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NCT07100080

Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer After Failure of EGFR TKI Therapy (IZABRIGHT-Lung01)

Last Updated: 2025-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2/PHASE3

Total Enrollment

596 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-05

Study Completion Date

2031-05-15

Brief Summary

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A Study of Izalontamab Brengitecan (BMS-986507) versus Platinum-Pemetrexed for EGFR-mutated Non-small Cell Lung Cancer after failure of EGFR TKI Therapy

Detailed Description

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Conditions

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Non-Small Cell Lung Cancer

Keywords

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Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitors Osimertinib Standard of Care Lung Neoplasms Antineoplastic Agents Izalontamab brengitecan Iza-bren BL-B01D1 Carboplatin Cisplatin Pemetrexed

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm A

Group Type EXPERIMENTAL

Iza-bren

Intervention Type DRUG

Specified dose on specified days

Arm B

Group Type EXPERIMENTAL

Iza-bren

Intervention Type DRUG

Specified dose on specified days

Arm C

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Arm D

Group Type EXPERIMENTAL

Iza-bren

Intervention Type DRUG

Specified dose on specified days

Arm E

Group Type ACTIVE_COMPARATOR

Carboplatin

Intervention Type DRUG

Specified dose on specified days

Cisplatin

Intervention Type DRUG

Specified dose on specified days

Pemetrexed

Intervention Type DRUG

Specified dose on specified days

Interventions

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Iza-bren

Specified dose on specified days

Intervention Type DRUG

Carboplatin

Specified dose on specified days

Intervention Type DRUG

Cisplatin

Specified dose on specified days

Intervention Type DRUG

Pemetrexed

Specified dose on specified days

Intervention Type DRUG

Other Intervention Names

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BMS-986507 BL-B01D1 Izalontamab brengitecan

Eligibility Criteria

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Inclusion Criteria

* Non-squamous NSCLC, not amenable to treatment in curative intent.
* Documented evidence of EGFR mutation (exon 19 deletion, L858R mutation).
* Progressive disease on a 3rd-generation (such as osimertinib, furmonertinib, lazertinib,...) EGFR-TKI-based mono- or combination therapy regimen as the most recent line of therapy in an adjuvant, locally advanced, or metastatic treatment setting.
* Eligible to receive a platinum-based doublet chemotherapy regimen (either cisplatin or carboplatin in combination with pemetrexed).

Exclusion Criteria

* Inadequate organ function and/or bone marrow reserve.
* Leptomeningeal metastases or spinal cord compression.
* Poorly controlled systemic medical conditions.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

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