Clinical Trial

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

Active, Not Recruiting Phase 1
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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).
Protocol Amendment History 29 amendments
This ClinicalTrials.gov record has been amended 29 times since 2022-05-03; most recent amendment 2026-03-11.
Status change: Recruiting → Active, Not Recruiting 2024-07-17
Status change: Not Yet Recruiting → Recruiting 2022-06-27
Trial Details
NCT Number NCT05364073
Lead Sponsor ArriVent BioPharma, Inc.
Conditions Non-Small Cell Lung Cancer (NSCLC), Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, HER2 Exon 20 Mutations, EGFR Exon 20 Mutations, EGFR Uncommon Mutations, Including G719X and S768I
Enrollment 160 participants
Start Date 2022-06-30
Primary Completion 2025-06-03 (estimated)
Study Completion 2026-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-03-13