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)
Starting soon · Phase 3
Conditions studied: Non-Small Cell Lung Cancer
In brief
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 facts
- Study ID
- NCT07680790
- Run by
- Bristol-Myers Squibb
- People needed
- 850
- Starts
- 2026-09-30
- Expected to finish
- 2031-12-30
- Last updated by the study team
- 2026-07-15
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Local Institution - 0504 — Fullerton, California, United States
- Local Institution - 0357 — La Jolla, California, United States
- Local Institution - 0520 — Pueblo, Colorado, United States
- Local Institution - 0527 — Fort Myers, Florida, United States
- Local Institution - 0366 — Orlando, Florida, United States
- Local Institution - 0519 — Palm Bay, Florida, United States
- Local Institution - 0210 — Honolulu, Hawaii, United States
- Local Institution - 0207 — Ottawa, Illinois, United States
- Local Institution - 0503 — Baltimore, Maryland, United States
- Local Institution - 0523 — Silver Spring, Maryland, United States
- Local Institution - 0521 — Edina, Minnesota, United States
- Local Institution - 0364 — Saint Paul, Minnesota, United States
- Local Institution - 0403 — St Louis, Missouri, United States
- Local Institution - 0402 — Omaha, Nebraska, United States
- Local Institution - 0290 — Lebanon, New Hampshire, United States
- Local Institution - 0183 — New Brunswick, New Jersey, United States
- Local Institution - 0153 — New York, New York, United States
- Local Institution - 0157 — The Bronx, New York, United States
- Local Institution - 0385 — Charlotte, North Carolina, United States
- Local Institution - 0438 — Sandusky, Ohio, United States
- Local Institution - 0404 — Portland, Oregon, United States
- Local Institution - 0487 — Easton, Pennsylvania, United States
- Local Institution - 0200 — Sioux Falls, South Dakota, United States
- Local Institution - 0199 — Memphis, Tennessee, United States
- Local Institution - 0212 — Beverly Hills, California, United States
Full record on ClinicalTrials.gov
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