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 | Unknown Phase 2

• 1 other identifier: CIBI375Y006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (1)

• objective response rate (ORR)

  ORR is defined as the proportion of subjects with complete response (CR) + those with partial response (PR) according to the RECIST1.1 criteria.

  an expected average of 2 years

Study Arms (1)

Pemigatinib

EXPERIMENTAL

Selective FGFR1-3 inhibitor

Drug: Pemigatinib

Interventions

Pemigatinib DRUG

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.

Also known as: Pemazyre

Pemigatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥ 18 years old;
• 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);
• Have at least one measurable lesion according to RECIST v1.1;
• Histologically confirmed FGFR 1-3 alterations, including but not limited to amplification, mutation, fusion/rearrangement, etc.;
• 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.
• No previous use of small molecule multi-target inhibitors targeting the FGFR pathway (including anlotinib, lenvatinib, sorafenib, etc.);
• ECOG physical performance status score of 0-1;
• Expected survival time \> 3 months;
• Patients with brain metastases who are asymptomatic or have stable symptoms after locoregional treatment can be enrolled as long as they:
• \) 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.
• \. Patients who have completed palliative radiotherapy one week prior to study enrollment with their radiotherapy-related toxicity reduced to grade 1 or lower (CTCAE5.0) can be enrolled.
• \. For evidence of sufficient organ functions, the subjects shall meet the following laboratory parameters:
• Absolute neutrophil count (ANC) ≥ 1.5 × 109/L without use of granulocyte colony stimulating factor in recent 14 days;
• Platelet count ≥ 100 × 109/L without blood transfusion in recent 14 days;
• Hemoglobin \> 9 g/dL without blood transfusion or erythropoietin use in recent 14 days;

You may not qualify if:

• 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;
• Previously treated with selective FGFR inhibitors;
• 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);
• 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;
• With known symptomatic central nervous system metastasis and/or carcinomatous meningitis. Subjects with previously treated brain metastases are eligible if the disease is stable (no imaging evidence of progression in at least 4 weeks prior to the first dose of study treatment), there is no evidence of new or enlarging brain metastases on repeated imaging, and corticosteroids are not required in at least 14 days prior to the first dose of study treatment. Patients with carcinomatous meningitis should be excluded regardless of their clinically stability;
• During pregnancy or lactation;
• Known history of allotransplantation or allogeneic hematopoietic stem cell transplantation;
• Subjects with abnormal laboratory parameters listed below:
• Serum phosphate \> ULN;
• Serum calcium exceeds the normal range, or the calcium concentration corrected for serum albumin exceeds the normal range when serum albumin exceeds the normal range;
• Potassium level \< lower limit of normal (LLN); potassium levels can be corrected by supplements at screening.
• With known history of human immunodeficiency virus (HIV) infection or confirmed with positive immune test results;
• Presence of severe infection in the active phase or with poor clinical control;
• Pleural effusion, ascites, or pericardial effusion with obvious clinical symptoms that require drainage;
• Acute or chronic active hepatitis B or C infection; hepatitis B virus (HBV) DNA \> 2000 IU/mL or 104 copies/mL; hepatitis C virus (HCV) RNA \> 103 copies/mL; hepatitis B surface antigen (HbsAg) and anti-HCV antibody positive concurrently. Those who with relevant parameters lower than the above criteria after nucleotide antiviral treatment can be enrolled;

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

the First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

RECRUITING

MeSH Terms

Interventions

pemigatinib

Study Officials

• Feng Ye, Doctor

  The First Affiliated Hospital of Xiamen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Feng Ye, Doctor

CONTACT

8613860458889; yefengdoctor@sina.com

Jingxun Wu, Doctor

CONTACT

8615160085395; 23889925@qq.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 18, 2022
• Study Start: January 21, 2022
• Primary Completion: January 21, 2024
• Study Completion: January 21, 2025
• Last Updated: March 18, 2022

Record last verified: 2022-03

Locations

CN (1)