Lung Cancer Clinical Trial

A Study of V940 Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)

Summary

The goal of this study is to evaluate V940 plus pembrolizumab versus placebo plus pembrolizumab for the adjuvant treatment of completely resected (R0) Stage II, IIIA, IIIB (with nodal involvement [N2]) non-small cell lung cancer (NSCLC). The primary hypothesis is that V940 plus pembrolizumab is superior to placebo plus pembrolizumab with respect to disease-free survival (DFS) as assessed by the investigator.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

The main inclusion criteria include but are not limited to the following:

Has surgically resected and histologically confirmed diagnosis of pathological Stage II, IIIA, IIIB (N2) squamous or nonsquamous NSCLC as 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.

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

868

Study ID:

NCT06077760

Recruitment Status:

Recruiting

Sponsor:

Merck Sharp & Dohme LLC

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There are 67 Locations for this study

See Locations Near You

Mid Florida Hematology and Oncology Center ( Site 0014)
Orange City Florida, 32763, United States More Info
Study Coordinator
Contact
407-353-1915
Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital ( Site 0012)
Marietta Georgia, 30060, United States More Info
Study Coordinator
Contact
770-281-5100
Beacon Cancer Care ( Site 0044)
Post Falls Idaho, 83854, United States More Info
Study Coordinator
Contact
208-755-2408
The University of Louisville, James Graham Brown Cancer Center ( Site 0037)
Louisville Kentucky, 40245, United States More Info
Study Coordinator
Contact
502-693-1206
St. Vincent Frontier Cancer Center ( Site 0043)
Billings Montana, 59102, United States More Info
Study Coordinator
Contact
406-238-6290
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0036)
Hackensack New Jersey, 07601, United States More Info
Study Coordinator
Contact
551-996-5863
Montefiore Medical Center- Montefiore Medical Park-Oncology ( Site 0080)
Bronx New York, 10461, United States More Info
Study Coordinator
Contact
718-405-8404
Perlmutter Cancer Center at NYU Langone Hospital - Long Island-Clinical Research Department ( Site 0
Mineola New York, 11501, United States More Info
Study Coordinator
Contact
216-903-4153
Laura and Isaac Perlmutter Cancer Center ( Site 0010)
New York New York, 10016, United States More Info
Study Coordinator
Contact
216-903-4153
Memorial Sloan Kettering Cancer Center ( Site 0029)
New York New York, 10065, United States More Info
Study Coordinator
Contact
646-608-3761
Altru Health System ( Site 0040)
Grand Forks North Dakota, 58201, United States More Info
Study Coordinator
Contact
701-780-5860
University Hospitals Cleveland Medical Center ( Site 0023)
Cleveland Ohio, 44106, United States More Info
Study Coordinator
Contact
216-844-5202
Good Samaritan Regional Medical Center-Samaritan Pastega Regional Cancer Center ( Site 0082)
Corvallis Oregon, 97330, United States More Info
Study Coordinator
Contact
541-768-4950
Instituto de Investigaciones Clínicas Mar del Plata ( Site 2908)
Mar del Plata Buenos Aires, B7600, Argentina More Info
Study Coordinator
Contact
+5492235937663
Fundacion Estudios Clinicos-Oncology ( Site 2907)
Rosario Santa Fe, S2000, Argentina More Info
Study Coordinator
Contact
+5493469699922
Clinica Adventista Belgrano-Oncology ( Site 2901)
Caba , 1430, Argentina More Info
Study Coordinator
Contact
5491132682903
Peter MacCallum Cancer Centre-Parkville Cancer Clinical Trials Unit (PCCTU) ( Site 0203)
Melbourne Victoria, 3000, Australia More Info
Study Coordinator
Contact
61385595000
St Vincent's Hospital-Oncology Clinical Trials ( Site 0202)
Melbourne Victoria, 3065, Australia More Info
Study Coordinator
Contact
61392313155
One Clinical Research ( Site 0200)
Nedlands Western Australia, 6009, Australia More Info
Study Coordinator
Contact
0410565868
Centre Hospitalier de l'Université de Montréal ( Site 0104)
Montréal Quebec, H2X 3, Canada More Info
Study Coordinator
Contact
5148908000ext26832
McGill University Health Centre ( Site 0100)
Montréal Quebec, H4A 3, Canada More Info
Study Coordinator
Contact
514934193443050
Orlandi Oncologia-Oncology ( Site 3102)
Santiago Region M. De Santiago, 75007, Chile More Info
Study Coordinator
Contact
56992214787
FALP-UIDO ( Site 3100)
Santiago Region M. De Santiago, 75009, Chile More Info
Study Coordinator
Contact
56224457254
Pontificia Universidad Catolica de Chile-Centro del Cáncer ( Site 3104)
Santiago Region M. De Santiago, 83300, Chile More Info
Study Coordinator
Contact
+56963413803
Bradfordhill-Clinical Area ( Site 3103)
Santiago Region M. De Santiago, 84203, Chile More Info
Study Coordinator
Contact
+56998744662
ONCOCENTRO APYS ( Site 3105)
Viña del Mar Valparaiso, 25205, Chile More Info
Study Coordinator
Contact
+56992369820
CIMCA ( Site 3300)
San José San Jose, 10103, Costa Rica More Info
Study Coordinator
Contact
50683893636
ICIMED ( Site 3301)
San José San Jose, 10108, Costa Rica More Info
Study Coordinator
Contact
506 88317449
Masarykuv onkologicky ustav-Klinika komplexni onkologicke pece ( Site 0700)
Brno Brno-mesto, 656 5, Czechia More Info
Study Coordinator
Contact
420543134008
Nemocnice AGEL Ostrava - Vitkovice a.s.-Plicni odd ( Site 0702)
Ostrava Ostrava Mesto, 703 0, Czechia More Info
Study Coordinator
Contact
00420 595 633 400
Fakultni nemocnice Olomouc-Klinika plicnich nemoci a tuberkulozy ( Site 0701)
Olomouc , 779 0, Czechia More Info
Study Coordinator
Contact
420588445657
North Estonia Medical Centre Foundation-Chemotherapy ( Site 0901)
Tallinn Harjumaa, 13419, Estonia More Info
Study Coordinator
Contact
3726171792
Nouvel Hôpital Civil (NHC)-Service de pneumologie ( Site 1100)
Strasbourg Alsace, 67091, France More Info
Study Coordinator
Contact
0033369550644
CHU Bordeaux Haut-Leveque ( Site 1106)
Pessac Aquitaine, 33600, France More Info
Study Coordinator
Contact
0557656338
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1102)
Montpellier Herault, 34090, France More Info
Study Coordinator
Contact
+33 467330759
Institut de Cancérologie de l'Ouest ( Site 1101)
ANGERS cedex 02 Maine-et-Loire, 49055, France More Info
Study Coordinator
Contact
33241352700
CHU GABRIEL MONTPIED ( Site 1105)
Clermont-Ferrand Puy-de-Dome, 63000, France More Info
Study Coordinator
Contact
04 73 75 16 49
European Interbalkan Medical Center-Oncology Department ( Site 1302)
Thessaloniki , 57001, Greece More Info
Study Coordinator
Contact
306942608228
Bacs-Kiskun Varmegyei Oktatokorhaz-Onkoradiologiai Kozpont ( Site 1401)
Kecskemét Bacs-Kiskun, 6000, Hungary More Info
Study Coordinator
Contact
+3676516719
Pécsi Tudományegyetem Klinikai Központ-Onkoterápiás Intézet ( Site 1402)
Pécs Baranya, 7624, Hungary More Info
Study Coordinator
Contact
36205264756
Somogy Megyei Kaposi Mór Oktató Kórház-Oncology center ( Site 1407)
Kaposvár Somogy, 7400, Hungary More Info
Study Coordinator
Contact
36203782777
P.O. "S. Maria della Misericordia" Azienda Sanitaria Univers-Oncology Department ( Site 1506)
Udine Friuli-Venezia Giulia, 33100, Italy More Info
Study Coordinator
Contact
390432559330
AO Santa Maria della Misericordia-Oncology Department ( Site 1501)
Perugia Umbria, 06132, Italy More Info
Study Coordinator
Contact
+390755782661
Azienda Ospedaliero Universitaria Maggiore della Carità ( Site 1502)
Novara , 28100, Italy More Info
Study Coordinator
Contact
393213733989
Hospital of Lithuanian University of Health Sciences Kauno klinikos-Pulmonology ( Site 1701)
Kaunas Kauno Apskritis, 50161, Lithuania More Info
Study Coordinator
Contact
37037326457
National Cancer Institute-Department of Thoracic Surgery and Oncology ( Site 1700)
Vilnius Vilniaus Miestas, 08660, Lithuania More Info
Study Coordinator
Contact
37060891491
New Zealand Clinical Research (Christchurch) ( Site 0300)
Christchurch Canterbury, 8011, New Zealand More Info
Study Coordinator
Contact
64278360830
Harbour Cancer & Wellness ( Site 0301)
Auckland , 1023, New Zealand More Info
Study Coordinator
Contact
6421783590
Akershus Universitetssykehus-Avdeling for lungesykdommer ( Site 1900)
Lørenskog Akershus, 1478, Norway More Info
Study Coordinator
Contact
004746261495
Stavanger Universitetssykehus ( Site 1901)
Stavanger Rogaland, 4011, Norway More Info
Study Coordinator
Contact
+4792216765
Centrum Onkologii im. Prof. Franciszka Lukaszczyka-Ambulatorium Chemioterapii ( Site 2003)
Bydgoszcz Kujawsko-pomorskie, 85-79, Poland More Info
Study Coordinator
Contact
48501446778
Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 2001)
Przemysl Podkarpackie, 37-70, Poland More Info
Study Coordinator
Contact
661957237
Bialostockie Centrum Onkologii ( Site 2005)
Bialystok Podlaskie, 15-02, Poland More Info
Study Coordinator
Contact
+48856646888
Wielkopolskie Centrum Pulmonologii i Torakochirurgii-Oddzial Onkologii Klinicznej z Pododdzialem Dz
Poznan Wielkopolskie, 60-56, Poland More Info
Study Coordinator
Contact
48616643300
Institut Català d'Oncologia - L'Hospitalet-Medical Oncology ( Site 2401)
Hospitalet Barcelona, 08907, Spain More Info
Study Coordinator
Contact
34932607283
HOSPITAL UNIVERSITARIO PUERTA DE HIERRO MAJADAHONDA-Medical Oncology ( Site 2403)
Majadahonda Madrid, Comunidad De, 28222, Spain More Info
Study Coordinator
Contact
34911917759
HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 2402)
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Study Coordinator
Contact
34914521987
Hospital Quirón Málaga ( Site 2405)
Málaga Malaga, 29004, Spain More Info
Study Coordinator
Contact
00349422033350000
Hospital Universitari Vall d'Hebron-Departamento de Oncologia- VHIO ( Site 2400)
Barcelona , 08035, Spain More Info
Study Coordinator
Contact
34934894158
Hospital Universitario Virgen Macarena-Unidad de Investigación Oncológica ( Site 2404)
Sevilla , 41009, Spain More Info
Study Coordinator
Contact
34955008932
Changhua Christian Hospital ( Site 0504)
Changhua County Changhua, 50006, Taiwan More Info
Study Coordinator
Contact
886472385957791
National Taiwan University Cancer Center (NTUCC) ( Site 0500)
Taipei City Taipei, 106, Taiwan More Info
Study Coordinator
Contact
02-2322-0322
National Taiwan University Hospital - Hsinchu branch ( Site 0501)
Hsinchu , 300, Taiwan More Info
Study Coordinator
Contact
886223368239
Taichung Veterans General Hospital-Chest ( Site 0503)
Taichung , 40705, Taiwan More Info
Study Coordinator
Contact
04-2359-2525
National Cheng Kung University Hospital-Clinical Trial Center ( Site 0505)
Tainan , 704, Taiwan More Info
Study Coordinator
Contact
National Taiwan University Hospital-Oncology ( Site 0506)
Taipei , 10022, Taiwan More Info
Study Coordinator
Contact
02-2312-3456
Taipei Medical University Hospital ( Site 0502)
Taipei , 11030, Taiwan More Info
Study Coordinator
Contact
886227372181-3599

How clear is this clinincal trial information?

Study is for people with:

Lung Cancer

Phase:

Phase 3

Estimated Enrollment:

868

Study ID:

NCT06077760

Recruitment Status:

Recruiting

Sponsor:


Merck Sharp & Dohme LLC

How clear is this clinincal trial information?

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