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A Randomized, Double-blinded, Multiregional Phase 3 Study of Ivonescimab Versus Pembrolizumab for the First-line Treatment of Metastatic Non-small Cell Lung Cancer in Patients Whose Tumors Demonstrate High PD-L1 Expression (HARMONi-7)

Status: Recruiting
The purpose of this research 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. Participants will have a 50% chance of being assigned to either the ivonescimab treatment group or the pembrolizumab treatment group.
Sex: Male or Female
Age Group: 18 years and over
Inclusion Criteria:
• may be restricted in physically strenuous activity but able to walk and carry out work of a light or sedentary nature, e.g., light house work, office work
• diagnosis of metastatic (Stage IV) Non-Small Cell Lung Cancer (NSCLC)
• have not received any treatment
• see link to clinicaltrials.gov for complete Inclusion criteria
Exclusion Criteria:
• small cell lung cancer
• known genetic alterations that have treatment options
• have received treatment for this cancer
• see link to clinicaltrials.gov for complete Exclusion criteria
Interventions:
Biological: Ivonescimab Injection, Biological: Pembrolizumab Injection
Conditions:
Cancer
Keywords:
Clinics and Surgery Center (CSC), Non-Small Cell Lung Cancer, NSCLC
Study Contact: Faysal Haroun - fharoun10@umphysicians.umn.edu
Principal Investigator: Faysal Haroun
Phase: PHASE3
IRB Number: STUDY00025046
See this study on ClinicalTrials.gov