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 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 at the time of providing documented consent for the main study.
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 25 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
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
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
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
Hôpital Arnaud de Villeneuve - CHU Montpellier ( Site 1102)
Montpellier Herault, 34090, France More Info
Study Coordinator
Contact
+33 467330759
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
Changhua Christian Hospital ( Site 0504)
Changhua County Changhua, 50006, Taiwan More Info
Study Coordinator
Contact
886472385957791
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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