V940 with or without MK-3475A in patients with NSCLC

• Research type

  Research Study

• Full title

  A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)

• IRAS ID

  1013439

• Contact name

  - -

• Contact email

  N/A

• Sponsor organisation

  Merck Sharp & Dohme LLC

• Research summary

  Researchers are looking for new ways to treat high risk, localised non-small cell lung cancer (NSCLC) that has been removed with surgery.

  People with high-risk, localised NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person’s immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer.

  The goal of this trial is to learn how long participants with NSCLC who receive intismeran with and without SC pembrolizumab are cancer free after surgery and treatment compared to participants who receive placebo.

  Up to 876 participants with high-risk, localised NSCLC will take part in the trial. They will be 18 years old or older and:

  • Had surgery that removed all the cancer
  • Do not have certain heart problems

  Participants will be assigned by equal chance to 1 of 3 groups:
  Group A - Participants will receive intismeran and SC pembrolizumab.
  Group B - Participants will receive intismeran
  Group C - Participants will receive placebo.

  In Group A, both the participants and the researchers will know which trial treatment a participant is getting (open-label trial). In Groups B and C, neither the participants nor the researchers will know which treatment a participant is getting (double-blind trial).

  A participant may be in this trial for about 10 years, which includes follow-up time. During the trial, participants may give urine, blood, and tumour samples, have imaging tests, have physical examinations, and answer questions about how they are feeling and their ability to do daily tasks.

• REC name

  South Central - Oxford A Research Ethics Committee

• REC reference

  26/SC/0104

• Date of REC Opinion

  8 May 2026

• REC opinion

  Further Information Favourable Opinion