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Clinical Trial of Intismeran and Pembrolizumab for High-Risk Lung Cancer

This study is looking for new ways to prevent high-risk non-small cell lung cancer (NSCLC) from returning after surgery. Researchers are testing two treatments: intismeran (V940) and pembrolizumab coformulated with berahyaluronidase alfa (MK-3475A). Intismeran is designed to help your immune system attack your specific cancer, and pembrolizumab is an immunotherapy that also helps your immune system fight cancer. You may be eligible if you are 18 or older, have a specific type of high-risk Stage I NSCLC that has been surgically removed, and meet other criteria. The main goal is to see if these treatments can increase the time you live without the cancer coming back, which will be tracked for up to approximately 98 months.

Study design
This is an interventional study planning to enroll 876 participants. It involves different treatment arms, including injections of intismeran, pembrolizumab, or a placebo.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your disease-free survival will be assessed for up to approximately 98 months after treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07513376

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)

Recruiting
PHASE3Ages 18+InterventionalTreatment
Merck Sharp & Dohme LLC
~876 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:IntismeranPembrolizumab coformulated with berahyaluronidase alfaPlacebo

At a glance

Recruiting sites
76 of 76 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Up to approximately 98 months

Conditions

Non-small Cell Lung Cancer

Explore related trials

Lung Non-Small Cell Carcinoma

Where it's being run

76 sites across 51 states
Turkey (Türkiye)7
Israel5
Taiwan5
Attica3
Kyonggi-do3
Spain3
North Carolina2
Ontario2

Study leadership

  • Medical Director · STUDY_DIRECTOR · Merck Sharp & Dohme LLC

Who to contact

Toll Free Number
[email protected]
1-888-577-8839
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • 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 CUp 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.