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)

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 2 months; Phase 3

Conditions: Non-Small Cell Lung Cancer

Treatments: Drug: Cisplatin; Drug: Iza-bren; Drug: Pemetrexed; Drug: Carboplatin; Drug: Osimertinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT07680790

CA244-0020

2026-526486-21 (Other Identifier)

U1111-1338-8955 (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 850 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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850 participants in 2 patient groups

Arm A

Experimental group

Treatment:

Drug: Osimertinib

Drug: Iza-bren

Arm B

Active Comparator group

Treatment:

Drug: Carboplatin

Drug: Osimertinib

Drug: Pemetrexed

Drug: Cisplatin