Clinical trial • Phase IV • Oncology
Ceritinib for Non-small cell lung cancer
Phase IV trial of Ceritinib for Non-small cell lung cancer. open-label, none/not specified-controlled. 156 participants.
Overview
- Trial Therapeutic Area
- Oncology
- Trial Disease
- Non-small cell lung cancer
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
- Paediatric Trial
- Yes
Key dates
- Initial CTIS Submission Date
- 22-04-2024
- First CTIS Authorization Date
- 13-06-2024
Trial design
open-label, none/not specified-controlled Phase IV trial across 10 sites in Belgium, Germany, Italy and others.
- Open Label
- Yes
- Comparator
- None/Not specified
- Biomarker Stratified
- True, biomarker: ALK (ALK-positive)
- Target Sample Size
- 156
- Trial Duration For Participant
- 113
Eligibility
Recruits 156 paediatric patients.
- Pregnancy Exclusion
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.
- Vulnerable Population
- Vulnerable populations are included (isVulnerablePopulationSelected = true). Written informed consent is required prior to enrolment; if consent cannot be expressed in writing it must be formally documented and witnessed (ideally via an independent trusted witness). Child assent and Parent/Legal Guardian ICF documents are included (child assent forms and parent/legal guardian ICFs listed), indicating procedures for parental consent and child assent. Consent/ICF documents are available in multiple languages (English, French, Italian, Polish, Bulgarian as available in the document list).
Inclusion criteria
- {"criterion_text":"- Patient is currently receiving treatment with ceritinib within a Novartis-sponsored study which has fulfilled the requirements for the primary objective and, in the opinion of the Investigator, would benefit from continued treatment.\n- Patient has demonstrated compliance, as assessed by the investigator, with the parent study protocol requirements.\n- Wilingness and ability to comply with scheduled visits, treatment plans and any other study procedures.\n- Written informed consent obtained prior to enrolling in the roll-over study and receiving study medication. If consent cannot be expressed in writing, it must be formally documented and witnessed, ideally via an independent trusted witness."}
Exclusion criteria
- {"criterion_text":"- Patient has been permanently discontinued from ceritinib study treatment in the parent study due to any reason.\n- Patient currently has unresolved toxicities for which ceritinib dosing has been interrupted in the parent study. (Patients meeting all other eligibility criteria may be enrolled once toxicities have resolved to allow ceritinib dosing to resume.)\n- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum hCG laboratory test.\n- Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception.\n- Sexually active males unless they use a condom during intercourse while taking drug and after stopping ceritinib and should not father a child in this period."}
Endpoints
Primary endpoints
- {"endpoint_text":"- Frequency and severity of AEs/SAEs","definition_or_measurement_approach":"Assessment of long-term safety by recording the frequency and severity of adverse events (AEs) and serious adverse events (SAEs); collection and reporting of SAEs and AEs as safety endpoints."}
Secondary endpoints
- {"endpoint_text":"- Proportion of patients with clinical benefit as assessed by the investigator at scheduled visits.","definition_or_measurement_approach":"Proportion of patients judged by the investigator to have clinical benefit at scheduled visits (assessed by investigator at visits; translations indicate scheduled visits every 12 weeks ±2 weeks)."}
Recruitment
- Planned Sample Size
- 156
- Recruitment Window Months
- 121
- Consent Approach
- Written informed consent obtained prior to enrolment. If consent cannot be expressed in writing it must be formally documented and witnessed, ideally via an independent trusted witness. Age-specific documents provided: adult ICFs, Parent/Legal Guardian ICF, Child Assent forms and follow-up ICFs for pregnant participants/partners. ICF and assent documents available in multiple languages (English, French, Italian, Polish, Bulgarian as indicated in the document list).
Geography
- Total Number Of Sites
- 10
- Total Number Of Participants
- 67
Belgium
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 432
- Number Of Sites
- 1
- Number Of Participants
- 8
Sites
- Site Name
- UZ Leuven
- Department Name
- 1030 : Department of Pneumology
- Principal Investigator Name
- Christophe Dooms
- Principal Investigator Email
- christophe.dooms@uzleuven.be
- Contact Person Name
- Christophe Dooms
- Contact Person Email
- christophe.dooms@uzleuven.be
Germany
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 432
- Number Of Sites
- 2
- Number Of Participants
- 13
Sites
- Site Name
- Universitaetsklinikum Essen AöR
- Department Name
- 1201:Westdeutsches Tumorzentrum Innere Klinik
- Principal Investigator Name
- Martin Schuler
- Principal Investigator Email
- Martin.schuler@uk-essen.de
- Contact Person Name
- Martin Schuler
- Contact Person Email
- Martin.schuler@uk-essen.de
- Site Name
- Thoraxklinik Heidelberg gGmbH
- Department Name
- 1200:Innere Medizin/ Onkologie
- Principal Investigator Name
- Michael Thomas
- Principal Investigator Email
- Michael.thomas@med.uni-heidelberg.de
- Contact Person Name
- Michael Thomas
- Contact Person Email
- Michael.thomas@med.uni-heidelberg.de
Italy
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 21-07-2025
- Processing Time Days
- 430
- Number Of Sites
- 4
- Number Of Participants
- 31
Sites
- Site Name
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
- Department Name
- 1418:U.O.C. Oncologia
- Principal Investigator Name
- Anna Cecilia Bettini
- Principal Investigator Email
- acbettini@yahoo.com
- Contact Person Name
- Anna Cecilia Bettini
- Contact Person Email
- acbettini@yahoo.com
- Site Name
- Centro Di Riferimento Oncologico Di Aviano
- Department Name
- 1416:S.C. Oncologia Medica A
- Principal Investigator Name
- Alessandra Bearz
- Principal Investigator Email
- abearz@cro.it
- Contact Person Name
- Alessandra Bearz
- Contact Person Email
- abearz@cro.it
- Site Name
- Istituto Europeo Di Oncologia S.r.l.
- Department Name
- 1400:Divisione di Oncologia Toracica
- Principal Investigator Name
- Filippo De Marinis
- Principal Investigator Email
- filippo.demarinis@ieo.it
- Contact Person Name
- Filippo De Marinis
- Contact Person Email
- filippo.demarinis@ieo.it
- Site Name
- Fondazione IRCCS Istituto Nazionale Dei Tumori
- Department Name
- 1409:S.C. Oncologia Medica 1
- Principal Investigator Name
- Filippo De Braud
- Principal Investigator Email
- filippo.debraud@istitutotumori.mi.it
- Contact Person Name
- Filippo De Braud
- Contact Person Email
- filippo.debraud@istitutotumori.mi.it
Poland
- Earliest CTIS Part Ii Submission Date
- 18-06-2024
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 400
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Uniwersyteckie Centrum Kliniczne
- Department Name
- 3800: Klinika Onkologii i Radioterapii Centrum Medycyny Nieinwazyjnej
- Principal Investigator Name
- Rafał Dziadziuszko
- Principal Investigator Email
- rafald@gumed.edu.pl
- Contact Person Name
- Rafał Dziadziuszko
- Contact Person Email
- rafald@gumed.edu.pl
France
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 23-07-2025
- Processing Time Days
- 432
- Number Of Sites
- 1
- Number Of Participants
- 7
Sites
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- 1103:Service de pneumologie, pôle de pathologie thoracique
- Principal Investigator Name
- Celine Mascaux
- Principal Investigator Email
- celine.mascaux@chru-strasbourg.fr
- Contact Person Name
- Celine Mascaux
- Contact Person Email
- celine.mascaux@chru-strasbourg.fr
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 17-05-2024
- Latest Decision Or Authorization Date
- 22-01-2026
- Processing Time Days
- 615
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- MBAL Serdika Ltd.
- Department Name
- 3301 : Second Department of Medical Oncology
- Principal Investigator Name
- Krassimir Koynov
- Principal Investigator Email
- kdkoynov@yahoo.co.uk
- Contact Person Name
- Krassimir Koynov
- Contact Person Email
- kdkoynov@yahoo.co.uk
Sponsor
Primary sponsor
- Full Name
- Novartis Pharma AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- IQVIA Limited
- Responsibilities
- IVRS30 – treatment randomisation, standard IRT system activities with regional drug distribution
- Name
- Parexel International (IRL) Limited
- Name
- Icon Clinical Research Limited
Third parties
- {"country":"United Kingdom","full_name":"DHL Supply Chain Limited","duties_or_roles":"regional drug depot","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Eco-Abc Sp. z o. o.","duties_or_roles":"Destruction of the investigational medicinal products","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"IVRS30 – treatment randomisation, standard IRT system activities with regional drug distribution","organisation_type":"Pharmaceutical company"}
- {"country":"Poland","full_name":"Statmed Sp. z o.o.","duties_or_roles":"Compensation for patients travel to the clinical site","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Phardis S.r.l.","duties_or_roles":"Local equipment storage","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- CERITINIB
- Active Substance
- Ceritinib
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- ORAL
- Authorisation Status
- LDK378 150 mg capsule, hard are identical to the marketed Zykadia 150 mg Hard Gelatin Capsules (product supplied as IMP identical to marketed product)
- Maximum Dose
- 750 mg
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