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Iza-bren

Phase 3

Non-Small Cell Lung Cancer | Small molecule | Oncology |Bristol-Myers Squibb Company|Last Updated: Jul 15, 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 Cancer
NCT07680790850
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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 31 months from first participant randomization

Assessed using Response Evaluation Criteriain Solid Tumors version 1.1 (RECIST v1.1) byblinded 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 Sites200

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 KoreaSpainTaiwanTurkey (Türkiye)BelgiumChileColombiaGreeceMexicoNetherlandsNorwayPolandRomaniaSingaporeSwitzerlandThailandUnited KingdomAustriaCzechiaIrelandIsraelSwedenPortugalSouth AfricaUnited Arab Emirates
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Competitive Landscape -Non-Small Cell Lung Cancer 395 trials

Top 20 of 86 competitors

CompanyTickerTrialsLead PhaseDrugs
Merck & Co., Inc.MRK25PHASE3Pembrolizumab, Olaparib, Etoposide, Carboplatin, Cisplatin
AstraZeneca PLCAZN62PHASE3Datopotamab deruxtecan, Durvalumab, Carboplatin, Pembrolizumab, Cisplatin
Revolution Medicines, Inc.RVMD8PHASE3daraxonrasib, docetaxel
Eli Lilly and CompanyLLY19PHASE3Selpercatinib, Carboplatin, Cisplatin, Pemetrexed, Pembrolizumab
AbbVie, Inc.ABBV10PHASE3Telisotuzumab Vedotin, Docetaxel
Amgen Inc.AMGN5PHASE3AMG 510, Docetaxel
Bristol-Myers Squibb CompanyBMY19PHASE3Repotrectinib, Crizotinib
BioNTech SE Sponsored ADRBNTX7PHASE3Gotistobart, Docetaxel
Gilead Sciences, Inc.GILD4PHASE3Sacituzumab Govitecan-hziy, Docetaxel
Johnson & JohnsonJNJ17PHASE3Lazertinib, Amivantamab, Pemetrexed, Carboplatin
ArriVent BioPharma, Inc.AVBP9PHASE3Firmonertinib
Pfizer Inc.PFE17PHASE3Lorlatinib, Crizotinib
GSK plc Sponsored ADRGSK4PHASE3Dostarlimab, Belrestotug, Pembrolizumab
Novartis AG Sponsored ADRNVS9PHASE3JDQ443, docetaxel
Summit Therapeutics IncSMMT2PHASE3Ivonescimab, Pembrolizumab
Nuvation Bio, Inc. Class ANUVB4PHASE3Taletrectinib, Crizotinib
Genmab A/S Sponsored ADRGMAB4PHASE3Acasunlimab, Pembrolizumab, Docetaxel
Regeneron Pharmaceuticals, Inc.REGN6PHASE2cemiplimab, Platinum Doublet, fianlimab
BeOne Medicines Ltd. Sponsored ADRONC6PHASE3Tislelizumab, Cisplatin, Paclitaxel, Pemetrexed Disodium, Carboplatin
BeyondSpring Inc.BYSI1PHASE3Plinabulin, Docetaxel
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Recent Changes (Last 90 Days)
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
LOWJun 10, 2026NCT06926868lastUpdatePostDate: changed
LOWJun 8, 2026NCT07106762lastUpdatePostDate: changed
LOWJun 8, 2026NCT07106762lastUpdatePostDate: changed
LOWJun 8, 2026NCT07106762lastUpdatePostDate: changed
LOWMay 29, 2026NCT06926868lastUpdatePostDate: changed
LOWMay 29, 2026NCT06926868lastUpdatePostDate: changed
LOWMay 29, 2026NCT06926868lastUpdatePostDate: changed
LOWMay 28, 2026NCT07100080Enrollment: 596 → 500
LOWMay 28, 2026NCT07100080Enrollment: 596 → 500
LOWMay 26, 2026NCT07106762primaryCompletionDate: changed
LOWMay 26, 2026NCT07100080primaryCompletionDate: changed