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Iza-bren

Phase 3

Non-Small Cell Lung Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Aug 25, 2026

Success Probability

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Trial Design

RandomizedACTIVE_CONTROLLEDDMC
Total Trials2
Total Enrollment1,350

FDA Designations

No designations recorded

Clinical trial landscape

Iza-bren · 4 trials · 3 indications

Phase 3 1Phase 2 3
NCT07680790Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)Non-Small Cell Lung Cancer
NOT YET_RECRUITING850 Analytics
PHASE3NOT YET_RECRUITING
Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy for EGFRmt Non-small Cell Lung Cancer (IZABRIGHT-Lung02)
Non-Small Cell Lung CancerUnlock trial analytics

Study Endpoints

Primary Endpoints

Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Up to approximately 3 years
Recommended Phase 3 Dose (RP3D) of BMS-986507
Approximately 3 months after the first dose

Phase 2

Progression-Free Survival (PFS) Assessed by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)
Up to 3 years

Phase 3

Phase 2: Recommended Phase 3 Dose (RP3D) of BMS-986507
Approximately 3 months
Phase 3: Progression-Free Survival (PFS)
Up to 5 years

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) per blinded independent central review (BICR)

Phase 3: Overall Survival (OS)
Up to 5 years
Progression-Free Survival (PFS)
Approximately 22 months from first participant randomization in Phase 3

Assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by blinded independent central review (BICR)

Secondary Endpoints

Overall Survival (OS)
Up to approximately 5 years
PFS assessed by the investigator as per RECIST v1.1
Up to approximately 3 years
Second Progression-Free Survival (PFS2) as assessed by the Investigator
Up to approximately 5 years
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm AEXPERIMENTAL -
Arm BACTIVE_COMPARATOR -
Arm CACTIVE_COMPARATOR -
Arm DEXPERIMENTAL -
Arm EACTIVE_COMPARATOR -
Arm A1EXPERIMENTAL -
Arm A2EXPERIMENTAL -

Interventions

NameTypeDescription
Iza-brenDRUGSpecified dose on specified days
OsimertinibDRUGSpecified dose on days
PemetrexedDRUGSpecified dose on specified days
CarboplatinDRUGSpecified dose on specified days
CisplatinDRUGSpecified dose on specified days
GemcitabineDRUGSpecified dose on specified days
Nab-paclitaxelDRUGSpecified dose on specified days
PaclitaxelDRUGSpecified dose on specified days
CapecitabineDRUGSpecified dose on specified days
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites208

Inclusion Criteria: * Participants must have histologically or cytologically confirmed non-squamous NSCLC, newly diagnosed locally advanced (Stage IIIB/IIIC), metastatic (Stage IVA/IVB), or recurrent disease not amenable to curative surgery or definitive radiotherapy and requiring systemic treatmen...

Countries:United StatesArgentinaAustraliaBrazilCanadaChinaFranceGermanyIndiaItalyJapanSouth KoreaSpainTaiwanThailandTurkey (Türkiye)BelgiumChileColombiaGreeceMexicoNetherlandsNorwayPolandRomaniaSingaporeSwitzerlandUnited KingdomAustriaCzechiaIrelandIsraelSwedenPortugalSouth AfricaUnited Arab Emirates
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Competitive Landscape -Non-Small Cell Lung Cancer 387 trials

Recent Changes (Last 90 Days)

LOWAug 25, 2026NCT07100080lastUpdatePostDate: changed
LOWAug 25, 2026NCT07100080lastUpdatePostDate: changed
LOWAug 24, 2026NCT07680790lastUpdatePostDate: changed
LOWAug 24, 2026NCT07680790lastUpdatePostDate: changed
LOWAug 11, 2026NCT06926868Enrollment: 500 → 600
LOWAug 11, 2026NCT06926868Enrollment: 500 → 600
LOWAug 11, 2026NCT06926868Enrollment: 500 → 600
LOWJul 29, 2026NCT07106762lastUpdatePostDate: changed
LOWJul 29, 2026NCT07100080lastUpdatePostDate: changed
LOWJul 29, 2026NCT07106762lastUpdatePostDate: changed
LOWJul 29, 2026NCT07100080lastUpdatePostDate: changed
LOWJul 15, 2026NCT07680790lastUpdatePostDate: changed
LOWJul 15, 2026NCT07680790lastUpdatePostDate: changed
LOWJul 7, 2026NCT07106762lastUpdatePostDate: changed
LOWJul 7, 2026NCT07106762lastUpdatePostDate: changed
LOWJul 2, 2026NCT07680790NEW_TRIAL: changed
LOWJul 2, 2026NCT07680790NEW_TRIAL: changed
LOWJun 22, 2026NCT07100080lastUpdatePostDate: changed
LOWJun 22, 2026NCT07100080lastUpdatePostDate: changed
LOWJun 10, 2026NCT06926868lastUpdatePostDate: changed

Frequently asked questions about Iza-bren

What is Iza-bren?

Iza-bren, also known as Izalontamab Brengitecan and BMS-986507, is an investigational small molecule being developed by Bristol-Myers Squibb for oncology indications. It is currently in Phase 2 clinical trials for urothelial cancer, breast neoplasms, and non-small cell lung cancer.

What is Iza-bren used for?

Iza-bren is being studied for the treatment of urothelial cancer, breast neoplasms, and non-small cell lung cancer. In clinical trials, it is being evaluated as a monotherapy and in combination with other agents for these advanced or metastatic cancers.

Who makes Iza-bren?

Iza-bren is being developed by Bristol-Myers Squibb Company, which trades under the ticker BMY. The company is conducting multiple clinical trials to evaluate the drug's safety and efficacy in various oncology indications.

What phase is Iza-bren in?

Iza-bren is currently in Phase 2 clinical development. It is being studied in active trials for urothelial cancer, breast neoplasms, and non-small cell lung cancer. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is Iza-bren in?

Iza-bren is being evaluated in several recruiting trials, including NCT06926868 for triple-negative breast cancer, NCT07100080 for EGFR-mutated non-small cell lung cancer, and NCT07106762 for metastatic urothelial cancer. These trials are actively enrolling participants.

Is Iza-bren the same as Izalontamab Brengitecan?

Yes, Iza-bren is the same as Izalontamab Brengitecan, which is also known by the code BMS-986507. These names refer to the same investigational drug being developed by Bristol-Myers Squibb for oncology indications.