drugset / Trial / NCT04222972
A Study of Pralsetinib Versus Standard of Care for First-Line Treatment of Advanced Non-Small Cell Lung Cancer (NSCLC)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an international, randomized, open-label, Phase 3 study designed to evaluate whether the potent and selective RET inhibitor, pralsetinib, improves outcomes when compared to a platinum chemotherapy-based regimen chosen by the Investigator from a list of standard of care treatments, as measured primarily by progression free survival (PFS), for participants with RET fusion-positive metastatic NSCLC who have not previously received systemic anticancer therapy for metastatic disease.
Timeline
- Start
- 2020-07-24
- Primary completion
- 2025-01-27
- Completion
- 2025-01-27
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Carboplatin | Small molecule | — | Intravenous |
| Comparator | Cisplatin | Other / unclassified | — | Intravenous |
| Comparator | Gemcitabine | Small molecule | — | Intravenous |
| Comparator | Paclitaxel | Small molecule | — | Intravenous |
| Comparator | Pembrolizumab | Monoclonal antibody | — | Intravenous |
| Comparator | Pemetrexed | Small molecule | — | Intravenous |
| Subject | Pralsetinib | Small molecule | — | Oral |