Last updated 33 days ago
Study of Pembrolizumab (MK-3475) Monotherapy Versus Sacituzumab Govitecan in Combination With Pembrolizumab for Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-3475-D46)
614 patients around the world
Available in Chile, United States
Merck Sharp & Dohme LLC
8Research sites
614Patients 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 a histologically or cytologically confirmed diagnosis of metastatic non-small cell lung cancer (NSCLC)Has confirmation that epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase 1 (ALK-1), or ROS proto-oncogene 1 (ROS-1)-directed therapy is not indicated as primary therapyHas provided tumor tissue that demonstrates PD-L1 tumor proportion score (TPS) ≥50% of tumor cells as assessed by immunohistochemistry (IHC) at a central laboratoryHas a life expectancy of at least 3 months
- Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 yearsHas received prior systemic chemotherapy or other targeted or biological antineoplastic therapy for their metastatic NSCLCHas previously received treatment with Topoisomerase 1 inhibitors or Trop-2 targeted therapyHas received prior therapy with an anti-programmed cell death 1 protein (anti-PD-1), anti-programmed cell death ligand 1 (anti-PD-L1), or anti anti- programmed cell death ligand 2 (PD-L2) agent or with an agent directed to another stimulatory or coinhibitory T-cell receptorHas received prior radiotherapy within 2 weeks of start of study intervention or has radiation-related toxicities requiring corticosteroidsHas received radiation therapy to the lung that is >30 Gray (Gy) within 6 months of the first dose of study interventionHas received a live or live-attenuated vaccine within 30 days before the first dose of study interventionHas received an investigational agent or has used an investigational device within 4 weeks before study intervention administrationHas cardiac diseaseHas active chronic inflammatory bowel diseaseHas diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of study medicationHas known active central nervous system (CNS) metastases and/or carcinomatous meningitisHas severe hypersensitivity (≥Grade 3) to pembrolizumab or sacituzumab govitecan and/or any of their excipientsHas active autoimmune disease that has required systemic treatment in past 2 years except replacement therapyHistory of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung diseaseHas active infection requiring systemic therapyHas history of human immunodeficiency virus (HIV) infectionHistory of hepatitis B or known active hepatitis C virus infectionHas history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the participant's participation for the full duration of the study, such that it is not in the best interest of the participant to participate, in the opinion of the treating investigatorHave not adequately recovered from major surgery or have ongoing surgical complications
Sites
Centro Regional Integrado de Oncologia - CRIO
Recruiting
Hospital Tacchini
Recruiting
Instituto de Oncologia Saint Gallen
Recruiting
Hospital de Câncer de Barretos - Fundação PIO XII
Recruiting
AC Camargo Cancer Center
Recruiting
Hospital de Clínicas de Passo Fundo
Recruiting
Oncovida - Santiago
Recruiting
Hospital Clínico Pontificia Universidad Católica de Chile - Santiago, Región Metropolitana
Recruiting
SponsorMerck Sharp & Dohme LLC
Study typeInterventional
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05609968
