Last updated 6 days ago
Pembrolizumab (MK-3475) Plus Investigational Agents in Resectable Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E/KEYMAKER-U01)
60 patients around the world
Available in Chile, United States
Merck Sharp & Dohme LLC
3Research sites
60Patients 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 previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) non-small cell lung cancer (NSCLC).Able to undergo protocol therapy, including necessary surgery.Confirmation that epidermal growth factor receptor (EGFR) -directed therapy is not indicated as primary therapy.Has an Eastern Cooperative Oncology Group (ECOG) performance status of either 0 or 1 as assessed within 10 days before initiation of study intervention.Is able to provide archival or newly obtained core/excisional biopsy of the primary lung tumor or lymph node metastasis.
- Has one of the following tumor locations/types: NSCLC involving the superior sulcus, large-cell neuro-endocrine cancer, mixed tumors containing small cell and non-small cell elements, or sarcomatoid tumor.Has Grade ≥2 peripheral neuropathy.Has history of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healing.Has active inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).Has uncontrolled, significant cardiovascular disease or cerebrovascular disease.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention.Received prior radiotherapy within 2 weeks of start of study intervention, or radiation related toxicities, requiring corticosteroids.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 intervention.Known additional malignancy that is progressing or has required active treatment within the past 5 years.Severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.Active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy (e.g. 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.Hepatitis B (defined as hepatitis B surface antigen [HBsAg] reactive) or Hepatitis C virus (defined as detectable hepatitis C virus (HCV) ribonucleic acid (RNA) [qualitative]) infection.Known history of human immunodeficiency virus (HIV) infection.History of allogeneic tissue/solid organ transplant.
Sites
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Centro de Estudios Clínicos SAGA - CECSAGA
Recruiting
Instituto Oncológico FALP (Fundación Arturo Lopez Perez)
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06788912
