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    The EU Clinical Trials Register currently displays   39361   clinical trials with a EudraCT protocol, of which   6446   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-004798-29
    Sponsor's Protocol Code Number:M18TAT
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2018-004798-29
    A.3Full title of the trial
    Track and treat in NSCLC (TATIN) – ctDNA guided treatment of early resistance to targeted treatment in patients with EGFR positive NSCLC
    Monitoren en behandelen van vroege resistentie tijdens osimertinib behandeling door middel van circulerend tumor DNA in het bloed bij patiënten met EGFR positief longkanker – de TATIN studie.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ctDNA guided treatment of early resistance to targeted treatment
    behandelen van vroege resistentie tijdens osimertinib behandeling door middel van circulerend tumor DNA in het bloed
    A.3.2Name or abbreviated title of the trial where available
    TATIN
    A.4.1Sponsor's protocol code numberM18TAT
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationStichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis
    B.5.2Functional name of contact pointDr. A.J. de Langen
    B.5.3 Address:
    B.5.3.1Street AddressPlesmanlaan 121
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1066 CX
    B.5.3.4CountryNetherlands
    B.5.4Telephone number00310205122958
    B.5.6E-mailj.d.langen@nki.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameosimertinib
    D.3.2Product code 1421373-65-0
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNosimertinib
    D.3.9.1CAS number L01Xe
    D.3.9.2Current sponsor codeEMEA/H/C/004124
    D.3.9.3Other descriptive nameOSIMERTINIB
    D.3.9.4EV Substance CodeSUB176340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Xalkori
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namecrizotinib
    D.3.2Product code 877399-52-5
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCrizotinib
    D.3.9.1CAS number 877399-52-5
    D.3.9.3Other descriptive nameCRIZOTINIB
    D.3.9.4EV Substance CodeSUB32267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation that are eligible for osimertinib treatment.
    Patiënten met gemetastaseerd histologisch bevestigede NSCLC, EGFR positief
    E.1.1.1Medical condition in easily understood language
    non small cell lung canser
    niet-kleincellig longkanker
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To identify the percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.
    • To determine the success rate of crizotinib and osimertinib combination treatment to eliminate MET amplification, defined by disappearance of the MET amplification clone in a subsequent ctDNA sample.
    • Het identificeren van het percentage patiënten waarbij een resistente kloon kan worden gedetecteerd met ctDNA voor radiologische progressie.
    • Bepalen van de slagingskans van crizotinib en osimertinib om MET-amplificatie te elimineren, door in een volgende ctDNA analyse aan te kunnen tonen dat de MET amplificatie verdwenen is.
    E.2.2Secondary objectives of the trial
    • Lag time between ctDNA based detection of a resistant clone and radiological progression.
    • Correlation of ctDNA results with that of the tumor biopsy upon radiological progression.
    • The time to disappearance of the MET amplification clone after crizotinib initiation as detected by ctDNA.
    • The time to re-appearance of MET amplification as detected by ctDNA or tumor biopsy in case of radiological progression after successful elimination with crizotinib treatment.
    • De tijd tussen op ctDNA gebaseerde detectie van een resistente kloon en de radiologische progressie.
    • Correlatie van ctDNA resultaten met die van de tumorbiopsie na radiologische progressie.
    • De tijd tot verdwijning van de MET amplificatie na toedienen van crizotinib zoals gedetecteerd door ctDNA.
    • De tijd tot het opnieuw verschijnen van MET-amplificatie zoals gedetecteerd door ctDNA of tumorbiopsie in het geval van radiologische progressie na succesvolle eliminatie met crizotinib-behandeling.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Histologically confirmed metastatic NSCLC, characterized by a sensitizing exon 19 deletion or exon 21 L858R EGFR mutation.
    2. WHO performance status 0-2.
    3. Eligible for osimertinib treatment according to the label and according to the treating physician.
    4. Patients must be ≥18 years of age.
    1. Gemetastaseerd histologisch bevestigde NSCLC, gekenmerkt door een sensibiliserende exon 19 deletie of exon 21 L858R EGFR-mutatie.
    2. WHO performance status 0-2.
    3. In aanmerking komen voor osimertinib-behandeling volgens het label en volgens de behandelend arts
    4. Patiënten moeten 18 jaar o ouder zijn.
    E.4Principal exclusion criteria
    1. Patients with symptomatic central nervous system metastases who are neurologically unstable. Unstable brain metastases except for those who have completed definitive therapy and have had a stable neurological status for 2 weeks after completion of definitive therapy. Patients may be on corticosteroids to control brain metastases if they have been on a stable dose for 2 weeks prior to the start of study treatment and are clinically asymptomatic.
    1. Patiënten met symptomatische uitzaaiingen in het centrale zenuwstelsel die neurologisch onstabiel zijn. Onstabiele hersenmetastasen met uitzondering van degenen die de hele behandeling hebben voltooid en een stabiele neurologische status hebben 2 weken na voltooiing van de therapie. Patiënten mogen corticosteroïden gebruiken om hersenmetastasen te beheersen als ze 2 weken voorafgaand aan de start van de studie een stabiele dosis hebben en klinisch asymptomatisch zijn.
    E.5 End points
    E.5.1Primary end point(s)
    1. The percentage of patients in which a drug resistant clone can be detected with ctDNA before the emergence of radiological progression.
    2. When crizotinib treatment results in elimination of the MET amplification positive clone in 4/7 (57%) of patients.
    1. Het percentage patiënten waarbij een resistente kloon kan worden gedetecteerd met ctDNA voor radiologische progressie.
    2. Wanneer behandeling met crizotinib resulteert in de eliminatie van de MET-amplificatie-positieve kloon bij 4/7 (57%) van de patiënten.

    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months after start treatment
    3 maanden na start van de behandeling
    E.5.2Secondary end point(s)
    1. Lag time between ctDNA based detection of a resistant clone and radiological progression.
    2. Correlation of ctDNA results with that of the tumor biopsy upon radiological progression.
    3. The time to disappearance of the MET amplification clone after crizotinib initiation as detected by ctDNA.
    4. The time to re-appearance of MET amplification as detected by ctDNA or tumor biopsy in case of radiological progression after successful elimination with crizotinib treatment.
    1. De tijd tussen op ctDNA gebaseerde detectie van een resistente kloon en de radiologische progressie.
    2. Correlatie van ctDNA resultaten met die van de tumorbiopsie na radiologische progressie.
    3. De tijd tot verdwijning van de MET amplificatie na toedienen van crizotinib zoals gedetecteerd door ctDNA.
    4. De tijd tot het opnieuw verschijnen van MET-amplificatie zoals gedetecteerd door ctDNA of tumorbiopsie in het geval van radiologische progressie na succesvolle eliminatie met crizotinib-behandeling.
    E.5.2.1Timepoint(s) of evaluation of this end point
    at time of radiological progression during osimertinib treatment
    op het moment van radiologische progressie tijdens osimertinib behandeling
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    geen
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-01-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-07-12
    P. End of Trial
    P.End of Trial StatusOngoing
    The status of studies in GB is no longer updated from 1.1.2021
    For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI
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