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Clinical Trial Summary

Primary objective: ● To evaluate the efficacy of pemigatinib in advanced non-small cell lung cancer patients with fibroblast growth factor receptor 1-3 (FGFR 1-3) alterations (including but not limited to FGFR amplification, rearrangement/fusion, mutation, etc.) who have failed standard therapy. Secondary objective: ● To evaluate the safety and tolerability of pemigatinib in advanced non-small cell lung cancer patients with known FGFR 1-3 alterations (including but not limited to FGFR amplification, rearrangement/fusion, mutation, etc.) who have failed standard therapy, including the incidence of adverse events (AEs) and serious adverse events (SAEs), as well as the incidence of AEs/SAEs resulting in treatment discontinuation.


Clinical Trial Description

This study is a prospective single-arm clinical study. Advanced non-small cell lung cancer patients with known 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


NCT number NCT05210946
Study type Interventional
Source The First Affiliated Hospital of Soochow University
Contact Xurui Shen
Phone 18896580380
Email [email protected]
Status Recruiting
Phase N/A
Start date December 6, 2021
Completion date December 6, 2024

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