Recently added Catalysts

BMS-986489

Phase 3

Extensive-Stage Small Cell Lung Cancer | Monoclonal antibody | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 31, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindACTIVE_CONTROLLEDDMC

Total Trials1

Total Enrollment530

FDA Designations

No designations recorded

Clinical trial landscape

BMS-986489 · 2 trials · 2 indications

Phase 3 1Phase 1 1

Indication

NCT06646276A Study to Compare the Efficacy and Safety of BMS-986489 (BMS-986012+ 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 (BMS-986012+ 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

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Study Endpoints

Primary Endpoints

Overall Survival (OS)

Up to 5 years

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

Arm	Type	Description
Arm A	EXPERIMENTAL	-
Arm B	ACTIVE_COMPARATOR	-
BMS-986489	EXPERIMENTAL	-

Interventions

Name	Type	Description
BMS-986489 (BMS-986012+Nivolumab)	BIOLOGICAL	Specified dose on specified days
Atezolizumab	BIOLOGICAL	Specified dose on specified days
Carboplatin	DRUG	Specified dose on specified days
Etoposide	DRUG	Specified dose on specified days
BMS-986489	DRUG	Specified dose on specified days

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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)

LOWAug 31, 2026NCT06646276lastUpdatePostDate: changed

LOWAug 31, 2026NCT06646276lastUpdatePostDate: changed

LOWAug 14, 2026NCT06646276lastUpdatePostDate: changed

LOWAug 14, 2026NCT06646276lastUpdatePostDate: changed

LOWJul 20, 2026NCT06646276lastUpdatePostDate: changed

LOWJul 20, 2026NCT06646276lastUpdatePostDate: changed

LOWJun 30, 2026NCT06646276lastUpdatePostDate: changed

LOWJun 30, 2026NCT06646276lastUpdatePostDate: changed

LOWJun 30, 2026NCT06646276lastUpdatePostDate: changed

LOWJun 16, 2026NCT06646276lastUpdatePostDate: changed

LOWJun 16, 2026NCT06646276lastUpdatePostDate: changed

LOWJun 16, 2026NCT06646276lastUpdatePostDate: changed

Frequently asked questions about BMS-986489

What is BMS-986489 used for?

BMS-986489 is an investigational monoclonal antibody being developed for extensive-stage small cell lung cancer and small cell lung carcinoma. It is being studied as a first-line therapy in combination with carboplatin plus etoposide for extensive-stage small cell lung cancer, and in Chinese participants with relapsed or refractory small cell lung cancer.

Who makes BMS-986489?

BMS-986489 is being developed by Bristol-Myers Squibb Company, traded on the New York Stock Exchange under the ticker BMY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in small cell lung cancer.

What phase is BMS-986489 in?

BMS-986489 is in Phase 3 clinical development for extensive-stage small cell lung cancer. A Phase 1 study is also active in China for relapsed or refractory small cell lung cancer. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is BMS-986489 in?

BMS-986489 is being evaluated in two clinical trials. NCT06646276 is a Phase 3 study comparing BMS-986489 with carboplatin plus etoposide to atezolizumab with carboplatin plus etoposide as first-line therapy in extensive-stage small cell lung cancer, enrolling 530 participants. NCT06799286 is a Phase 1 study in Chinese participants with relapsed or refractory small cell lung cancer.

Is BMS-986489 the same as BMS-986012 plus nivolumab?

Yes, BMS-986489 is a fixed-dose combination of BMS-986012 and nivolumab. The drug is being studied as a combination therapy for small cell lung cancer, with the Phase 3 trial evaluating it alongside chemotherapy as a first-line treatment for extensive-stage disease.

What is the design of the BMS-986489 Phase 3 trial?

The Phase 3 trial NCT06646276 is a randomized, double-blind, active-controlled study. It compares BMS-986489 plus carboplatin and etoposide against atezolizumab plus carboplatin and etoposide in 530 participants with extensive-stage small cell lung cancer. The trial is recruiting in multiple countries including the United States, China, and European nations.