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    Summary
    EudraCT Number:2015-001279-39
    Sponsor's Protocol Code Number:D419AC00001
    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:2015-10-15
    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 number2015-001279-39
    A.3Full title of the trial
    A Phase III Randomized, Open-Label, Multi-Center, Global Study of MEDI4736 in Combination with Tremelimumab Therapy or MEDI4736 Monotherapy Versus Standard of Care Platinum-Based Chemotherapy in First Line Treatment of Patients with Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) (MYSTIC)
    Ensayo internacional fase 3, aleatorizado, abierto y multicéntrico, con
    MEDI4736 en combinación con Tremelimumab o MEDI4736 en
    monoterapia, frente a la quimioterapia habitual basada en Platino, en el
    tratamiento de primera línea en pacientes con cáncer de pulmón no
    microcítico (NSCLC) avanzado o metastásico (MYSTIC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of MEDI4736 with or without Tremelimumab Versus standard of
    care chemotherapy in lung cancer (MYSTIC Study)
    Estudio de MEDI4736 con o sin Tremelimumab frente a la quimioterapia habitual en cáncer de pulmón (Estudio MYSTIC)
    A.3.2Name or abbreviated title of the trial where available
    MYSTIC
    MYSTIC
    A.4.1Sponsor's protocol code numberD419AC00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02453282
    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 AddressSerrano Galvache, 56
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number900200444
    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 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 nameMEDI4736
    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.3.9.3Other descriptive nameMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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: 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 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 nameTremelimumab
    D.3.2Product code MEDI1123
    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 INNTremelimumab
    D.3.9.1CAS number 745013-19-6
    D.3.9.2Current sponsor codeMEDI1123
    D.3.9.3Other descriptive nameMEDI1123
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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: 3
    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 Paclitaxel
    D.2.1.1.2Name of the Marketing Authorisation holderTeva 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 namePaclitaxel
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.4EV Substance CodeSUB09583MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 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 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
    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 INNCARBOPLATIN
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    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: 5
    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 Gemcitabine
    D.2.1.1.2Name of the Marketing Authorisation holderActivis Group PTC ehf.
    D.2.1.2Country which granted the Marketing AuthorisationIceland
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGEMCITABINE
    D.3.9.1CAS number 95058-81-4
    D.3.9.4EV Substance CodeSUB07892MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number38
    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 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 Cisplatin
    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 nameCisplatin
    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 INNcisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.3Other descriptive nameCISPLATIN
    D.3.9.4EV Substance CodeSUB07483MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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: 7
    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 Pemetrexed
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland BV
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    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
    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 INNPEMETREXED
    D.3.9.1CAS number 137281-23-3
    D.3.9.4EV Substance CodeSUB09655MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number25
    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
    Locally Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naiive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumour pathology.
    Pacientes con CPNM avanzado o metastásico sin mutaciones en el receptor del factor de crecimiento epidérmico (EGFR) ni en la cinasa del linfoma anaplásico (ALK).
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called "non-small cell lung cancer" (NSCLC)
    Un tipo específico de cáncer de pulmón llamado "Cáncer de pulmón no microcítico) (CPNM)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    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 MEDI4736 + tremelimumab combination therapy compared to SoC in terms of PFS in patients with NSCLC
    Evaluar la eficacia del tratamiento de combinación de MEDI4736 + tremelimumab en comparación con el Tratamiento Standar en términos de SLP en pacientes con CPNM.
    E.2.2Secondary objectives of the trial
    To assess the efficacy of MEDI4736 + tremelimumab combination therapy or MEDI4736 monotherapy compared to SoC in terms of PFS, ORR, DoR, APF12, PFS2, and OS

    To assess the efficacy of MEDI4736 + tremelimumab combination therapy compared to MEDI4736 monotherapy in terms of PFS and ORR

    To assess disease-related symptoms and HRQoL in patients treated with MEDI4736 + tremelimumab and MEDI4736 therapies compared to SoC using the EORTC QLQ C30 v3 and the LC13 module

    To assess the PK of MEDI4736 + tremelimumab and MEDI4736 therapies

    To investigate the immunogenicity of MEDI4736 and tremelimumab

    To explore irRECIST as an assessment methodology for clinical benefit of MEDI4736 + tremelimumab compared to SoC with assessment by BICR

    To assess the safety and tolerability profile of MEDI4736 + tremelimumab and MEDI4736 therapies compared to SoC in the first-line setting for treatment of locally advanced or metastatic NSCLC patients
    Evaluar en más detalle eficacia del tto. de combinación de MEDI4736 + tremelimumab o MEDI4736 en monoterapia en comp. con el TR en términos de SLP, TRO, DdR, VSP12, SLP2 y SG.
    Evaluar eficacia tto. de comb. de MEDI4736 + tremelimumab en comp. con MEDI4736 en monoterapia en términos de SLP y TRO.
    Evaluar sínt. relacionados con la enf. y la CdVRS en pac. tratados con tto. combinación de MEDI4736 + tremelimumab y MEDI4736 en monoterapia en comp. con TR usando el QLQ-C30 v3 de la EORTC y módulo LC13.
    Evaluar FC del tto. de comb. de MEDI4736 + tremelimumab y de MEDI4736 en monoterapia.
    Investigar la inmunogenicidad de MEDI4736 y tremelimumab.
    Explorar los RECISTri como metodología de eval. del benef. clínico de MEDI4736 + tremelimumab en comp. con TR con
    evaluación RCIE.
    Evaluar el perfil de seg. y tolerab. del tto. de combinación de MEDI4736 + tremelimumab y de MEDI4736 en monot. en comp. con el TR en el contexto de primera línea para el tto. de pac. con CPNM avanzado o metastásico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    ? Aged at least 18 years
    ? Documented evidence of Stage IV NSCLC
    ? No activating EGFR mutation or ALK rearrangement
    ? No prior chemotherapy or any other systemic therapy for
    advanced/metastatic NSCLC
    ? World Health Organization (WHO) Performance Status of 0 or 1
    1. Edad > o = 18 años en el momento de la selección
    2. CPNM en estadio IV documentado histológicamente o citológicamente con enfermedad no susceptible de cirugía o radioterapia curativas
    3. Los pacientes deben presentar tumores que carezcan de mutación activadora de EGFR y reordenación de ALK.
    4. Ninguna quimioterapia previa o cualquier otro tratamiento sistémico previo para CPNM avanzado o metastásico.
    5. Estado funcional de la Organización Mundial de la Salud (OMS)/Eastern Cooperative Oncology Group (ECOG) de 0 o 1 al reclutamiento.
    E.4Principal exclusion criteria
    Patients should not enter the study if any of the
    following exclusion criteria are fulfilled:
    ? Mixed small-cell lung cancer and NSCLC histology or not otherwise specified (NSCLC NOS)
    ? Brain metastases or spinal cord compression unless asymptomatic, treated and stable (not requiring steroids)
    ? Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
    Los pacientes no deben entrar en el ensayo si cumplen cualquiera de los siguientes criterios de exclusión:
    1. Histología mixta de cáncer microcítico de pulmón y CPNM o no especificada (CPNM NE)
    2. Metástasis cerebrales o compresión de la médula espinal a menos que el paciente esté asintomático y estable sin esteroides ni anticonvulsivantes durante al menos 1 mes antes del tratamiento del ensayo.
    3. Trastornos autoinmunitarios o inflamatorios documentados, activos o previos (incluida enfermedad inflamatoria intestinal [p. ej., colitis o enfermedad de Crohn],
    E.5 End points
    E.5.1Primary end point(s)
    Progression Free Survival (PFS) using investigator assessments according to Response Evaluation Criteria in Solid Tumours (RECIST 1.1).
    El análisis principal de la SLP se basará en los RECIST 1 -1 derivados programáticamente usando las evaluaciones tumorales por el investigador.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At baseline, after that every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression.
    La eficacia en todos los pacientes se evaluará mediante evaluaciones objetivas del tumor cada 6 semanas durante las primeras 48 semanas y
    después cada 8 semanas hasta progresión de la enfermedad.
    E.5.2Secondary end point(s)
    PFS in patients with PD-L1 negative NSCLC using Investigator assessments according to RECIST 1.1

    PFS in patients with PD-L1 positive NSCLC using Investigator assessments according to RECIST 1.1

    ORR, DoR, and APF12 using Investigator assessments according to RECIST 1.1

    PFS2 using local standard clinical practice OS

    PFS and ORR using Investigator assessments according to RECIST 1.1

    EORTC QLQ-C30: Questionnaire consisting of 30 items measuring subjects general cancer
    symptoms and functioning.

    EORTC QLQ-LC13: A complementary questionnaire measuring lung cancer symptoms and
    side effects from conventional chemo- and radiotherapy.

    Changes in World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status will also be assessed.

    Concentration of MEDI4736 and tremelimumab in blood and non-compartmental PK parameters, such as peak concentration and trough (as data allow; sparse sampling)

    Presence of ADAs for MEDI4736 and tremelimumab

    PFS and ORR using BICR assessment according to irRECIST

    AEs, physical examinations, laboratory findings, and vital signs
    SLP en pacientes con CPNM negativo para PD-L1 usando las evaluaciones del investigador de acuerdo con los RECIST 1.1.

    SLP en pacientes con CPNM positivo para PD-L1 usando las evaluaciones por el investigador de acuerdo con los RECIST 1.1.

    TRO, DdR y VSP12 usando las evaluaciones por el investigador de acuerdo con los RECIST 1.1.

    SLP2 según la práctica clínica habitual local 00SG.

    SLP y TRO usando las evaluaciones por el investigador de acuerdo con los RECIST 1.1.

    QLQ-C30 de la EORTC: Cuestionario de calidad de vida fundamental de 30 apartados.

    QLQ-LC13 de la EORTC: Cuestionario de calidad de vida para el cáncer de pulmón de 13 apartados.

    Se evaluarán también los cambios en el estado funcional de la Organización Mundial de la Salud (OMS)/el Eastern Cooperative Oncology Group (ECOG).

    Concentración de MEDI4736 y tremelimumab en sangre y parámetros FC no compartimentales, como la concentración máxima y en el valle (según lo permitan los datos; toma de muestras dispersa).

    Presencia de AAF frente a MEDI4736 y tremelimumab.

    SLP y TRO usando la evaluación por RCIE de acuerdo con los RECISTri.
    AA, exploraciones físicas, hallazgos de laboratorio y constantes vitales.
    E.5.2.1Timepoint(s) of evaluation of this end point
    For PFS - At baseline, then every 6 weeks for the first 48 weeks relative to the date of randomization, and then every 8 weeks until progression.
    EORTC QLQ-C30- Every 4 weeks for the first 8 weeks relative to randomization, then every 8 weeks until second progression/death (whichever comes first).
    EORTC QLQ-LC13 - Every 2 weeks for the first 8 weeks relative to randomization, then every 4 weeks until second progression (PFS2)/death (whichever comes first).

    WHO/ECOG - At timepoints consistent with tumor assessments; at 30, 60, and 90 days following confirmation of progression; and then at initiation of subsequent anticancer therapy

    PK (MEDI4736) - 12 and 24 weeks from randomization.

    PK (Tremelimumab) - 12 weeks from randomization.

    ADAs - 12 and 24 weeks from randomization.
    - SLP- Se realizarán evaluaciones tumorales cada 6 sem. durante las primeras 48 sem. y luego cada 8 sem. hT la progresión confirmada de la enf..
    - EORTC QLQ-C30 - Cada 4 sem. durante las primeras 8 sem. en relación con la fecha de aleatorización, luego cada 8 sem. en adelante hasta segunda progresión/muerte (lo que suceda antes)
    EORTC QLQ-LC13 - Cada 2 sem. durante las primeras 8 sem. en relación con la fecha de aleator., luego cada 4 sem. en adelante ht la segunda progresión/muerte (lo que suceda antes)
    OMS/ECOG- En momentos coherentes con las eval. tumorales; a los 30, 60 y 90 días; y luego al inicio del tto. oncológico posterior.
    - FC (MEDI4736) ? 12 y 24 sem. tras la aleatorización.
    - FC (Tremelimumab) ? 12 sem. tras la randomización.
    - ADAs ? 12 y 24 sem. tras la random..
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Quimioterapia en doblete basado en platino
    Platinum-based doublet chemotherapy
    E.8.2.4Number of treatment arms in the trial3
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA48
    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
    Australia
    Belgium
    Canada
    France
    Germany
    Hungary
    Italy
    Japan
    Korea, Republic of
    Netherlands
    Russian Federation
    Spain
    Taiwan
    Thailand
    United States
    Vietnam
    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
    LVLS
    Última visita del último paciente.
    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 months2
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months2
    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: 455
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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.4.2 For a multinational trial
    F.4.2.1In the EEA 235
    F.4.2.2In the whole clinical trial 675
    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.
    Ninguna.
    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 Decision2015-10-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-10-21
    P. End of Trial
    P.End of Trial StatusOngoing
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