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NCT Number: 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)

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

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Local Institution - 0077, Mar del Plata, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Iza-bren

Drug

Specified dose on specified days

Other names: BMS-986507, BL-B01D1, Izalontamab brengitecan

Osimertinib

Drug

Specified dose on days

Pemetrexed

Drug

Specified dose on specified days

carboplatin

Drug

Specified dose on specified days

Cisplatin

Drug

Specified dose on specified days

Primary outcomes

  1. 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)

    Time frame: Up to approximately 3 years

Secondary outcomes

  1. Overall Survival (OS)

    Time frame: Up to approximately 5 years

  2. PFS assessed by the investigator as per RECIST v1.1

    Time frame: Up to approximately 3 years

  3. Second Progression-Free Survival (PFS2) as assessed by the Investigator

    Time frame: Up to approximately 5 years

  4. Objective Response Rate (ORR) assessed by the BICR as per RECIST v1.1

    Time frame: Up to approximately 3 years

  5. Objective Response Rate (ORR) assessed by the investigator as per RECIST v1.1

    Time frame: Up to approximately 3 years

  6. Disease Control Rate (DCR) assessed by the BICR as per RECIST v1.1

    Time frame: Up to approximately 3 years

  7. Disease Control Rate (DCR) assessed by the investigator as per RECIST v1.1

    Time frame: Up to approximately 3 years

  8. Duration of Response (DOR) assessed by the BICR as per RECIST v1.1

    Time frame: Up to approximately 3 years

  9. Duration of Response (DOR) assessed by the investigator as per RECIST v1.1

    Time frame: Up to approximately 3 years

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Jul 2, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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