drugset / Trial / NCT06362980
A Study With BPI-1178 and Osimertinib in Advanced Non-small Cell Lung Cancer Patients With EGFR Mutations
NaSingle-groupOpen-labelTreatment
Summary
BPI-1178 is a novel, orally administered inhibitor of both cyclin-dependent kinase 4 (CDK4) and CDK6 kinase activity. This open-label investigator-initiated trial (IIT) phase I study was designed to evaluate the safety and efficacy of oral BPI-1178 in combination with osimertinib in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) Mutations.
Timeline
- Start
- 2024-05-22
- Primary completion
- 2025-04-01
- Completion
- 2026-04-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BPI-1178 | Unknown | 200 mg | Oral |
| Subject | BPI-1178 | Unknown | 300 mg | Oral |
| Subject | Osimertinib | Small molecule | 80 mg | Oral |