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

NSCLC Clinical Trial

Official title:
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

Clinical Trial 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

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04958967
Study type Interventional
Source Allist Pharmaceuticals, Inc.
Contact
Status Withdrawn
Phase Phase 1
Start date October 1, 2021
Completion date August 1, 2022
View Details
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