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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 | Clinical Trials | Clareo Health

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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

NCT05287386•The First Affiliated Hospital of Xiamen University

View on ClinicalTrials.gov

Summary

Detailed 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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Aged ≥ 18 years old;
•2. Histologically or cytologically confirmed unresectable stage IIIB-IIIC or stage IV NSCLC (staged according to the 8th Edition of the TNM Classification for Lung Cancer published by the International Association for the Study of Lung Cancer and American Joint Committee on Cancer);
•3. Have at least one measurable lesion according to RECIST v1.1;
•4. Histologically confirmed FGFR 1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.;
•5. Have failed or intolerated second-line and above standard therapies. Patients who have EGFR-sensitive mutations or are positive for ALK/ROS1 rearrangements shall receive at least one line of EGFR/ALK/ROS1 inhibitor treatment; Note: Patients who have a relapse within 6 months after a radical surgery or radical concurrent chemoradiotherapy can be enrolled if they have failed at least one line of systematic therapy after the relapse.
•6. No previous use of small molecule multi-target inhibitors targeting the FGFR pathway (including anlotinib, lenvatinib, sorafenib, etc.);
•7. ECOG physical performance status score of 0-1;
•8. Expected survival time \> 3 months;
•9. Patients with brain metastases who are asymptomatic or have stable symptoms after locoregional treatment can be enrolled as long as they:
•1\) Have measurable lesions outside the central nervous system; 2) Have no central nervous system symptoms or no aggravation of symptoms for at least 2 weeks; 3) Do not need glucocorticoid treatment or stop glucocorticoid treatment within 7 days before the first dose of the investigational drug.
+34 more criteria

Exclusion Criteria

•1. Diagnosed with malignant tumors other than non-small cell lung cancer within 5 years before the first dose, excluding radically cured cutaneous basal cell carcinoma, cutaneous squamous cell carcinoma, and/or radically resected carcinoma in situ;
•2. Previously treated with selective FGFR inhibitors;
•3. Have received any other investigational drug treatment or participated in another interventional clinical trial within 28 days before the first dose of the investigational drug, or have received anti-tumor drug treatment within 28 days before the first dose of the investigational drug (including Chinese herbal medicine with anti-tumor indications);
•4. Have not recovered (i.e., reaching ≤ grade 1 or the baseline status, excluding asthenia and alopecia) from toxicity and/or complications caused by any intervention before the start of treatment;

Locations (1)

the First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Key Dates

Start Date

January 21, 2022

Primary Completion Date

January 21, 2024

Completion Date

January 21, 2025

Last Updated

March 18, 2022

Enrollment

ESTIMATED participants

Conditions

Advanced Non-Small Cell Lung Cancer

Interventions

Pemigatinib

DRUG

Contacts

Feng Ye, Doctor

CONTACT

8613860458889 yefengdoctor@sina.com

Jingxun Wu, Doctor

CONTACT

8615160085395 23889925@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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