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SNCTP000003239 | NCT03762122 | BASEC2018-02355

SAKK 19/18
Rogaratinib zur Behandlung von Patienten mit fortgeschrittenem, nicht-kleinzelligem Lungenkrebs (Plattenepithelkarzinom) und hoher Produktion von Rezeptoren für den Wachstumsfaktor FGF.

Data source: BASEC (Imported from 03.07.2020), WHO (Imported from 05.07.2020)
Changed: 16.06.2020
Disease category: Lung Cancer

Brief description of trial (Data source: BASEC)

Die Studie untersucht, ob und wie gut die Prüfsubstanz Rogaratinib bei Patienten mit einem fortgeschrittenen Plattenepithelkarzinom der Lunge («squamous cell lung cancer, SQCLC») wirkt und wie verträglich resp. sicher diese Substanz ist.

Health conditions investigated (Data source: BASEC)

Fortgeschrittener, nicht-kleinzelliger Lungenkrebs (Plattenepithelkarzinom)

Health conditions (Data source: WHO)

Squamous-cell Non-small Cell Lung Cancer

Rare disease (Data source: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Data source: BASEC)

Das Studienmedikament Rogaratinib wird zweimal täglich in Tablettenform eingenommen (je 600 mg pro Dosis, also insgesammt 1200 mg pro Tag). Diese Behandlung wird so lange fortgeführt, bis die Krebskrankheit erneut fortschreitet, die Behandlung abgebrochen werden muss (z.B. wegen Nebenwirkungen) oder der Teilnehmer die Behandlung nicht mehr weiterführen möchte.
Alle Teilnehmer der Studie werden lebenslang von den Studienärzten nachkontrolliert.

Interventions (Data source: WHO)

Drug: Rogaratinib

Criteria for participation in trial (Data source: BASEC)

An der Studie können Personen teilnehmen, die an einem Plattenepithelkarzinom der Lunge leiden, und deren Tumorzellen übermässig stark FGFR produzieren.
Mindestens eine Behandlung des Plattenepithelkarzinoms muss schon vor Studienbeginn durchgeführt worden sein (z.B. Chemotherapie).
Die teilnehmenden Personen müssen damit einverstanden sein, dass ihr Tumorgewebe für zusätzliche studienspezifische Forschungsprojekte untersucht wird.

Exclusion criteria (Data source: BASEC)

Personen, die in den drei Wochen vor geplantem Studienbeginn eine Chemo- oder Immuntherapie erhalten haben, oder die bestimmte Medikamente einnehmen, dürfen an dieser Studie nicht teilnehmen.
Personen, die an einer Erkrankung der Netzhaut im Auge leiden und
Frauen, die schwanger werden möchten, schwanger sind oder stillen, können ebenfalls nicht an der Studie teilnehmen.

Inclusion/Exclusion Criteria (Data source: WHO)


Inclusion Criteria:

- Written informed consent according to Swiss law and ICH-GCP regulations before
registration and prior to any trial specific procedures including screening
procedures. Informed consent for trial entry must be offered only after positive
results of individual FGFR testing has been received.

- Histologically or cytologically confirmed diagnosis of locally advanced or metastatic
NSCLC (from inoperable stage IIIB to stage IV according to the 8th edition of the
American Joint Commission on Cancer TNM staging system) with squamous-cell or
predominantly squamous-cell histology (referred to SQCLC).

- Archival or fresh tumor biopsy specimen for FGFR (subtypes 1-3) mRNA expression
testing available. Acceptable samples include core needle biopsies for deep tumor
tissue (minimum three cores) or excisional, incisional, punch, or forceps biopsies for
cutaneous, subcutaneous, or mucosal lesions.

- High FGFR1-3 mRNA expression levels based on central analysis of archival or fresh
tumor biopsy specimen (high expression defined as = 1 FGFR isoform with RNAscope score
of 3 or 4).

- Measurable or evaluable disease (according to RECIST v1.1). Previously irradiated
lesions should not be counted as target lesions unless there has been demonstrated
progression in the lesion since radiotherapy before enrolment and no other lesions are
available for selection as target lesions.

- Patient failed standard systemic therapy for locally advanced or metastatic disease
(1-3 prior chemotherapy regimens and at least 1 immune checkpoint inhibitor
(combination allowed)).

- Patients with known brain metastases must have undergone definitive treatment (surgery
and/or radiation) at least 2 weeks prior to registration and must be clinically stable
(no requirement of steroids and no worsening neurological deficits for 2 weeks prior
registration).

- Patients with a prior malignancy and treated with curative intention are eligible if
treatment of that malignancy was completed at least 2 years before registration and
the patient has no evidence of disease at registration. Less than 2 years is
acceptable for malignancies with low risk of recurrence and/or no late recurrence.

- Known human immunodeficiency virus (HIV)-infected patients who are healthy and have a
low risk of AIDS-related outcomes are eligible, if,

- CD4+ T-cell counts are = 350 cells/uL

- No history of AIDS-defining opportunistic infection within past 12 months

- Patient agrees to concomitant antiretroviral therapy (ART) if not currently on
ART, or is on ART for ? 4 weeks and has a HIV viral load ? 400 copies/mL.

- Age = 18 years.

- WHO performance status 0-2.

- Adequate bone marrow function: absolute neutrophil count (ANC) = 1.5 x 109/L1,
platelet count = 100 x 109/L2, hemoglobin = 90 g/L2

1. without granulocyte colony-stimulating factor support within 2 weeks before the
first administration of trial treatment

2. without transfusion or erythropoietin within 2 weeks before the first
administration of trial treatment

- Adequate hepatic function: total bilirubin = 1.5 x ULN (= 3 x ULN for patients with
known Gilbert syndrome), ALT and AST = 2.5 x ULN (= 5 x ULN for patients with liver
involvement of their cancer).

- Adequate renal function: estimated glomerular filtration rate (eGFR) > 30
mL/min/1.73m2 according to the CKD-EPI (Chronic Kidney Disease Epidemiology
Collaboration) abbreviated formula.

- Adequate pancreatic function: lipase = 2 x ULN.

- Women with childbearing potential are using highly effective contraception, are not
pregnant or lactating and agree not to become pregnant during trial treatment and
during 5 months thereafter. A negative urine or serum pregnancy test before
registration is required for all women with child-bearing potential.

- Men agree not to donate sperm or father a child. Men without a vasectomy and with a
partner of childbearing potential must agree to use condoms during trial treatment and
during 5 months thereafter.

- Patient is able and willing to swallow the trial IMP as whole tablet.

- Patient consents to the mandatory translational research projects with biopsied tumor
material.

Exclusion Criteria:

- Symptomatic untreated brain metastases or leptomeningeal disease.

- Previous treatment with anti-FGFR directed therapies (e.g. receptor tyrosine kinase
inhibitors including rogaratinib or FGFR-specific antibodies).

- Chemotherapy, or radiotherapy, or immunotherapy, or small molecule drugs within 3
weeks (1 week for palliative radiotherapy) prior to registration.

- Other investigational medicinal products within 4 weeks prior registration.

- Major surgery within 2 weeks prior registration.

- Concomitant use of other anti-cancer drugs or radiotherapy except for local pain
control.

- Concomitant therapies that are known to increase serum phosphate levels (i.e.
antacids, laxatives oral/rectal, oral phosphate binders, potassium phosphate) and that
cannot be discontinued or switched to a different medication before trial entry.

- Use of strong inhibitors of CYP3A4 and strong inducers of CYP3A4 within 2 weeks prior
registration or during trial treatment.

- History or current condition of an uncontrolled cardiovascular disease including any
of the following conditions:

- Congestive heart failure (CHF) NYHA Class 2 or greater, unstable angina (symptoms
of angina at rest).

- New-onset angina (within last 3 months prior registration).

- Myocardial infarction (MI) within past 6 months prior registration.

- Unstable cardiac arrhythmias requiring anti-arrhythmic therapy. Patients with
arrhythmia not requiring therapy or under control with anti-arrhythmic therapy
are eligible.

- Patients with known coronary artery disease, congestive heart failure not meeting
the above criteria, must be on a stable medical regimen that is optimized in the
opinion of the treating physician, in consultation with a cardiologist if
appropriate.

- Symptomatic arterial hypotension.

- Current diagnosis of any retinal disorders including retinal detachment, retinal
pigment epithelial detachment (RPED), serous retinopathy or retinal vein occlusion.

- Current evidence of endocrine alteration of calcium phosphate homeostasis (e.g.

Further information on the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT03762122

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT03762122

Further information on trial

Date trial registered

30.11.2018

Incorporation of the first participant

25.07.2019

Recruitment status

Recruiting

Academic title (Data source: WHO)

Fibroblast Growth Factor Receptor (FGFR) Inhibitor Rogaratinib in Patients With Advanced Pretreated Squamous-cell Non-small Cell Lung Cancer (SQCLC) Overexpressing FGFR mRNA. A Multicenter, Single Arm Phase II Trial

Type of trial (Data source: WHO)

Interventional

Design of the trial (Data source: WHO)

Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).

Phase (Data source: WHO)

Phase 2

Primary end point (Data source: WHO)

Progression-free survival (PFS) at 6 months

Secundary end point (Data source: WHO)

Objective response (OR);Progression-free survival (PFS);Overall survival (OS);Adverse events (AEs)

Contact information (Data source: WHO)

Please refer to primary and secondary sponsors

Trial results (Data source: WHO)

Results summary

no information available yet

Link to the results in the primary register

no information available yet

Information on the availability of individual participant data

no information available yet

Trial sites

Trial sites in Switzerland (Data source: BASEC)

Baden, Basel, Bellinzona, Bern, Bruderholz, Brugg, Chur, Freiburg, Geneva, Liestal, St. Gallen, Winterthur

Countries (Data source: WHO)

Switzerland

Contact for further information on the trial

Details of contact in Switzerland (Data source: BASEC)

SAKK, Gilles Godard
+41 31 389 91 91
trials@sakk.ch

Contact for general information (Data source: WHO)

Alfredo Addeo, MD;Gilles Godar
University Hospital, Geneva
+41 31 389 91 91
trials@sakk.ch

Contact for scientific information (Data source: WHO)

Alfredo Addeo, MD;Gilles Godar
University Hospital, Geneva
+41 31 389 91 91
trials@sakk.ch

Principal Sponsor/Investigator

Principal sponsor (Data source: WHO)

Swiss Group for Clinical Cancer Research

Authorisation by the ethics committee (Data source: BASEC)

Name of the authorising ethics committee (for multicentre studies only the lead committee)

Commission Cantonale d’éthique de la recherche Genève (CCER)

Date of authorisation by the ethics committee

26.03.2019

Further trial identification numbers

Trial identification number of the ethics committee (BASEC-ID) (Data source: BASEC)

2018-02355

Secondary ID (Data source: WHO)

SAKK 19/18