A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
Launched by MERCK SHARP & DOHME LLC · Oct 5, 2023
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at a new treatment combination for patients with non-small cell lung cancer (NSCLC) who have had surgery to remove their cancer. The study compares the effects of a drug called V940 combined with pembrolizumab (a type of cancer immunotherapy) against a placebo (an inactive substance) also combined with pembrolizumab. The main goal is to see if the V940 combination helps patients live longer without their cancer returning after surgery.
Eligible participants are adults aged 65 and older who have had their NSCLC completely removed through surgery and have no signs of cancer left. They should have already received standard chemotherapy and should be able to start this study treatment within about six months after their surgery. Throughout the study, participants will receive regular check-ups to monitor their health and how well the treatment is working. It's important for patients to know that there are specific criteria that determine who can join, including health conditions and previous treatments. If you or a loved one is interested, please talk to a doctor to see if this trial is a good fit.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- The main inclusion criteria include but are not limited to the following:
- • Has undergone margin negative, completely resected non-small cell lung cancer (NSCLC), and has pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous tumor, node, metastasis (TNM) staging per American Joint Committee on Cancer (AJCC) Eighth Edition guidelines.
- • Has no evidence of disease before randomization.
- • Has received at least one dose of adjuvant treatment with standard of care platinum doublet chemotherapy.
- • No more than 24 weeks have elapsed between surgical resection of curative intent and the first dose of pembrolizumab.
- • 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.
- • Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).
- Exclusion Criteria:
- The main exclusion criteria include but are not limited to the following:
- • Diagnosis of small cell lung cancer (SCLC) or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large cell components or a sarcomatoid carcinoma.
- • HIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.
- • Received prior neoadjuvant therapy for their current NSCLC diagnosis.
- • Received or is a candidate to receive radiotherapy for their current NSCLC diagnosis.
- • Received prior therapy with an anti-programmed cell death 1 protein (PD-1), anti-PD-ligand 1 (L1), or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor.
- • Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
- • Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.
- • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration.
- • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication.
- • Known additional malignancy that is progressing or has required active treatment within the past 5 years.
- • Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid) is allowed.
- • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
- • Active infection requiring systemic therapy.
About Merck Sharp & Dohme Llc
Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., is a leading global biopharmaceutical company dedicated to discovering, developing, and delivering innovative medicines and vaccines that address unmet medical needs. With a strong focus on research and development, Merck Sharp & Dohme leverages advanced science and technology to enhance patient outcomes across various therapeutic areas, including oncology, infectious diseases, and cardiovascular health. Committed to ethical practices and regulatory compliance, the company actively engages in clinical trials to advance medical knowledge and improve health care for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Toronto, Ontario, Canada
New York, New York, United States
Seoul, , Korea, Republic Of
Warszawa, Mazowieckie, Poland
Yvoir, Namur, Belgium
Olsztyn, Warminsko Mazurskie, Poland
Orange City, Florida, United States
Marietta, Georgia, United States
Christchurch, Canterbury, New Zealand
Hackensack, New Jersey, United States
Nedlands, Western Australia, Australia
Mineola, New York, United States
New York, New York, United States
Louisville, Kentucky, United States
Billings, Montana, United States
New York, New York, United States
Melbourne, Victoria, Australia
San José, San Jose, Costa Rica
San José, San Jose, Costa Rica
Auckland, , New Zealand
Tainan, , Taiwan
Taipei, , Taiwan
Bronx, New York, United States
Grand Forks, North Dakota, United States
Hsinchu, , Taiwan
Taipei, , Taiwan
Caba, , Argentina
Melbourne, Victoria, Australia
Montpellier, Herault, France
Changhua County, Changhua, Taiwan
Taichung, , Taiwan
Mar Del Plata, Buenos Aires, Argentina
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Santiago, Region M. De Santiago, Chile
Viña Del Mar, Valparaiso, Chile
Pécs, Baranya, Hungary
Pozuelo De Alarcon, Madrid, Spain
Sevilla, , Spain
Cleveland, Ohio, United States
Clermont Ferrand, Puy De Dome, France
Thessaloniki, , Greece
Kecskemét, Bacs Kiskun, Hungary
Kaposvár, Somogy, Hungary
Bialystok, Podlaskie, Poland
Barcelona, , Spain
Taipei City, Taipei, Taiwan
Montréal, Quebec, Canada
Pessac, Aquitaine, France
Kaunas, Kauno Apskritis, Lithuania
Vilnius, Vilniaus Miestas, Lithuania
Stavanger, Rogaland, Norway
Bydgoszcz, Kujawsko Pomorskie, Poland
Poznan, Wielkopolskie, Poland
Málaga, Malaga, Spain
Corvallis, Oregon, United States
Strasbourg, Alsace, France
Perugia, Umbria, Italy
Lørenskog, Akershus, Norway
Przemysl, Podkarpackie, Poland
Montréal, Quebec, Canada
Olomouc, , Czechia
Angers Cedex 02, Maine Et Loire, France
Udine, Friuli Venezia Giulia, Italy
Novara, , Italy
Majadahonda, Madrid, Comunidad De, Spain
Taipei, , Taiwan
New York, New York, United States
Post Falls, Idaho, United States
Rosario, Santa Fe, Argentina
Brno, Brno Mesto, Czechia
Ostrava, Ostrava Mesto, Czechia
Tallinn, Harjumaa, Estonia
Hospitalet, Barcelona, Spain
Colorado Springs, Colorado, United States
Charleston, South Carolina, United States
Gyor, Gyor Moson Sopron, Hungary
Drammen, Buskerud, Norway
Porto, , Portugal
Sioux Falls, South Dakota, United States
Yuma, Arizona, United States
Fargo, North Dakota, United States
Nashville, Tennessee, United States
Fairfax, Virginia, United States
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina
Rosario, Santa Fe, Argentina
Natal, Rio Grande Do Norte, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Barretos, Sao Paulo, Brazil
São José Do Rio Preto, Sao Paulo, Brazil
Sao Paulo, , Brazil
San Jose, , Costa Rica
Copenhagen, Hovedstaden, Denmark
Odense, Syddanmark, Denmark
Paris, , France
Athens, Attiki, Greece
Athens, Attiki, Greece
Kaposvár, Somogy, Hungary
Dublin, , Ireland
Aviano, Friuli Venezia Giulia, Italy
Milan, Lombardia, Italy
Milan, Milano, Italy
Catania, Sicilia, Italy
Riga, , Latvia
Taipei City, Taipei, Taiwan
Anchorage, Alaska, United States
Orange, California, United States
Orlando, Florida, United States
Tartu, Tartumaa, Estonia
Törökbálint, Pest, Hungary
Bari, Puglia, Italy
Cincinnati, Ohio, United States
Gera, Thuringen, Germany
L Hospitalet, Barcelona, Spain
Caba, Buenos Aires, Argentina
Odense C, Syddanmark, Denmark
Kuantan, Pahang, Malaysia
Lisbon, Lisboa, Portugal
Los Angeles, California, United States
Iowa City, Iowa, United States
Stony Brook, New York, United States
Fortaleza, Ceara, Brazil
Porto Alegre, Rio Grande Do Sul, Brazil
Vaasa, Pohjanmaa, Finland
Oulu, Pohjois Pohjanmaa, Finland
Marseille, Bouches Du Rhone, France
Kempten, Bayern, Germany
Paderborn, Nordrhein Westfalen, Germany
Berlin, , Germany
Cheongju Si, Chungbuk, Korea, Republic Of
Seongnam, Kyonggi Do, Korea, Republic Of
Suwon Si, Kyonggi Do, Korea, Republic Of
Daegu, Taegu Kwangyokshi, Korea, Republic Of
Seoul, , Korea, Republic Of
Kuching, Sarawak, Malaysia
Gdansk, Pomorskie, Poland
Banska Bystrica, Banskobystricky Kraj, Slovakia
Porto Alegre, Rio Grande Do Sul, Brazil
Münster, Nordrhein Westfalen, Germany
Goyang Si, Kyonggi Do, Korea, Republic Of
Seoul, , Korea, Republic Of
Lembah Pantai, Kuala Lumpur, Malaysia
Putrajaya, Kuala Lumpur, Malaysia
Columbus, Ohio, United States
Rio De Janeiro, , Brazil
Sao Paulo, , Brazil
Tampere, Pirkanmaa, Finland
Brampton, Ontario, Canada
Knoxville, Tennessee, United States
Turku, Varsinais Suomi, Finland
Esslingen, Baden Wurttemberg, Germany
Pecs, Baranya, Hungary
George Town, Pulau Pinang, Malaysia
Praha 2, , Czechia
Bochum, Nordrhein Westfalen, Germany
Louisville, Kentucky, United States
Aalst, Oost Vlaanderen, Belgium
Sint Niklaas, Oost Vlaanderen, Belgium
Bratislava, Bratislavsky Kraj, Slovakia
Ann Arbor, Michigan, United States
Naples, Napoli, Italy
San Juan City, Metro Manila, National Capital Region, Philippines
Ankara, , Turkey
Philadelphia, Pennsylvania, United States
Regensburg, Bayern, Germany
Regensburg, Bayern, Germany
Cuneo, , Italy
Grand Rapids, Michigan, United States
Lincoln, Nebraska, United States
Albany, New York, United States
Edegem, Antwerpen, Belgium
Gauting, Bayern, Germany
Santiago, Region M. De Santiago, Chile
Fargo, North Dakota, United States
Edmonton, Alberta, Canada
Kawasaki, Kanagawa, Japan
Krakow, Malopolskie, Poland
Stanbul, Istanbul, Turkey
Ankara, , Turkey
Ankara, , Turkey
Istanbul, , Turkey
Bornova, Izmir, Turkey
Ankara, , Turkey
Akron, Ohio, United States
Mar Del Plata., Buenos Aires, Argentina
Aalst, Oost Vlaanderen, Belgium
Orange, California, United States
Edgewood, Kentucky, United States
Seattle, Washington, United States
Natal., Rio Grande Do Norte, Brazil
Santiago, Region M. De Santiago, Chile
Thessaloniki, , Greece
Hiroshima, , Japan
Caba., Buenos Aires, Argentina
L'hospitalet De Llobregat, Barcelona, Spain
Edgewood, Kentucky, United States
Dallas, Texas, United States
Rosario, Santa Fe, Argentina
Osakasayama, Osaka, Japan
Davao City, Davao Del Sur, Philippines
Tampa, Florida, United States
Caen, Calvados, France
Santiago, Region M. De Santiago, Chile
Yokohama, Kanagawa, Japan
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Chihuahua, , Mexico
Quezon City, National Capital Region, Philippines
Warszawa, Mazowieckie, Poland
Mineola, New York, United States
New York, New York, United States
Yvoir, Namur, Belgium
Athens, Attiki, Greece
Chihuahua, , Mexico
Krakow, Malopolskie, Poland
Olsztyn, Warminsko Mazurskie, Poland
Poznan, Wielkopolskie, Poland
Changhua, , Taiwan
Oaxaca, , Mexico
Newnan, Georgia, United States
Nashville, Tennessee, United States
Huntington, West Virginia, United States
Oaxaca, , Mexico
Tucson, Arizona, United States
Majadahonda, , Spain
Patients applied
Trial Officials
Medical Director
Study Director
Merck Sharp & Dohme LLC
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported