Trial Profile
A Phase 3 Randomized, Open-label Clinical Study to Evaluate the Pharmacokinetics and Safety of Subcutaneous Pembrolizumab Coformulated With Hyaluronidase (MK-3475A) Versus Intravenous Pembrolizumab, Administered With Chemotherapy, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer
Status:
Active, no longer recruiting
Phase of Trial:
Phase III
Latest Information Update: 28 Mar 2025
Price :
$35
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At a glance
- Drugs Hyaluronidase/Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Filgrastim; Paclitaxel; Pembrolizumab; Pemetrexed
- Indications Non-small cell lung cancer; Squamous cell cancer
- Focus Pharmacokinetics; Registrational
- Acronyms MK-3475A-D77
- Sponsors Merck Sharp & Dohme
- 27 Mar 2025 According to a Merck media release, the European Medicines Agency (EMA) has validated an extension application to introduce a new pharmaceutical form and new route of administration for KEYTRUDA.
- 27 Mar 2025 According to a Merck media release, the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) seeking approval of subcutaneous pembrolizumab across all previously approved solid tumor indications for KEYTRUDA. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Sept. 23, 2025.
- 27 Mar 2025 According to a Merck media release, data from this study presented at the European Lung Cancer Congress (ELCC) 2025 and published simultaneously in Annals of Oncology.