Purpose of this Study
We are doing this study to find the most effective, safe dose of an experimental drug called ivonescimab (the study drug) compared to pembrolizumb in adults with metastatic non-small cell lung cancer (NSCLC).
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with metastatic (Stage IV) NSCLC
- Have high PD-L1 expression based tumor tissue testing
- Have not received any previous systemic treatment targeted toward metastatic NSCLC
- Have no known genomic alterations (e.g., EGFR, ALK, ROS1, and BRAF V600E) based on testing
Age Range
18-110
Sex/Genders
Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to either:
- Get the study drug; OR
- Get the standard treatment, which is pembrolizumab
Locations
Duke University Hospital
Duke Raleigh Hospital
Visit Timing
Weekdays
Compensation
No
Spanish Materials Available
No
Study Details
Full Title
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)
Principal Investigator
Eziafa
Oduah
Protocol Number
PRO00117902
NCT ID
NCT06767514
Phase
III
Enrollment Status
Pending Open to Enrollment