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)

Bristol-Myers Squibb (BMS)

Status and phase: Begins enrollment in 1 month; Phase 3; Phase 2

Conditions: Non-Small Cell Lung Cancer

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT07100080

WHO

CA244-0010

EU CTR (Other Identifier)

Details and patient eligibility

About

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

Enrollment: 596 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.
• 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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596 participants in 5 patient groups

Arm A

Experimental group

Treatment:

Drug: Iza-bren

Arm B

Experimental group

Treatment:

Drug: Iza-bren

Arm C

Active Comparator group

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed

Arm D

Experimental group

Treatment:

Drug: Iza-bren

Arm E

Active Comparator group

Treatment:

Drug: Cisplatin

Drug: Carboplatin

Drug: Pemetrexed