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)

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Bristol-Myers Squibb
Study ID
NCT07680790
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iza-bren — DRUG
    Specified dose on specified days
  • Osimertinib — DRUG
    Specified dose on days
  • Pemetrexed — DRUG
    Specified dose on specified days
  • Carboplatin — DRUG
    Specified dose on specified days
  • Cisplatin — DRUG
    Specified dose on specified days

Study Details

The purpose of this study is to evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy

Key Dates

Start date
Sep 30, 2026
Status verified
Jun 2026
Primary completion
Dec 30, 2031
Completion
Dec 30, 2031

Study Design

Enrollment
850 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
  • Active Comparator: Arm B

Primary Outcome Measure

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) [ Time Frame: Up to approximately 3 years ]

Central Contacts

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
    855-907-3286
  • First line of the email MUST contain NCT # and Site #.

Locations (33)

FacilityCityStateZIPSite coordinators
Local Institution - 0212Beverly HillsCalifornia90211
Site 0212
Local Institution - 0504FullertonCalifornia92835
Site 0504
Local Institution - 0357La JollaCalifornia92093
Site 0357
Local Institution - 0520PuebloColorado81003
Site 0520
Local Institution - 0366OrlandoFlorida32806
Site 0366
Local Institution - 0519Palm BayFlorida32901
Site 0519
Local Institution - 0210HonoluluHawaii96813
Site 0210
Local Institution - 0207OttawaIllinois61350
Site 0207
Local Institution - 0503BaltimoreMaryland21202
Site 0503
Local Institution - 0523Silver SpringMaryland20904
Site 0523
Local Institution - 0521EdinaMinnesota55435
Site 0521
Local Institution - 0364Saint PaulMinnesota55102
Site 0364
Local Institution - 0403St LouisMissouri63110
Site 0403
Local Institution - 0402OmahaNebraska68198
Site 0402
Local Institution - 0290LebanonNew Hampshire03756
Site 0290
Local Institution - 0183New BrunswickNew Jersey08901
Site 0183
Local Institution - 0153New YorkNew York10021
Site 0153
Local Institution - 0157The BronxNew York10461
Site 0157
Local Institution - 0385CharlotteNorth Carolina28204
Site 0385
Local Institution - 0438SanduskyOhio44870
Site 0438
Local Institution - 0404PortlandOregon97213
Site 0404
Local Institution - 0487EastonPennsylvania18045
Site 0487
Local Institution - 0200Sioux FallsSouth Dakota57105
Site 0200
Local Institution - 0199MemphisTennessee38120
Site 0199
Local Institution - 0522BeaumontTexas77702
Site 0522
Local Institution - 0525DallasTexas75246
Site 0525
Local Institution - 0529San AntonioTexas78217
Site 0529
Local Institution - 0411Salt Lake CityUtah84112
Site 0411
Local Institution - 0165FairfaxVirginia22031
Site 0165
Local Institution - 0530FairfaxVirginia22031
Site 0530
Local Institution - 0528WinchesterVirginia22601
Site 0528
Local Institution - 0283SeattleWashington98104
Site 0283
Local Institution - 0502MorgantownWest Virginia26505
Site 0502

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