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Study of Pembrolizumab and V940 for Treating Non-Small Cell Lung Cancer in Patients with Resectable Stage II to IIIB (N2) Not Achieving Complete Response

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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 treatments for Non-Small Cell Lung Cancer (NSCLC), a common type of lung cancer. The study will explore the effectiveness of a combination of treatments, including pembrolizumab (also known as Keytruda) and a new investigational treatment called mRNA-4157. Pembrolizumab is a medication that helps the immune system fight cancer, while mRNA-4157 is a new type of treatment being tested for its potential to improve outcomes in cancer therapy. The study will also involve a comparison with a placebo, which is a substance with no active medication.

The purpose of the study is to compare the effects of the combination of mRNA-4157 and pembrolizumab with pembrolizumab alone in patients with resectable Stage II to IIIB NSCLC who have not achieved a complete response after initial treatment. Participants will receive these treatments through intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of up to 42 weeks, during which participants will be monitored for their response to the treatment and any side effects they may experience.

Throughout the study, researchers will assess various outcomes, including how long patients remain free of cancer, overall survival rates, and the quality of life of participants. The study aims to provide valuable information on whether the addition of mRNA-4157 to pembrolizumab can offer better results for patients with NSCLC. This research is part of ongoing efforts to find more effective treatments for lung cancer and improve the lives of those affected by this disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the participant will be assessed to confirm eligibility based on specific criteria, including a confirmed diagnosis of non-small cell lung cancer (NSCLC) and other health conditions.

  2. Step 2

    Initial treatment phase

    Participants will receive neoadjuvant treatment, which includes chemotherapy with platinum-based drugs and pembrolizumab, a medication administered through an intravenous infusion. This phase is completed before surgery.

  3. Step 3

    Surgery

    After the initial treatment phase, participants will undergo surgery to remove the tumor. The success of the surgery will be evaluated to determine the next steps in the study.

  4. Step 4

    Adjuvant treatment phase

    Participants who do not achieve a complete response from the initial treatment will enter the adjuvant treatment phase. This involves receiving pembrolizumab and either V940 or a placebo. Pembrolizumab is given as an intravenous infusion, while V940 is administered intramuscularly.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants will be monitored for disease-free survival and overall health. Regular assessments will be conducted to track the effectiveness of the treatment and any side effects experienced.

  6. Step 6

    Completion of the study

    The study is expected to continue until 2038. Participants will be followed up regularly to assess long-term outcomes, including overall survival and quality of life.

Who can join the trial?

8 criteria

  • The patient must have a confirmed diagnosis of a type of lung cancer called Non-Small Cell Lung Cancer (NSCLC) that is at Stage II, IIIA, or IIIB (N2) and can be surgically removed.
  • The patient should have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still do light work.
  • The patient is eligible if they did not achieve a complete response to initial chemotherapy and pembrolizumab treatment before surgery.
  • The patient must not need a specific treatment for a type of mutation in the cancer called EGFR mutation.
  • If the patient has HIV, it must be well controlled with medication.
  • If the patient has hepatitis B, they must have been treated 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, the virus must not be detectable in their blood at the time of screening.
  • The study is open to both male and female patients.

Who cannot join the trial?

3 criteria

  • Patients with any other type of cancer besides Non-Small Cell Lung Cancer cannot participate. Non-Small Cell Lung Cancer is a type of lung cancer that grows and spreads more slowly than other types.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may need special protection, like children or people with certain disabilities.
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Investigated drugs

  • Pembrolizumab

    is a medication used in this trial to help the immune system fight cancer. It works by blocking a specific protein on cancer cells, allowing the immune system to better recognize and attack these cells. In this study, it is used both before and after surgery to treat lung cancer.

  • V940

    is an investigational medication being tested in this trial. It is used in combination with pembrolizumab to see if it can improve the effectiveness of the treatment in preventing the return of lung cancer after surgery. The goal is to see if this combination can help patients live longer without the cancer coming back.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently well-established in medical literature as an immunotherapy for various cancers, including non-small cell lung cancer (NSCLC). The main therapeutic indication for pembrolizumab in this trial is to treat NSCLC that has not achieved a complete response after initial chemotherapy. At the molecular level, pembrolizumab works by blocking the PD-1 pathway, which helps the immune system recognize and attack cancer cells. It is classified as a monoclonal antibody and immune checkpoint inhibitor.

  • V940

    V940 is administered as an adjuvant therapy, often in combination with other treatments like pembrolizumab, and is given through injection. It is currently under investigation in clinical trials and is not yet widely established in medical literature. The main therapeutic indication for V940 in this trial is to improve disease-free survival in patients with resectable NSCLC. The mechanism of action at the molecular level involves enhancing the immune response against cancer cells, although specific details are still being studied. V940 is classified as an investigational cancer vaccine.

Investigated diseases

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It typically grows and spreads more slowly than small cell lung cancer. The disease begins in the tissues of the lungs and can spread to other parts of the body. 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 may affect other organs. The progression and impact of the disease can vary based on the stage at which it is diagnosed.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506327-29-00Protocol codeV940-009Estimated enrolment682 patientsSponsorMerck Sharp & Dohme LLC

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