Intismeran: IM injection
Pembrolizumab coformulated with berahyaluronidase alfa: SC injection
Placebo: IM injection
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.
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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