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)
Recruiting · NCT07100080 · Interventional (participants receive a specific treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is 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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 15 US states.
- UCI Health - Chao Family Comprehensive Cancer Center and Ambulatory Care building - Irvine, California, United States
- University of California, Irvine (UCI) Health - UC Irvine Medical Center - Orange, California, United States
- Shaw Cancer Center - Edwards, Colorado, United States
- Local Institution - 0085 - Gainesville, Florida, United States
- Local Institution - 0142 - Pembroke Pines, Florida, United States
- Piedmont Healthcare - Atlanta, Georgia, United States
- John B Amos Cancer Center - Columbus, Georgia, United States
- Rush University Medical Center - Chicago, Illinois, United States
- Dana-Farber Cancer Institute - Boston, Massachusetts, United States
- Washington University School of Medicine - St Louis, Missouri, United States
- Renown Regional Medical Center - Reno, Nevada, United States
- Perlmutter Cancer Center at NYU Langone Hospital - Long Island - Mineola, New York, United States
- NYU Langone Health - New York, New York, United States
- Weill Cornell Medical College - New York, New York, United States
- Rochester General Hospital Infectious Disease - Rochester, New York, United States
- University Hospitals Cleveland Medical Center - Cleveland, Ohio, United States
- The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C - Columbus, Ohio, United States
- Providence Cancer Institute Franz Clinic - Portland, Oregon, United States
- Providence St. Vincent Medical Center - Portland, Oregon, United States
- Oregon Health and Science University - Portland, Oregon, United States
- Hospital of the University of Pennsylvania - Philadelphia, Pennsylvania, United States
- West Penn Allegheny Health - Pittsburgh, Pennsylvania, United States
- Local Institution - 0268 - Chattanooga, Tennessee, United States
- Tennessee Oncology - Nashville, Tennessee, United States
- Local Institution - 0025 - Houston, Texas, United States
- Local Institution - 0173 - San Antonio, Texas, United States
- University of Virginia Health System - Charlottesville, Virginia, United States
- Virginia Commonwealth University (Vcu) - Richmond, Virginia, United States
- Local Institution - 0137 - Avellino, Italy
- Local Institution - 0264 - Bangkok, Thailand
- Local Institution - 0189 - Bellinzona, Switzerland
- Local Institution - 0211 - Berlin, Germany
- Local Institution - 0115 - Bucharest, Romania
- Local Institution - 0219 - Bydgoszcz, Poland
- Local Institution - 0222 - Chihuahua City, Mexico
- Local Institution - 0133 - Cluj-Napoca, Romania
- Hospital Privado Universitario de Córdoba - Córdoba, Argentina
- Local Institution - 0215 - Gauting, Germany
- Local Institution - 0242 - Hamburg, Germany
- Local Institution - 0210 - Heidelberg, Germany
- Local Institution - 0124 - Iași, Romania
- Local Institution - 0119 - Iași, Romania
- E-Da hospital - Kaohsiung City, Taiwan
- Local Institution - 0239 - Kassel, Germany
- Local Institution - 0012 - Marseille, France
- Local Institution - 0223 - Mexico City, Mexico
- Local Institution - 0032 - Milan, Italy
- Local Institution - 0178 - Málaga, Spain
- Local Institution - 0260 - Nanning, China
- Local Institution - 0278 - Nantes, France
- Local Institution - 0034 - Naples, Italy
- Local Institution - 0105 - Oslo, Norway
- Local Institution - 0011 - Paris, France
- Local Institution - 0015 - Paris, France
- Local Institution - 0029 - Parma, Italy
- Local Institution - 0182 - Seville, Spain
- Local Institution - 0263 - Singapore, Singapore
- Local Institution - 0262 - Singapore, Singapore
- Local Institution - 0266 - Songkhla, Thailand
- Local Institution - 0281 - Sulton, Surrey, United Kingdom
Showing 60 of 186 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →