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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)

RecruitingPhase 3

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)

Who can join

Ages 18 and older · All sexes

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

About the study

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.

What is being tested

Sponsor: Merck Sharp & Dohme LLC · Participants: 876 · Started: May 4, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07513376

Locations in the U.S.

CaliforniaUC Davis Comprehensive Cancer Center ( Site 3204), Sacramento
ColoradoUniversity of Colorado Cancer Center ( Site 3268), Aurora
ConnecticutSmilow Cancer Center at Yale-New Haven ( Site 3253), New Haven
IllinoisIllinois Cancer Care ( Site 7000), Peoria
MontanaBillings Clinic ( Site 3255), Billings
NebraskaNHO Revive Research Institute, LLC ( Site 3218), Lincoln
NevadaRenown Regional Medical Center-Renown Health Medical Oncology ( Site 3207), Reno
New YorkNew York Oncology Hematology, P.C. ( Site 9000), Albany
White Plains Hospital ( Site 3213), White Plains
North CarolinaCharles George VA Medical Center ( Site 3233), Asheville
UNC Lineberger Comprehensive Cancer Center ( Site 3250), Chapel Hill
WakeMed Raleigh Campus ( Site 3214), Raleigh
North DakotaSanford Fargo Medical Center ( Site 3236), Fargo
Altru Health System ( Site 3254), Grand Forks
PennsylvaniaPerelman Center for Advanced Medicine ( Site 3205), Philadelphia
South DakotaAvera Cancer Institute ( Site 3209), Sioux Falls
Sanford Cancer Center ( Site 3266), Sioux Falls
TennesseeThe University of Tennessee Medical Center ( Site 3223), Knoxville
VirginiaHematology Oncology Associates of Fredericksburg ( Site 3275), Fredericksburg
West VirginiaWest Virginia University ( Site 3237), Morgantown

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.