drugset / Trial / NCT06312137
A Study to Assess Efficacy and Safety of Pembrolizumab With or Without Sacituzumab Tirumotecan (MK- 2870) in Adult Participants With Resectable Non Small Cell Lung Cancer (NSCLC) Not Achieving Pathological Complete Response (pCR) (MK-2870-019)
Non-randomizedParallel-groupSingle-blindTreatment
Summary
This study will assess if adding sacituzumab tirumotecan with pembrolizumab after surgery is effective in treating NSCLC for participants not achieving pathological complete response. The primary hypothesis of this study is sacituzumab tirumotecan plus pembrolizumab is superior to pembrolizumab monotherapy with respect to disease free survival (DFS) as assessed by blinded independent central review (BICR).
Timeline
- Start
- 2024-04-03
- Primary completion
- 2034-02-21
- Completion
- 2034-10-23
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |
| Subject | Sacituzumab Tirumotecan | Other / unclassified | 4 mg/kg | Intravenous |
| Comparator | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Comparator | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1000 mg/m2 | Intravenous |
| Comparator | Gemcitabine | Small molecule | 1250 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |