Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New mRNA vaccine combo aims to prevent lung cancer recurrence in High-Risk patients

NCT ID NCT07513376

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 19 times

Summary

This phase 3 trial tests whether a personalized mRNA cancer vaccine (intismeran) alone or combined with an immunotherapy drug (pembrolizumab) can prevent non-small cell lung cancer from coming back after complete surgical removal. About 876 people with high-risk stage I lung cancer will be randomly assigned to receive the vaccine, the combination, or a placebo. The study aims to see if these treatments improve disease-free survival compared to placebo.

What this could mean

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

Active substance
intismeran (mRNA cancer vaccine) and pembrolizumab (immunotherapy)
What this could lead to
If successful, this could offer a new way to prevent early-stage lung cancer from coming back after surgery, potentially improving long-term survival.
What could go wrong
This is a large phase 3 trial, but the treatment is experimental. It may not work better than placebo, and side effects from immunotherapy or the vaccine could be serious.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 876 people

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

Started

May 2026

Expected to finish

May 2038

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: The main inclusion criteria include but are not limited to the following: * Has a histological diagnosis of pathological Stage I (tumor ≤4 cm) non-small cell lung cancer (NSCLC) per American Joint Committee on Cancer (AJCC) 9th Edition with at least 1of the following high-risk pathologic features as assessed locally: tumor size \>2cm, visceral pleural invasion, lymphovascular invasion, or high-grade histology * Has undergone a complete surgical resection of the primary NSCLC * Has not received other prior treatment outside of definitive surgery (including but not limited to chemotherapy, immunotherapy, targeted therapy, or radiotherapy) for their current Stage I NSCLC * Has provided a tissue sample from recent surgery along with the required blood sample * Human immunodeficiency virus (HIV)-infected participants must have well-controlled HIV on antiretroviral therapy (ART) * Participants who are hepatitis B surface antigen (HBsAg) positive 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 at screening Exclusion Criteria: The main exclusion criteria include but are not limited to the following: * Has diagnosis of any 1 of the following: small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, neuroendocrine tumor with large cell components, sarcomatoid carcinoma, or two synchronous primary NSCLCs * Has any clinically significant cardiovascular disease within 12 months before randomization, including a history of coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI), valvular heart disease requiring surgical intervention, New York Heart Association Class III-IV heart failure, unstable angina, myocardial infarction (MI), pulmonary hypertension, cardiovascular accident (CVA), or hemodynamically unstable cardiac arrhythmia * HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease * Has known additional malignancy that is progressing or has required active treatment within the past 3 years * Has active autoimmune disease that has required systemic treatment in the past 2 years. Hormonal supplementation (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed * Has history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease * Has active infection requiring systemic therapy other than those permitted in protocol * Has history of stem cell/solid organ transplant * Participants who have not adequately recovered from major surgery or have ongoing surgical complications

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Non-small cell lung cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

non-small cell lung carcinoma

As listed by the trial registrant

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

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

    93 sites in 18 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

  • Adana Medical Park Seyhan Hastanesi ( Site 4302)

    RECRUITING

    Adana, 1140, Turkey (Türkiye)

  • Altru Health System ( Site 3254)

    RECRUITING

    Grand Forks, North Dakota, 58201, United States

  • Ankara Bilkent Sehir Hastanesi ( Site 4306)

    RECRUITING

    Ankara, 6800, Turkey (Türkiye)

  • Asan Medical Center ( Site 5205)

    RECRUITING

    Seoul, 05505, South Korea

  • Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309)

    RECRUITING

    Ankara, 6280, Turkey (Türkiye)

  • Augusta-Kranken-Anstalt ( Site 2702)

    RECRUITING

    Bochum, North Rhine-Westphalia, 44791, Germany

  • Avera Cancer Institute ( Site 3209)

    RECRUITING

    Sioux Falls, South Dakota, 57105, United States

  • Azienda Ospedaliera Universitaria Careggi ( Site 2806)

    RECRUITING

    Florence, Tuscany, 50134, Italy

  • Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)

    RECRUITING

    Novara, 28100, Italy

  • Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)

    RECRUITING

    Kecskemét, Bács-Kiskun county, 6000, Hungary

  • Billings Clinic ( Site 3255)

    RECRUITING

    Billings, Montana, 59101, United States

  • Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)

    RECRUITING

    Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

  • CHU GABRIEL MONTPIED ( Site 2608)

    RECRUITING

    Clermont-Ferrand, Puy-de-Dome, 63000, France

  • Centre Hospitalier de l'Université de Montréal ( Site 2501)

    RECRUITING

    Montreal, Quebec, H2X 3E4, Canada

  • Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Charles George VA Medical Center ( Site 3233)

    RECRUITING

    Asheville, North Carolina, 28805, United States

  • China Medical University Hospital ( Site 5303)

    RECRUITING

    Taichung, 40447, Taiwan

  • Chungbuk National University Hospital ( Site 5201)

    RECRUITING

    Cheongju-si, North Chungcheong, 28644, South Korea

  • Ege Universitesi Hastanesi ( Site 4301)

    RECRUITING

    Izmir, 35100, Turkey (Türkiye)

  • Elisabeth-TweeSteden Ziekenhuis ( Site 4801)

    RECRUITING

    Tilburg, North Holland, 5022 GC, Netherlands

  • Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)

    RECRUITING

    Kayseri, 38039, Turkey (Türkiye)

  • Errikos Dunant Hospital Center ( Site 5004)

    RECRUITING

    Athens, Attica, 115 26, Greece

  • European Interbalkan Medical Center-Oncology Department ( Site 5000)

    RECRUITING

    Thessaloniki, 570 01, Greece

  • Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)

    RECRUITING

    Milan, Lombardy, 20133, Italy

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)

    RECRUITING

    Roma, 00168, Italy

  • Frisius Medisch Centrum ( Site 4808)

    RECRUITING

    Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

  • Fukushima Medical University Hospital ( Site 5501)

    RECRUITING

    Fukushima, 960-1295, Japan

  • HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)

    RECRUITING

    Madrid, 28009, Spain

  • Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)

    RECRUITING

    Ankara, 6230, Turkey (Türkiye)

  • Hadassah Medical Center ( Site 3305)

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

    RECRUITING

    Hamilton, Ontario, L8V 5C2, Canada

  • Hematology Oncology Associates of Fredericksburg ( Site 3275)

    RECRUITING

    Fredericksburg, Virginia, 22408, United States

  • Hospital Clinico San Carlos ( Site 0303)

    RECRUITING

    Madrid, 28040, Spain

  • Hospital Sírio Libanês ( Site 3611)

    RECRUITING

    São Paulo, 01308-060, Brazil

  • Hospital Universitari Vall d'Hebron ( Site 0300)

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

  • Hospital Universitario Virgen Macarena ( Site 0306)

    RECRUITING

    Seville, 41007, Spain

  • Hospital Universitario de Badajoz ( Site 0305)

    RECRUITING

    Badajoz, 06006, Spain

  • Hospital Virgen de la Victoria ( Site 0309)

    RECRUITING

    Málaga, Malaga, 29010, Spain

  • Hospital de Cruces ( Site 0308)

    RECRUITING

    Barakaldo, Bizkaia, 48903, Spain

  • Hôpital Foch ( Site 2604)

    RECRUITING

    Suresnes, Hauts-de-Seine, 92150, France

  • ICO - Hospital Duran i Reynals ( Site 0301)

    RECRUITING

    L'Hospitalet de Llobregat, Barcelona, 08908, Spain

  • IP Clinic ( Site 4204)

    RECRUITING

    Lodz, Łódź Voivodeship, 90-752, Poland

  • Illinois Cancer Care ( Site 7000)

    RECRUITING

    Peoria, Illinois, 61615, United States

  • Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200)

    RECRUITING

    Warsaw, Masovian Voivodeship, 01-138, Poland

  • Isala, locatie Zwolle ( Site 4804)

    RECRUITING

    Zwolle, Overijssel, 8025 AB, Netherlands

  • KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308)

    RECRUITING

    Istanbul, 34890, Turkey (Türkiye)

  • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)

    RECRUITING

    Kingston, Ontario, K7L 2V7, Canada

  • Meander Medisch Centrum ( Site 4802)

    RECRUITING

    Amersfoort, Utrecht, 3813 TZ, Netherlands

  • Meir medical center ( Site 3306)

    RECRUITING

    Kfar Saba, 4428164, Israel

  • NHO Revive Research Institute, LLC ( Site 3218)

    RECRUITING

    Lincoln, Nebraska, 68506, United States

  • National Cancer Center ( Site 5202)

    RECRUITING

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

  • National Cheng Kung University Hospital ( Site 5300)

    RECRUITING

    Tainan, 704, Taiwan

  • Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)

    RECRUITING

    Amsterdam, North Holland, 1066 CX, Netherlands

  • New York Oncology Hematology, P.C. ( Site 9000)

    RECRUITING

    Albany, New York, 12206, United States

  • Nograd Varmegyei Szent Lazar Korhaz ( Site 4410)

    RECRUITING

    Salgótarján, Nógrád megye, 3100, Hungary

  • One Clinical Research ( Site 0501)

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • Országos Onkológiai Intézet ( Site 4405)

    RECRUITING

    Budapest, 1122, Hungary

  • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)

    RECRUITING

    Pécs, Baranya, 7623, Hungary

  • Perelman Center for Advanced Medicine ( Site 3205)

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Princess Alexandra Hospital ( Site 0503)

    RECRUITING

    Brisbane, Queensland, 4102, Australia

  • Rabin Medical Center ( Site 3304)

    RECRUITING

    Petah Tikva, 4941492, Israel

  • Radboudumc ( Site 4806)

    RECRUITING

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Rambam Health Care Campus ( Site 3303)

    RECRUITING

    Haifa, 3109601, Israel

  • Reformatus Pulmonologiai Centrum ( Site 4403)

    RECRUITING

    Törökbálint, Pest County, 2045, Hungary

  • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)

    RECRUITING

    Reno, Nevada, 89502, United States

  • Royal North Shore Hospital ( Site 0502)

    RECRUITING

    St Leonards, New South Wales, 2065, Australia

  • Samsung Medical Center ( Site 5206)

    RECRUITING

    Seoul, 06351, South Korea

  • Sanford Cancer Center ( Site 3266)

    RECRUITING

    Sioux Falls, South Dakota, 57104, United States

  • Sanford Fargo Medical Center ( Site 3236)

    RECRUITING

    Fargo, North Dakota, 58102, United States

  • Seoul National University Bundang Hospital ( Site 5200)

    RECRUITING

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

  • Shaare Zedek Medical Center ( Site 3301)

    RECRUITING

    Jerusalem, 9103102, Israel

  • Sheba Medical Center ( Site 3302)

    RECRUITING

    Ramat Gan, 5265601, Israel

  • Singleton Hospital ( Site 0403)

    RECRUITING

    Swansea, SA2 8QA, United Kingdom

  • Smilow Cancer Center at Yale-New Haven ( Site 3253)

    RECRUITING

    New Haven, Connecticut, 06511, United States

  • St Bartholomew's Hospital ( Site 0400)

    RECRUITING

    London, London, City of, EC1A 7BE, United Kingdom

  • THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001)

    RECRUITING

    Athens, Attica, 115 27, Greece

  • Taichung Veterans General Hospital ( Site 5301)

    RECRUITING

    Taichung, 407, Taiwan

  • Taipei Medical University Hospital ( Site 5305)

    RECRUITING

    Taipei, 110, Taiwan

  • The Catholic University Of Korea St. Vincent's Hospital ( Site 5203)

    RECRUITING

    Suwon, Kyonggi-do, 16247, South Korea

  • The University of Tennessee Medical Center ( Site 3223)

    RECRUITING

    Knoxville, Tennessee, 37920, United States

  • Thoraxklinik-Heidelberg gGmbH ( Site 2703)

    RECRUITING

    Heidelberg, Baden-Wurttemberg, 69126, Germany

  • UC Davis Comprehensive Cancer Center ( Site 3204)

    RECRUITING

    Sacramento, California, 95817, United States

  • UNC Lineberger Comprehensive Cancer Center ( Site 3250)

    RECRUITING

    Chapel Hill, North Carolina, 27514, United States

  • University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003)

    RECRUITING

    Athens, Attica, 124 62, Greece

  • University Medical Center Groningen ( Site 4807)

    RECRUITING

    Groningen, 9713 GZ, Netherlands

  • University of Colorado Cancer Center ( Site 3268)

    RECRUITING

    Aurora, Colorado, 80045, United States

  • WakeMed Raleigh Campus ( Site 3214)

    RECRUITING

    Raleigh, North Carolina, 27610, United States

  • West Virginia University ( Site 3237)

    RECRUITING

    Morgantown, West Virginia, 26506, United States

  • White Plains Hospital ( Site 3213)

    RECRUITING

    White Plains, New York, 10601, United States

  • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-569, Poland

  • Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206)

    RECRUITING

    Chęciny, Świętokrzyskie Voivodeship, 26-060, Poland

  • Ziekenhuis St. Jansdal ( Site 4800)

    RECRUITING

    Harderwijk, Gelderland, 3844 DG, Netherlands

  • İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)

    RECRUITING

    Istanbul, 34010, Turkey (Türkiye)

More trials for these conditions

Other studies related to the condition(s) this trial covers.