Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Irvine, California and other locations
Dates
study started
study ends around
Principal Investigator
by Cathleen Park

Description

Summary

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

Official Title

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

Keywords

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

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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).

You CAN'T join if...

  • 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.

Locations

  • UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building accepting new patients
    Irvine California 92612 United States
  • University of California, Irvine (UCI) Health - UC Irvine Medical Center accepting new patients
    Orange California 92868-3201 United States

Lead Scientist at UC Irvine

  • Cathleen Park
    Assistant Health Sciences Professor, Medicine, School of Medicine. Authored (or co-authored) 9 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
ID
NCT07100080
Phase
Phase 2/3 research study
Study Type
Interventional
Participants
Expecting 500 study participants
Last Updated