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    Summary
    EudraCT Number:2018-004720-11
    Sponsor's Protocol Code Number:MK-7339-006
    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:2019-04-12
    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 number2018-004720-11
    A.3Full title of the trial
    A Phase 3 Study of Pembrolizumab in Combination with Pemetrexed/Platinum (Carboplatin or Cisplatin) Followed by Pembrolizumab and Maintenance Olaparib vs Maintenance Pemetrexed in the First-Line Treatment of Participants with Metastatic Nonsquamous Non-Small-Cell Lung Cancer
    Estudio de fase 3 de pembrolizumab en combinación con pemetrexed/platino (carboplatino o cisplatino) seguido de pembrolizumab y olaparib de mantenimiento en comparación con pemetrexed de mantenimiento en el tratamiento de primera línea de participantes con cáncer de pulmón no microcítico, de histología no epidermoide, metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 3 Study of Pembrolizumab with Maintenance Olaparib or Maintenance Pemetrexed in 1L Metastatic Nonsquamous NSCLC
    Estudio de fase 3 de pembrolizumab con olaparib o pemetrexed de mantenimiento como tratamiento de primera línea en el CPNM no epidermoide metastásico
    A.4.1Sponsor's protocol code numberMK-7339-006
    A.5.4Other Identifiers
    Name:INDNumber:140819
    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 SponsorMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.1.3.4CountryUnited States
    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 supportMerck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck Sharp & Dohme de España S.A.
    B.5.2Functional name of contact pointInvestigación Clínica
    B.5.3 Address:
    B.5.3.1Street AddressC/ Josefa Valcárcel, 38
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28037
    B.5.3.4CountrySpain
    B.5.4Telephone number+34913210600
    B.5.5Fax number+34913210590
    B.5.6E-mailensayos_clinicos@merck.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 KEYTRUDA® (pembrolizumab, MK-3475)
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme 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.3.4Pharmaceutical 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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    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 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) Yes
    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 namePembrolizumab
    D.3.2Product code MK-3475
    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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codeMK-3475
    D.3.9.4EV Substance CodeSUB167136
    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 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) Yes
    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 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 nameOlaparib
    D.3.2Product code MK-7339
    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 INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeMK-7339
    D.3.9.3Other descriptive nameOLAPARIB; KU-0059436; AZD2281; CO-CE 42
    D.3.9.4EV Substance CodeSUB32234
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 nameOlaparib
    D.3.2Product code MK-7339
    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 INNOlaparib
    D.3.9.1CAS number 763113-22-0
    D.3.9.2Current sponsor codeMK-7339
    D.3.9.3Other descriptive nameOLAPARIB; KU-0059436; AZD2281; CO-CE 42
    D.3.9.4EV Substance CodeSUB32234
    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: 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 ALIMTA
    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.3.4Pharmaceutical 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
    D.3.9.1CAS number 150399-23-8
    D.3.9.3Other descriptive namePEMETREXED DISODIUM
    D.3.9.4EV Substance CodeSUB03669MIG
    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: 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 ALIMTA
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Australia Pty Limited
    D.2.1.2Country which granted the Marketing AuthorisationAustralia
    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.3.4Pharmaceutical 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
    D.3.9.1CAS number 150399-23-8
    D.3.9.3Other descriptive namePEMETREXED DISODIUM
    D.3.9.4EV Substance CodeSUB03669MIG
    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.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
    Stage IV lung cancer condition
    Cáncer de pulmón en estadio IV
    E.1.1.1Medical condition in easily understood language
    Stage IV lung cancer condition
    Cáncer de pulmón en estadio IV
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous non-small cell lung cancer
    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
    1. To compare pembrolizumab (MK-3475) plus maintenance olaparib (MK-7339) with pembrolizumab plus maintenance pemetrexed with respect to progression-free survival (PFS) assessed according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by blinded independent central review (BICR) in participants with stage IV nonsquamous non–small- cell lung cancer (NSCLC) with stable disease (SD), partial response (PR), or complete response (CR) following induction treatment with pembrolizumab combined with pemetrexed and platinum (carboplatin or cisplatin).

    2. To compare pembrolizumab plus maintenance olaparib with pembrolizumab plus maintenance pemetrexed with respect to overall survival (OS) in participants with stage IV NSCLC with SD, PR, or CR following induction treatment with pembrolizumab combined with pemetrexed and platinum (carboplatin or cisplatin).
    -Comparar pembro (Mk3475) más olaparib (MK7339) de mantenimiento con pembro más pemetrexed de mantenimiento en cuanto a la supervivencia sin progresión (SSP) evaluada conforme a los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1, según una revisión central independiente y enmascarada (RCIE) en participantes con cáncer de pulmón no microcítico (CPNM), de histología no epidermoide, en estadio IV y con enfermedad estable (EE), respuesta parcial (RP) o respuesta completa (RC) tras el tratamiento de inducción con pembro combinado con pemetrexed y platino.
    -Comparar pembro más olaparib de mantenimiento con pembro más pemetrexed de mantenimiento en cuanto a la supervivencia global (SG), en participantes con cáncer de pulmón no microcítico (CPNM), de histología no epidermoide, en estadio IV y con enfermedad estable (EE), respuesta parcial (RP) o respuesta completa (RC) tras el tratamiento de inducción con pembro combinado con pemetrexed y platino.
    E.2.2Secondary objectives of the trial
    1. To evaluate the safety and tolerability of pembrolizumab plus maintenance olaparib compared to pembrolizumab plus maintenance pemetrexed in participants with stage IV NSCLC with SD, PR, or CR following induction treatment with pembrolizumab combined with pemetrexed and platinum (carboplatin or cisplatin).

    2. To evaluate the change from baseline (at randomization) and the time to true deterioration (TTD) in global health status/quality of life (QoL), cough, chest pain, dyspnea and physical functioning following treatment with pembrolizumab plus maintenance olaparib compared with pembrolizumab plus pemetrexed in participants with stage IV NSCLC with SD, PR, or CR following induction treatment with pembrolizumab combined with pemetrexed and platinum (carboplatin or cisplatin).
    -Evaluar la seguridad y la tolerabilidad de pembro más olaparib de mantenimiento en comparación con pembro más pemetrexed de mantenimiento, en participantes con cáncer de pulmón no microcítico (CPNM), de histología no epidermoide, en estadio IV y con enfermedad estable (EE), respuesta parcial (RP) o respuesta completa (RC) tras el tratamiento de inducción con pembro combinado con pemetrexed y platino.
    -Evaluar la variación con respecto al momento basal (en la aleatorización) y el tiempo hasta el deterioro real (THD) en las escalas de estado de salud general/calidad de vida, tos, dolor torácico, disnea y función física después del tratamiento con pembro más olaparib de mantenimiento en comparación con pembro más pemetrexed, en participantes con cáncer de pulmón no microcítico (CPNM), de histología no epidermoide, en estadio IV y con enfermedad estable (EE), respuesta parcial (RP) o respuesta completa (RC) tras el tratamiento de inducción con pembro combinado con pemetrexed y platino.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Merck will conduct Future Biomedical Research on DNA (blood and tissue) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.
    MSD realizará investigaciones biomédicas futuras en ADN de las muestra recogidas (sangre y tejido) durante este ensayo clínico. Tales investigaciones son para analizar biomarcardores para responder ciertas preguntas que no se han descrito en el protocolo (como parte del estudio principal) y solo será realizadas en muestras de sujetos que hayan consentido apropiadamente. El objetivo de recoger muestras para investigaciones biomédicas futuras es explorar e identificar biomarcadores que puedan ayudar a los científicos a entender las enfermedades y/o sus tratamientos terapéuticos. El objetivo final es usar dicha información para desarrollar medicamentos más seguros y efectivos y /o asegurar que los sujetos reciben la dosis correcta de la medicación adecuada en el momento correcto.
    E.3Principal inclusion criteria
    1. Have a histologically confirmed or cytologically confirmed diagnosis of nonsquamous NSCLC.
    2. Have stage IV (T any, N any, M1a, M1b, or M1c - American Joint Committee on Cancer (AJCC) 8th Edition) nonsquamous NSCLC.
    3. Have confirmation that EGFR, ALK, or ROS1-directed therapy is not indicated (documentation of absence of tumor-activating EGFR mutations AND absence of ALK and ROS1 gene rearrangements, OR presence of a K-Ras mutation).
    4. Have measurable disease, based on RECIST 1.1, as determined by the local site investigator/radiology assessment. Lesions that appear measurable, but are situated in a previously irradiated area, can be considered measurable (eligible for selection as target lesions) if they have shown documented growth since the completion of radiation.
    5. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. Formalin-fixed, paraffin-embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.
    6. Have a life expectancy of at least 3 months.
    7. Have an ECOG performance score of 0 or 1 assessed within 7 days prior to the administration of study intervention.
    8. Have not received prior systemic treatment for their advanced/metastatic NSCLC. Participants who received adjuvant or neoadjuvant therapy are eligible if the adjuvant/neoadjuvant therapy was completed at least 12 months prior to the development of metastatic disease.
    9. Have adequate organ function. All screening laboratory tests should be performed within 10 days prior to the first dose of study intervention.
    10. Be at least 18 years of age at the time of signing the informed consent.
    11. Male participants are eligible to participate if they agree to the following during the intervention period and for at least 180 days after the last dose of study intervention:
    - Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent
    OR
    - Agree to use contraception, unless confirmed to be azoospermic (vasectomized or secondary to medical cause)
    12. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
    a) Is not a WOCBP
    OR
    b) Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 180 days after the last dose of study intervention. The investigator should evaluate the potential for contraceptive method failure (ie, noncompliance, recently initiated) in relationship to the first dose of study intervention.
    13. Have (or legally acceptable representative if applicable) provided written informed consent/assent for the study. The participant may also provide consent/assent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
    14. Have a CR/PR or SD of their NSCLC after completion of the study-specified Induction Phase, as determined by central imaging review.
    1. Tener un diagnóstico confirmado histológica o citológicamente de CPNM no epidermoide.
    2. Presentar un CPNM no epidermoide en estadio IV (cualquier T, cualquier N, M1a, M1b o M1c; criterios del American Joint Committee on Cancer (AJCC), 8ª Edición).
    3. Tener confirmación de que no está indicado el tratamiento dirigido contra EGFR, ALK o ROS1 (ausencia documentada de mutaciones de EGFR activadoras del tumor Y ausencia de reordenamientos génicos de ALK y ROS1 O presencia de una mutación de K-Ras).
    4. Presentar enfermedad mensurable conforme a los criterios RECIST 1.1, según la evaluación del investigador o radiólogo del centro. Las lesiones que parecen mensurables, pero están ubicadas en una zona irradiada previamente, pueden considerarse mensurables (elegibles para su selección como lesiones diana) si han mostrado crecimiento documentado desde la finalización de la radioterapia.
    5. Proporcionar una muestra de tejido tumoral de archivo o de una biopsia reciente, con aguja gruesa o por escisión, de una lesión tumoral no irradiada previamente. Se prefieren los bloques de tejido fijados en formol e incluidos en parafina (FFIP) a los cortes para microscopio. Se prefiere el uso de biopsias recientes al tejido de archivo.
    6. Tener una esperanza de vida mínima de tres meses.
    7. Tener una puntuación de estado funcional del ECOG de 0 o 1 en los 7 días previos a la administración de la intervención del estudio.
    8. No haber recibido previamente tratamiento sistémico contra el CPNM avanzado o metastásico. Los posibles participantes que hayan recibido tratamiento adyuvante o neoadyuvante podrán participar en el estudio siempre que dicho tratamiento se haya completado al menos 12 meses antes de la aparición de la enfermedad metastásica.
    9. Tener una función orgánica adecuada, conforme a lo indicado por los valores analíticos. Todas las pruebas analíticas de selección deberán realizarse en los 10 días previos a la primera dosis de la intervención del estudio.
    10. Edad mínima de 18 años en el momento de firmar el consentimiento informado.
    11. Podrán participar en el estudio los varones que se comprometan a todo lo siguiente durante el período de intervención y hasta, como mínimo, 180 días después de recibir la última dosis de la intervención del estudio:
    - Abstenerse de mantener relaciones heterosexuales como modo de vida habitual y preferido (abstinencia a largo plazo y persistente) y compromiso de mantener dicha abstinencia sexual.
    O
    - Comprometerse a utilizar métodos anticonceptivos a menos que se confirme que presentan azoospermia (por vasectomía o secundaria a una causa médica.
    12. Una mujer podrá participar si no está embarazada, no está amamantando y cumple al menos una de las condiciones siguientes:
    a) No es una MEF.
    O
    - b) Es una MEF y utiliza un método anticonceptivo muy eficaz (con un índice de fallos < 1 % anual) o practica la abstinencia de relaciones heterosexuales como modo de vida preferido y habitual (abstinencia a largo plazo y persistente), según se describe en el apéndice 5, durante el período de intervención y hasta, como mínimo, 180 días después de recibir la última dosis de la intervención del estudio. El investigador deberá evaluar la posibilidad de fracaso del método anticonceptivo (es decir, incumplimiento, inicio reciente) en relación con la primera dosis de la intervención del estudio.
    13. El participante (o su representante legal cuando proceda) otorga su consentimiento/asentimiento informado por escrito para el estudio. El participante también podrá otorgar su consentimiento/asentimiento para las investigaciones biomédicas futuras. No obstante, podrá participar en el estudio principal sin necesidad de hacerlo en las investigaciones biomédicas futuras.
    14. Presencia de una RC/RP o EE del CPNM una vez finalizada la fase de inducción especificada en el estudio, según lo determinado mediante una revisión centralizada de las imágenes.
    E.4Principal exclusion criteria
    1. Has predominantly squamous cell histology NSCLC.
    2. Has a known additional malignancy that is progressing or has progressed within the past 3 years requiring active treatment.
    3. Has known active central nervous system metastases and/or carcinomatous meningitis.
    4. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.
    5. Participant has a known hypersensitivity to any components or excipients of cisplatin, carboplatin, pemetrexed, or olaparib.
    6. Has active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy is not considered a form of systemic treatment and is allowed.
    7. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study intervention.
    8. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
    9. Has an active infection requiring systemic therapy.
    10. Has a known history of human immunodeficiency virus (HIV) infection. No HIV testing is required, unless mandated by local health authority.
    11. Has a known history of hepatitis B or known active hepatitis C virus infection.
    12. Has a known history of active tuberculosis.
    13. Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
    14. Has a known history of interstitial lung disease. Lymphangitic spread of the NSCLC is not exclusionary.
    15. Has myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
    16. Before the first dose of study intervention:
    a. Has received prior systemic cytotoxic chemotherapy for metastatic disease.
    b. Has received antineoplastic biological therapy (eg, erlotinib, crizotinib, cetuximab) for metastatic disease.
    c. Had major surgery (<3 weeks prior to study intervention) or has not recovered from any effects of any major surgery.
    17. Has received prior therapy with olaparib or with any other PARP inhibitor.
    18. Has received radiation therapy to the lung that is >30 Gy within 6 months of the first dose of study intervention.
    19. Is expected to require any other form of antineoplastic therapy while on study.
    20. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).
    21. Has received a live vaccine within 30 days prior to the first dose of study drug.
    22. Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs, other than an aspirin dose ≤1.3 g per day, for a 5-day period (an 8-day period for long-acting agents, such as piroxicam).
    23. Is unable or unwilling to take folic acid or vitamin B12 supplementation.
    24. Received colony-stimulating factors (eg, granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor or recombinant erythropoietin) within 28 days prior to the first dose of study intervention.
    25. Is currently receiving either strong or moderate inhibitors of cytochrome P450 (CYP)3A4 that cannot be discontinued for the duration of the study.
    26. Is currently receiving either strong or moderate inducers of CYP3A4 that cannot be discontinued for the duration of the study.
    27. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
    28. Has resting electrocardiogram (ECG) indicating uncontrolled, potentially reversible cardiac conditions, as judged by the investigator (eg, unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, electrolyte disturbances, etc.), or participant has congenital long QT syndrome.
    29. Is considered a poor medical risk, in the opinion of the treating investigator, due to a serious, uncontrolled medical disorder or nonmalignant systemic disease.
    30. Has a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the study.
    31. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the Screening Visit through 180 days after the last dose of study intervention.
    32. Is unable to swallow orally administered medication, or has a gastrointestinal disorder affecting absorption (eg, gastrectomy, partial bowel obstruction, or malabsorption).
    33. Has had an allogenic-tissue/solid-organ transplant.
    1. Presencia de un CPNM de histología predominantemente epidermoide.
    2. Presencia de otra neoplasia maligna conocida que está en progresión o que ha progresado en los últimos tres años y ha precisado tratamiento activo.
    3. Presencia de metástasis activas conocidas en el sistema nervioso central y/o meningitis carcinomatosa.
    4. Presencia de hipersensibilidad grave (grado ≥ 3) a pembrolizumab y/o a cualquiera de sus excipientes.
    5. Hipersensibilidad conocida a cualquiera de los componentes o excipientes de cisplatino, carboplatino, pemetrexed u olaparib.
    6. Presencia de una enfermedad autoinmunitaria activa que ha precisado tratamiento sistémico en los dos últimos años. El tratamiento de reposición no se considera una forma de tratamiento sistémico y se permitirá su uso.
    7. Diagnóstico de inmunodeficiencia o recepción de tratamiento sistémico crónico con esteroides (en dosis superiores a 10 mg diarios de prednisona o equivalente) o cualquier otra forma de tratamiento inmunodepresor en los siete días previos a la primera dosis del tratamiento del estudio.
    8. Antecedentes de neumonitis (no infecciosa) que haya precisado la administración de esteroides o presencia de una neumonitis activa.
    9. Infección activa con necesidad de tratamiento sistémico.
    10. Antecedentes de infección por el virus de la inmunodeficiencia humana (VIH). No es necesario realizar pruebas de VIH a menos que lo exijan las autoridades sanitarias locales.
    11. Antecedentes de infección por el virus de la hepatitis B o de infección activa por el virus de la hepatitis C.
    12. Antecedentes de tuberculosis activa.
    13. Presencia de ascitis o derrame pleural sintomático. Podrán participar sujetos que se encuentren clínicamente estables tras recibir tratamiento por estos procesos (como toracocentesis o paracentesis terapéuticas).
    14. Antecedentes de neumopatía intersticial. La diseminación linfangítica del CPNM no será motivo de exclusión.
    15. Presencia de un síndrome mielodisplásico (SMD)/leucemia mieloide aguda (LMA) o signos indicativos de SMD/LMA.
    16. Antes de la primera dosis de la intervención del estudio:
    a. Recepción de quimioterapia citotóxica sistémica previa por metástasis
    b. Recepción de tratamiento biológico antineoplásico (por ejemplo, erlotinib, crizotinib o cetuximab) por metástasis.
    c. Intervención de cirugía mayor en las 3 semanas previas a la intervención del estudio o ausencia de recuperación de los efectos de una intervención de cirugía mayor.
    17. Recepción de tratamiento previo con olaparib o cualquier otro inhibidor de la PARP.
    18. Recepción de radioterapia sobre el pulmón > 30 Gy en los seis meses previos a la primera dosis de la intervención del estudio.
    19. Previsión de que se precise cualquier otra forma de tratamiento antineoplásico durante el estudio.
    20. Recepción de un tratamiento previo con un fármaco anti-PD-1, anti-PD-L1 o anti-PD-L2 o con un fármaco dirigido contra otro receptor de los linfocitos T estimulador o coinhibidor (como CTLA-4, OX-40 o CD137).
    21. Recepción de una vacuna de microorganismos vivos en los 30 días previos a la administración de la primera dosis del fármaco del estudio.
    22. Imposibilidad de interrumpir el tratamiento con ácido acetilsalicílico u otros antiinflamatorios no esteroideos (excepto una dosis de ácido acetilsalicílico ≤ 1,3 g al día) durante 5 días (8 días en caso de fármacos de acción prolongada, como piroxicam).
    23. Incapacidad o falta de disposición a tomar un suplemento de ácido fólico o vitamina B12.
    24. Recepción de factores estimulantes de colonias (por ejemplo, factor estimulante de las colonias de granulocitos [G-CSF], factor estimulante de las colonias de granulocitos y macrófagos o eritropoyetina recombinante) en los 28 días previos a la primera dosis de la intervención del estudio.
    25. Recepción activa de inhibidores potentes o moderados del citocromo P450 (CYP)3A4 que no pueden suspenderse durante el estudio.
    26. Recepción activa de inductores potentes o moderados de la enzima CYP3A4 que no pueden suspenderse durante el estudio.
    27. Participación activa o pasada en un estudio de un fármaco en investigación o uso de un dispositivo en investigación en las cuatro semanas previas a la administración de la primera dosis del tratamiento del estudio.
    28. Presencia de un electrocardiograma (ECG) en reposo que indica la existencia de cardiopatías no controladas y potencialmente reversibles, según el criterio del investigador (por ejemplo, isquemia inestable, arritmia sintomática no controlada, insuficiencia cardíaca congestiva, trastornos electrolíticos, etc.), o existencia de un síndrome de QT largo congénito.
    29. Se considera que existe un riesgo médico desfavorable, en opinión del investigador encargado del tratamiento, debido a un trastorno médico grave y no controlado o a una enfermedad sistémica no maligna.

    Leer resto en el protocolo
    E.5 End points
    E.5.1Primary end point(s)
    1. Progression-free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
    2. Overall Survival (OS)
    1. Supervivencia sin progresión (SSP) evaluada conforme a los Criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1
    2. Supervivencia global (SG)
    E.5.1.1Timepoint(s) of evaluation of this end point
    1. Up to ~3 years
    2. Up to ~5 years
    1. Hasta ~ 3 años
    2. Hasta ~ 5 años
    E.5.2Secondary end point(s)
    1. Number of Participants Experiencing an Adverse Event (AE)
    2. Number of Participants Discontinuing Study Treatment Due to an Adverse Event (AE)
    3. Change from Baseline in European Organization for Research and Treatment (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30) Global Health Status / Quality of Life (Items 29 & 30) Scale Score
    4. Change from Baseline in EORTC Quality of Life Questionnaire Lung Cancer Module 13 (QLQ-LC13) Cough (Item 1) Scale Score
    5. Change from Baseline in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
    6. Change from Baseline in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
    7. Change from Baseline in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
    8. Time to True Deterioration (TTD) in EORTC QLQ-C30 Global Health Status / Quality of Life (Items 29 & 30) Scale Score
    9. Time to True Deterioration (TTD) in EORTC QLQ-LC13 Cough (Item 1) Scale Score
    10. Time to True Deterioration (TTD) in EORTC QLQ-LC13 Chest Pain (Item 10) Scale Score
    11. Time to True Deterioration (TTD) in EORTC QLQ-C30 Dyspnea (Item 8) Scale Score
    12. Time to True Deterioration (TTD) in EORTC QLQ-C30 Physical Functioning (Items 1 to 5) Scale Score
    1. Número de participantes que experimentan acontecimientos adversos (AA).
    2. Número de participantes que discontinúan del tratamiento del estudio debido a acontecimientos adversos (AA).
    3. Variación con respecto al momento basal del cuestionario QLQ (Cuestionario de calidad de vida) de la Organización Europea para la investigación y el Tratamiento del Cáncer (EORTC) . QLQ-C30, estado general de salud, apartados 29 y 30.
    4. Variación con respecto al momento basal del cuestionario QLQ (Cuestionario de calidad de vida) de la Organización Europea para la investigación y el Tratamiento del Cáncer (EORTC) . QLQ-LC13, tos, apartado 1.
    5. Variación con respecto al momento basal del cuestionario QLQ (Cuestionario de calidad de vida) de la Organización Europea para la investigación y el Tratamiento del Cáncer (EORTC) . QLQ-LC13, dolor torácico, apartados 10.
    6. Variación con respecto al momento basal del cuestionario QLQ (Cuestionario de calidad de vida) de la Organización Europea para la investigación y el Tratamiento del Cáncer (EORTC) . QLQ-C30, disnea, apartado 8.
    7. Variación con respecto al momento basal del cuestionario QLQ (Cuestionario de calidad de vida) de la Organización Europea para la investigación y el Tratamiento del Cáncer (EORTC) . QLQ-C30, función física, apartados 1 a 5.
    8. Tiempo hasta el deterioro real (THD) en EORTC QLQ-C30 estado general de salud, apartados 29 y 30.
    9. Tiempo hasta el deterioro real (THD) en EORTC QLQ-LC13, tos, apartado 1.
    10. Tiempo hasta el deterioro real (THD) en EORTC QLQ-LC13, dolor torácico, apartados 10.
    11. Tiempo hasta el deterioro real (THD) en EORTC . QLQ-C30, disnea, apartado 8.
    12. Tiempo hasta el deterioro real (THD) en EORTC QLQ-C30, función física, apartados 1 a 5.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to ~5 years
    2. Up to ~5 years
    3. Baseline (at randomization) and Week 18 post-randomization
    4. Baseline (at randomization) and Week 18 post-randomization
    5. Baseline (at randomization) and Week 18 post-randomization
    6. Baseline (at randomization) and Week 18 post-randomization
    7. Baseline (at randomization) and Week 18 post-randomization
    8. Up to ~5 years
    9. Up to ~5 years
    10. Up to ~5 years
    11. Up to ~5 years
    12. Up to ~5 years
    1. Hasta ~ 5 años
    2. Hasta ~ 5 años
    3. Línea de base (en la aleatorización) y Semana 18 después de la aleatorización
    4. Línea de base (en la aleatorización) y Semana 18 después de la aleatorización
    5. Línea de base (en la aleatorización) y Semana 18 después de la aleatorización
    6. Línea de base (en la aleatorización) y Semana 18 después de la aleatorización
    7. Línea de base (en la aleatorización) y Semana 18 después de la aleatorización
    8. Hasta ~ 5 años
    9. Hasta ~ 5 años
    10. Hasta ~ 5 años
    11. Hasta ~ 5 años
    12. Hasta ~ 5 años
    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 Yes
    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) 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 No
    E.8.2.4Number of treatment arms in the trial2
    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 EEA94
    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
    Argentina
    Australia
    Austria
    Brazil
    Canada
    Colombia
    France
    Germany
    Japan
    Korea, Republic of
    New Zealand
    Poland
    Romania
    Russian Federation
    Spain
    Taiwan
    Turkey
    Ukraine
    United Kingdom
    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
    LPLV
    LPLV
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months0
    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: 400
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 392
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state30
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 417
    F.4.2.2In the whole clinical trial 792
    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
    Ninguno
    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 Decision2019-06-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
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