drugset / Trial / NCT04165070
KEYMAKER-U01 Substudy 01A: Efficacy and Safety Study of Pembrolizumab (MK-3475) With or Without Chemotherapy When Used With Investigational Agents in Treatment-naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A/KEYMAKER-U01A)
RandomizedParallel-groupOpen-labelTreatment
Summary
The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) with or without chemotherapy in combination with vibostolimab (MK-7684), boserolimab (MK-5890), MK-4830, MK-0482, I-DXd, or HER3-DXd in treatment-naïve participants with advanced squamous or non-squamous NSCLC. This study is one of the pembrolizumab substudies being conducted under one pembrolizumab umbrella master protocol (MK-3475-U01/KEYMAKER-U01).
Timeline
- Start
- 2019-12-19
- Primary completion
- 2032-02-13
- Completion
- 2032-02-13
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Boserolimab | Monoclonal antibody | — | Intravenous |
| Subject | Carboplatin | Small molecule | — | Intravenous |
| Subject | Ifinatamab Deruxtecan | Other / unclassified | — | Intravenous |
| Subject | MK-0482 | Unknown | — | Intravenous |
| Subject | MK-4830 | Unknown | — | Intravenous |
| Subject | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Patritumab deruxtecan | Monoclonal antibody | — | Intravenous |
| Subject | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Subject | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Subject | Vibostolimab | Monoclonal antibody | — | Intravenous |