Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-24 @ 4:46 PM
NCT ID:
NCT03827850
Eligibility Criteria:
Inclusion Criteria:
* Age \> 18 years
* Stage IIIB/IV NSCLC patients with activating FGFR alteration after the failure on any prior line of 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
* 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.
* ECOG performance status score 0, 1, or 2.
* Clinical laboratory values and cardiovascular measurements at screening as defined in protocol
* Disease measurable per Response Evaluation Criteria in Solid Tumors (RECIST 1.1) for cohort 1 and 2. or evaluable disease.
* A woman of childbearing potential who is sexually active must have a negative pregnancy test (human chorionic gonadotropin \[hCG\]) at Screening (urine or serum, minimum sensitivity 25 IU/L or equivalent units of b-HCG) within 24 hours prior to the start of erdafitinib
* Women of childbearing potential (WOCBP) and men who are sexually active with WOCBP must use appropriate method(s) of contraception with a failure rate of less than 1% per year before study entry, during the study and until 5 months after taking the last dose of study drug. And other Criteria
Exclusion Criteria:
* 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)
* Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to recruitment
* Treatment with small molecules or chemotherapy within 7 days prior C1D1
* Treatment with monoclonal antibodies within 28 days prior C1D1 if related to the underlying malignancy
* Any other history of 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.:
* History of or current evidence of CeSR or retinal vascular occlusion (RVO)
* Active wet, age-related macular degeneration (AMD)
* Diabetic retinopathy with macular edema (non-proliferative)
* Uncontrolled glaucoma (per local standard of care)
* Corneal pathology such as keratitis, keratoconjunctivitis, keratopathy, corneal abrasion, inflammation or ulceration.
* Has persistent phosphate level \>ULN during screening (on 2 consecutive assessments at least 1 week apart, within 14 days prior to Cycle 1 Day 1) and despite medical management
* Has a history of or current uncontrolled cardiovascular disease as defined in protocol
* Known human immunodeficiency virus (HIV) infection, testing is mandatory (a-HIV 1/2)
* Patients with acute or chronic Hepatitis B infection (tests should include assessment of HBsAg and HBc IgG antibody. If one parameter is positive, determine HBV-DNA to confirm acute infection. Patients with positive results for HBsAg and/or HBV-DNA are considered positive for acute or chronic infection.
* Patients with acute or chronic Hepatitis C infection (determine HCV-RNA. Patients with positive result for HCV-RNA are considered positive for acute or chronic infection).
* Has not recovered from reversible toxicity of prior anticancer therapy (except toxicities which are not clinically significant such as alopecia, skin discoloration, Grade 1 neuropathy, Grade 1-2 hearing loss)
* Has impaired wound healing capacity defined as skin/decubitus ulcers, chronic leg ulcers, known gastric ulcers, or unhealed incisions
* Major surgery within 2 weeks of the first dose, or will not have fully recovered from surgery, or has surgery planned during the time the patient is expected to participate in the study or within 2 weeks after the last dose of study drug administration. (patients with planned surgical procedures to be conducted under local anesthesia may participate).
* Any serious underlying medical condition, such as:
* Evidence of serious active viral, bacterial, or uncontrolled systemic fungal infection requiring current systemic treatment
* Psychiatric conditions (eg, alcohol or drug abuse), dementia, or altered mental status
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03827850
Study Brief:
Protocol Section:
NCT03827850