Last updated 5 days ago
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)
850 patients around the world
Available in United States, Brazil, Argentina
Bristol-Myers Squibb
2Research sites
850Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.
Sites
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
StudyIZABRIGHT-Lung02
SponsorBristol-Myers Squibb
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07680790
