A Phase 3 Study of Ivonescimab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy as Initial Treatment for Advanced Lung Cancer

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Full Title

A Randomized, Controlled, Multiregional Phase 3 Study of Ivonescimab Combined with Chemotherapy Versus Pembrolizumab Combined with Chemotherapy for the First-line Treatment of Metastatic Squamous Non-small Cell Lung Cancer (HARMONi-3) (WCG)

Purpose

Researchers are measuring the safety of ivonescimab when given with standard lung cancer treatments and seeing how well it works. The people in this study have been newly diagnosed with squamous non-small cell lung cancer that has metastasized (spread).

Ivonescimab is an antibody. It blocks two proteins in the body that help cancer cells live, grow, and spread. If you join this study, you will be randomly assigned to get one of these treatments:

  • Ivonescimab with the chemotherapy drugs carboplatin plus either paclitaxel or nab-paclitaxel
  • Pembrolizumab immunotherapy with carboplatin plus either paclitaxel or nab-paclitaxel

All of these medications are given intravenously (by vein).

Who Can Join

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

  • Have newly diagnosed, previously untreated metastatic squamous non-small cell lung cancer.
  • 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 or to see if you can join this study, please call Dr. Paul Paik’s office at 646-608-3759.

Protocol

24-255

Phase

Phase III (phase 3)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT05899608