NCT04858958

Study of FURMONERTINIB in Patients With NSCLC Having Exon 20 Insertion Mutation

A Phase Ib, Randomized, Open-label, Multi-center Study to Evaluate the Preliminary Efficacy and Safety of Furmonertinib Mesilate in Patients With Locally Advanced or Metastatic Non-small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutation

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase Ⅰb multi-center clinical study. To explore the preliminary efficacy and safety of Furmonertinib Mesilate at different doses in locally advanced or metastatic NSCLC patients with EGFR exon 20 insertion mutation. The study plans to enroll 30 subjects, including 20 treated patients and 10 treatment-naïve patients. The subjects with disease progression after previous systematic anti-tumor therapy will be randomized to receive Furmonertinib Mesilate 160 mg/day (N=10) or 240 mg/day (N=10), respectively. The treatment-naïve patients do not need to be randomized and all will receive Furmonertinib Mesilate 240 mg/day (N=10) until disease progression, death or intolerability. The primary endpoint is ORR; the secondary study endpoints include DCR, DOR, DepOR, PFS, OS, CNS ORR, safety and the PK profile of Furmonertinib Mesilate and its metabolites (AST5902). In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Furmonertinib 160mg	randomized to 160mg QD
DRUG	Furmonertinib 240mg	randomized to 240mg QD

Timeline

• Start date: 2020-08-10
• Primary completion: 2024-12-05
• Completion: 2026-02-28
• First posted: 2021-04-26
• Last updated: 2025-11-19

Locations

1 site across 1 country: China