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Sacituzumab tirumotecan (MK-2870) versus pemetrexed and carboplatin combination therapy in participants with advanced non-squamous epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC) who have progressed on prior EGFR tyrosine kinase inhibitors (MK-2870-009)-06305754

Study ID: 06305754

A phase 3, randomized, open-label study of MK-2870 versus platinum doublets in participants with advanced non-squamous non-small cell lung cancer (NSCLC) with EGFR mutation who have progressed on prior EGFR tyrosine kinase inhibitors.

About the study:

 

Inclusion criteria: * Histologically or cytologically confirmed diagnosis of advanced-stage non-squamous non-small cell lung cancer (NSCLC). * Participants who experienced adverse events (AEs) due to prior anticancer therapies must have recovered to Grade <1 or baseline. * Participants who are positive for hepatitis B surface antigen (HBsAg) are eligible if they have received antiviral therapy for hepatitis B virus (HBV) for at least 4 weeks and have an undetectable HBV viral load. * Participants with a history of hepatitis C virus (HCV) infection are eligible if their HCV viral load is undetectable. * Participants infected with human immunodeficiency virus (HIV) must have well-controlled HIV with antiretroviral therapy. * Life expectancy of at least 3 months. Exclusion criteria: * NSCLC with predominantly squamous cell histology. * History of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years. * 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. * Active inflammatory bowel disease requiring immunosuppressive medication or a history of inflammatory bowel disease. * Uncontrolled or significant cardiovascular or cerebrovascular disease. * Received prior radiation therapy within 2 weeks prior to the start of the study intervention, or radiation-related toxicities requiring corticosteroids. * Received a live or live attenuated vaccine within 30 days prior to the first dose of the study intervention. Administration of killed vaccines is permitted. * Received radiation therapy to the lung that is >30 Gray within 6 months after the first dose of the study intervention. * Known active metastases to the central nervous system and/or carcinomatous meningitis. * Active infection requiring systemic therapy. * History of (non-infectious) pneumonitis/interstitial lung disease requiring steroids or current pneumonitis/interstitial lung disease. * Participants with HIV infection and a history of Kaposi's sarcoma or multicentric Castleman disease. * Concurrent active HBV and HCV infection. * History of allogeneic solid organ/tissue transplantation. * Participants who have not recovered adequately from major surgery or have ongoing surgical complications.

Total length

Target audiences

Ages: 18 - N/A years
Sex: All

Location

Merck Sharp & Dohme LLC

Associated diseases

  • Adults
  • Non-small cell lung cancer

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