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)
Sponsor: Bristol-Myers Squibb
ClinicalTrials ID:NCT07680790
This study evaluates the efficacy of izalontamab brengitecan with osimertinib in untreated EGFR-mutant NSCLC. Eligible participants have advanced or metastatic non-squamous NSCLC with EGFR-TKI-sensitizing mutations and measurable disease. Interventions include drugs: iza-bren, osimertinib, pemetrexed, carboplatin, and cisplatin, administered in specified doses.
Patient Parameters
| Parameter | Options |
|---|
Program Overview
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.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Local Institution - 0212 | 90211 | Beverly Hills | California |
| Local Institution - 0504 | 92835 | Fullerton | California |
| Local Institution - 0357 | 92093 | La Jolla | California |
| Local Institution - 0520 | 80304 | Boulder | Colorado |
| Local Institution - 0527 | 33901 | Fort Myers | Florida |
| Local Institution - 0366 | 32806 | Orlando | Florida |
| Cancer Care Centers of Brevard - Rockledge | 32901 | Palm Bay | Florida |
| Local Institution - 0526 | 33701 | St. Petersburg | Florida |
| Local Institution - 0524 | 33401 | West Palm Beach | Florida |
| Local Institution - 0207 | 61350 | Ottawa | Illinois |
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