Lung CancerPhase 2FINDNCT03827850
FGFR Inhibitor in FGFR Dysregulated Cancer
A Phase 2 study testing ERDAFITINIB in people with Lung Cancer and NSCLC, run by Lung Cancer Group Cologne at 11 sites in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer, NSCLC, Pulmonary Neoplasm
- What is being tested?
- ERDAFITINIB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 11 sitesGermany
- Study dates
- 25 Mar 2019to 14 Oct 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Uniklinik RWTH Aachen - Klinik für Hämotologie, Onkologie
Aachen, North Rhine-Westphalia, 52074
Evangelische Lungenklink Berlin
Berlin, 13125
Städtisches Klinikum Braunschweig
Braunschweig, Lower Saxony, 38114
University Hospital of Cologne
Cologne, North Rhine-Westphalia, 50937
Uniklinik Carl Gustav Carus Dresden
Dresden, Saxony, 01307
Uniklinik Frankfurt
Frankfurt am Main, Hesse, 60590
Universitätsklinik Freiburg
Freiburg im Breisgau, 79106
Asklepios Klinik München Gauting
Gauting, Bavaria, 82131
Universitätsklinik des Saarlandes Homburg
Homburg, 66421
Pius Hospital Oldenburg
Oldenburg, Lower Saxony, 26121
Universitätsklinikum Würzburg Comprehensive Cancer center
Würzburg, North Rhine-Westphalia, 97080
About this study
Official title: A Phase II Trial to Evaluate Efficacy and Safety of Erdafitinib in Patients With Advanced Non Small Cell Lung Carcinoma (NSCLC) Harboring Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations After Relapse of Standard Therapy.
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.
Read the detailed description
Downstream signaling of fibroblast growth factor receptors 1-4 (FGFR 1-4) regulates cell proliferation, migration, differentiation and survival in healthy cells. Genetic alterations (amplifications, point-mutations and translocations) in FGFR1-4 genes cause altered signaling and oncogenic transformation. FGFR-alterations with sensitivity to kinase inhibition have been identified in a variety of tumors such as breast-, bladder- and endometrial-cancer, squamous cell lung and head and neck cancer, cholangiocarcinoma and glioblastoma.
First-in-man/phase-I clinical trials with erdafitinib and BGJ398 - both selective FGFR inhibitors - enrolled patients with any genetic alterations in FGFR. The trials showed clinical responses with differences according to the type of FGFR alterations and histological subtypes. In the BGJ398 trial, the partial response rate was 11% (4/36) in patients with FGFR1 amplified squamous NSCLC (sqNSCLC) and 38% (3/8) in patients with FGFR3-mutant bladder cancer. No PR was observed in patients with FGFR1/2 amplified (n=25) and FGFR3 mutant (n=1) breast cancer. All patients with FGFR2-translocated (n=2) and FGFR2-mutated cholangiocarcinoma (n=1) showed reduced tumor burden of 20% and 10%, respectively. In the erdafitinib trial, 5 partial responses were seen in FGFR translocated tumors: 3/8 (37.5%) patients with urothelial carcinoma, 1/3 (33%) patients with glioblastoma and 1 patient with endometrial cancer reached PR. Summing up the results of the phase-I trials, the inhibition of FGFR downstream pathways in FGFR translocated and mutated solid tumors exerted clinical activity. Thus, focusing treatment with FGFR inhibitors on FGFR mutated and translocated solid tumors may increase response rates, progression free and overall survival in these tumors with otherwise adverse prognosis.
In NSCLC patients without druggable alterations in genes as EGFR, ALK or ROS1 and without high PD-L1 (Programmed cell death 1 ligand 1) expression, prognosis remains adverse with a median survival time of about 18 months. Particularly in sqNSCLC, only few driver mutations have been identified yet. Of these, solely mutations of the KRAS gene (although observed at low frequency in sqNSCLC) were explored in large clinical studies targeting KRAS downstream signaling with no survival benefit comparing to chemotherapy. Immunotherapy with PD-1 antibodies such as nivolumab and pembrolizumab showed benefit in patients with high PD-L1 expression mainly.
The frequency of somatic FGFR1-3 mutations in lung cancer is about 4% (Helsten et al., 2016). Translocations occur with a similar frequency of about 4% in lung cancer. Multiple of these FGFR alterations are shown to have oncogenic potential as demonstrated in multiple in vitro, in vivo and first-in-man studies.
Preclinical models in NSCLC cell lines and xenografts showed oncogenic activity of FGFR2/3 mutations with consecutive sensitivity to FGFR inhibitors. Similarly, FGFR3-TACC translocation exerted kinase activation in sqNSCLC cell lines and other tumor types. Furthermore, patient derived FGFR3-fusion lung xenograft model showed responses to FGFR targeted treatment.
In summary, on the basis of genetically and phenotypically validated cell-line panels, in vivo and particularly on the basis of clinical data, there is strong evidence for a clinical benefit from FGFR inhibition for patients with FGFR altered NSCLC.
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.
- Being tested
- ERDAFITINIB
- Keywords
- sqNSCLC, FGFR Mutations
- Medical subject headings
- Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERDAFITINIBDrug
Also called JNJ -42756493, WHO NUMBER 10147
Daily in a range from 3 mg to 9 mg
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 FGFR trans | Active comparator | Cohort 1: Activating (high confidence) FGFR translocations (max. 15 patients) under daily Erdaifitinib treatment Receives: Drug: ERDAFITINIB |
| Cohort 2 FGFR mut | Active comparator | Cohort 2: Activating (high confidence) hotspot FGFR mutations (max. 15 patients) under daily Erdafitinib treatment Receives: Drug: ERDAFITINIB |
| Cohort 3 FGFR other | Active comparator | Cohort 3: Activating (low confidence) FGFR alteration (max. 20 patients) Receives: Drug: ERDAFITINIB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Overall response rate (ORR) per RECIST 1.1 under erdafitinib treatment in sqNSCLC with genetic alteration in FGFR
Measured: 3 years
Secondary outcomes (3)
number of adverse events per patient
assessment of adverse events according to CTC-AE
Measured: 3 years
time length of progression free survival
assessment of progression free survival
Measured: 3 years
time length of overall survival
assessment of overall survival
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2019
- Study start25 Mar 2019
- Primary completion30 Sep 2022
- Study completion14 Oct 2022
Why it stopped: Study-related difficulties faced with patient enrolment, no safety-related reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lung Cancer Group Cologne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lucia Nogova, MD, Principal investigator, University Clinic Cologne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827850
- Sponsor's protocol ID
- Uni-Koeln-3254
- Other IDs
- 2018-000399-13, 2018
- Acronym
- FIND
- Status last verified
- Jun 2023
- First submitted
- 22 Jan 2019
- Last updated
- 9 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27870574Hierro 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.
PubMed 26615127Schildhaus 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.
PubMed 25806220
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Trial to Evaluate Efficacy and Safety of Erdafitinib in Patients With Advanced Non Small Cell Lung Carcinoma (NSCLC) Harboring Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations After Relapse of Standard Therapy.
- ClinicalTrials.gov ID
- NCT03827850
- Acronym / sponsor ID
- FIND / Uni-Koeln-3254
- Keywords
- sqNSCLC, FGFR Mutations
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study-related difficulties faced with patient enrolment, no safety-related reasons
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Lung Cancer Group CologneUniversity, hospital or other
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 30 Sep 2022 (actual)
- Study completion
- 14 Oct 2022 (actual)
- First posted
- 4 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Downstream signaling of fibroblast growth factor receptors 1-4 (FGFR 1-4) regulates cell proliferation, migration, differentiation and survival in healthy cells. Genetic alterations (amplifications, point-mutations and translocations) in FGFR1-4 genes cause altered signaling and oncogenic transformation. FGFR-alterations with sensitivity to kinase inhibition have been identified in a variety of tumors such as breast-, bladder- and endometrial-cancer, squamous cell lung and head and neck cancer, cholangiocarcinoma and glioblastoma.
First-in-man/phase-I clinical trials with erdafitinib and BGJ398 - both selective FGFR inhibitors - enrolled patients with any genetic alterations in FGFR. The trials showed clinical responses with differences according to the type of FGFR alterations and histological subtypes. In the BGJ398 trial, the partial response rate was 11% (4/36) in patients with FGFR1 amplified squamous NSCLC (sqNSCLC) and 38% (3/8) in patients with FGFR3-mutant bladder cancer. No PR was observed in patients with FGFR1/2 amplified (n=25) and FGFR3 mutant (n=1) breast cancer. All patients with FGFR2-translocated (n=2) and FGFR2-mutated cholangiocarcinoma (n=1) showed reduced tumor burden of 20% and 10%, respectively. In the erdafitinib trial, 5 partial responses were seen in FGFR translocated tumors: 3/8 (37.5%) patients with urothelial carcinoma, 1/3 (33%) patients with glioblastoma and 1 patient with endometrial cancer reached PR. Summing up the results of the phase-I trials, the inhibition of FGFR downstream pathways in FGFR translocated and mutated solid tumors exerted clinical activity. Thus, focusing treatment with FGFR inhibitors on FGFR mutated and translocated solid tumors may increase response rates, progression free and overall survival in these tumors with otherwise adverse prognosis.
In NSCLC patients without druggable alterations in genes as EGFR, ALK or ROS1 and without high PD-L1 (Programmed cell death 1 ligand 1) expression, prognosis remains adverse with a median survival time of about 18 months. Particularly in sqNSCLC, only few driver mutations have been identified yet. Of these, solely mutations of the KRAS gene (although observed at low frequency in sqNSCLC) were explored in large clinical studies targeting KRAS downstream signaling with no survival benefit comparing to chemotherapy. Immunotherapy with PD-1 antibodies such as nivolumab and pembrolizumab showed benefit in patients with high PD-L1 expression mainly.
The frequency of somatic FGFR1-3 mutations in lung cancer is about 4% (Helsten et al., 2016). Translocations occur with a similar frequency of about 4% in lung cancer. Multiple of these FGFR alterations are shown to have oncogenic potential as demonstrated in multiple in vitro, in vivo and first-in-man studies.
Preclinical models in NSCLC cell lines and xenografts showed oncogenic activity of FGFR2/3 mutations with consecutive sensitivity to FGFR inhibitors. Similarly, FGFR3-TACC translocation exerted kinase activation in sqNSCLC cell lines and other tumor types. Furthermore, patient derived FGFR3-fusion lung xenograft model showed responses to FGFR targeted treatment.
In summary, on the basis of genetically and phenotypically validated cell-line panels, in vivo and particularly on the basis of clinical data, there is strong evidence for a clinical benefit from FGFR inhibition for patients with FGFR altered NSCLC.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 FGFR trans | Active comparator | Drug: ERDAFITINIBCohort 1: Activating (high confidence) FGFR translocations (max. 15 patients) under daily Erdaifitinib treatment |
| Cohort 2 FGFR mut | Active comparator | Drug: ERDAFITINIBCohort 2: Activating (high confidence) hotspot FGFR mutations (max. 15 patients) under daily Erdafitinib treatment |
| Cohort 3 FGFR other | Active comparator | Drug: ERDAFITINIBCohort 3: Activating (low confidence) FGFR alteration (max. 20 patients) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERDAFITINIBAlso: JNJ -42756493, WHO NUMBER 10147Daily in a range from 3 mg to 9 mg | Drug | Cohort 1 FGFR trans, Cohort 2 FGFR mut, Cohort 3 FGFR other |
Primary outcome
Overall Response Rate
Time frame: 3 years
Overall response rate (ORR) per RECIST 1.1 under erdafitinib treatment in sqNSCLC with genetic alteration in FGFR
3 secondary outcomes
number of adverse events per patient
Time frame: 3 years
time length of progression free survival
Time frame: 3 years
time length of overall survival
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Study-related difficulties faced with patient enrolment, no safety-related reasons). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2023.
- Background: PubMed 27870574Nogova 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.
- Background: PubMed 26615127Hierro 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.
- Background: PubMed 25806220Schildhaus 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lucia Nogova, MD principal investigator
University Clinic Cologne
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ERDAFITINIB in people with Lung Cancer and NSCLC, run by Lung Cancer Group Cologne at 11 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 9 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study-related difficulties faced with patient enrolment, no safety-related reasons). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827850, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2023.