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) (INTerpath-014)

July 15, 2026 updated by: Merck Sharp & Dohme LLC

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)

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

876

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Western Australia
      • Nedlands, Western Australia, Australia, 6009
        • Recruiting
        • One Clinical Research ( Site 0501)
        • Contact:
          • Study Coordinator
          • Phone Number: +61410565868
  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)
        • Contact:
          • Study Coordinator
          • Phone Number: 905-387-9495
      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
        • Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)
        • Contact:
          • Study Coordinator
          • Phone Number: 6135496666
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Recruiting
        • Centre Hospitalier de l'Université de Montréal ( Site 2501)
        • Contact:
          • Study Coordinator
          • Phone Number: 5148908000x26832
  • Greece
      • Thessaloniki, Greece, 570 01
        • Recruiting
        • European Interbalkan Medical Center-Oncology Department ( Site 5000)
        • Contact:
          • Study Coordinator
          • Phone Number: +302310400213
  • Hungary
      • Budapest, Hungary, 1122
        • Recruiting
        • Országos Onkológiai Intézet ( Site 4405)
        • Contact:
          • Study Coordinator
          • Phone Number: +3612248600
    • Baranya
      • Pécs, Baranya, Hungary, 7623
        • Recruiting
        • Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)
        • Contact:
          • Study Coordinator
          • Phone Number: +36 72 535890
    • Borsod-Abauj Zemplen county
      • Miskolc, Borsod-Abauj Zemplen county, Hungary, 3526
        • Recruiting
        • Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)
        • Contact:
          • Study Coordinator
          • Phone Number: +36304835188
  • Israel
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus ( Site 3303)
        • Contact:
          • Study Coordinator
          • Phone Number: +97247772688
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center ( Site 3305)
        • Contact:
          • Study Coordinator
          • Phone Number: +97226777333
      • Ramat Gan, Israel, 5265601
        • Recruiting
        • Sheba Medical Center ( Site 3302)
        • Contact:
          • Study Coordinator
          • Phone Number: +97235307096
  • Italy
      • Novara, Italy, 28100
        • Recruiting
        • Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)
        • Contact:
          • Study Coordinator
          • Phone Number: 003903213732296
  • Netherlands
      • Groningen, Netherlands, 9713 GZ
        • Recruiting
        • University Medical Center Groningen ( Site 4807)
        • Contact:
          • Study Coordinator
          • Phone Number: +31503614679
    • Gelderland
      • Harderwijk, Gelderland, Netherlands, 3844 DG
        • Recruiting
        • Ziekenhuis St. Jansdal ( Site 4800)
        • Contact:
          • Study Coordinator
          • Phone Number: +31341463742
      • Nijmegen, Gelderland, Netherlands, 6525 GA
        • Recruiting
        • Radboudumc ( Site 4806)
        • Contact:
          • Study Coordinator
          • Phone Number: +31243610353
    • Provincie Friesland
      • Leeuwarden, Provincie Friesland, Netherlands, 8934 AD
        • Recruiting
        • Frisius Medisch Centrum ( Site 4808)
        • Contact:
          • Study Coordinator
          • Phone Number: +31503614679
    • Utrecht
      • Amersfoort, Utrecht, Netherlands, 3813 TZ
        • Recruiting
        • Meander Medisch Centrum ( Site 4802)
        • Contact:
          • Study Coordinator
          • Phone Number: +31338507843
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-569
        • Recruiting
        • Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)
        • Contact:
          • Study Coordinator
          • Phone Number: +48616654242
    • Łódź Voivodeship
      • Lodz, Łódź Voivodeship, Poland, 90-752
        • Recruiting
        • IP Clinic ( Site 4204)
        • Contact:
          • Study Coordinator
          • Phone Number: +48 48 42 208 97 98
  • Spain
      • Seville, Spain, 41007
        • Recruiting
        • Hospital Universitario Virgen Macarena ( Site 0306)
        • Contact:
          • Study Coordinator
          • Phone Number: +34955008000
  • Taiwan
      • Kaohsiung City, Taiwan, 83301
        • Recruiting
        • Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)
        • Contact:
          • Study Coordinator
          • Phone Number: +886 7-7317123
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 5301)
        • Contact:
          • Study Coordinator
          • Phone Number: +886423592525
      • Taichung, Taiwan, 40447
        • Recruiting
        • China Medical University Hospital ( Site 5303)
        • Contact:
          • Study Coordinator
          • Phone Number: +886422052121
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital ( Site 5300)
        • Contact:
          • Study Coordinator
          • Phone Number: +88662353535
      • Taipei, Taiwan, 110
        • Recruiting
        • Taipei Medical University Hospital ( Site 5305)
        • Contact:
          • Study Coordinator
          • Phone Number: +886227372181
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 6230
        • Recruiting
        • Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)
        • Contact:
          • Study Coordinator
          • Phone Number: +905523567926
  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Recruiting
        • Smilow Cancer Center at Yale-New Haven ( Site 3253)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-688-4242
    • Montana
      • Billings, Montana, United States, 59101
        • Recruiting
        • Billings Clinic ( Site 3255)
        • Contact:
          • Study Coordinator
          • Phone Number: 406-435-7480
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
        • Recruiting
        • NHO Revive Research Institute, LLC ( Site 3218)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-484-4900
    • Nevada
      • Reno, Nevada, United States, 89502
        • Recruiting
        • Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
        • Contact:
          • Study Coordinator
          • Phone Number: 775-982-4000
    • New York
      • White Plains, New York, United States, 10601
        • Recruiting
        • White Plains Hospital ( Site 3213)
        • Contact:
          • Study Coordinator
          • Phone Number: 914-849-7500
    • North Carolina
      • Raleigh, North Carolina, United States, 27610
        • Recruiting
        • WakeMed Raleigh Campus ( Site 3214)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-350-2873
    • North Dakota
      • Grand Forks, North Dakota, United States, 58201
        • Recruiting
        • Altru Health System ( Site 3254)
        • Contact:
          • Study Coordinator
          • Phone Number: 701-780-5400
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • Recruiting
        • The University of Tennessee Medical Center ( Site 3223)
        • Contact:
          • Study Coordinator
          • Phone Number: 865-305-8780
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • Recruiting
        • West Virginia University ( Site 3237)
        • Contact:
          • Study Coordinator
          • Phone Number: 304-598-4500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa
Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.
Biological: Intismeran
IM injection
Other Names:
  • mRNA-4157
  • V940
Biological: Pembrolizumab coformulated with berahyaluronidase alfa
SC injection
Other Names:
  • MK-3475A
Experimental: Arm B: Intismeran
Participants will receive intismeran 1 mg via IM injection.
Biological: Intismeran
IM injection
Other Names:
  • mRNA-4157
  • V940
Placebo Comparator: Arm C: Placebo
Participants will receive dose-matched placebo via IM injection.
Other: Placebo
IM injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease-Free Survival (DFS) as Assessed by Blinded Independent Central Review (BICR) in Participants With Nonsquamous Non-Small Cell Lung Cancer (NSCLC) in Arm A and Arm C
Time Frame: Up to approximately 98 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.
Up to approximately 98 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
DFS as Assessed by BICR
Time Frame: Up to approximately 98 months
DFS is defined as the time from randomization to any recurrence (local, locoregional, regional, or distant) by BICR, or death due to any cause, whichever occurs first.
Up to approximately 98 months
Distant Metastasis-Free Survival (DMFS)
Time Frame: Up to approximately 111 months
DMFS is defined as the time from randomization to the first diagnosis of a distant metastasis by BICR or death due to any cause, whichever occurs first. Distant metastasis refers to cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes.
Up to approximately 111 months
Overall Survival (OS)
Time Frame: Up to approximately 123 months
OS is defined as the time from randomization to death due to any cause.
Up to approximately 123 months
Number Participants Who Experience an Adverse Events (AE)
Time Frame: Up to approximately 144 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to approximately 144 months
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 144 months
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study intervention due to an AE will be reported.
Up to approximately 144 months
Change From Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Combined Global Health Status / Quality of Life (Items 29 & 30) Scale Combined Score
Time Frame: Baseline and up to approximately 36 months
EORTC QLQ-C30 is a questionnaire to assess the overall quality of life (QoL) of cancer patients. Participant responses to questions regarding Global Health Status (GHS; "How would you rate your overall health during the past week?") and QoL ("How would you rate your overall quality of life during the past week?") are scored on a 7-point scale (1= Very poor to 7=Excellent). The combined score of GHS (Item 29) and QoL (Item 30) is computed by averaging the raw scores of the 2 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in global health status/quality of life (EORTC QLQ-C30 Items 29 and 30) combined score will be presented.
Baseline and up to approximately 36 months
Change From Baseline in Physical Functioning (EORTC QLQ-C30 Items 1-5) Score
Time Frame: Baseline and up to approximately 36 months
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to 5 questions about their physical functioning (Items 1 to 5) are scored on a 4-point scale (1=Not at All to 4=Very Much). The combined score of items 1 to 5 was computed by averaging the raw scores of the 5 items and then applying a linear transformation to standardize the average score, so that the combined scores range from 0-100. A higher score indicates a better outcome. The change from baseline in EORTC QLQ-C30 physical functioning (Items 1-5) combined score will be presented.
Baseline and up to approximately 36 months
Change From Baseline in Role Functioning (EORTC QLQ-C30 Items 6-7) Score
Time Frame: Baseline and up to approximately 36 months
EORTC QLQ-C30 is a questionnaire to assess the overall QoL of cancer patients. Participant responses to the questions "Were you limited in doing either your work or other daily activities during the past week?" and " Were you limited in pursuing your hobbies or other leisure time activities during the past week?" will be scored on a 4-point scale (1=Not at All to 4=Very Much). Using linear transformation, raw scores will be standardized, so that scores range from 0 to 100. A higher score indicates a worse level of role functioning. The change from baseline in role functioning (EORTC QLQ-C30 Items 6 and 7) combined score will be presented.
Baseline and up to approximately 36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

ModernaTX, Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 4, 2026

Primary Completion (Estimated)

August 22, 2034

Study Completion (Estimated)

May 11, 2038

Study Registration Dates

First Submitted

April 1, 2026

First Submitted That Met QC Criteria

April 1, 2026

First Posted (Actual)

April 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 17, 2026

Last Update Submitted That Met QC Criteria

July 15, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V940-014 (Other Identifier: MSD)
  • U1111-1323-9950 (Registry Identifier: UTN)
  • 2025-522643-18-00 (Registry Identifier: EU CT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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