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A Single-Arm Clinical Study of Pemigatinib in the Treatment of Advanced Non-Small Cell Lung Cancer Patients

NCT05210946 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2022-01-27

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Pemigatinib

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.

Sponsors & Collaborators

  • The First Affiliated Hospital of Soochow University

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-06
Primary Completion
2023-12-06
Completion
2024-12-06

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05210946 on ClinicalTrials.gov