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Recruiting
NCT07680790
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)
Conditions: Non-Small Cell Lung Cancer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE3
Enrollment: 850
Sponsor: Bristol-Myers Squibb
Location: Local Institution - 0212 Beverly Hills California
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
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.
Source: ClinicalTrials.gov (NCT07680790). StuddyBuddy aggregates publicly available trial information.