drugset / Trial / NCT05364073

Study of Furmonertinib in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Activating, Including Uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) Mutations

NCT05364073

Phase 1 Active not recruiting 160 enrolled ArriVent BioPharma, Inc.
Non-randomizedSequentialOpen-labelTreatment

Summary

This is a Phase 1b, open-label, multi-center, dose-escalation and dose expansion study designed to evaluate the safety, pharmacokinetics (PK), and preliminary antitumor activity of furmonertinib in patients with advanced or metastatic non-small cell lung cancer (NSCLC) with activating, including uncommon, Epidermal Growth Factor Receptor (EGFR) or Human Epidermal Growth Factor Receptor 2 (HER2) mutations. Patients will be enrolled into one of 2 stages: Stage 1 (Dose Escalation and Backfill Cohorts) and Stage 2 (Dose Expansion).

Timeline

Start
2022-06-30
Primary completion
2025-06-03
Completion
2026-12-31

Drugs

EvaluationDrugModalityDoseRoute
Subject Firmonertinib Small molecule