Recruiting
Phase 3

Iza-Bren & Osimertinib

Sponsor:

Bristol-Myers Squibb

Code:

NCT07680790

Conditions

Non-Small Cell Lung Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Iza-bren

Osimertinib

Pemetrexed

Carboplatin

Cisplatin

Study Details

Brief summary:

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

Conditions

Non-Small Cell Lung Cancer

Study ID

NCT07680790

Start date

Sep 8, 2026

Status verified date

Sep, 2026

Completion date

Dec 30, 2031

Anticipated

Primary completion date

Dec 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

850 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A

active comparator: Arm B

Interventions

Iza-bren

Specified dose on specified days

Osimertinib

Specified dose on days

Pemetrexed

Specified dose on specified days

Carboplatin

Specified dose on specified days

Cisplatin

Specified dose on specified days

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

855-907-3286Clinical.Trials@bms.com

Locations

Cancer Care Centers of Brevard - Rockledge

Recruiting

Palm Bay, Florida, United States, 32901

Contacts

Venkat Pavan Kancharla, Site 0519

111-111-1111

Texas Oncology

Recruiting

Beaumont, Texas, United States, 77702

Contacts

Ashok Malani, Site 0522

713-792-2740

Texas Oncology - San Antonio

Recruiting

San Antonio, Texas, United States, 78217

Contacts

Krishna Alluri, Site 0529

210-656-7177

Shenandoah Oncology, P.C. (Shenandoah Oncology Associates, P.C.)

Recruiting

Winchester, Virginia, United States, 22601

More Information

Sponsor

Bristol-Myers Squibb

Last update posted

Oct 8, 2026

Last verified

Sep, 2026

Keywords

  • NSCLC
  • EGFR
  • First line
  • Izalontamab brengitecan
  • Osimertinib
  • ADC
  • IZABRIGHT-Lung02

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by Bristol-Myers Squibb on 2026-10-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.