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    Summary
    EudraCT Number:2018-003974-29
    Sponsor's Protocol Code Number:D6186C00001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-06-11
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2018-003974-29
    A.3Full title of the trial
    A Biomarker-Directed Phase 2 Platform Study in Patients with Advanced Non-Small Cell Lung Cancer whose Disease has Progressed on First-Line Osimertinib Therapy
    Ensayo de plataforma de fase 2 basado en biomarcadores en pacientes con cáncer de pulmón no microcítico avanzado cuya enfermedad ha progresado durante el tratamiento con osimertinib en primera línea (ORCHARD)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study in patients with Non-Small Cell Lung Cancer whose disease has got worse on Osimertinib treatment.
    Ensayo en pacientes con Cáncer de pulmón no microcítico cuya enfermedad ha empeorado con Osimertinib como tratamiento.
    A.3.2Name or abbreviated title of the trial where available
    ORCHARD
    ORCHARD
    A.4.1Sponsor's protocol code numberD6186C00001
    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 SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A.
    B.5.2Functional name of contact pointUnidad de Investigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Serrano Galvache, 56; Parque Norte, Edificio Álamo
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number0034900200444
    B.5.6E-mailinformacionEECC-Spain@astrazeneca.com
    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 TAGRISSO
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 AZD9291
    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 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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 AB
    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 AZD9291
    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 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    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: 3
    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 No
    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 nameSavolitinib
    D.3.2Product code AZD6094
    D.3.4Pharmaceutical form 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 INNSavolitinib
    D.3.9.1CAS number 1313725-88-0
    D.3.9.2Current sponsor codeAZD6094
    D.3.9.3Other descriptive nameSavolitinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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: 4
    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 No
    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 nameSavolitinib
    D.3.2Product code AZD6094
    D.3.4Pharmaceutical form 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 INNSavolitinib
    D.3.9.1CAS number 1313725-88-0
    D.3.9.2Current sponsor codeAZD6094
    D.3.9.3Other descriptive nameSAVOLITINIB
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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: 5
    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 Carboplatin
    D.2.1.1.2Name of the Marketing Authorisation holderHospira UK Limited
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    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 namecarboplatin 10 mg/mL intravenous infusion
    D.3.4Pharmaceutical form 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 INNCarboplatin
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeCarboplatin
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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: 6
    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 Portrazza
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V
    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 namenecitumumab (Portrazza™) 800 mg concentrate for solution for infusion
    D.3.4Pharmaceutical form 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 INNNecitumumab
    D.3.9.1CAS number 906805-06-9
    D.3.9.2Current sponsor codeNecitumumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number800
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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: 7
    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 Pemetrexed
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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 namepemetrexed 500 mg powder for concentrate for solution for infusion
    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 INNPemetrexed disodium
    D.3.9.1CAS number 150399-23-8
    D.3.9.2Current sponsor codePemetrexed
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 8
    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 Iressa
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameIressa
    D.3.4Pharmaceutical form 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 INNGefitinib
    D.3.9.1CAS number 184475-35-2
    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.IMP: 9
    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 No
    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 nameDurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form 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 INNdurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    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 Yes
    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 Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico avanzado
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Lung Cancer
    Cáncer de pulmón no microcítico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of each treatment by evaluation of objective response rate.
    Evaluar la eficacia de cada tratamiento mediante la tasa de respuestas objetivas.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of each treatment by evaluation of tumour response and overall survival (progression-free survival, Duration of response, Overall survival).

    To assess the pharmacokinetics (PK) of each treatment (Plasma concentrations may be measured only for specific agents at limited time points in each study treatment)

    To assess the safety and tolerability of each treatment
    Evaluar la eficacia de cada tratamiento mediante la respuesta tumoral y la supervivencia global (supervivencia sin progresión, duración de la respuesta, supervivencia global).

    Evaluar la farmacocinética (FC) de cada tratamiento (Las concentraciones plasmáticas de los fármacos pueden ser medidas sólo por agentes específicos en momentos limitados en cada tratamiento del estudio)

    Evaluar la seguridad y la tolerabilidad de cada tratamiento
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria applicable to all study treatment modules (Groups A/B):
    • NSCLC with the following features –
    o Locally advanced or metastatic disease (i.e., advanced NSCLC) not amenable to curative surgery or radiotherapy at study entry.
    o Histologically or cytologically confirmed adenocarcinoma of the lung harbouring EGFR mutation(s) known to be associated with EGFR TKI sensitivity at diagnosis.
    o Received only 1 line of therapy, with single-agent osimertinib, for advanced NSCLC, with clinical benefit as judged by investigator discretion.
    o Evidence of radiological disease progression on first-line monotherapy with osimertinib 80mg once daily.
    • Suitable for a mandatory biopsy defined as having an accessible tumour and a stable clinical condition that will allow the patient to tolerate the procedure. The biopsy should be performed within 60 days prior to the planned first dose of study treatment.
    • Patients must have measurable disease per RECIST 1.1.
    • World Health Organisation (WHO) performance status 0 or 1 with no deterioration between screening and the first dose of study treatment and a minimum life expectancy of 12 weeks.
    • Adequate coagulation parameters, defined as: International Normalisation Ratio (INR) <1.5 × ULN and activated partial thromboplastin time <1.5 × ULN unless patients are receiving therapeutic anti-coagulation which affects these parameters.
    • Patients with known tumour thrombus or deep vein thrombosis are eligible if clinically stable on low molecular weight heparin, factor Xa inhibitors or thrombin inhibitors for ≥2 weeks.
    • Willingness to adhere to the study treatment-specific contraception requirements.
    Module 1:
    • NSCLC with confirmed MET amplification as determined by Next Generation Sequencing on tumour tissue collected on or after disease progression on prior monotherapy with osimertinib.
    • No transfusion of blood or blood-derived products in the past 2 weeks
    Module 2:
    • Possess a mutation at the C797 residue in the EGFR receptor as determined by Next Generation Sequencing on tumour tissue collected on or after disease progression on prior monotherapy with osimertinib
    Module 3:
    • For the Group A (biomarker matched) cohort only, must possess EGFR amplification as determined by Next Generation Sequencing on tumour tissue collected on or after disease progression on prior monotherapy with osimertinib
    Module 4:
    • No prior exposure to immune-mediated therapy including, but not limited to, anti-PD-1, anti-PD-L1, and anti‑programmed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccine.
    • Body weight >30 kg.
    Observational Cohort (Group C):
    • Patients diagnosed with histopathological transformation to SCLC or SCC (squamous cell carcinoma) on the mandatory baseline biopsy
    • Actionable mutation with potential treatment that is not currently available within ORCHARD
    • Screen failures for study treatment module.
    Criterios de inclusión aplicables a todos los módulos de tratamiento del ensayo (grupos A/B):
    •Carcinoma pulmonar no microcítico (CPNM) con las características siguientes:
    oEnfermedad localmente avanzada o metastásica (es decir, CPNM avanzado) no susceptible de curación quirúrgica ni de radioterapia en el momento de la incorporación al ensayo.
    oAdenocarcinoma de pulmón confirmado histológica o citológicamente con mutaciones del EGFR asociadas a sensibilidad a los TKI del EGFR en el momento del diagnóstico.
    oHaber recibido solo una línea de tratamiento con osimertinib en monoterapia para el CPNM avanzado, con beneficio clínico, a criterio del investigador.
    oSignos de progresión radiológica de la enfermedad con la monoterapia de primera línea con 80 mg de osimertinib una vez al día.
    •Paciente apto para una biopsia obligatoria, es decir, con un tumor accesible y una situación clínica estable que permita al paciente tolerar el procedimiento. La biopsia deberá realizarse en los 60 días previos a la primera dosis prevista del tratamiento del ensayo.
    •Los pacientes deberán presentar enfermedad mensurable según los criterios RECIST 1.1.
    •Estado funcional de la Organización Mundial de la Salud (OMS) de 0 o 1 sin deterioro entre la selección y la primera dosis del tratamiento del ensayo y una esperanza de vida mínima de 12 semanas.
    •Parámetros de coagulación adecuados, definidos como: Índice internacional normalizado (INR) < 1,5 × LSN y tiempo de tromboplastina parcial activado < 1,5 × LSN, a menos que los pacientes estén recibiendo un tratamiento anticoagulante que afecte a dichos parámetros.
    •Los pacientes con un trombo tumoral conocido o trombosis venosa profunda podrán participar si se encuentran clínicamente estables con una heparina de bajo peso molecular, inhibidores del factor Xa o inhibidores de la trombina durante ≥ 2 semanas.
    •Disposición a cumplir los requisitos de anticoncepción específicos del tratamiento del ensayo.
    Módulo 1:
    •CPNM con amplificación de MET confirmada, determinada mediante secuenciación masiva en tejido tumoral obtenido durante o después de la progresión de la enfermedad durante el tratamiento previo con osimertinib en monoterapia.
    •Ausencia de transfusiones de sangre o hemoderivados en las 2 últimas semanas.
    Módulo 2:
    •Presencia de una mutación en el residuo C797 del receptor de EGFR, determinada mediante secuenciación masiva en tejido tumoral obtenido durante o después de la progresión de la enfermedad durante el tratamiento previo con osimertinib en monoterapia.
    Módulo 3:
    •Solo para la cohorte del grupo A (emparejada por biomarcadores): presencia de amplificación de EGFR, determinada mediante secuenciación masiva en tejido tumoral obtenido durante o después de la progresión de la enfermedad durante el tratamiento previo con osimertinib en monoterapia.
    Módulo 4:
    •Ausencia de exposición previa a inmunoterapia, entre otros, anticuerpos anti-PD-1, anti-PD-L1 y anti-PD‑L2 (ligando 2 de la proteína de muerte celular programada), excepto vacunas antitumorales terapéuticas.
    •Peso corporal mayor de 30 kg.
    Cohorte observacional (grupo C):
    •Pacientes diagnosticados de transformación histopatológica en CPM (carcinoma pulmonar microcítico) o CE (carcinoma epidermoide) en la biopsia basal obligatoria.
    •Mutación aprovechable terapéuticamente con posible tratamiento que actualmente no está disponible en ORCHARD.
    •Fracasos de selección para el módulo de tratamiento del ensayo.
    E.4Principal exclusion criteria
    Exclusion Criteria applicable to all study treatment modules (Groups A/B):
    • Patients whose disease has progressed within the first 3 months of osimertinib treatment
    • Patients must not have experienced a toxicity(-ies) that led to permanent discontinuation or dose reduction of prior osimertinib or have any unresolved toxicities from prior osimertinib treatment greater than CTCAE Grade 1 at the time of starting study treatment
    • Patients should not have discontinued osimertinib >60 days prior to the first dose of study treatment
    • Prior or concurrent treatment with any systemic anti-cancer therapy for locally advanced/metastatic NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug (exceptions do apply)
    • Major surgery within the 28 days prior to the first dose of study treatment except:
    o After minor surgery, at least 7 postoperative days must elapse before study treatment is initiated. After placement of vascular access, this waiting period is not required.
    • Receipt of live attenuated vaccine within 30 days prior to the first dose of study treatment.
    • Treatment with warfarin/coumarin analogues within 7 days prior to the first dose of study treatment
    • Diagnosis of small cell lung cancer (SCLC) or squamous cell carcinoma (SCC)
    • Spinal cord compression, symptomatic and unstable brain metastases, except for those patients who have completed definitive therapy, are not on steroids, have a stable neurologic status for at least 2 weeks after completion of the definitive therapy and steroids.
    • Allogenic organ transplantation
    • History of another primary malignancy except for:
    o Malignancy treated with curative intent and with no known active disease for at least 2 years before the first dose of study treatment.
    o Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease
    o Adequately treated carcinoma in situ without evidence of disease.
    o Localised non-invasive primary disease under surveillance.
    • Active infection, including infections with hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
    • Pregnancy or breastfeeding in female patients
    • Any of the following cardiac criteria:
    o Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
    o Unstable atrial fibrillation or unstable cardiac arrhythmia with a ventricular rate >100 bpm on an ECG at rest.
    o Uncontrolled hypertension
    o Uncontrolled angina or acute coronary syndrome within 6 months prior to screening.
    o At risk for brain perfusion problems or stroke, or transient ischemic attack in the last 6 months prior to screening
    o Symptomatic heart failure - prior or current cardiomyopathy.
    o Severe valvular heart disease
    • Inadequate bone marrow reserve or organ function
    • Creatinine clearance <50 mL/min, calculated by Cockcroft-Gault equation

    Module 1,2 & 3 only:
    • Past medical history of interstitial lung disease (ILD), drug-induced ILD, radiation pneumonitis requiring steroid treatment, or any evidence of clinically active ILD.
    • Patients currently receiving medications or herbal supplements known to be strong inducers or strong inhibitors of CYP3A4 (for Module 1 only, this includes strong inhibitors of CYP1A2, or CYP3A4 substrates which have a narrow therapeutic range) within 2 weeks of the first dose of study treatment (3 weeks for St John’s Wort) are excluded.
    • History of hypersensitivity to study drugs, any of their excipients or drugs with a similar chemical structure or class.
    • Any additional factors that increase the risk of QTc prolongation or arrhythmic events

    Module 1 only:
    • Mean resting corrected QT interval using Fridericia’s correction (QTcF) >470 msec for women and >450 msec for men at screening.
    • Heart failure of any New York Heart Association (NYHA) Grade

    Module 2 only:
    • Mean resting corrected QT interval using Fridericia’s correction (QTcF) >470 msec

    Module 3 only:
    • Mean QT interval corrected using Fridericia’s correction (QTcF) ≥450msec

    Module 4 only:
    • Active or prior documented autoimmune or inflammatory disorders (exceptions do apply)
    • Uncontrolled intercurrent illness and active infection including tuberculosis
    • History of allogeneic organ transplantation
    • Known allergy or hypersensitivity to any of the study treatments in this Module or any of their excipients
    • Any unresolved toxicity National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade ≥2 from previous anticancer therapy except for alopecia, vitiligo, and the laboratory values defined in the inclusion criteria
    • Osimertinib therapy within 14 days prior to the first dose of study treatment
    • Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug
    • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab
    Criterios de exclusión generales. Grupos A/B:

    Progresión en los 3 primeros meses con osimertinib.

    Toxicidad con suspensión definitiva del tto previo con osimertinib o reducción de dosis y sin toxicidad grado>1 de CTCAE no resuelta de tto previo con osimertinib al inicio del tto del ensayo.

    Pacientes sin suspender osimertinib>60 días antes de primera dosis del ensayo.

    Tto previo o concomitante con terapia antineoplásica sistémica para CPNM localmente avanzado o metastásico: quimioterapia, tratamiento biológico, inmunoterapia o cualquier fármaco en investigación (excepciones).

    Cirugía mayor en 28 días previos a primera dosis del ensayo, excepto:
    Cirugía menor, deben pasar min 7 días antes de inicio del tto de ensayo. No es necesario tras colocación de acceso vascular.

    Vacunarse con virus atenuados en 30 días previos a primera dosis de tto de ensayo.
    Tto con warfarina/análogos cumarínicos en 7 días previos a primera dosis de tto de ensayo.

    Carcinoma pulmonar microcítico o carcinoma epidermoide.

    Compresión medular, metástasis cerebrales sintomáticas e inestables, excepto pacientes tto definitivo completado, sin corticoides y estado neurológico estable durante min 2 semanas tras tto definitivo y corticoides.

    Alotrasplante de órgano.

    Antecedentes de otra neoplasia maligna primaria, excepto:
    Ha sido tratada con intención curativa y sin enfermedad activa durante min 2 años antes de primera dosis de tto de ensayo.
    Cáncer de piel no melanoma o lentigo maligno tratados y sin signos de enfermedad.
    Carcinoma in situ tratado sin signos de enfermedad.
    Enfermedad primaria no invasiva localizada en seguimiento.
    Infección activa, incluye infección por virus hepatitis B, hepatitis C o VIH.
    Embarazo o lactancia.
    Cualquiera de estos criterios cardiacos:
    Anomalía clínicamente importante del ritmo, conducción o morfología en ECG en reposo.
    Fibrilación auricular inestable o arritmia cardiaca inestable con frecuencia ventricular>100 lpm en ECG reposo.
    Hipertensión no controlada.
    Angina no controlada o SCA en 6 meses previos a selección.
    Riesgo perfusión cerebral o ictus o AIT en 6 meses previos a selección.
    Insuficiencia cardiaca sintomática; miocardiopatía previa o actual.
    Valvulopatía cardíaca grave.
    Reserva medular, función orgánica insuficiente.
    Aclaramiento creatinina<50ml/min, mediante ecuación Cockcroft-Gault.

    Módulos 1, 2 y 3:
    Antecedentes enfermedad pulmonar intersticial, EPI por fármacos, neumonitis por radiación necesaria de tto con corticoides o indicio EPI clínicamente activa.
    Se excluirá a pacientes con medicamentos o suplementos de herbolario inductores potentes o inhibidores potentes CYP3A4 (Módulo 1, además inhibidores potentes CYP1A2 o sustratos CYP3A4 con margen terapéutico estrecho) en 2 semanas previas a primera dosis del tto del ensayo (3 semanas si hipérico).
    Antecedentes de hipersensibilidad a fármacos de ensayo, cualquiera de sus excipientes o fármacos de mismo grupo o estructura química similar.
    Otros factores que aumenten riesgo prolongación intervalo QT o arritmias.

    Módulo 1:
    Media QTcF en reposo>470 ms en mujeres y >450 ms en varones en selección.
    Insuficiencia cardiaca cualquier grado de NYHA.

    Módulo 2:
    Media de QTcF en reposo>470 ms.

    Módulo 3:
    Media de QTcF en reposo≥450 ms.

    Módulo 4:
    Trastornos autoinmunitarios o inflamatorios activos o previos (excepciones).
    Enfermedad intercurrente e infección activa no controlada, incluida tuberculosis.
    Antecedentes de alotrasplante.
    Alergia o hipersensibilidad a los ttos de ensayo o a excipientes.
    Toxicidad no resuelta grado≥2 según CTCAE por tto antineoplásico previo, excepto alopecia, vitíligo y valores analíticos en criterios de inclusión.
    Tto con osimertinib en 14 días previos a primera dosis de tto del ensayo.
    Radioterapia>30 % de médula ósea o con campo de irradiación amplio en 4 semanas previas a primera dosis de ensayo.
    Tto con inmunodepresores actual o en 14 días previos a primera dosis de durvalumab.
    E.5 End points
    E.5.1Primary end point(s)
    To assess the efficacy of each treatment by evaluation of objective
    response rate -

    Endpoint based on Response Evaluation Criteria in Solid Tumours
    (RECIST 1.1)
    • Objective response rate (ORR)
    Evaluar la eficacia de cada tratamiento mediante la tasa de respuestas objetivas.

    Criterio de valoración basado en los Criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1).
    • Tasa de respuestas objetivas (TRO).
    E.5.1.1Timepoint(s) of evaluation of this end point
    RECIST measurements will be made every 6 weeks (±1 week) for the first 24 weeks relative to the start of study treatment (Cycle 1, Day 1) and every 9 weeks (±1 week) thereafter until RECIST 1.1 defined disease progression or cessation of study treatment (if treating beyond disease progression).
    Se realizarán determinaciones conforme a los criterios RECIST cada 6 semanas (± 1 semana) durante las 24 primeras semanas desde el comienzo del tratamiento del ensayo (día 1 del ciclo 1) y, a partir de entonces, cada 9 semanas (± 1 semana) hasta la progresión de la enfermedad definida según los criterios RECIST 1.1 o la suspensión del tratamiento del ensayo (si se trata después de la progresión de la enfermedad).
    E.5.2Secondary end point(s)
    • Overall survival (OS)
    Endpoint based on Response Evaluation Criteria in Solid Tumours
    (RECIST 1.1):
    • Progression-free survival (PFS)
    • Duration of response (DoR)

    •To assess the pharmacokinetics (PK) of each treatment plasma concentrations will be measured.
    •To assess the safety and tolerability of each treatment -
    • Adverse events/serious adverse events (AEs/SAEs):
    • Physical examinations
    • Laboratory findings
    • Vital signs
    • Electrocardiogram (ECG).
    • Left ventricular ejection fraction (LVEF)
    • Supervivencia global (SG).
    Criterio de valoración basado en los Criterios de evaluación de la respuesta en tumores sólidos (RECIST 1.1):
    • Supervivencia libre de progresión (SLP).
    • Duración de la respuesta (DR).

    • Evaluación de la farmacocinética (FC) de cada tratamiento mediante la determinación de las concentraciones plasmáticas.
    • Evaluación de la seguridad y la tolerabilidad de cada tratamiento.
    • Acontecimientos adversos/ acontecimientos adversos graves (AA/AAG):
    • Exploraciones físicas.
    • Resultados analíticos.
    • Constantes vitales.
    • Electrocardiograma (ECG).
    • Fracción de eyección del ventrículo izquierdo (FEVI).
    E.5.2.1Timepoint(s) of evaluation of this end point
    • OS: survival follow-up will be performed every 12 weeks from disease progression until cohort final data cut-off or death

    • PFS and DoR: RECIST measurements will be made every 6 weeks for the first 24 weeks relative to the start of study treatment (Cycle 1, Day 1) and every 9 weeks thereafter until RECIST 1.1 defined disease progression or cessation of study treatment (if treating beyond disease progression)

    •PK: plasma concentrations will be measured for specific drugs at limited time points during treatment and up to safety follow up.

    • Safety and tolerability: AE/SAEs collected from prescreening ICF signature throughout the treatment period (including the safety follow-up). All other assessments performed throughout the treatment period (including the safety follow up).
    Momentos de evaluación de este criterio de valoración
    SG: Seguimiento supervivencia cada 12 semanas desde progresión hasta corte final de datos de cohorte o hasta muerte.
    SLP y DR: Determinaciones conforme criterios RECIST cada 6 semanas durante 24 1ªs semanas desde inicio tto de ensayo (día1 ciclo1) y después cada 9 semanas hasta progresión definida según criterios RECIST 1.1 o suspensión de tto de ensayo (si se trata tras la progresión).
    FC: Concentraciones plasmáticas de fármacos en ciertos momentos durante el tto y hasta seguimiento de seguridad.
    Seguridad y tolerabilidad: AA/AAG recogido desde firma de DCI antes de selección y durante el periodo de tto (incluido seguimiento de seguridad). Resto de evaluaciones durante el tratamiento (incluido seguimiento de seguridad).
    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 Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarkers
    Biomarcadores
    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 Yes
    E.8.1.7.1Other trial design description
    Estudio de diseño modular, consiste en cohortes de biomarcadores emparejados y no-emparejados
    Study is modular in design, consisting of biomarker matched & biomarker non-matched cohorts
    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 trial5
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA23
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Denmark
    Japan
    Korea, Republic of
    Netherlands
    Norway
    Spain
    Sweden
    United States
    E.8.7Trial has a data monitoring committee Yes
    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
    Last scheduled visit or contact of the last patient enrolled in the study
    La última visita o contacto del último paciente reclutado en el estudio
    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 months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months6
    E.8.9.2In all countries concerned by the trial 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: 75
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state18
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 79
    F.4.2.2In the whole clinical trial 150
    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)
    Patients receiving their assigned study treatment at the time of the final cohort data
    cut-off will be able to continue to receive study treatment if, in the opinion of the investigator, they are still deriving clinical benefit.
    Patients who remain on study treatment after the final cohort data cut-off will be managed by the investigator according to routine clinical practice.
    Los pacientes que están recibiendo el tratamiento asignado del estudio en el momento del corte de datos de cohorte final podrán continuar recibiendo el tratamiento del estudio si, en opinión del investigador, aún les deriva en beneficio clínico.
    Los pacientes que permanecen con el tratamiento del estudio después del corte de datos de cohorte final podrán ser gestionados por el investigador de acuerdo a la práctica clínica de rutina.
    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 Decision2019-06-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-20
    P. End of Trial
    P.End of Trial StatusOngoing
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    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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