Harmoni-7 1st Line metastatic Non-Small Cell Lung Cancer with high PDL-1

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
For more information, contact the study team at annemarie.peters@duke.edu.

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
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.

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
ClinicalTrials.gov