NCT03827850

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for phase_2 lung-cancer

Timeline
Completed

Started Mar 2019

Geographic Reach
1 country

11 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 22, 2019

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 4, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 14, 2022

Completed
Last Updated

June 9, 2023

Status Verified

June 1, 2023

Enrollment Period

3.5 years

First QC Date

January 22, 2019

Last Update Submit

June 7, 2023

Conditions

Lung CancerNSCLCPulmonary NeoplasmSquamous Cell Lung CancerNSCLC Stage IV

Keywords

sqNSCLCFGFR Mutations

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate

    Overall response rate (ORR) per RECIST 1.1 under erdafitinib treatment in sqNSCLC with genetic alteration in FGFR

    3 years

Secondary Outcomes (3)

  • number of adverse events per patient

    3 years

  • time length of progression free survival

    3 years

  • time length of overall survival

    3 years

Study Arms (3)

Cohort 1 FGFR trans

ACTIVE COMPARATOR

Cohort 1: Activating (high confidence) FGFR translocations (max. 15 patients) under daily Erdaifitinib treatment

Drug: ERDAFITINIB

Cohort 2 FGFR mut

ACTIVE COMPARATOR

Cohort 2: Activating (high confidence) hotspot FGFR mutations (max. 15 patients) under daily Erdafitinib treatment

Drug: ERDAFITINIB

Cohort 3 FGFR other

ACTIVE COMPARATOR

Cohort 3: Activating (low confidence) FGFR alteration (max. 20 patients)

Drug: ERDAFITINIB

Interventions

ERDAFITINIBDRUG

Daily in a range from 3 mg to 9 mg

Also known as: JNJ -42756493, WHO NUMBER 10147
Cohort 1 FGFR transCohort 2 FGFR mutCohort 3 FGFR other

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Asklepios Klinik München Gauting

Gauting, Bavaria, 82131, Germany

Location

Uniklinik Frankfurt

Frankfurt am Main, Hesse, 60590, Germany

Location

Städtisches Klinikum Braunschweig

Braunschweig, Lower Saxony, 38114, Germany

Location

Pius Hospital Oldenburg

Oldenburg, Lower Saxony, 26121, Germany

Location

Uniklinik RWTH Aachen - Klinik für Hämotologie, Onkologie

Aachen, North Rhine-Westphalia, 52074, Germany

Location

University Hospital of Cologne

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Würzburg Comprehensive Cancer center

Würzburg, North Rhine-Westphalia, 97080, Germany

Location

Uniklinik Carl Gustav Carus Dresden

Dresden, Saxony, 01307, Germany

Location

Evangelische Lungenklink Berlin

Berlin, 13125, Germany

Location

Universitätsklinik Freiburg

Freiburg im Breisgau, 79106, Germany

Location

Universitätsklinik des Saarlandes Homburg

Homburg, 66421, Germany

Location

Related Publications (3)

  • Nogova L, Sequist LV, Perez Garcia JM, Andre F, Delord JP, Hidalgo M, Schellens JH, Cassier PA, Camidge DR, Schuler M, Vaishampayan U, Burris H, Tian GG, Campone M, Wainberg ZA, Lim WT, LoRusso P, Shapiro GI, Parker K, Chen X, Choudhury S, Ringeisen F, Graus-Porta D, Porter D, Isaacs R, Buettner R, Wolf J. Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study. J Clin Oncol. 2017 Jan 10;35(2):157-165. doi: 10.1200/JCO.2016.67.2048. Epub 2016 Nov 21.

    PMID: 27870574BACKGROUND

  • Hierro C, Rodon J, Tabernero J. Fibroblast Growth Factor (FGF) Receptor/FGF Inhibitors: Novel Targets and Strategies for Optimization of Response of Solid Tumors. Semin Oncol. 2015 Dec;42(6):801-19. doi: 10.1053/j.seminoncol.2015.09.027. Epub 2015 Sep 24.

    PMID: 26615127BACKGROUND

  • Schildhaus HU, Nogova L, Wolf J, Buettner R. FGFR1 amplifications in squamous cell carcinomas of the lung: diagnostic and therapeutic implications. Transl Lung Cancer Res. 2013 Apr;2(2):92-100. doi: 10.3978/j.issn.2218-6751.2013.03.03.

    PMID: 25806220BACKGROUND

MeSH Terms

Conditions

Lung NeoplasmsCarcinoma, Non-Small-Cell Lung

Interventions

erdafitinib

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesCarcinoma, BronchogenicBronchial Neoplasms

Study Officials

  • Lucia Nogova, MD

    University Clinic Cologne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Patients with NSCLC and FGFR alteration with high evidence on oncogenic transformation according to FIND molecular board will be included to cohort 1 (FGFR translocated NSCLC patients) and cohort 2 (FGFR mutated NSCLC patients). Patients with NSCLC and FGFR alterations without enough evidence (intermediate / low evidence according to FIND molecular tumor board) for recruitment into cohorts 1 or 2, will be treated in cohort 3. Overall response rate under Erdafitinib treatment will be the primary endpoint.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2019

First Posted

February 4, 2019

Study Start

March 25, 2019

Primary Completion

September 30, 2022

Study Completion

October 14, 2022

Last Updated

June 9, 2023

Record last verified: 2023-06

Locations

DE(11)