FGFR Inhibitor in FGFR Dysregulated Cancer
NCT03827850 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2023-06-09
Summary
In the FIND trial, Non Small Cell Lung Carcinoma (NSCLC) patients with Fibroblast Growth Factor Receptor (FGFR) genetic alteration will be treated with the selective FGFR1-4 inhibitor erdafitinib. Archival samples, fresh frozen tumor samples and blood for circulating tumor DNA (ctDNA) will be collected before treatment. Patients will be treated until disease progression or unacceptable toxicity. In case of progression, fresh frozen tumor biopsies and ctDNA analyses will be performed to assess resistance mechanisms. The primary objective of the trial is to analyze the efficacy of erdafitinib in NSCLC patients with FGFR genetic alterations. NSCLC patient number will be based on a statistical hypothesis aiming at increasing the response rate comparing to chemotherapy/immunotherapy after standard treatment.
Conditions
- Lung Cancer
- NSCLC
- Pulmonary Neoplasm
- Squamous Cell Lung Cancer
- NSCLC Stage IV
Interventions
- DRUG
-
ERDAFITINIB
Daily in a range from 3 mg to 9 mg
Sponsors & Collaborators
-
Lung Cancer Group Cologne
lead OTHER
Principal Investigators
-
Lucia Nogova, MD · University Clinic Cologne
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-03-25
- Primary Completion
- 2022-09-30
- Completion
- 2022-10-14
Countries
- Germany
Study Locations
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