IZABRIGHT-Lung01: A Randomized, Open-label, Phase 2/3 Study of Izalontamab Brengitecan (BMS-986507) Versus Platinum-based Chemotherapy in Patients With EGFR-mutated Non-small Cell Lung Cancer and Disease Progression on EGFR Tyrosine Kinase Inhibitor Therapy

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07100080Tipo: INTERVENTIONALInicio: 5 de nov de 2025Fin estimado: 15 de may de 2031

Traducción no disponible, mostrando original

Resumen

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

Elegibilidad

Edad mínima: 18 YearsSexo: ALL

Criterios de inclusión

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).

Criterios de exclusión

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

Intervenciones

drug

Iza-bren

Specified dose on specified days

drug

Carboplatin

Specified dose on specified days

drug

Cisplatin

Specified dose on specified days

drug

Pemetrexed

Specified dose on specified days

Ubicaciones

Local Institution - 0008

Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina

Site 0008

NOT_YET_RECRUITING

Local Institution - 0004

ABB, Buenos Aires F.D., Argentina

Site 0004

NOT_YET_RECRUITING

Local Institution - 0094

Córdoba, Córdoba Province, Argentina

Site 0094

NOT_YET_RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

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

First line of the email MUST contain NCT # and Site #.

CONTACT

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