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Taking peoplePhase 3

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
Buk-Gu, Cheongju-si, Dalseo, Goyang-si, Gyeongsangnam-do, Hwasun-Gun, Seocho -Gu, Seongnam-si, Seoul, and Songpa-Gu, South KoreaSee the 12 sites
Phase
Phase 3

Where in South Korea

  • Buk-GuBuk-Gu, South KoreaNot yet recruiting
  • Cheongju-siCheongju-si, South KoreaNot yet recruiting
  • DalseoDalseo, South KoreaNot yet recruiting
  • Goyang-siGoyang-si, South KoreaNot yet recruiting
  • Gyeongsangnam-doGyeongsangnam-do, South KoreaNot yet recruiting
  • Hwasun-GunHwasun-Gun, South KoreaNot yet recruiting
  • Seocho -GuSeocho -Gu, South KoreaNot yet recruiting
  • Seongnam-siSeongnam-si, South KoreaNot yet recruiting
  • SeoulSeoul, South KoreaNot yet recruiting
  • SeoulSeoul, South KoreaNot yet recruiting
  • SeoulSeoul, South KoreaNot yet recruiting
  • Songpa-GuSongpa-Gu, South KoreaNot yet recruiting

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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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.

ClinicalTrials.gov NCT07680790 · EU CTIS 2026-526486-21-00