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)
NCT05607550 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 398
Last updated 2025-06-22
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.
Conditions
- Metastatic Non-Small Cell Lung Cancer
- Advanced Non-Small Cell Lung Cancer
- EGFR Exon 20 Mutations
Interventions
- DRUG
-
furmonertinib 240 mg oral, daily
furmonertinib tablet
- DRUG
-
furmonertinib 160 mg oral, daily
furmonertinib tablet
- DRUG
-
platinum-based chemotherapy
(carboplatin or cisplatin based on investigator's choice) + pemetrexed intravenously (IV)
Sponsors & Collaborators
-
Allist Pharmaceuticals, Inc.
collaborator INDUSTRY -
ArriVent BioPharma, Inc.
lead INDUSTRY
Principal Investigators
-
Morgan Lam · ArriVent BioPharm
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-01
- Primary Completion
- 2025-08-15
- Completion
- 2028-02-15
- FDA Drug
- Yes
Countries
- United States
- Australia
- Brazil
- Canada
- China
- France
- Israel
- Italy
- Japan
- Malaysia
- Mexico
- Netherlands
- Philippines
- Singapore
- South Korea
- Spain
- Taiwan
- Thailand
- United Kingdom
Study Locations
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