A Study of ZN-e4 in Subjects With Epidermal Growth Factor Receptor Mutated Non-Small Cell Lung Cancer
Status:
Recruiting
Trial end date:
2022-12-20
Target enrollment:
Participant gender:
Summary
This is a Phase 1/2, open-label, multicenter, sequential dose-escalation study to evaluate
the safety, tolerability, pharmacokinetics (PK), and preliminary efficacy of ZN-e4
administered orally in subjects with advanced non-small cell lung cancer (NSCLC) with
activating EGFR mutations who have progressed while on treatment with an EGFR tyrosine kinase
inhibitor (TKI) agent (other lines of treatment are allowed, except for other epidermal
growth factor receptor inhibitors [EGFRis]) for Phase 1; and for Phase 2, subjects who have
T790M+ and are osimertinib naïve (Cohort 1), and also those who have not been treated with an
EGFR Inhibitor (EGFRi) (Cohort2).