Harmoni-7 1st Line metastatic Non-Small Cell Lung Cancer with high PDL-1
What is the 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).
What is the Condition Being Studied?
Non-small Cell Lung Cancer (NSCLC)
Who Can Participate in the Study?
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
For more information, contact the study team at annemarie.peters@duke.edu.
Age Group
Adults
What is Involved?
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
Regardless of your drug assignment, you will get and intravenous (IV) infusion every 3 weeks of either the study drug or pembrolizumab. The infusions will last for 1-2 hours each. You will get infusions for up to 2 years.
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)
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
Assistant Professor of Medicine
Protocol Number
IRB:
PRO00117902
NCT:
NCT06767514
Phase
Phase
III
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
INSTITUTIONAL APPROVAL SIGNOFF