drugset / Trial / NCT06212752
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
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-06-13
- Primary completion
- 2024-11-06
- Completion
- 2028-05-22
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Subcutaneous |
| Subject | Pembrolizumab | Monoclonal antibody | 790 mg | Subcutaneous |
| Background | Berahyaluronidase alfa | Protein / enzyme biologic | — | Subcutaneous |
| Background | Carboplatin | Small molecule | 5 unknown | — |
| Background | Carboplatin | Small molecule | 6 unknown | — |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | — | — |
| Background | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | filgrastim | Protein / enzyme biologic | — | — |