Izalontamab brengitecan plus osimertinib for first treatment of EGFR-mutant non-small cell lung cancer
Tests izalontamab brengitecan with osimertinib in adults with untreated EGFR-mutant non-small cell lung cancer.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Bergamo, Brescia, Candiolo, Meldola, Milan, Pavia, and Peschiera del Garda, ItalySee the 9 sites
- Phase
- Phase 3
Where in Italy
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIIIBergamo, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, ItalyNot yet recruiting
- Istituto di Candiolo Fondazione del Piemonte per l'oncologia IRCCSCandiolo, ItalyNot yet recruiting
- Istituto Romagnolo per lo Studio dei Tumori "Dino Amadori" - IRST S.r.lMeldola, ItalyNot yet recruiting
- Azienda Socio Sanitaria Territoriale Santi Paolo E CarloMilan, ItalyNot yet recruiting
- Fondazione IRCCS - Istituto Nazionale dei TumoriMilan, ItalyNot yet recruiting
- Istituto Europeo di Oncologia s.r.lMilan, ItalyNot yet recruiting
- Fondazione IRCCS Policlinico San MatteoPavia, ItalyNot yet recruiting
- Ospedale P. Pederzoli Casa di Cura Privata S.p.A.Peschiera del Garda, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Bristol-Myers Squibb
- Trial code
- NCT07680790EU 2026-526486-21-00
- Record updated
- 10 November 2026
- Original description
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 chemotherapyRead full original descriptionShow less
A Phase III, Randomized, Open-label Study of Izalontamab Brengitecan (BMS-986507) in Combination With Osimertinib Versus Osimertinib Monotherapy or Osimertinib in Combination With Platinum-based Chemotherapy as First-Line Therapy in Patients With EGFR-Mutant Locally Advanced or Metastatic Non-small Cell Lung Cancer
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
Inclusion: 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: Participants must not have history of ILD/pneumonitis requiring treatment with steroids (≥ Grade 2), or current or suspected ILD/pneumonitis; Participants must not have unstable, symptomatic, or uncontrolled CNS metastases, including brain, leptomeningeal disease, and/or spinal cord compression; Participants must not have clinically significant cardiac disease; Other protocol-defined inclusion/exclusion criteria apply.