Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A study of mRNA-4157 and a drug combination for patients with stage IV non-small cell lung cancer

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study investigates treatments for Metastatic Squamous Non-Small Cell Lung Cancer, which is a type of lung cancer that has spread to other parts of the body. The purpose of the study is to compare the effectiveness of a drug called V940 when used alongside other therapies compared to a placebo. The experimental treatment involves combining V940 with pembrolizumab, an immunotherapy, and a chemotherapy regimen consisting of carboplatin and either paclitaxel albumin-bound, paclitaxel, or docetaxel. These medications are delivered through an intravenous infusion, which is a method of delivering fluids or medicine directly into a vein.

Participants in the study may also receive mRNA-4157, which is an intramuscular injection, meaning it is administered directly into a muscle. The study is designed as a randomized and double-blind trial, which means participants are assigned to different treatment groups by chance, and neither the participants nor the researchers know which specific treatment is being given during the course of the study. This approach helps ensure that the results are as objective as possible.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Study participation and treatment assignment

    After joining the study, a treatment group is assigned through a process called randomization, which means the group is chosen by chance.

    The study is double-blind, meaning neither the patient nor the medical staff knows which specific treatment is being administered during the trial.

  2. Step 2

    Administration of combination therapy

    Treatment involves receiving a combination of immunotherapy (a type of medicine that helps the immune system fight cancer), chemotherapy (medicine used to kill cancer cells), and V940.

    The V940 component is either the active medication or a placebo, which is an inactive substance used for comparison.

  3. Step 3

    Medication details

    The pembrolizumab is administered as an intravenous infusion (medicine delivered directly into a vein) at a dose of 400 mg.

    The platinum chemotherapy part of the treatment involves an intravenous infusion of either carboplatin at a dose of 900 mg or paclitaxel at a dose of 200 mg/m2 (milligrams per square meter of body surface area).

    Other possible treatments include paclitaxel albumin-bound at a dose of 100 mg/m2 via intravenous infusion or docetaxel at a dose of 75 mg/m2 via intravenous infusion.

    The medication mRNA-4157 may be administered via intramuscular use (an injection into the muscle) at a dose of 1 mg.

  4. Step 4

    Monitoring and evaluation

    The effectiveness of the treatment is monitored by measuring progression-free survival, which is the length of time during and after treatment that the cancer does not grow or spread.

    The overall survival, which is the total length of time from the start of the treatment that the patient remains alive, is also tracked.

    Medical professionals monitor for adverse events, which are any side effects or medical problems that occur during the study.

Who can join the trial?

15 criteria

  • You must have a confirmed diagnosis of squamous non-small cell lung cancer, which is a specific type of lung cancer, at Stage IV, meaning the cancer has spread to other parts of the body.
  • The cancer must be confirmed by looking at cells under a microscope, a process called histological or cytological confirmation.
  • If your tumor has different types of cells, the main type must be squamous cells, and you cannot have small cell elements, which is another type of lung cancer.
  • You must be expected to live for at least 3 months.
  • Your major organs, such as your heart, liver, and kidneys, must be working well, which is known as having adequate organ function.
  • You can be of any sex or gender and must be at least 18 years old at the time of signing the consent forms.
  • Your cancer must be measurable, meaning a doctor can clearly see and track the size of the tumors using standard medical imaging rules called RECIST 1.1.
  • You must provide a tissue sample (a small piece of the tumor) taken at the time of or after your cancer was found to have spread, and this sample must come from a part of the body that has not received radiation therapy.
  • Any adverse events (side effects) from previous cancer treatments must have improved to Grade 1 or less, which means they are very mild.
  • If you have side effects related to your hormones, you must be adequately treated with hormone replacement.
  • If you have neuropathy (nerve damage that causes numbness or tingling), it must be Grade 2 or less.
  • If you have HIV, the virus must be well controlled using antiretroviral therapy (medicine used to treat the virus).
  • If you have Hepatitis B, you must have been taking antiviral medicine for at least 4 weeks, and the amount of virus in your blood, called the viral load, must be undetectable.
  • If you have a history of Hepatitis C, the amount of virus in your blood must be undetectable, and you must have finished treatment to cure the infection at least 4 weeks before starting the study.
  • Your ECOG performance status, which is a scale used by doctors to measure how well you can perform daily activities, must be 0 or 1, meaning you are still mostly active and able to carry out light work.

Who cannot join the trial?

17 criteria

  • People living with HIV who have also had Kaposi’s sarcoma (a type of cancer that causes patches on the skin) or Multicentric Castleman’s disease (a rare condition involving swelling of the lymph nodes).
  • People who have another type of cancer that is currently growing or has been treated in the last 3 years.
  • People with metastases (cancer that has spread) in the central nervous system (the brain and spinal cord) or carcinomatous meningitis (cancer that has spread to the protective layers covering the brain).
  • People who have a severe hypersensitivity (a strong allergic reaction) to the study drugs or their excipients (inactive substances used to deliver a medication).
  • People with an active autoimmune disease (a condition where the immune system attacks the body) that required systemic treatment (medicine that travels through the whole body) in the last 2 years.
  • People with a history of pneumonitis (inflammation of lung tissue) or interstitial lung disease (scarring or inflammation of the lungs) that required steroids (medicines used to reduce inflammation), or those who have these conditions now.
  • People with an active infection that requires systemic therapy (medicine taken throughout the entire body, such as antibiotics).
  • People who have previously had a stem cell transplant or a solid organ transplant (such as a kidney or liver transplant).
  • People who have not fully recovered from a major surgery or are still experiencing surgical complications (problems following an operation).
  • People who have previously used a cancer vaccine or a personalized cancer vaccine.
  • People who have already received systemic anticancer therapy (body-wide cancer treatments) for their metastatic NSCLC (lung cancer that has spread to other parts of the body).
  • People who have used drugs that target PD-1, PD-L1, or PD-L2 (special proteins used by the immune system to control cell activity) or other drugs that affect T-cells (a type of white blood cell that fights infection and cancer).
  • People who have had radiotherapy (using high-energy rays to kill cancer cells) within the last 2 weeks, or those experiencing radiation-related toxicities (harmful side effects from radiation) that require corticosteroids (anti-inflammatory medicines).
  • People who received a high dose of radiation (more than 30 gray, which is a unit used to measure radiation dose) to the lungs within the last 6 months.
  • People who have received a live or live-attenuated vaccine (vaccines that use a weakened form of the germ) within 30 days before the study starts.
  • People who have used an investigational agent (an experimental drug) or an investigational device (an experimental medical tool) within 4 weeks before the study.
  • People with immunodeficiency (a weakened immune system) or those taking chronic systemic steroid therapy (long-term steroid medicine) or other immunosuppressive therapy (medicine that lowers the body's ability to fight infection) within 7 days of the first dose.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Paclitaxel albumin-bound

    is a type of chemotherapy drug used to help treat cancer by stopping cancer cells from growing and dividing.

  • Paclitaxel

    is a chemotherapy medication used to treat various types of cancer by interfering with the ability of cancer cells to multiply.

  • Docetaxel

    is a chemotherapy drug used to treat cancer by preventing cancer cells from dividing and spreading.

  • Pembrolizumab

    is an immunotherapy medication that helps the body's own immune system recognize and attack cancer cells.

  • mRNA-4157

    is an experimental therapy designed to work with the immune system to help it fight cancer cells.

  • Carboplatin

    is a chemotherapy drug used to treat cancer by damaging the DNA of cancer cells, which prevents them from growing.

What is already known about the treatment

  • Paclitaxel albumin-bound

    This medication is a chemotherapy drug administered through an intravenous infusion into the bloodstream. It is an established treatment used to manage various types of cancer, including certain lung cancers. At a molecular level, it works by interfering with the internal structure of cancer cells, preventing them from dividing and growing. It belongs to a class of drugs known as taxanes.

  • Paclitaxel

    This is a chemotherapy agent delivered to the patient via intravenous infusion. It is widely used in medical practice to treat several types of solid tumors. The drug works by stabilizing the internal framework of cells, which stops cancer cells from multiplying. It is classified as a taxane-based chemotherapy medication.

  • Docetaxel

    This medication is a type of chemotherapy given through an intravenous infusion. It is currently used in clinical settings to treat various cancers, such as breast, lung, and prostate cancer. Its mechanism involves blocking the process that allows cancer cells to divide by affecting their internal structural proteins. It is categorized as a taxane.

  • Pembrolizumab

    This drug is administered as an intravenous infusion using a concentrated solution. It is a well-known immunotherapy used to treat many types of cancer by helping the immune system recognize and attack tumor cells. It works by blocking specific proteins on immune cells that normally prevent them from attacking cancer. This medication is classified as an immune checkpoint inhibitor.

  • mRNA-4157

    This is an experimental therapeutic administered via an intramuscular injection into the muscle. It is currently being studied in clinical trials for its potential to prevent cancer recurrence. The drug uses messenger RNA technology to teach the body's immune system to recognize and target specific cancer markers. It is classified as a personalized cancer vaccine.

  • Carboplatin

    This medication is a chemotherapy drug administered through intravenous infusion. It is a standard treatment used for many different types of cancer to slow down disease progression. It works at the molecular level by damaging the DNA of cancer cells, which prevents them from reproducing. It is categorized as a platinum-based chemotherapy agent.

Investigated diseases

Non-small cell lung cancer stage IV - This is a type of lung cancer that begins in the cells that make up the airways and lung tissue. In stage IV, the cancer has spread from its original location in the lung to other parts of the body, such as the liver, bones, or the other lung. The disease progresses as cancer cells continue to multiply and move through the bloodstream or lymphatic system to distant organs. As the cancer grows, it can interfere with the normal functions of the affected organs. The progression is characterized by the increasing presence of tumor cells throughout various systems in the body.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-520902-37-00Protocol codeV940-013Estimated enrolment182 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).