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)

NCT04743505

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

EvaluationDrugModalityDoseRoute
Subject Vebreltinib Small molecule Oral
Background Osimertinib Small molecule 80 mg Oral