Clinical Trials | 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

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with EGFR-mutated Non-small Cell Lung Cancer that have had their disease progress on amivantamab+lazertinib as the first treatment for locally advanced or metastatic disease. The purpose of this study is to help us learn whether the study drug iza-bren (also known as Izalontamab Brengitecan or BMS-986507) works in patients with a certain type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that has a specific mutation in the epidermal growth factor receptor (EGFR) gene and has worsened after receiving treatment with EGFR tyrosine kinase inhibitors (TKI). In this study, you will You will be randomly assigned to get either iza-bren or the comparison treatment. You will be assigned by chance, like the flip of a coin. The study has two stages. If you participate in the first stage, you will have an equal chance to get one of three treatments. If you participate in the second stage, you will have an equal chance to get one of two treatments. The most common risks or discomforts that you may expect from the study drug iza-bren include: • Changes to lab test results, including liver function tests, potassium and sodium levels, and various blood cell counts • Constipation • Decreased appetite • Diarrhea • Dizziness • Feeling tired or weak (asthenia) • Hair loss (alopecia) • High blood sugar, potential diabetes (hyperglycemia) • Mouth sores; inflammation of the mouth (stomatitis) • Nausea • Skin rash • Vomiting • Weight loss You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. We expect that your taking part in this research will last for a maximum of approximately 5 years. Additional information found here: https://www.clinicaltrials.gov/study/NCT07100080?titles=IZABRIGHT&rank=1 For questions, contact: [email protected]