Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

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

Details

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