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The European Union Clinical Trials Register allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   42556   clinical trials with a EudraCT protocol, of which   7007   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2018-002885-38
    Sponsor's Protocol Code Number:M18TEO
    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:2018-08-01
    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 number2018-002885-38
    A.3Full title of the trial
    Trastuzumab-emtansine and osimertinib combination treatment to target HER2 bypass track resistance in EGFR mutation positive NSCLC
    Trastuzumab-emtasine en osimertinib combinatie behandeling bij HER2 bypass track resistentie in EGFR mutatie positief NSCLC
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Combination treatment with trastuzumab-emtansine and osimertinib to treat patients with advanced EGFR mutated non small cell lung cancer with HER2 tumor expression after progressive disease during EGFR targeted therapy
    Combinatiebehandeling met trastuzumab-emtansine en osimertinib bij de behandeling van patiënten met gevorderd EGFR gemuteerd niet-kleincellig longkanker en HER2 tumor expressie bij progressie van ziekte tijdens EGFR gerichte behandeling
    A.3.2Name or abbreviated title of the trial where available
    TRAEMOS
    A.4.1Sponsor's protocol code numberM18TEO
    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 Leuewenhoek 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 Leuewenhoek 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 Leuewenhoek 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 number0031205129111
    B.5.5Fax number0031205122572
    B.5.6E-mailj.d.langen@nki.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    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 Kadcyla
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Ltd
    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 nametrastuzumab-emtansine
    D.3.2Product code RO5304020/F02
    D.3.4Pharmaceutical form Powder for concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNL01XC14
    D.3.9.1CAS number 1018448-65-1
    D.3.9.3Other descriptive nameTRASTUZUMAB EMTANSINE
    D.3.9.4EV Substance CodeSUB35467
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number3.6
    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 RoleTest
    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.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
    Advanced EGFR mutation positive non small cell lung cancer with HER2 bypass track resistance
    Gevorderd EGFR mutatie positief niet-kleincellig longkanker met HER2 bypass track resistentie
    E.1.1.1Medical condition in easily understood language
    non small cell lung cancer
    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 PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 evaluate the safety of the combination treatment of T-DM1 and osimertinib. Safety will be collected for 6 weeks (2 cycles each of 3 weeks) after initiation of each dose.
    -To determine the MTD/recommended phase II dose (RP2D).
    -To assess the objective response rate (ORR) of T-DM1 and osimertinib combination treatment.
    -Om de veiligheid van de combinatie behandeling van T-DM1 en osimertinib te beoordelen. Veiligheid zal worden beoordeeld gedurende 6 weken (2 cycli van 3 weken) na de start van iedere dosering
    -Om de MTD/aanbevolen fase II dosering (RP2D) vast te stellen
    -Om de objective response rate (ORR) van T-DM1 en osimertinib combinatie behandeling te beoordelen
    E.2.2Secondary objectives of the trial
    -To evaluate the safety of the combination treatment of T-DM1 and osimertinib.
    -To assess progression-free survival (PFS).
    -To assess disease control rate (DCR) after 3 months of treatment.
    -To assess overall survival (OS).
    -Om de veiligheid van de combinatie behandeling van T-DM1 en osimertinib te beoordelen.
    -Om de progressie vrije overleving vast te bepalen.
    -Om de disease control rate (DCR) na 3 maanden behandeling te bepalen.
    -Om de overall survival (OS) te bepalen.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Histologically or cytologically confirmed stage IV non-squamous NSCLC, characterized by an activating EGFR mutation.
    -Progressive disease according to RECIST 1.1 on first, second or third generation EGFR TKI and still receiving the drug.
    -A rebiopsy after having acquired resistance to a first, second or third generation TKI-treatment must have been performed and be:
    a. Negative for T790M in case of treatment with a first or second generation EGFR TKI. After progression on a third generation EGFR TKI patients may either be positive or negative for T790M.
    b. Positive for HER2-overexpression (positive membranous immunohistochemistry staining IHC ≥2+ (on a scale of 0-3) in ≥10% of the cells) must have been detected.
    -There must be at least one measurable disease site, according to RECIST 1.1 criteria.
    -Absence of symptomatic brain metastases. All patients will be scanned at baseline with a brain MRI.
    -Patients must be willing and able to comply with the protocol for the duration of study including undergoing treatment and scheduled visits and examinations.
    -World Health Organization (WHO) performance status 0-2.
    -Patients must have a life expectancy ≥12 weeks.
    -Ability to give written informed consent before patient registration.
    -Patients must be ≥18 years of age.
    -Men and women of child bearing potential should be willing to take adequate contraceptive measures during the study and until three months after study drug discontinuation.
    -Histologisch of cytologisch bevestigd stadium IV NSCLC met een activerende EGFR mutatie
    -Progressieve ziekte volgens RECIST 1.1 na 1e, 2e of 3e generatie EGFR TKI behandeling en deze medicatie nog steeds gebruiken
    -Post-progressie biopt met analyse naar resistentie mechanisme tegen 1e, 2e of 3e generatie TKI behandeling moet zijn verricht en een van de volgende kenmerken bevatten:
    a. Negatief voor T790M in geval van behandeling met 1e of 2e generatie EGFR TKI. Na progressie tijdens behandeling met 3e generatie EGFR TKI mogen patiënten zowel negatief als positief zijn voor T790M.
    b. Positief voor HER2-overexpressie (positieve membraan immunohistochemie kleuring, IHC, ≥2+ (op schaal van 0-3) in ≥10% van de cellen.
    -Meetbare ziekte volgens RECIST 1.1
    -Afwezigheid van symptomatische hersenmetastasen. Voor start van de studiebehandeling zal iedere patiënt een MRI hersenen krijgen.
    -De proefpersoon is bereid en in staat om te voldoen aan het protocol gedurende de duur van het onderzoek, inclusief het ondergaan van de behandeling en de geplande bezoeken en onderzoeken inclusief follow-up.
    -World Health Organization (WHO) performance status 0-2.
    -Levensverwachting van ≥12 weken
    -Mogelijkheid om schriftelijke geïnformeerde toestemming te geven voor de registratie van de patiënt
    -Patiënten moeten 18 jaar of ouder zijn
    -Mannen en vrouwen in de vruchtbare leeftijd moeten ermee instemmen passende voorzorgsmaatregelen te nemen om te voorkomen dat er een kind wordt verwekt tijdens de studie en tot drie maanden na de laatste toediening van de studiegeneesmiddelen
    E.4Principal exclusion criteria
    -Uncontrolled infectious disease.
    -Other active malignancy.
    -Major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS biopsy) in the previous 4 weeks.
    -Known hypersensitivity to T-DM1 or osimertinib (or drugs with a similar chemical structure or class) or any excipients of these agents.
    -Previous treatment with a HER2 monoclonal antibody.
    -Clinically significant cardiac disease or a Left Ventricular Ejection Fraction (LVEF) of <40%.
    -Inadequate bone marrow reserve or organ function, as demonstrated by any of the following laboratory values: Haematology: haemoglobin <5.6mmol/L, absolute neutrophil count <1.5 x 10^9/L, platelet count <100 x 10^9/L. Biochemistry: alanine aminotransferase, aspartate aminotransferase and bilirubin ≤ 3x ULN, except in the case of liver metastases where these values must be ≤ 5x ULN. Creatinine clearance <50 ml/min (measured or calculated by Cockroft and Gault equation).
    -Patients with symptomatic central nervous system metastases who are neurologically unstable.
    -Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow osimertinib or previous significant bowel resection that would preclude adequate resorption of osimertinib.
    -Patients on anticoagulant treatment will not be excluded, but should be monitored closely during T-DM1 treatment.
    -Males and females of reproductive potential who are not using an effective method of birth control and females who are pregnant or breastfeeding or have a positive (serum) pregnancy test prior to study entry.
    -Judgment by the investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions and requirements.
    -Ongecontroleerde infectieziekte
    -Andere actieve maligniteit
    -Grote operatie (exclusief diagnostische procedures zoals mediastinoscopie of VATS biopt) 4 weken voorafgaand aan studie
    -Voorgeschiedenis van overgevoeligheid voor T-DM1 of osimertinib (of medicatie met vergelijkbare chemische structuren of klasse) of eventuele excipienten van deze middelen
    -Eerdere behandeling met HER2 monoklonaal antilichaam
    -Klinisch significante cardiale ziekte of Linker Ventrikel Ejectie Fractie (LVEF) <40%
    -Inadequate beenmerg- en/of orgaanfunctie zoals hieronder gedefinieerd: Hematologie: hemoglobine <5.6mmol/L, absoluut aantal neutrofielen <1.5 x 10^9/L, aantal bloedplaatjes <100 x 10^9/L. Biochemie: aspartaat-aminotransferase, alanine-aminotransferase en bilirubine ≤ 3x de institutionele bovenlimiet van normaal tenzij levermetastasen aanwezig zijn, in welk geval het ≤ 5x ULN moet zijn. Serum creatinine klaring <50 ml/min (volgens de Cockroft-Gault-formule).
    -Patiënten met symptomatische metastasen van het centrale zenuwstelsel, die neurologisch instabiel zijn.
    -Refractaire misselijkheid en braken, chronische gastro-intestinale ziekte, moeite/niet mogelijk tot orale inname osimertinib of voorgeschiedenis van darm resectie die adequate resorptie van osimertinib zou belemmeren.
    -Patiënten die behandeld worden met anticoagulantia zullen niet geexcludeerd worden, maar moeten gemonitord worden tijdens T-DM1 behandeling.
    -Mannen en vrouwen in de vruchtbare leeftijd die niet instemmen met effectieve contraceptieve methode en vrouwen die zwanger zijn of borstvoeding geven of een positieve zwangerschapstest hebben (serum) voor start van de studiebehandeling
    -Beoordeling van de onderzoeker dat de patient niet deel kan nemen aan de studie als de patient niet kan voldoen en adequaat kan deelnemen aan de studieprocedure, restricties en vereisten van studie.
    E.5 End points
    E.5.1Primary end point(s)
    (S)AEs according to CTC AE 4.03.
    Objective response rate according to RECIST v1.1 after 3 months of treatment.
    (S)AEs volgens CTC AE 4.03.
    Objectieve tumorresponse volgens RECIST v1.1 na 3 maanden behandeling.
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 months
    3 maanden
    E.5.2Secondary end point(s)
    (Serious) Adverse Events, (S)AEs according to CTC AE 4.03.
    Progression free survival (PFS), defined as the time from first administration of the study drug combination to disease progression by RECIST v1.1. or lost to follow up or death.
    Disease control rate (DCR), defined as the percentage of patients with stable disease (SD), partial response (PR) or complete response (CR).
    Overall survival (OS), defined as the time from first administration of the study drug combination to lost to follow up or death.
    (S)AEs volgens CTC AE 4.03.
    Progressie vrije overleving (PFS), gedefinieerd als interval tussen de start van de onderzoeksbehandeling en de datum van ziekte progressie volgens RECIST v1.1, lost to follow up of overlijden.
    Disease control rate (DCR), gedefinieerd als het percentage patienten met stabiele ziekte (SD), partiele response (PR) or complete response (CR).
    Totale overleving (OS), gedefinieerd als het interval tussen start van de onderzoeksbehandeling, lost to follow up of overlijden.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Response rates and survival: 6 weekly until progression or death
    Safety: 3 weekly during treatment, thereafter every 6 weeks
    Response rate en overleving: elke 6 weken tot progressie of overlijden
    Veiligheid: elke 3 weken tijdens de behandeling, daarna elke 6 weken
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    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.8.3 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
    Laatste visite van de laatste patient
    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 months0
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 28
    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 state58
    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 Decision2018-08-01
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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