Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib … (NCT07680790) | Clinical Trial Compass
Not Yet RecruitingPhase 3
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)
United States, Argentina, Australia850 participantsStarted 2026-09-30
Plain-language summary
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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This is a Phase 3 trial comparing izalontamab brengitecan plus osimertinib against osimertinib alone or osimertinib with chemotherapy — given that osimertinib is already a standard treatment for EGFR-mutated lung cancer, how does adding this new drug compare to what I could receive right now outside of a trial?
2Since the trial isn't recruiting yet, do you know when it's expected to open, and is waiting for it a realistic option given where my cancer is right now?
3The trial has three different treatment arms — if I were to enroll, would I have any say in which group I'm placed in, or would that be randomly assigned, and how would that affect my care?
4The main thing this trial is measuring is how long patients go without their cancer progressing — can you help me understand what that means in practical terms, and whether slowing progression is the most important goal for my specific situation?
5Are there other trials or standard treatments I should consider alongside this one, so I can compare my options before deciding whether it's worth waiting for this study to open?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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)
Timeframe: Up to approximately 3 years
Trial details
NCT IDNCT07680790
SponsorBristol-Myers Squibb
Sponsor typeINDUSTRY
Study typeINTERVENTIONAL
Primary completion2031-12-30
Contact for this trial
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com