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

868 patients around the world
Available in Costa Rica, Argentina, United States
Merck Sharp & Dohme LLC
11Research sites
868Patients around the world

This study is for people with

Lung cancer
Non-small cell lung carcinoma

Requirements for the patient

From 18 Years
All Gender

Medical requirements

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).
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.

Sites

Clínica Adventista Belgrano - CABA - Buenos Aires
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Estomba 1710, CABA, Buenos Aires
Instituto de Investigaciones Clínicas Mar del Plata
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Av. Colón 3456, Mar del Plata, Buenos Aires
Sanatorio Parque - Rosario
Recruiting
Boulevard Oroño 860, Rosario, Santa Fe
Instituto Médico de la Fundación Estudios Clínicos - Rosario
Recruiting
Italia 428, Rosario - Santa Fe
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Av. Crámer 1180, CABA, Buenos Aires
Hospital Italiano de Buenos Aires - CABA, Buenos Aires
Recruiting
Juan Domingo Perón 4190, Piso 1, Ciudad Autónoma de Buenos Aires, C1181ACH
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Manzano 343, Recoleta, Región Metropolitana, Santiago
Oncocentro APYS - Valparaíso
Recruiting
Avenida La Marina 1702, Viña del Mar, Valparaíso
Instituto Oncológico FALP - UIDO
Recruiting
José Manuel Infante 805, Providencia, Región Metropolitana
Orlandi Oncología
Recruiting
General Salvo 159, Providencia, Región Metropolitana, Santiago, 7500713
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