drugset / Trial / NCT04743505
Safety and Efficacy of Combining APL-101 With Frontline Osimertinib in Patients With EGFR-mutated Metastatic Non-small Cell Lung Cancer (NSCLC)
Phase 1/2
Active not recruiting
27 enrolled
Washington University School of Medicine
Apollomics Inc. · collab
Non-randomizedSequentialOpen-labelTreatment
Summary
In this study, patients with metastatic non-small cell lung cancer that is EGFR-mutated, who have received at least 8 and not more than 12 weeks of treatment with osimertinib without demonstrating disease progression, will receive APL-101 in combination with osimertinib until progression. Dosing of APL-101 will be escalated until the maximum tolerated dose is determined, at which point 10 additional patients will be enrolled at that dose in the expansion cohort.
Timeline
- Start
- 2022-01-18
- Primary completion
- 2027-01-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vebreltinib | Small molecule | — | Oral |
| Background | Osimertinib | Small molecule | 80 mg | Oral |