Clinical Trials | A Randomized, Double-blinded Phase 3 Study of Ivonescimab Versus Pembrolizumab for the Treatment of Newly Diagnosed, Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with non-small cell lung cancer in patients whose tumors demonstrate high PD-L1 expression that have received no prior treatment for metastatic NSCLC. The purpose of this study is to measure the safety and effectiveness of ivonescimab compared to pembrolizumab. Ivonescimab is an antibody designed to block proteins that help cancer cells grow and spread, and by blocking these proteins may potentially slow cancer progression. In this study, you will visit the clinic every three weeks for infusions, possibly up to 24 months. You will be randomly placed in one of two groups to either get the study drug (ivonescimab) or pembrolizumab. After you stop treatment, you’ll have clinic visits after you finish treatment or sooner if starting a new treatment. If you stop treatment for reasons other than cancer progression, you’ll have regular tumor evaluations until your cancer worsens, or you leave the study. Study drugs may cause some side effects, including some that are life-threatening. There is the possibility of death occurring because of study treatment(s) and its side effects. The use of ivonescimab in this study may present risks that have not been previously identified. There are always risks associated with using new medications, but we will take all feasible precautions and encourage you to report any issues to your medical team. You may or may not benefit because 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 approximately 4 years which includes a treatment period of up to 24 months followed by 2 years of long-term follow up to see how you are doing. Additional information found here: https://www.clinicaltrials.gov/study/NCT06767514?titles=Harmoni-7&rank=1 For questions, contact: [email protected]