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Study of V940 and Pembrolizumab for Patients with Resected Stage II, IIIA, IIIB Non-Small Cell Lung Cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Non-small Cell Lung Cancer (NSCLC), specifically in stages II, IIIA, and IIIB. The study is investigating the effects of a treatment combination involving two medications: V940 (mRNA-4157) and Pembrolizumab, which is also known by the brand name KEYTRUDA. Pembrolizumab is a medication that helps the immune system fight cancer cells, while mRNA-4157 is a new type of treatment that uses a small piece of genetic material to help the body recognize and attack cancer cells.

The purpose of the study is to compare the effectiveness of the combination of V940 and Pembrolizumab against a combination of a placebo and Pembrolizumab. Participants in the study will have already undergone surgery to remove their lung cancer and will receive additional treatment to help prevent the cancer from returning. The study will involve regular visits to the clinic for treatment and monitoring over a period of time. Participants will receive either the active treatment or a placebo, which is a substance with no active medication, along with Pembrolizumab.

The study aims to understand how well the treatment works in preventing the return of cancer and improving survival rates. It will also monitor the overall health and quality of life of participants during the study. The trial will help determine if the new treatment combination is more effective than the current standard treatment in keeping the cancer from coming back and improving the lives of those affected by this type of lung cancer.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after confirmation of eligibility, which includes having undergone surgery for non-small cell lung cancer (NSCLC) and meeting specific health criteria.

    Eligibility is confirmed based on the absence of disease and completion of prior chemotherapy.

  2. Step 2

    Initial treatment phase

    The treatment involves receiving pembrolizumab and either mRNA-4157 or a placebo.

    Pembrolizumab is administered as an intravenous infusion, which means it is given directly into a vein.

    mRNA-4157 or placebo is given as an intramuscular injection, which means it is injected into a muscle.

  3. Step 3

    Treatment schedule

    The specific dosage and frequency of the medications are determined by the study protocol and will be explained during the treatment phase.

    The duration of the treatment phase is aligned with the study's objectives and will be communicated during participation.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess health status and response to treatment.

    Follow-up includes evaluations of disease-free survival and overall health, using questionnaires and medical assessments.

  5. Step 5

    Completion of the study

    The study is estimated to conclude by December 21, 2035.

    Final assessments will be conducted to evaluate the long-term effects of the treatment.

Who can join the trial?

8 criteria

  • The patient must have had a type of lung cancer called non-small cell lung cancer that was completely removed by surgery. The cancer should be at Stage II, IIIA, or IIIB with certain lymph node involvement, according to specific guidelines.
  • The patient must show no evidence of disease before being assigned to a treatment group in the study.
  • The patient must have received at least one dose of a follow-up treatment called platinum doublet chemotherapy, which is a standard treatment after surgery.
  • No more than 24 weeks should have passed between the surgery and the first dose of a medication called pembrolizumab.
  • If the patient has a history of hepatitis B, they can participate if they have been on antiviral therapy for at least 4 weeks and have no detectable virus in their blood before starting the study.
  • If the patient has a history of hepatitis C, they can participate if there is no detectable virus in their blood at the time of screening.
  • If the patient is infected with HIV, they must have the virus well controlled with medication.
  • Both male and female patients can participate in the study.

Who cannot join the trial?

3 criteria

  • Patients with a different type of lung cancer than **Stage II, IIIA, IIIB (N2) Non-small Cell Lung Cancer** cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, cannot participate.
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Investigated drugs

  • V940 (mRNA-4157)

    is an investigational medication being studied for its potential to help the immune system recognize and fight cancer cells. It is designed to work by using messenger RNA (mRNA) technology to instruct the body to produce proteins that can trigger an immune response against cancer.

  • Pembrolizumab

    is a medication that helps the immune system detect and fight cancer cells. It works by blocking a specific protein on the surface of immune cells, which allows these cells to better identify and attack cancer cells. Pembrolizumab is used in various types of cancer treatments and is being studied in combination with V940 to see if it improves outcomes for patients with certain types of lung cancer.

What is already known about the treatment

  • V940 (mRNA-4157)

    This medication is administered as an injection and is currently being studied in clinical trials for its effectiveness in treating certain types of lung cancer. It is specifically being tested for use in patients with resected Stage II, IIIA, and IIIB (N2) non-small cell lung cancer. The medication works by using mRNA technology to stimulate the immune system to recognize and attack cancer cells. It is classified as an investigational cancer vaccine.

  • Pembrolizumab

    This medication is given as an intravenous infusion and is widely used in the treatment of various cancers, including lung cancer. It is approved for use in patients with resected Stage II, IIIA, and IIIB (N2) non-small cell lung cancer as part of the clinical trial. Pembrolizumab works by blocking a specific protein on cancer cells, allowing the immune system to better detect and destroy them. It is classified as an immune checkpoint inhibitor.

Investigated diseases

Non-small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as squamous cell carcinoma, adenocarcinoma, and large cell carcinoma. It is the most common type of lung cancer, accounting for about 85% of cases. NSCLC typically grows and spreads more slowly than small cell lung cancer. In stages II, IIIA, and IIIB (N2), the cancer has spread to nearby lymph nodes or other parts of the lung but not to distant organs. Symptoms may include a persistent cough, chest pain, and shortness of breath. As the disease progresses, it can lead to more severe respiratory issues and other systemic symptoms.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504923-20-00Protocol codeV940-002Estimated enrolment1 121 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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