Clinical Trial

Study to Compare Furmonertinib to Platinum-Based Chemotherapy for Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion Mutations (FURVENT)

Active, Not Recruiting Phase 3
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Record status
This record was last updated June 22, 2025 (before its estimated August 15, 2025 completion). Its status may not reflect the trial's current state.
Summary
Global, Phase 3, randomized, multicenter, open-label study evaluating the efficacy and safety of furmonertinib (firmonertinib) at 2 dose levels (160 mg once daily \[QD\] and 240 mg QD) compared to platinum-based chemotherapy in previously untreated patients with locally advanced or metastatic non-squamous Non-Small Cell Lung Cancer (NSCLC) with Epidermal Growth Factor Receptor (EGFR) exon 20 insertion mutations. A target of approximately 375 patients will be randomized in a 1:1:1 ratio to treatment with furmonertinib 240 mg QD, furmonertinib 160 mg QD, or platinum-based chemotherapy.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2022-11-04; most recent amendment 2025-06-18.
Status change: Recruiting → Active, Not Recruiting 2025-04-17
Status change: Not Yet Recruiting → Recruiting 2022-12-14
Trial Details
NCT Number NCT05607550
Lead Sponsor ArriVent BioPharma, Inc.
Collaborators: Allist Pharmaceuticals, Inc.
Conditions Metastatic Non-Small Cell Lung Cancer, Advanced Non-Small Cell Lung Cancer, EGFR Exon 20 Mutations
Enrollment 398 participants
Start Date 2023-06-01
Primary Completion 2025-08-15 (estimated)
Study Completion 2028-02-15 (estimated)
Updated on ClinicalTrials.gov 2025-06-22