drugset / Trial / NCT06731907
A Study of Pembrolizumab With or Without Chemotherapy in Combination With Additional Treatments for Advanced Non-Small Cell Lung Cancer (NSCLC) (MK-3475-01G/KEYMAKER U01)
RandomizedParallel-groupSingle-blindTreatment
Summary
Researchers are investigating new treatments for untreated advanced non-small cell lung cancer (NSCLC), which is the most common form of lung cancer and lung cancer that has spread beyond surgical removal. Standard treatments include immunotherapy, such as pembrolizumab, and chemotherapy. This study aims to determine the effectiveness of adding other treatments, including the human epidermal growth factor receptor 3-directed antibody-drug conjugate (HER3-DXd) patritumab deruxtecan, to pembrolizumab, with or without chemotherapy. The primary goals are to assess safety and efficacy of the treatments.
Timeline
- Start
- 2025-03-30
- Primary completion
- 2032-03-12
- Completion
- 2032-03-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Comparator | Paclitaxel | Small molecule | 100 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Subject | Patritumab deruxtecan | Monoclonal antibody | 5.6 mg/kg | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |