Last updated 30 days ago
Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab Versus Pembrolizumab Alone in Metastatic Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥ 50% (MK-2870-007)
614 patients around the world
Available in Chile, United States, Argentina
Merck Sharp & Dohme LLC
9Research 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
- Histologically or cytologically confirmed diagnosis of squamous or nonsquamous NSCLC.Confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), or proto-oncogene tyrosine-protein kinase ROS (ROS1-) directed therapy is not indicated as primary therapy.Provided tumor tissue that demonstrates programmed cell death ligand 1 (PD-L1) expression in ≥50% of tumor cells as assessed by an immunohistochemistry (IHC) central laboratory.An Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 assessed within 7 days before randomization.A life expectancy of at least 3 months.Human immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapy (ART).
- Diagnosis of small cell lung cancer or, for mixed tumors, presence of small cell elements.Has Grade ≥2 peripheral neuropathy.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 clear history of inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, or chronic diarrhea).Has uncontrolled, significant cardiovascular disease or cerebrovascular disease within the 6 months preceding study intervention.Received prior systemic anticancer therapy for their metastatic NSCLC.Received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent, or with an agent directed to another stimulatory or coinhibitory T-cell receptor. Note: Prior treatment with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent in the neoadjuvant or adjuvant setting for nonmetastatic resectable NSCLC is allowed as long as therapy was completed at least 12 months before diagnosis of metastatic NSCLC.Received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.Received radiation therapy to the lung that is >30 Gy within 6 months of start of study intervention.Received prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroids.Received a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines are allowed.Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy.Known additional malignancy that is progressing or has required active treatment within the past 3 years.Known active central nervous system (CNS) metastases and/or carcinomatous meningitis.Known intolerance to sacituzumab tirumotecan or pembrolizumab and/or any of their excipients; for pembrolizumab, severe hypersensitivity (≥Grade 3) is exclusionary.Known hypersensitivity to sacituzumab tirumotecan or other biologic therapy.Active autoimmune disease that has required systemic treatment in the past 2 years.History of (noninfectious) pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.Active infection requiring systemic therapy.Concurrent active Hepatitis B and Hepatitis C virus infection.Human immunodeficiency virus (HIV)-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's Disease.History of allogeneic tissue/solid organ transplant.Requires treatment with a strong inhibitor or inducer of Cytochrome P450 3A4 (CYP3A4) at least 14 days before the first dose of study intervention and throughout the study.
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Hospital Alemán
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Centro Privado de RMI Río Cuarto
Recruiting
Centro de Investigación Clínica Bradford Hill - Santiago, Región Metropolitana
Recruiting
Orlandi Oncología
Recruiting
Instituto Oncológico FALP - UIDO
Recruiting
Clínica Universidad Católica del Maule
Recruiting
StudyMK 2870-007
SponsorMerck Sharp & Dohme LLC
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06170788
