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)

NCT07513376 | Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: V940-014U1111-1323-99502025-522643-18-00
• Study Type: interventional
• Target: 876
• Locations: 13 countries
• Sites: 46

Brief Summary

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.

Conditions

Non-small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (8)

• DFS as Assessed by BICR

  Up to approximately 98 months

• Distant Metastasis-Free Survival (DMFS)

  Up to approximately 111 months

• Overall Survival (OS)

  Up to approximately 123 months

• Number Participants Who Experience an Adverse Events (AE)

  Up to approximately 144 months

• Number of Participants Who Discontinue Study Treatment Due to an AE

  Up to approximately 144 months

Study Arms (3)

Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa

EXPERIMENTAL

Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.

Biological: Intismeran; Biological: Pembrolizumab coformulated with berahyaluronidase alfa

Arm B: Intismeran

EXPERIMENTAL

Participants will receive intismeran 1 mg via IM injection.

Biological: Intismeran

Arm C: Placebo

PLACEBO COMPARATOR

Participants will receive dose-matched placebo via IM injection.

Other: Placebo

Interventions

Placebo OTHER

IM injection

Arm C: Placebo

Pembrolizumab coformulated with berahyaluronidase alfa BIOLOGICAL

SC injection

Also known as: MK-3475A

Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa

Intismeran BIOLOGICAL

IM injection

Also known as: V940, mRNA-4157

Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa; Arm B: Intismeran

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• ModernaTX, Inc.: collaborator

Study Sites (46)

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

New Haven, Connecticut, 06511, United States

RECRUITING

Billings Clinic ( Site 3255)

Billings, Montana, 59101, United States

RECRUITING

NHO Revive Research Institute, LLC ( Site 3218)

Lincoln, Nebraska, 68506, United States

RECRUITING

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

Reno, Nevada, 89502, United States

RECRUITING

White Plains Hospital ( Site 3213)

White Plains, New York, 10601, United States

RECRUITING

WakeMed Raleigh Campus ( Site 3214)

Raleigh, North Carolina, 27610, United States

RECRUITING

Altru Health System ( Site 3254)

Grand Forks, North Dakota, 58201, United States

RECRUITING

The University of Tennessee Medical Center ( Site 3223)

Knoxville, Tennessee, 37920, United States

RECRUITING

West Virginia University ( Site 3237)

Morgantown, West Virginia, 26506, United States

RECRUITING

Royal North Shore Hospital ( Site 0502)

St Leonards, New South Wales, 2065, Australia

RECRUITING

One Clinical Research ( Site 0501)

Nedlands, Western Australia, 6009, Australia

RECRUITING

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

Hamilton, Ontario, L8V 5C2, Canada

RECRUITING

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

Kingston, Ontario, K7L 2V7, Canada

RECRUITING

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

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Augusta-Kranken-Anstalt ( Site 2702)

Bochum, North Rhine-Westphalia, 44791, Germany

RECRUITING

Errikos Dunant Hospital Center ( Site 5004)

Athens, Attica, 115 26, Greece

RECRUITING

European Interbalkan Medical Center-Oncology Department ( Site 5000)

Thessaloniki, 570 01, Greece

RECRUITING

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)

Pécs, Baranya, 7623, Hungary

RECRUITING

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

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

RECRUITING

Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)

Kecskemét, Bács-Kiskun county, 6000, Hungary

RECRUITING

Országos Onkológiai Intézet ( Site 4405)

Budapest, 1122, Hungary

RECRUITING

Rambam Health Care Campus ( Site 3303)

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center ( Site 3301)

Jerusalem, 9103102, Israel

RECRUITING

Hadassah Medical Center ( Site 3305)

Jerusalem, 9112001, Israel

RECRUITING

Meir medical center ( Site 3306)

Kfar Saba, 4428164, Israel

RECRUITING

Sheba Medical Center ( Site 3302)

Ramat Gan, 5265601, Israel

RECRUITING

Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)

Novara, 28100, Italy

RECRUITING

Ziekenhuis St. Jansdal ( Site 4800)

Harderwijk, Gelderland, 3844 DG, Netherlands

RECRUITING

Radboudumc ( Site 4806)

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

Frisius Medisch Centrum ( Site 4808)

Leeuwarden, Provincie Friesland, 8934 AD, Netherlands

RECRUITING

Meander Medisch Centrum ( Site 4802)

Amersfoort, Utrecht, 3813 TZ, Netherlands

RECRUITING

University Medical Center Groningen ( Site 4807)

Groningen, 9713 GZ, Netherlands

RECRUITING

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)

Poznan, Greater Poland Voivodeship, 60-569, Poland

RECRUITING

IP Clinic ( Site 4204)

Lodz, Łódź Voivodeship, 90-752, Poland

RECRUITING

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

Chęciny, Świętokrzyskie Voivodeship, 26-060, Poland

RECRUITING

Hospital de Cruces ( Site 0308)

Barakaldo, Bizkaia, 48903, Spain

RECRUITING

HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)

Madrid, 28009, Spain

RECRUITING

Hospital Clinico San Carlos ( Site 0303)

Madrid, 28040, Spain

RECRUITING

Hospital Universitario Virgen Macarena ( Site 0306)

Seville, 41007, Spain

RECRUITING

Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)

Kaohsiung City, 83301, Taiwan

RECRUITING

China Medical University Hospital ( Site 5303)

Taichung, 40447, Taiwan

RECRUITING

Taichung Veterans General Hospital ( Site 5301)

Taichung, 407, Taiwan

RECRUITING

National Cheng Kung University Hospital ( Site 5300)

Tainan, 704, Taiwan

RECRUITING

Taipei Medical University Hospital ( Site 5305)

Taipei, 110, Taiwan

RECRUITING

Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)

Ankara, 6230, Turkey (Türkiye)

RECRUITING

İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Related Links

• Merck Clinical Trials Information
• Plain Language Summary

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Central Study Contacts

Toll Free Number

CONTACT

1-888-577-8839; Trialsites@msd.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Arm A - Open Label Arms B and C - Double Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 1, 2026
• First Posted: April 7, 2026
• Study Start: May 4, 2026
• Primary Completion (Estimated): August 22, 2034
• Study Completion (Estimated): May 11, 2038
• Last Updated: July 31, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1); US (9); IL (5); PL (3); CA (3); HU (4); TW (5); AU (2); NL (5); TU (2); IT (1); GR (2); ES (4)