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.
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.
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There are 34 Locations for this study
Orange City Florida, 32763, United States More Info
Marietta Georgia, 30060, United States More Info
Louisville Kentucky, 40245, United States More Info
Hackensack New Jersey, 07601, United States More Info
Bronx New York, 10461, United States More Info
Mineola New York, 11501, United States More Info
New York New York, 10016, United States More Info
New York New York, 10065, United States More Info
Mar del Plata Buenos Aires, B7600, Argentina More Info
Melbourne Victoria, 3000, Australia More Info
Melbourne Victoria, 3065, Australia More Info
Santiago Region M. De Santiago, 83300, Chile More Info
Montpellier Herault, 34090, France More Info
Pécs Baranya, 7624, Hungary More Info
Christchurch Canterbury, 8011, New Zealand More Info
Pozuelo de Alarcon Madrid, 28223, Spain More Info
Sevilla , 41009, Spain More Info
Tainan , 704, Taiwan More Info
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