Last updated 16 days ago
Sacituzumab Tirumotecan (MK-2870) Versus Pemetrexed and Carboplatin Combination Therapy in Participants With Epidermal Growth Factor (EGFR)-Mutated, Advanced Nonsquamous Non-small Cell Lung Cancer (NSCLC) and Have Progressed on Prior EGFR Tyrosine Kinase Inhibitors (MK-2870-009)
520 patients around the world
Available in Argentina, United States
Participants will be randomized 1:1 into two arms:
- Sacituzumab tirumotecan
- Pemetrexed plus Carboplatin
Participants will receive treatment until any of the criteria for discontinuation of
study intervention are met.
Merck Sharp & Dohme LLC
6Research sites
520Patients 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 advanced-stage nonsquamous non-small cell lung cancer (NSCLC)Participants who have adverse events (AEs) due to previous anticancer therapies must have recovered to Grade <1 or baselineParticipants 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 loadParticipants with history of Hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectableHuman immunodeficiency virus (HIV)-infected participants must have well controlled HIV on antiretroviral therapyLife expectancy of at least 3 months
- Predominantly squamous cell histology NSCLCHistory of second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 yearsGrade >2 peripheral neuropathyHistory of documented severe dry eye syndrome, severe Meibomian gland disease and/or blepharitis, or corneal disease that prevents/delays corneal healingActive inflammatory bowel disease requiring immunosuppressive medication or previous history of inflammatory bowel diseaseUncontrolled, or significant cardiovascular disease or cerebrovascular diseaseReceived prior radiotherapy within 2 weeks of start of study intervention, or radiation-related toxicities, requiring corticosteroidsReceived a live or live-attenuated vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowedReceived radiation therapy to the lung that is >30 Gray within 6 months of the first dose of study interventionKnown active central nervous system metastases and/or carcinomatous meningitisActive infection requiring systemic therapyHistory of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung diseaseHIV-infected participants with a history of Kaposi's sarcoma and/or Multicentric Castleman's DiseaseConcurrent active HBV and HCV infectionHistory of allogeneic tissue/solid organ transplantParticipants who have not adequately recovered from major surgery or have ongoing surgical complications
Sites
Hospital Británico de Buenos Aires - CABA
Recruiting
Fundación Cori para la Investigación y Prevención del Cáncer - La Rioja
Recruiting
Clínica Adventista Belgrano - CABA - Buenos Aires
Recruiting
Instituto Médico Especializado Alexander Fleming - CABA, Buenos Aires
Recruiting
Instituto de Oncología de Rosario - IOR
Recruiting
Centro Privado de RMI Río Cuarto
Recruiting
SponsorMerck Sharp & Dohme LLC
Conditions
Non-small cell lung carcinomaLung cancer
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06305754
