NCT06698042

A Clinical Study of Pembrolizumab (+) Berahyaluronidase Alfa (MK-3475A) to Treat Newly-diagnosed Metastatic Non-small Cell Lung Cancer (MK-3475A-F84)

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, in the First-line Treatment of Participants With Metastatic Non-small Cell Lung Cancer With PD-L1 TPS 50% or Greater

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Researchers are looking for new ways to treat non-small cell lung cancer (NSCLC) that is metastatic, which means cancer has spread to other parts of the body. Some people with metastatic NSCLC are treated with pembrolizumab, an immunotherapy treatment that is given into a vein as an intravenous (IV) infusion. Pembrolizumab (+) Berahyaluronidase alfa is pembrolizumab that is given under the skin as a subcutaneous (SC) injection. The goal of this study is to learn what happens to pembrolizumab in a person's body over time when it is given as an IV infusion or SC injection.

Conditions

• Lung Cancer
• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Pembrolizumab (+) Berahyaluronidase alfa	Administered subcutaneously on Day 1 of each cycle
BIOLOGICAL	Pembrolizumab	Administered intravenously on Day 1 of each cycle

Timeline

• Start date: 2024-11-21
• Primary completion: 2026-03-12
• Completion: 2030-02-11
• First posted: 2024-11-20
• Last updated: 2026-04-01

Locations

67 sites across 12 countries: United States, China, Germany, Guatemala, Japan, Peru, Poland, Romania, South Korea, Spain, Turkey (Türkiye), United Kingdom

Regulatory

• FDA-regulated drug study