Spots Global Cancer Trial Database for A Single-Arm Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients

Study Description

Brief 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.

Detailed 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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