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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)
A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer
Who can join
Ages 18 and older · All sexes
Full eligibility criteria
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 treatment * Participants must have documented EGFR-TKI-sensitizing mutation (exon 19 deletion or exon 21 L858R substitution) * Participants must have measurable extracranial disease per RECIST v1.1 as assessed by the investigator * Participants must have ECOG Performance Status 0-1 Exclusion Criteria: * Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression * Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis * Participants must not have clinically significant cardiac disease * Other protocol-defined inclusion/exclusion criteria apply.
About the study
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
What is being tested
- Iza-bren (drug)
- Osimertinib (drug)
- Pemetrexed (drug)
- Carboplatin (drug)
- Cisplatin (drug)
Sponsor: Bristol-Myers Squibb · Participants: 850 · Started: Sep 8, 2026
Contact the study team
- BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · Phone: 855-907-3286
Official record on ClinicalTrials.gov — NCT07680790
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.