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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)

Status: Recruiting
Location: See all (76) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
California
UC Davis Comprehensive Cancer Center ( Site 3204)
RECRUITING
Sacramento
Connecticut
Smilow Cancer Center at Yale-New Haven ( Site 3253)
RECRUITING
New Haven
Montana
Billings Clinic ( Site 3255)
RECRUITING
Billings
North Carolina
Charles George VA Medical Center ( Site 3233)
RECRUITING
Asheville
WakeMed Raleigh Campus ( Site 3214)
RECRUITING
Raleigh
North Dakota
Altru Health System ( Site 3254)
RECRUITING
Grand Forks
Nebraska
NHO Revive Research Institute, LLC ( Site 3218)
RECRUITING
Lincoln
Nevada
Renown Regional Medical Center-Renown Health Medical Oncology ( Site 3207)
RECRUITING
Reno
New York
White Plains Hospital ( Site 3213)
RECRUITING
White Plains
South Dakota
Avera Cancer Institute ( Site 3209)
RECRUITING
Sioux Falls
Tennessee
The University of Tennessee Medical Center ( Site 3223)
RECRUITING
Knoxville
West Virginia
West Virginia University ( Site 3237)
RECRUITING
Morgantown
Other Locations
Australia
Princess Alexandra Hospital ( Site 0503)
RECRUITING
Brisbane
One Clinical Research ( Site 0501)
RECRUITING
Nedlands
Royal North Shore Hospital ( Site 0502)
RECRUITING
St Leonards
Canada
Hamilton Health Sciences-Juravinski Cancer Centre ( Site 2506)
RECRUITING
Hamilton
Kingston Health Sciences Centre-Kingston General Hospital Site ( Site 2503)
RECRUITING
Kingston
Centre Hospitalier de l'Université de Montréal ( Site 2501)
RECRUITING
Montreal
France
Hôpital Foch ( Site 2604)
RECRUITING
Suresnes
Germany
Augusta-Kranken-Anstalt ( Site 2702)
RECRUITING
Bochum
Thoraxklinik-Heidelberg gGmbH ( Site 2703)
RECRUITING
Heidelberg
Greece
Errikos Dunant Hospital Center ( Site 5004)
RECRUITING
Athens
THORACIC GENERAL HOSPITAL OF ATHENS I SOTIRIA ( Site 5001)
RECRUITING
Athens
University General Hospital ''Attikon'' - General Hospital of West Attica H AGIA VARVARA ( Site 5003)
RECRUITING
Athens
European Interbalkan Medical Center-Oncology Department ( Site 5000)
RECRUITING
Thessaloniki
Hungary
Országos Onkológiai Intézet ( Site 4405)
RECRUITING
Budapest
Bacs-Kiskun Varmegyei Oktatokorhaz ( Site 4406)
RECRUITING
Kecskemét
Borsod-Abaúj-Zemplén Vármegyei Központi Kórház És Egyetemi Oktatókórház ( Site 4409)
RECRUITING
Miskolc
Pecsi Tudomanyegyetem Klinikai Kozpont ( Site 4401)
RECRUITING
Pécs
Reformatus Pulmonologiai Centrum ( Site 4403)
RECRUITING
Törökbálint
Israel
Rambam Health Care Campus ( Site 3303)
RECRUITING
Haifa
Hadassah Medical Center ( Site 3305)
RECRUITING
Jerusalem
Shaare Zedek Medical Center ( Site 3301)
RECRUITING
Jerusalem
Meir medical center ( Site 3306)
RECRUITING
Kfar Saba
Sheba Medical Center ( Site 3302)
RECRUITING
Ramat Gan
Italy
Azienda Ospedaliera Universitaria Careggi ( Site 2806)
RECRUITING
Florence
Fondazione IRCCS Istituto Nazionale Dei Tumori ( Site 2800)
RECRUITING
Milan
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 2803)
RECRUITING
Novara
Fondazione Policlinico Universitario Agostino Gemelli IRCCS - Università Cattolica del Sacro Cuore ( Site 2801)
RECRUITING
Roma
Netherlands
Meander Medisch Centrum ( Site 4802)
RECRUITING
Amersfoort
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL) ( Site 4809)
RECRUITING
Amsterdam
University Medical Center Groningen ( Site 4807)
RECRUITING
Groningen
Ziekenhuis St. Jansdal ( Site 4800)
RECRUITING
Harderwijk
Frisius Medisch Centrum ( Site 4808)
RECRUITING
Leeuwarden
Radboudumc ( Site 4806)
RECRUITING
Nijmegen
Elisabeth-TweeSteden Ziekenhuis ( Site 4801)
RECRUITING
Tilburg
Poland
Wojewodzki Szpital Specjalistyczny im. sw. Rafala w Czerwonej Gorze ( Site 4206)
RECRUITING
Chęciny
IP Clinic ( Site 4204)
RECRUITING
Lodz
Wielkopolskie Centrum Pulmonologii i Torakochirurgii ( Site 4202)
RECRUITING
Poznan
Instytut Gruzlicy i Chorob Pluc w Warszawie ( Site 4200)
RECRUITING
Warsaw
Republic of Korea
Chungbuk National University Hospital ( Site 5201)
RECRUITING
Cheongju-si
National Cancer Center ( Site 5202)
RECRUITING
Goyang-si
Seoul National University Bundang Hospital ( Site 5200)
RECRUITING
Seongnam-si
Asan Medical Center ( Site 5205)
RECRUITING
Seoul
The Catholic University Of Korea St. Vincent's Hospital ( Site 5203)
RECRUITING
Suwon
Spain
Hospital de Cruces ( Site 0308)
RECRUITING
Barakaldo
Hospital Universitari Vall d'Hebron ( Site 0300)
RECRUITING
Barcelona
ICO - Hospital Duran i Reynals ( Site 0301)
RECRUITING
L'hospitalet De Llobregat
Hospital Clinico San Carlos ( Site 0303)
RECRUITING
Madrid
HOSPITAL GENERAL UNIVERSITARIO GREGORIO MARAÑON ( Site 0307)
RECRUITING
Madrid
Hospital Virgen de la Victoria ( Site 0309)
RECRUITING
Málaga
Hospital Universitario Virgen Macarena ( Site 0306)
RECRUITING
Seville
Taiwan
Chang Gung Memorial Hospital at Kaohsiung ( Site 5302)
RECRUITING
Kaohsiung City
China Medical University Hospital ( Site 5303)
RECRUITING
Taichung
Taichung Veterans General Hospital ( Site 5301)
RECRUITING
Taichung
National Cheng Kung University Hospital ( Site 5300)
RECRUITING
Tainan
Taipei Medical University Hospital ( Site 5305)
RECRUITING
Taipei
Turkey
Adana Medical Park Seyhan Hastanesi ( Site 4302)
RECRUITING
Adana
Ankara Bilkent Sehir Hastanesi ( Site 4306)
RECRUITING
Ankara
Atatürk Göğüs Hastalıkları Ve Göğüs Cerrahisi Eğitim Araştırma Hastanesi ( Site 4309)
RECRUITING
Ankara
Hacettepe Universite Hastaneleri-oncology hospital ( Site 4300)
RECRUITING
Ankara
İstinye Üniversitesi Liv Hospital-Topkapi ( Site 4307)
RECRUITING
Istanbul
KARTAL DR. LÜTF KIRDAR ETM VE ARATIRMA HASTANES. ( Site 4308)
RECRUITING
Istanbul
Erciyes Universitesi Tıp Fakultesi Hastaneleri ( Site 4304)
RECRUITING
Kayseri
United Kingdom
St Bartholomew's Hospital ( Site 0400)
RECRUITING
London
Singleton Hospital ( Site 0403)
RECRUITING
Swansea
Contact Information
Primary
Toll Free Number
Trialsites@msd.com
1-888-577-8839
Time Frame
Start Date: 2026-05-04
Estimated Completion Date: 2038-05-11
Participants
Target number of participants: 876
Treatments
Experimental: Arm A: Intismeran + Pembrolizumab with Berahyaluronidase Alfa
Participants will receive intismeran 1 mg via intramuscular (IM) injection plus pembrolizumab coformulated with berahyaluronidase alfa 790 mg via subcutaneous (SC) injection.
Experimental: Arm B: Intismeran
Participants will receive intismeran 1 mg via IM injection.
Placebo_comparator: Arm C: Placebo
Participants will receive dose-matched placebo via IM injection.
Sponsors
Collaborators: ModernaTX, Inc.
Leads: Merck Sharp & Dohme LLC

This content was sourced from clinicaltrials.gov

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