drugset / Trial / NCT05607550

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

Phase 3 Active not recruiting 398 enrolled ArriVent BioPharma, Inc. Allist Pharmaceuticals, Inc. · collab
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2023-06-01
Primary completion
2025-08-15
Completion
2028-02-15

Drugs

EvaluationDrugModalityDoseRoute
Comparator Carboplatin Small molecule
Comparator Cisplatin Other / unclassified
Subject Firmonertinib Small molecule 160 mg Oral
Subject Firmonertinib Small molecule 240 mg Oral
Comparator Pemetrexed Small molecule Intravenous