A phase II trial to evaluate efficacy and safety of erdafitinib in patients with advanced NSCLC harbouring FGFR genetic alterations after relapse of standard therapy - FIND

niversity of Cologne0 sites50 target enrollmentOctober 18, 2018

Overview

No summary available.

Registry

who.int

Start Date

October 18, 2018

End Date

TBD

Last Updated

3 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

niversity of Cologne

•Age \> 18 years
•Stage IIIB/IV NSCLC patients with activating FGFR alteration after failure on standard treatment, or in the opinion of the investigator no effective standard therapy exists, is appropriate, tolerated, or is considered equivalent to study treatment
•Activating FGFR alteration as approved by FIND Molecular Board
•ECOG performance status score 0, 1, or 2\.
•Must sign an informed consent form (ICF) (or their legally acceptable representative must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
•Clinical laboratory values and cardiovascular measurements at screening:
•Hemoglobin?8 g/dL (?5 mmol/L) (must be without red blood cell \[RBC] transfusion within 7 days prior to the laboratory test; recombinant human erythropoietin use is permitted)
•Platelets?75×109/L
•Absolute Neutrophil Count (ANC)?1\.5×109/L (prior growth factor support is permitted more than 7 days prior to the laboratory test)
•AST and ALT\=2\.5 × upper limit of normal (ULN) or

•Pathogenic somatic alterations in the following genes: EGFR, BRAF, ALK ROS1 and NTRK (Please note that molecular testing might be reduced in heavy smokers with NSCLC. If discrepancies occur, please contact the sponsor). •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 30 days or 5 half\-life times (whichever is longer) prior to recruitment.
•Treatment with small molecules or chemotherapy within 7 days prior to C1D1
•Treatment with monoclonal antibodies within 28 days prior to C1D1\.
•Any other ongoing malignancy that would potentially interfere with the interpretation of erdafitinib efficacy.
•Symptomatic central nervous system metastases.
•Received prior FGFR inhibitor treatment or if the patient has known allergies, hypersensitivity, or intolerance to erdafitinib or its excipients
•Any corneal or retinal abnormality likely to increase the risk of eye toxicity, i.e.:
•a.History of or current evidence of central serous retinopathy (CeSR) or retinal vascular occlusion (RVO)
•b.Active wet, age\-related macular degeneration (AMD)
•c.Diabetic retinopathy with macular edema (non\-proliferative)