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Study of Izalontamab Brengitecan for EGFR-mutant Non-Small Cell Lung Cancer

This study is testing a new combination treatment, izalontamab brengitecan (iza-bren) with osimertinib, for people with locally advanced or metastatic non-small cell lung cancer (NSCLC). This type of lung cancer has a specific change in the EGFR gene (EGFR-mutant). Researchers want to see if this combination works better than osimertinib alone, or osimertinib combined with chemotherapy drugs like pemetrexed, carboplatin, or cisplatin. You may be able to join if you have newly diagnosed, advanced NSCLC with an EGFR-TKI-sensitizing mutation. The main goal is to see how long people live without their cancer growing or spreading. This study is currently recruiting about 850 participants.

Study design
This is an interventional study comparing different treatment combinations. It plans to enroll about 850 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for progression-free survival for up to approximately 3 years.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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)

Not Yet Recruiting
PHASE3Ages 18+InterventionalTreatment
Bristol-Myers Squibb
~850 participants
Updated 2026-08-24 on ClinicalTrials.gov
What's tested:Iza-brenOsimertinibPemetrexedCarboplatinCisplatin

At a glance

Recruiting sites
0 of 208 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)
Measured over Up to approximately 3 years

Conditions

Non-Small Cell Lung Cancer

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NCT07680790

Where you'd take part

This study runs at 208 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Local Institution - 0001

    Munich, Bavaria, Germanyno site contact published

  • Local Institution - 0003

    Ankara, Turkey (Türkiye)no site contact published

  • Local Institution - 0008

    Ankara, Turkey (Türkiye)no site contact published

  • Local Institution - 0012

    Toronto, Ontario, Canadano site contact published

  • Local Institution - 0014

    Adana, Turkey (Türkiye)no site contact published

  • Local Institution - 0015

    Antalya, Turkey (Türkiye)no site contact published

  • Local Institution - 0019

    Adana, Turkey (Türkiye)no site contact published

  • Local Institution - 0021

    Sur, Diyarbakır, Turkey (Türkiye)no site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Eligibility criteria

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 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

What this trial measures

  • Progression-Free Survival (PFS) using blinded independent central review (BICR) assessment as defined by Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1)Up to approximately 3 years