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

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What is this study about?

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.

Who Can Join the Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centr Georges Francois Leclerc	Dijon	France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie	Koszalin	Poland
Hospital Clinico San Carlos	Madrid	Spain
Hospital Jerez de la Frontera	Jerez De La Frontera	Spain
Comite Entreprise Paul Papin	Angers	France

Other Sites

Site Name	City	Country
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Ospedale San Raffaele S.r.l.	Milan	Italy
Wielkopolskie Centrum Pulmonologii I Torakochirurgii Im. Eugenii I Janusza Zeylandow	Poznan	Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
Azienda Unita Sanitaria Locale Della Romagna	Faenza	Italy
Inegnmbh Chnvns Dauxquxmaduenjcxq	L'hospitalet De Llobregat	Spain
Upoasalkyvfahy Cjyoscl Kjnupprjn	Gdansk	Poland
Njbstodr Istvyfyq Obxsvcfzb Ikm Myurj Sxaklscvxvaapyrhusainqdcuzjc Iqyehzcs Bonjeftg	Cracow	Poland
Hvfatbkz Vsgo dnlbzfrj	Barcelona	Spain
Wqcbhjrbyt Svynoqy Ids Scwymnz Pjt W Pcrwinjzz	Przemysl	Poland

Trial status

Country	Status	Recruitment Start
France	Recruiting	20.10.2025
Italy	Recruiting	20.10.2025
Poland	Recruiting	20.10.2025
Spain	Recruiting	20.10.2025

Trial locations

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.

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 ID:

2025-520902-37-00

Protocol code:

V940-013

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?