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Clinical Trials in the UK / NCT07513376
Recruiting Phase 3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Merck Sharp & Dohme LLC
Phase
Phase 3
Started
2026-05-04
Last updated
2026-09-14

Condition(s) studied

Non-small Cell Lung Cancer

Investigational drug(s) / intervention(s)

IntismeranPembrolizumab coformulated with berahyaluronidase alfaPlacebo

Intismeran: IM injection

Pembrolizumab coformulated with berahyaluronidase alfa: SC injection

Placebo: IM injection

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (86)

FacilityCityRegionStatus
UC Davis Comprehensive Cancer Center ( Site 3204) Sacramento California Recruiting
University of Colorado Cancer Center ( Site 3268) Aurora Colorado Recruiting
Smilow Cancer Center at Yale-New Haven ( Site 3253) New Haven Connecticut Recruiting
Illinois Cancer Care ( Site 7000) Peoria Illinois Recruiting
Billings Clinic ( Site 3255) Billings Montana Recruiting
NHO Revive Research Institute, LLC ( Site 3218) Lincoln Nebraska Recruiting
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207) Reno Nevada Recruiting
New York Oncology Hematology, P.C. ( Site 9000) Albany New York Recruiting
White Plains Hospital ( Site 3213) White Plains New York Recruiting
Charles George VA Medical Center ( Site 3233) Asheville North Carolina Recruiting
WakeMed Raleigh Campus ( Site 3214) Raleigh North Carolina Recruiting
Altru Health System ( Site 3254) Grand Forks North Dakota Recruiting
Perelman Center for Advanced Medicine ( Site 3205) Philadelphia Pennsylvania Recruiting
Sanford Cancer Center ( Site 3266) Sioux Falls South Dakota Recruiting
Avera Cancer Institute ( Site 3209) Sioux Falls South Dakota Recruiting
The University of Tennessee Medical Center ( Site 3223) Knoxville Tennessee Recruiting
Hematology Oncology Associates of Fredericksburg ( Site 3275) Fredericksburg Virginia Recruiting
West Virginia University ( Site 3237) Morgantown West Virginia Recruiting
Royal North Shore Hospital ( Site 0502) St Leonards New South Wales Recruiting
Princess Alexandra Hospital ( Site 0503) Brisbane Queensland Recruiting
One Clinical Research ( Site 0501) Nedlands Western Australia Recruiting
Hospital Sírio Libanês ( Site 3611) São Paulo Brazil Recruiting
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506) Hamilton Ontario Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503) Kingston Ontario Recruiting
Centre Hospitalier de l'Université de Montréal ( Site 2501) Montreal Quebec Recruiting
Hôpital Foch ( Site 2604) Suresnes Hauts-de-Seine Recruiting
Thoraxklinik-Heidelberg gGmbH ( Site 2703) Heidelberg Baden-Wurttemberg Recruiting
Augusta-Kranken-Anstalt ( Site 2702) Bochum North Rhine-Westphalia Recruiting
Errikos Dunant Hospital Center ( Site 5004) Athens Attica Recruiting
THORACIC GENERAL HOSPITAL OF ATHENS "I SOTIRIA" ( Site 5001) Athens Attica Recruiting
University General Hospital ''Attikon'' - General Hospital of West Attica "H AGIA VARVARA" ( Site 5003) Athens Attica Recruiting
European Interbalkan Medical Center-Oncology Department ( Site 5000) Thessaloniki Greece Recruiting
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401) Pécs Baranya Recruiting
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409) Miskolc Borsod-Abauj Zemplen county Recruiting
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406) Kecskemét Bács-Kiskun county Recruiting
Nograd Varmegyei Szent Lazar Korhaz ( Site 4410) Salgótarján Nógrád megye Recruiting
Reformatus Pulmonologiai Centrum ( Site 4403) Törökbálint Pest County 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

+ 46 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07513376 on ClinicalTrials.gov ↗ ← All trials in the UK