOS).
Extensive-Stage Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Overall Survival (OS)
Up to 5 years
Evaluate the efficacy of BMS-986489 vs durvalumab by Overall Survival (OS).
From date of randomization up to 5 years. Every 8 weeks for participants who stopped treatment before disease progression and before completing 6 months of treatment and every 12 weeks for participants who stopped treatment before disease progression and

Overall Survival (OS) is defined as the time between the date of randomization and the date of death due to any cause.

Number of participants with adverse events (AEs)
Up to 19 months after last participant's first treatment
Number of participants with Serious AEs (SAEs)
Up to 19 months after last participant's first treatment
Number of participants with AEs leading to discontinuation of study treatment
Up to 19 months after last participant's first treatment
Number of participants with select AEs
Up to 19 months after last participant's first treatment
Number of participants with immune-mediated AEs (IMAEs)
Up to 19 months after last participant's first treatment
Number of deaths
Up to 19 months after last participant's first treatment
Number of participants with laboratory abnormalities
Up to 19 months after last participant's first treatment
Maximum observed concentration (Cmax) for BMS-986012
Up to 19 months after last participant's first treatment
Time of maximum observed concentration (Tmax) for BMS-986012
Up to 19 months after last participant's first treatment
Trough observed plasma concentration (Ctrough) for BMS-986012
Up to 19 months after last participant's first treatment
Concentration at the end of a dosing interval (Ctau) for BMS-986012
Up to 19 months after last participant's first treatment
Average concentration over a dosing interval ([AUC(TAU)/TAU]) (Cavg(TAU)) for BMS-986012
Up to 19 months after last participant's first treatment
Area under the concentration-time curve within one dosing interval (AUC(TAU)) for BMS-986012
Up to 19 months after last participant's first treatment
Total body clearance (CLT) for BMS-986012
Up to 19 months after last participant's first treatment
Observed concentration at end of infusion (Ceoi) for BMS-986012
Up to 19 months after last participant's first treatment

Secondary Endpoints

Time to definitive deterioration (TTDD)based on the LCSS ASBI defined as the time from randomization until a definitive clinically meaningful decline (≥ 10 point increase from baseline in LCSS ASBI score).
Up to 5 years
Number of participants with Adverse Events (AEs)
Up to 135 days after last treatment
Number of Participants with Serious Adverse Events (SAEs)
Up to 135 days after last treatment
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
BMS-986489 (atigotatug + nivolumab)EXPERIMENTALParticipants will receive a fixed dose of BMS-986489 (atigotatug + nivolumab) intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.
DurvalumabACTIVE_COMPARATORParticipants will receive standard of care Durvalumab intravenously each cycle. Cycles will be 28 days. Up to 125 participants will be enrolled into this arm.
BMS-986489EXPERIMENTAL -

Interventions

NameTypeDescription
BMS-986489 (Atigotatug+Nivolumab)BIOLOGICALSpecified dose on specified days
AtezolizumabBIOLOGICALSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
EtoposideDRUGSpecified dose on specified days
BMS-986489DRUGBMS-986489 (fixed dose combination of atigotatug + nivolumab) will be administered as an intravenous infusion to be given once every 4 weeks for up to 2 years.
DurvalumabDRUGDurvalumab will be administered as a fixed dose intravenous infusion to be given once every 4 weeks for up to 2 years.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites183

Inclusion Criteria * Participants must have diagnosis of Extensive-Stage Small Cell Lung Cancer (ES-SCLC). * Participants must be Healthy enough to do their normal activities with little or no help based on the ECOG performance scale. * Participants must have at least one tumor that can be measured...

Countries:United StatesArgentinaAustraliaAustriaBelgiumBrazilCanadaChileChinaCzechiaFranceGermanyGreeceIndiaItalyJapanMalaysiaMexicoNetherlandsPolandRomaniaSouth KoreaSpainSwitzerlandTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)

LOWOct 13, 2026NCT06646276primaryCompletionDate: changed
LOWOct 13, 2026NCT06646276primaryCompletionDate: changed
HIGHSep 24, 2026NCT06799286Status: ACTIVE_NOT_RECRUITING → COMPLETED
HIGHSep 24, 2026NCT06799286Status: ACTIVE_NOT_RECRUITING → COMPLETED
MEDIUMSep 11, 2026NCT06646276lastUpdatePostDate: changed
MEDIUMSep 11, 2026NCT06646276lastUpdatePostDate: changed
LOWAug 31, 2026NCT06646276lastUpdatePostDate: changed
LOWAug 31, 2026NCT06646276lastUpdatePostDate: changed
LOWAug 14, 2026NCT06646276lastUpdatePostDate: changed
LOWAug 14, 2026NCT06646276lastUpdatePostDate: changed

Frequently asked questions about BMS-986489

What is BMS-986489 used for?

BMS-986489 is being developed for the treatment of small cell lung cancer, including extensive-stage small cell lung cancer, limited-stage small cell lung cancer, and small cell lung carcinoma. It is an investigational monoclonal antibody combination therapy and is not yet approved for any indication.

Who is developing BMS-986489?

BMS-986489 is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is running clinical trials of the agent in small cell lung cancer across multiple countries.

What phase is BMS-986489 in?

BMS-986489 is in Phase 3 clinical development. The Phase 3 TIGOS trial is currently recruiting participants with extensive-stage small cell lung cancer, while a Phase 2 trial in limited-stage disease is active but not recruiting.

What clinical trials is BMS-986489 in?

BMS-986489 has been studied in three registered trials. NCT06646276 is a recruiting Phase 3 trial in extensive-stage small cell lung cancer. NCT06773910 is an active Phase 2 trial in limited-stage disease. NCT06799286 is a completed Phase 1 trial in Chinese participants with relapsed or refractory small cell lung cancer.