Last updated 6 days ago
A Study of Pembrolizumab (MK-3475) With or Without V940 in Participants With Non-small Cell Lung Cancer (V940-009/INTerpath-009)
680 patients around the world
Available in Argentina, Chile
Merck Sharp & Dohme LLC
6Research sites
680Patients 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 histologically/cytologically confirmed diagnosis of previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC) [American Joint Committee on Cancer (AJCC) 8th Edition].Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 within 7 days before the first dose of study intervention.Participants who have not achieved a pathological complete response (pCR) following completion of neoadjuvant chemotherapy and pembrolizumab followed by surgery will be eligible.Confirmation that epidermal growth factor receptor (EGFR)-directed therapy is not indicated as primary therapy (documentation of absence of tumor-activating EGFR mutations [eg, DEL19 or L858R]).Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on anti-retroviral therapy (ART).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.
- Diagnosis of SCLC or, for mixed tumors, presence of small cell elements, or has a neuroendocrine tumor with large-cell components, or a sarcomatoid carcinoma, or a pancoast tumor.Documentation by local test report indicating presence of anaplastic lymphoma kinase (ALK) gene rearrangements.Received prior neoadjuvant therapy for their current NSCLC diagnosis.Received prior therapy with an anti-programmed cell death 1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti-programmed cell-death ligand 2 (PD-L2) agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein [CTLA-4], OX-40, CD137).Received prior systemic anticancer therapy including investigational agents other than what is specified in this protocol.Received prior treatment with a cancer vaccine.Received prior radiotherapy within 2 weeks of start of study intervention, or has radiation-related toxicities, requiring corticosteroids.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.
Sites
CEMIC - Hospital Universitario Sede Saavedra - CABA, Buenos Aires
Recruiting
Instituto de Investigaciones Clínicas Mar del Plata
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Fundación Intecnus
Recruiting
Instituto Oncológico de Córdoba IONC - Fundación Richardet Longo
Recruiting
Oncocentro APYS - Viña del Mar
Recruiting
SponsorMerck Sharp & Dohme LLC
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06623422
