A Phase 3 Study of Ivonescimab Versus Pembrolizumab Immunotherapy for the Initial Treatment of Metastatic Non-Small Cell Lung Cancer

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) (WCG)

Purpose

Researchers are comparing ivonescimab with pembrolizumab immunotherapy for the initial treatment of advanced lung cancer. The people in this study have non-small cell lung cancer (NSCLC) that has metastasized (spread).

Ivonescimab is designed to block proteins that help cancer cells grow and spread. By blocking these proteins, ivonescimab could slow cancer growth.

If you join this study, you will be randomly assigned to get either ivonescimab or pembrolizumab. Both drugs are given intravenously (by vein).

Who Can Join

To join this study, there are a few conditions. You must:

  • Have metastatic NSCLC that makes moderate to high amounts of a protein called PD-L1.
  • Not have genetic mutations in genes such as EGFR, ALK, ROS1, or BRAF V600E, for which other treatments may be available.
  • Have not had anti-cancer medication for advanced NSCLC.
  • Be well enough to walk and take care of yourself. You must be able to do activities such as office work or light housework.
  • Be age 18 or older.

Contact

For more information about this study or to see if you can join, please call Dr. Paul Paik’s office at 646-608-3759.

Protocol

25-329

Phase

Phase III (phase 3)

Disease Status

Newly Diagnosed

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06767514