drugset / Trial / NCT05687266
Phase III, Open-label, First-line Study of Dato-DXd in Combination With Durvalumab and Carboplatin for Advanced NSCLC Without Actionable Genomic Alterations
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase III, randomized, open-label, multicenter, global study to compare the efficacy and safety of Datopotamab Deruxtecan (Dato-DXd) in combination with durvalumab and carboplatin compared with pembrolizumab in combination with histology-specific platinum-based chemotherapy as first-line treatment of adults with stage IIIB, IIIC, or IV NSCLC without actionable genomic alterations (including sensitizing EGFR mutations, and ALK and ROS1 rearrangements).
Timeline
- Start
- 2022-12-29
- Primary completion
- 2027-11-01
- Completion
- 2027-11-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Subject | Datopotamab deruxtecan | Monoclonal antibody | 6 mg/kg | Intravenous |
| Subject | Durvalumab | Monoclonal antibody | 1120 mg | Intravenous |
| Comparator | Paclitaxel | Small molecule | 200 mg/m2 | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | 200 mg | Intravenous |
| Comparator | Pemetrexed | Small molecule | 500 mg/m2 | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |