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

NSCLC Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04858958
Study type Interventional
Source Allist Pharmaceuticals, Inc.
Contact QianYu Zhao, PHD
Phone 021-51320230
Email zhaoqy@allist.com.cn
Status Recruiting
Phase Phase 1
Start date August 10, 2020
Completion date December 2023
View Details
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