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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) logo

Bristol-Myers Squibb (BMS)

Status and phase

Begins enrollment in 2 months
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)

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

Trial contacts and locations

148

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Central trial contact

First line of the email MUST contain the NCT# and Site#; BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Data sourced from clinicaltrials.gov

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