NCT04958967

Phase Ib Study of FURMONERTINIB in Patients with NSCLC Having Exon 20 Insertion Mutation

A Phase Ib Open-Label, Randomization Multi-Center Study to Evaluate Efficacy and Safety of FURMONERTINIB MESILATE in PATIENTS with LOCALLY ADVANCED or METASTATIC NON-SMALL CELL LUNG CANCER HARBOURING EGFR EXON 20 INSERTION MUTATION

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Allist Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 1 multi-center clinical study. To explore the 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 20subjects, including 20 treated patients aThe subjects will receive Furmonertinib Mesilate 240 mg/day or 160mg/day until disease progression, death or intolerability. The primary endpoint is Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC); the secondary study endpoints include ORR（ Assessed by the Investigator），DCR，DOR，DpR，PFS，OS，CNS ORR（ Assessed by the Independent Review Committee） In addition, the peripheral blood ctDNA will be collected and analyzed in this study

Conditions

• NSCLC

Interventions

Type	Name	Description
DRUG	Furmonertinib 240mg	treated subjects will receive Furmonertinib 240mg/day
DRUG	Furmonertinib 160mg	treated subjects will receive Furmonertinib 160mg/day

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-05-01
• Completion: 2022-08-01
• First posted: 2021-07-12
• Last updated: 2025-03-14

Locations

1 site across 1 country: China