RecruitingPhase III🇵🇱 PolandEN originalLung cancerEarly / localized

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)

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This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Rak płuca (NSCLC) wykryty we wczesnym stadium (Etap I) usunięty chirurgicznie.
  • Rak płuca o podwyższonym ryzyku nawrotu po operacji.
  • Brak wcześniejszego leczenia raka poza operacją (np. chemioterapii, radioterapii).
  • Dostarczenie próbki tkanki nowotworowej i próbki krwi z ostatniej operacji.
  • Osoby zakażone wirusem HIV muszą mieć dobrze kontrolowane zakażenie przyjmowanymi lekami.
  • Osoby zakażone wirusem zapalenia wątroby typu B (WZW B) muszą być leczone i mieć niewykrywalną ilość wirusa we krwi.
  • Osoby po przebyciu zakażenia wirusem zapalenia wątroby typu C (WZW C) muszą mieć niewykrywalną ilość wirusa we krwi.

✗ Disqualifies

  • Inny rodzaj raka płuca (np. rak drobnokomórkowy) lub niejednoznaczny typ guza.
  • Znaczące problemy z sercem w ciągu ostatniego roku przed badaniem (np. przebyty zawał, niewydolność serca, poważne choroby zastawek).

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
July 17, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (35)

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

New Haven, United States

Billings Clinic ( Site 3255)

Billings, United States

NHO Revive Research Institute, LLC ( Site 3218)

Lincoln, United States

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

Reno, United States

White Plains Hospital ( Site 3213)

White Plains, United States

WakeMed Raleigh Campus ( Site 3214)

Raleigh, United States

Altru Health System ( Site 3254)

Grand Forks, United States

The University of Tennessee Medical Center ( Site 3223)

Knoxville, United States

West Virginia University ( Site 3237)

Morgantown, United States

One Clinical Research ( Site 0501)

Nedlands, Australia

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)

Hamilton, Canada

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

Kingston, Canada

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

Montreal, Canada

European Interbalkan Medical Center-Oncology Department ( Site 5000)

Thessaloniki, Greece

Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)

Pécs, Hungary

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

Miskolc, Hungary

Országos Onkológiai Intézet ( Site 4405)

Budapest, Hungary

Rambam Health Care Campus ( Site 3303)

Haifa, Israel

Hadassah Medical Center ( Site 3305)

Jerusalem, Israel

Sheba Medical Center ( Site 3302)

Ramat Gan, Israel

Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)

Novara, Italy

Ziekenhuis St. Jansdal ( Site 4800)

Harderwijk, Netherlands

Radboudumc ( Site 4806)

Nijmegen, Netherlands

Frisius Medisch Centrum ( Site 4808)

Leeuwarden, Netherlands

Meander Medisch Centrum ( Site 4802)

Amersfoort, Netherlands

University Medical Center Groningen ( Site 4807)

Groningen, Netherlands

Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)

Poznan, Poland

IP Clinic ( Site 4204)

Lodz, Poland

Hospital Universitario Virgen Macarena ( Site 0306)

Seville, Spain

Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)

Kaohsiung City, Taiwan

China Medical University Hospital ( Site 5303)

Taichung, Taiwan

Taichung Veterans General Hospital ( Site 5301)

Taichung, Taiwan

National Cheng Kung University Hospital ( Site 5300)

Tainan, Taiwan

Taipei Medical University Hospital ( Site 5305)

Taipei, Taiwan

Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)

Ankara, Turkey (Türkiye)

Trial contact

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/7/2026.

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