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New mRNA vaccine combo takes on tough lung cancer in phase 2 trial

NCT ID NCT07221474

Disease control Sponsor: Merck Sharp & Dohme LLC Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This Phase 2 trial tests whether adding a personalized mRNA vaccine (V940) to standard pembrolizumab and chemotherapy helps people with newly diagnosed metastatic squamous non-small cell lung cancer live longer and keep the cancer from growing. About 180 participants will receive either the vaccine combo or a placebo with the same standard therapy. The study is currently recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
V940 (mRNA-4157, intismeran autogene) plus pembrolizumab and chemotherapy
What this could lead to
If it works, this could lead to a new first-line treatment that helps people with metastatic squamous lung cancer live longer and delay cancer growth.
What could go wrong
This is an early Phase 2 trial with only 180 participants, so results may not apply to everyone. The added mRNA vaccine may not improve outcomes over standard chemo-immunotherapy and could cause additional side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

May 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion Criteria include, but are not limited to: * Has a histologically or cytologically confirmed diagnosis of squamous non-small cell lung cancer (NSCLC) (Stage IV: M1a, M1b, M1c1, M1c2, AJCC Staging Manual, Version 9). NOTE: Mixed tumors will be characterized by the predominant cell type; however, small cell elements are not permitted. * Has measurable disease per Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as assessed by the local site investigator/radiology * Has provided a tissue sample that is collected either at the time of or after the diagnosis of metastatic disease AND is from a site not previously irradiated * Adverse events (AEs) due to previous anticancer therapies must have recovered to ≤Grade 1. Participants with endocrine-related AEs who are adequately treated with hormone replacement or participants who have ≤Grade 2 neuropathy are eligible * Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART) * Hepatitis B surface antigen (HBsAg) positive participants are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks, and have undetectable HBV viral load prior to randomization * Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable. NOTE: Participants must have completed curative antiviral therapy at least 4 weeks prior to randomization * Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization * Has a life expectancy of at least 3 months * Has adequate organ function Exclusion Criteria: Exclusion Criteria include, but are not limited to: * Is HIV-infected with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has received prior treatment with a cancer vaccine, including another personalized cancer vaccine (PCV) * Has received prior systemic anticancer therapy for their metastatic NSCLC * Has received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti-programmed cell death ligand 2 (anti-PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. NOTE: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC * Has received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids * Has received radiation therapy to the lung that is \>30 gray within 6 months of start of study intervention * Has received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed * Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration * Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study intervention * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis * Has severe hypersensitivity (≥Grade 3) to V940, pembrolizumab, or any of the protocol allowed chemotherapy agents and/or any of their excipients * Has active autoimmune disease that has required systemic treatment in the past 2 years * Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy * Has a history of stem cell/solid organ transplant * Has not adequately recovered from major surgery or has ongoing surgical complications

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Conditions

The condition(s) this trial relates to.

non-small cell squamous lung carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Squamous non-small cell lung cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    55 sites in 11 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Ankara Bilkent Şehir Hastanesi ( Site 1402)

    RECRUITING

    Ankara, 06800, Turkey (Türkiye)

  • Asan Medical Center ( Site 0503)

    RECRUITING

    Seoul, 05505, South Korea

  • Bradford Hill Norte ( Site 0308)

    RECRUITING

    Antofagasta, 1263521, Chile

  • Bradfordhill ( Site 0301)

    RECRUITING

    Santiago, Region M. de Santiago, 8420383, Chile

  • CHU GABRIEL MONTPIED ( Site 0802)

    RECRUITING

    Clermont-Ferrand, Puy-de-Dome, 63001, France

  • Centre Georges François Leclerc ( Site 0805)

    RECRUITING

    Dijon, Cote-d Or, 21000, France

  • Centro de Estudios Clínicos SAGA ( Site 0307)

    RECRUITING

    Santiago, Region M. de Santiago, 7500653, Chile

  • Chang Gung Medical Foundation-Linkou Branch ( Site 0605)

    RECRUITING

    Taoyuan, 33305, Taiwan

  • China Medical University Hospital ( Site 0606)

    RECRUITING

    Taichung, 404, Taiwan

  • Chungbuk National University Hospital-Internal medicine ( Site 0501)

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Cleveland Clinic - Ohio ( Site 0016)

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Clinica Adventista Belgrano ( Site 0206)

    RECRUITING

    Caba., Buenos Aires F.D., C1430EGF, Argentina

  • FALP ( Site 0300)

    RECRUITING

    Santiago, Region M. de Santiago, 7500921, Chile

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 1000)

    RECRUITING

    Milan, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 1001)

    RECRUITING

    Roma, 00168, Italy

  • Fundacion Estudios Clinicos ( Site 0207)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0025)

    RECRUITING

    Corvallis, Oregon, 97330, United States

  • Hacettepe Universitesi Tıp Fakultesi ( Site 1400)

    RECRUITING

    Ankara, 06230, Turkey (Türkiye)

  • Hospital Clinico San Carlos... ( Site 1313)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Italiano de Buenos Aires ( Site 0200)

    RECRUITING

    Ciudad Autonoma de Buenos Aires., Buenos Aires, C1199ABB, Argentina

  • Hospital Jerez de la Frontera-UGC Oncología ( Site 1315)

    RECRUITING

    Jerez de la Frontera, Cadiz, 11407, Spain

  • Hospital Ramon y Cajal ( Site 1314)

    RECRUITING

    Madrid, 28034, Spain

  • Hospital Universitari Vall d''Hebron ( Site 1310)

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 1312)

    RECRUITING

    Seville, 41009, Spain

  • ICO L Hospitalet ( Site 1311)

    RECRUITING

    Hospitalet, Barcelona, 08907, Spain

  • Institut de Cancérologie de l'Ouest ( Site 0801)

    RECRUITING

    Angers, Pays de la Loire Region, 49055, France

  • Instituto Alexander Fleming ( Site 0201)

    RECRUITING

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1426ANZ, Argentina

  • Instituto de Investigaciones Clínicas Mar del Plata ( Site 0205)

    RECRUITING

    Mar del Plata, Buenos Aires, B7600FZO, Argentina

  • Koç Üniversitesi Hastanesi ( Site 1403)

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

  • Mackay Memorial Hospital ( Site 0604)

    RECRUITING

    Taipei, 104, Taiwan

  • Memorial Ankara Hastanesi ( Site 1401)

    RECRUITING

    Ankara, 06520, Turkey (Türkiye)

  • Moffitt Cancer Center ( Site 0021)

    RECRUITING

    Tampa, Florida, 33612, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1100)

    RECRUITING

    Warsaw, Masovian Voivodeship, 02-781, Poland

  • National Cancer Center ( Site 0504)

    RECRUITING

    Goyang-si, Kyonggi-do, 10408, South Korea

  • National Cheng Kung University Hospital ( Site 0601)

    RECRUITING

    Tainan, 70403, Taiwan

  • National Taiwan University Cancer Center (NTUCC) ( Site 0600)

    RECRUITING

    Taipei, 106, Taiwan

  • New York Oncology Hematology (NYOH) - Albany Medical Center ( Site 9001)

    RECRUITING

    Albany, New York, 12206, United States

  • One Clinical Research ( Site 0402)

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Ospedale San Raffaele-Oncologia Medica ( Site 1002)

    RECRUITING

    Milan, 20132, Italy

  • Ospedale Santa Maria delle Croci-Dipartimento Oncoematologico ( Site 1004)

    RECRUITING

    Ravenna, Emilia-Romagna, 48121, Italy

  • Princess Alexandra Hospital ( Site 0403)

    RECRUITING

    Woolloongabba, Queensland, 4102, Australia

  • Samsung Medical Center ( Site 0502)

    RECRUITING

    Seoul, 06351, South Korea

  • Sanatorio Parque ( Site 0203)

    RECRUITING

    Rosario, Santa Fe Province, S2000DSV, Argentina

  • Seoul National University Bundang Hospital ( Site 0500)

    RECRUITING

    Seongnam-si, Kyonggi-do, 13620, South Korea

  • Swedish Medical Center-Swedish Cancer Institute ( Site 0023)

    RECRUITING

    Seattle, Washington, 98104, United States

  • Taipei Veterans General Hospital ( Site 0602)

    RECRUITING

    Taipei, 11217, Taiwan

  • Tennessee Oncology, PLLC - Elliston Place Plaza Medical Oncology & Hematology ( Site 9000)

    RECRUITING

    Nashville, Tennessee, 37203, United States

  • Texas Oncology - Central/South Texas ( Site 8002)

    RECRUITING

    Austin, Texas, 78745, United States

  • VA Ann Arbor Healthcare System ( Site 0019)

    RECRUITING

    Ann Arbor, Michigan, 48105, United States

  • Valley Health Systems - Ridgewood Campus ( Site 0010)

    RECRUITING

    Paramus, New Jersey, 07652, United States

  • Virginia Cancer Specialists ( Site 0003)

    RECRUITING

    Fairfax, Virginia, 22031, United States

  • Washington University School of Medicine ( Site 0024)

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Westmead Hospital ( Site 0400)

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 1101)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1102)

    RECRUITING

    Przemyśl, Podkarpackie Voivodeship, 37-700, Poland

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