Overview

A Study of Subcutaneous (SC) Pembrolizumab Coformulated With Berahyaluronidase Alfa (MK-3475A) vs Intravenous Pembrolizumab in Adult Participants With Metastatic Non-small Cell Lung Cancer (NSCLC) (MK-3475A-D77)-Japan Extension

Status:
ACTIVE_NOT_RECRUITING
Trial end date:
2028-05-22
Target enrollment:
Participant gender:
Summary
This study is to assess the pharmacokinetics (PK) and safety of SC pembrolizumab (+) berahyaluronidase alfa vs intravenous (IV) pembrolizumab, administered with chemotherapy in first line treatment of adult Japanese participants with metastatic non-small cell lung cancer. The primary hypotheses of this study are pembrolizumab (+) berahyaluronidase alfa subcutaneous (SC) is noninferior to pembrolizumab IV with respect to PK parameters.
Phase:
PHASE3
Details
Lead Sponsor:
Merck Sharp & Dohme LLC
Treatments:
130-nm albumin-bound paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Cisplatin
Filgrastim
Paclitaxel
pembrolizumab
Pemetrexed