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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)

NCT07680790

Not Yet RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Non-Small Cell Lung Cancer

Interventions: Iza-bren, Osimertinib, Pemetrexed, Carboplatin, Cisplatin

Countries: United States, Argentina, Australia, Brazil, Canada, China, France, Germany

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (200)

Beverly Hills, California, United States
Fullerton, California, United States
La Jolla, California, United States
Pueblo, Colorado, United States
Fort Myers, Florida, United States
Orlando, Florida, United States
Palm Bay, Florida, United States
Honolulu, Hawaii, United States
Ottawa, Illinois, United States
Baltimore, Maryland, United States
Silver Spring, Maryland, United States
Edina, Minnesota, United States
Saint Paul, Minnesota, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
New York, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
Sandusky, Ohio, United States
Portland, Oregon, United States
Easton, Pennsylvania, United States
Sioux Falls, South Dakota, United States
Memphis, Tennessee, United States
Beaumont, Texas, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Fairfax, Virginia, United States
+ 170 more on CT.gov