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A Single-Arm Phase II Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy

Advanced Non-Small Cell Lung Cancer Clinical Trial

Official title:
A Single-Arm Phase II Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients With FGFR Alterations Who Have Failed Standard Therapy

Clinical Trial Summary

This study is a prospective single-arm phase II clinical study. Advanced non-small cell lung cancer patients with FGFR 1-3 alterations (including but not limited to FGFR amplification, rearrangement/fusion, mutation, etc.) who have failed standard therapy will be enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening.

Clinical Trial Description

This study is a prospective single-arm phase II clinical study. Advanced non-small cell lung cancer patients with FGFR 1-3 alterations (including but not limited to FGFR amplification, rearrangement/fusion, mutation, etc.) who have failed standard therapy will be enrolled in this study once they have signed the informed consent form (ICF) and been identified as eligible in screening. The patients will receive 13.5 mg of pemigatinib once a day (QD) orally following a 2-week administration/1-week interruption regimen. They will be dosed until disease progression or intolerable toxicity. During treatment, clinical tumor imaging evaluation will be performed according to RECIST v1.1 every 6 weeks (± 7 days) and then every 9 weeks (± 7 days) after week 48. Safety will be assessed according to NCI-CTCAE 5.0. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05287386
Study type Interventional
Source The First Affiliated Hospital of Xiamen University
Contact Feng Ye, Doctor
Phone 8613860458889
Email yefengdoctor@sina.com
Status Recruiting
Phase Phase 2
Start date January 21, 2022
Completion date January 21, 2025
View Details
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