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)
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |