A Clinical Trial of Adjuvant Intismeran (V940) With or Without Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) in High-Risk Stage I Non-Small Cell Lung Cancer (V940-014)
A Phase 3, Randomized, Placebo-Controlled Study of Adjuvant Intismeran Autogene Plus Subcutaneous Pembrolizumab and Berahyaluronidase Alfa (MK-3475A) or Intismeran Autogene Monotherapy Versus Placebo in Participants With Completely Resected High-Risk Stage I Non-Small Cell Lung Cancer (INTerpath-014)
- Non-small Cell Lung Cancer
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Merck Sharp & Dohme LLC
- Enrolment target
- 876
- Started
- 4 May 2026
- Main results due
- 22 August 2034
- Study sites
- 94
- Registry updated
- 28 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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
What this study is about
In the sponsor’s own words, from the registry.
Researchers are looking for new ways to treat high-risk, localized non-small cell lung cancer (NSCLC) that has been removed with surgery.
People with high-risk, localized NSCLC are often treated with surgery. Researchers want to learn if participants can receive 1 or 2 trial treatments to help prevent NSCLC from coming back after surgery. One trial medicine is intismeran (also called V940/mRNA-4157) and the other is subcutaneous pembrolizumab (also called SC pembrolizumab and MK-3475A). Intismeran is designed to help a person's immune system attack their specific cancer. SC pembrolizumab is an immunotherapy treatment which helps the immune system fight cancer.
The main purpose of this study is to evaluate whether adjuvant intismeran autogene (V940) in combination with SC pembrolizumab and berahyaluronidase alfa (MK-3475A) or intismeran monotherapy improves disease-free survival (DFS) compared with placebo in participants with completely resected high-risk Stage I NSCLC.
Study sites(94)
UC Davis Comprehensive Cancer Center ( Site 3204)
Sacramento, California, United States
Recruiting
University of Colorado Cancer Center ( Site 3268)
Aurora, Colorado, United States
Recruiting
Smilow Cancer Center at Yale-New Haven ( Site 3253)
New Haven, Connecticut, United States
Recruiting
Illinois Cancer Care ( Site 7000)
Peoria, Illinois, United States
Recruiting
Billings Clinic ( Site 3255)
Billings, Montana, United States
Recruiting
NHO Revive Research Institute, LLC ( Site 3218)
Lincoln, Nebraska, United States
Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
Reno, Nevada, United States
Recruiting
New York Oncology Hematology, P.C. ( Site 9000)
Albany, New York, United States
Recruiting
White Plains Hospital ( Site 3213)
White Plains, New York, United States
Recruiting
Charles George VA Medical Center ( Site 3233)
Asheville, North Carolina, United States
Recruiting
UNC Lineberger Comprehensive Cancer Center ( Site 3250)
Chapel Hill, North Carolina, United States
Recruiting
WakeMed Raleigh Campus ( Site 3214)
Raleigh, North Carolina, United States
Recruiting
Sanford Fargo Medical Center ( Site 3236)
Fargo, North Dakota, United States
Recruiting
Altru Health System ( Site 3254)
Grand Forks, North Dakota, United States
Recruiting
Perelman Center for Advanced Medicine ( Site 3205)
Philadelphia, Pennsylvania, United States
Recruiting
Sanford Cancer Center ( Site 3266)
Sioux Falls, South Dakota, United States
Recruiting
Avera Cancer Institute ( Site 3209)
Sioux Falls, South Dakota, United States
Recruiting
The University of Tennessee Medical Center ( Site 3223)
Knoxville, Tennessee, United States
Recruiting
Hematology Oncology Associates of Fredericksburg ( Site 3275)
Fredericksburg, Virginia, United States
Recruiting
West Virginia University ( Site 3237)
Morgantown, West Virginia, United States
Recruiting
Royal North Shore Hospital ( Site 0502)
St Leonards, New South Wales, Australia
Recruiting
Princess Alexandra Hospital ( Site 0503)
Brisbane, Queensland, Australia
Recruiting
One Clinical Research ( Site 0501)
Nedlands, Western Australia, Australia
Recruiting
Hospital Sírio Libanês ( Site 3611)
São Paulo, Brazil
Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)
Hamilton, Ontario, Canada
Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)
Kingston, Ontario, Canada
Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 2501)
Montreal, Quebec, Canada
Recruiting
Hôpital Foch ( Site 2604)
Suresnes, Hauts-de-Seine, France
Recruiting
CHU GABRIEL MONTPIED ( Site 2608)
Clermont-Ferrand, Puy-de-Dome, France
Recruiting
Thoraxklinik-Heidelberg gGmbH ( Site 2703)
Heidelberg, Baden-Wurttemberg, Germany
Recruiting
Augusta-Kranken-Anstalt ( Site 2702)
Bochum, North Rhine-Westphalia, Germany
Recruiting
Errikos Dunant Hospital Center ( Site 5004)
Athens, Attica, Greece
Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001)
Athens, Attica, Greece
Recruiting
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003)
Athens, Attica, Greece
Recruiting
European Interbalkan Medical Center-Oncology Department ( Site 5000)
Thessaloniki, Greece
Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)
Pécs, Baranya, Hungary
Recruiting
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)
Miskolc, Borsod-Abauj Zemplen county, Hungary
Recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)
Kecskemét, Bács-Kiskun county, Hungary
Recruiting
Nograd Varmegyei Szent Lazar Korhaz ( Site 4410)
Salgótarján, Nógrád megye, Hungary
Recruiting
Reformatus Pulmonologiai Centrum ( Site 4403)
Törökbálint, Pest County, Hungary
Recruiting
Országos Onkológiai Intézet ( Site 4405)
Budapest, Hungary
Recruiting
Rambam Health Care Campus ( Site 3303)
Haifa, Israel
Recruiting
Shaare Zedek Medical Center ( Site 3301)
Jerusalem, Israel
Recruiting
Hadassah Medical Center ( Site 3305)
Jerusalem, Israel
Recruiting
Meir medical center ( Site 3306)
Kfar Saba, Israel
Recruiting
Rabin Medical Center ( Site 3304)
Petah Tikva, Israel
Recruiting
Sheba Medical Center ( Site 3302)
Ramat Gan, Israel
Recruiting
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)
Milan, Lombardy, Italy
Recruiting
Azienda Ospedaliera Universitaria Careggi ( Site 2806)
Florence, Tuscany, Italy
Recruiting
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)
Novara, Italy
Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)
Roma, Italy
Recruiting
Fukushima Medical University Hospital ( Site 5501)
Fukushima, Japan
Recruiting
Ziekenhuis St. Jansdal ( Site 4800)
Harderwijk, Gelderland, Netherlands
Recruiting
Radboudumc ( Site 4806)
Nijmegen, Gelderland, Netherlands
Recruiting
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)
Amsterdam, North Holland, Netherlands
Recruiting
Elisabeth-TweeSteden Ziekenhuis ( Site 4801)
Tilburg, North Holland, Netherlands
Recruiting
Isala, locatie Zwolle ( Site 4804)
Zwolle, Overijssel, Netherlands
Recruiting
Frisius Medisch Centrum ( Site 4808)
Leeuwarden, Provincie Friesland, Netherlands
Recruiting
Meander Medisch Centrum ( Site 4802)
Amersfoort, Utrecht, Netherlands
Recruiting
University Medical Center Groningen ( Site 4807)
Groningen, Netherlands
Recruiting
Showing 60 of 94 sites — filter to narrow it down. 94 of the 94 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07513376. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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