A Phase 3 Study of V940 Plus Pembrolizumab Immunotherapy After Surgery in People With Non-Small Cell Lung Cancer

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Full Title

Phase 3, Randomized, Double-Blind, Placebo- and Active-Comparator-Controlled Clinical Study of Adjuvant V940 (mRNA-4157) Plus Pembrolizumab Versus Adjuvant Placebo Plus Pembrolizumab in Participants With Resected Stage II, IIIA, IIIB (N2) Non-Small Cell Lung Cancer (INTerpath-002)

Purpose

Researchers are assessing a personalized cancer vaccine called V940 plus pembrolizumab immunotherapy to prevent lung cancer recurrence. The people in this study had surgery to remove non-small cell lung cancer (NSCLC), followed by chemotherapy.

The V940 vaccine uses mRNA, the part of your cells that provides instructions for making proteins your body needs. The vaccine is custom-made for each patient using tumor and blood samples. V940 uses the genes in your cancer to teach your immune system to fight your specific cancer. It is given as an injection into a muscle.

Pembrolizumab is a standard treatment for NSCLC. It boosts the ability of your immune system to find and kill cancer cells. It is given intravenously (by vein).

If you join this study, you will be randomly assigned to get one of these treatments:

  • V940 plus pembrolizumab
  • Placebo (inactive drug) plus pembrolizumab

Who Can Join

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

  • Have stage 2, 3A, or 3B NSCLC that was taken out with surgery within the last 6 months.
  • Have received at least one dose of platinum-based chemotherapy after surgery.
  • Have completed any prior chemotherapy at least 4 weeks before getting the study treatment. No prior immunotherapy for NSCLC is allowed.
  • 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 and to see if you can join this study, please call Dr. Jamie Chaft’s office at 646-608-3761.

Protocol

24-036

Phase

Phase III (phase 3)

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

ClinicalTrials.gov ID

NCT06077760