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    The EU Clinical Trials Register currently displays   43719   clinical trials with a EudraCT protocol, of which   7255   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2016-003732-20
    Sponsor's Protocol Code Number:GECP16/03
    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:2016-11-17
    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 number2016-003732-20
    A.3Full title of the trial
    NEO -ADJUVANT CHEMO/IMMUNOTHERAPY FOR THE TREATMENT OF RESECTABLE STAGE IIIA NON SMALL CELL LUNG CANCER (NSCLC): A PHASE II MULTICENTER EXPLORATORY STUD
    Ensayo clínico fase II, exploratorio y multicéntrico, de quimioinmunoterapia neo-adyuvante para el tratamiento del cáncer de pulmón no microcítico estadío III operable
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Treatment with immunotherapy before and after surgery for the non small cell lung cancer
    Tratamiento con immunoterapia antes y después de la cirugía en pacientes con cáncer de pulmón no microcítico
    A.3.2Name or abbreviated title of the trial where available
    Neo-Adjuvant Immunotherapy (NADIM)
    NADIM
    A.4.1Sponsor's protocol code numberGECP16/03
    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 SponsorGrupo Español de Cáncer de Pulmón
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportGrupo Español de Cáncer de Pulmón
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGrupo Español de Cáncer de Pulmón
    B.5.2Functional name of contact pointClinical Trial Information section
    B.5.3 Address:
    B.5.3.1Street AddressAvenida Meridiana 358 6ª planta
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08027
    B.5.3.4CountrySpain
    B.5.4Telephone number+34934302006
    B.5.5Fax number+34934191768
    B.5.6E-mailepereira@gecp.org
    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 OPDIVO
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Myers Squibb Pharma
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 INNNivolumab
    D.3.9.3Other descriptive nameNIVOLUMAB
    D.3.9.4EV Substance CodeSUB122750
    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 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 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
    Non small cell lung cáncer limited stage IIIA
    cáncer de pulmón no microcítico estadío limitado IIIA
    E.1.1.1Medical condition in easily understood language
    Resectable lung cancer
    Cáncer de pulmón operable
    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
    Estimate progression-free survival (PFS) at 24 months from diagnosis
    Estimar la supervivencia libre de progresión a los 24 meses desde el diagnóstico
    E.2.2Secondary objectives of the trial
    - Assess the toxicity profile of the combination, the down-staging rate, complete resection rate, time to progression and overall survival at 3 years (follow up visits after adjuvant treatment, every 3 months for 3 years). Also, surgical outcome and operative and post-operative complications will be assessed.
    - Perform correlatives studies with the objectives of exploring the expression of other biomarkers, such as PD-L1, in tumor tissue: at screening and after surgery (resected tumor sample), free DNA and circulating tumor cells in liquid biopsy
    - To describe whether PD-L1 expression is a predictive biomarker for ORR
    - To describe Progression Free Survival (PFS) in PD-L1+ (>=1%) population
    - Report imaging response vs pathological response rate
    - Evaluar el perfil de toxicidad de la combinación, la tasa de estadificación descendente, la tasa de resección completa, el tiempo hasta la progresión y la supervivencia global a los 3 años (visitas de seguimiento después del tratamiento adyuvante, cada 3 meses durante 3 años). También se evaluará el resultado quirúrgico y las complicaciones operativas y postoperatorias.
    - Realizar estudios correlativos con los objetivos de explorar la expresión de otros biomarcadores, como PD-L1, en el tejido tumoral: en el cribado y después de la cirugía (muestra de tumor resecada), ADN libre y células tumorales circulantes en biopsia líquida
    - Describir si la expresión de PD-L1 es un biomarcador predictivo para ORR
    - Describir la Supervivencia Libre de Progresión (PFS) en la población PD-L1 + (> = 1%)
    - Informe de la respuesta de imagen vs tasa de respuesta patológica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. The subjects eligible for the study are those with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to version 7 of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and previously untreated

    2. Tumor should be considered resectable before study entry by a multidisciplinary team

    3. Performance Status of 0 or 1 if using ECOG/Zubrod

    4. Screening laboratory values must meet the following criteria and should be obtained within 14 days prior to registration/inclusion
    i. WBC ≥ 2000/μL
    ii. Neutrophils ≥ 1500/μL
    iii. Platelets ≥ 100 x103/μL
    iv. Hemoglobin > 9.0 g/dL
    v. Serum creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥ 40 mL/min (if using the Cockcroft-Gault formula below):
    a. Female CrCl = (140 - age in years) x weight in kg x 0.85
    vi. AST/ALT ≤ 3 x ULN
    vii. Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total bilirubin < 3.0 mg/dL)
    viii. The patients need to have a forced expiratory volume (FEV1) ≥ 1.2 liters
    ix. INR/APTT within normal limits

    5. All patients are notified of the investigational nature of this study and signed a written informed consent in accordance with institutional and national guidelines, including the Declaration of Helsinki prior to any trial-related intervention

    Age and Reproductive Status

    6. Patients aged > 18 years

    7. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. WOCBP should use an adequate method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drug
    Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of nivolumab
    8. Women must not be breastfeeding
    9. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 31 weeks after the last dose of investigational product. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile as well as azoospermic men do not require contraception)
    1. Los sujetos elegibles para el estudio son aquellos con NSCLC histológicamente o citológicamente documentados que presentan la enfermedad en estadio IIIA (según la versión 7 de la Asociación Internacional para el Estudio del Manual de Estadificación del Cáncer de Pulmón en Oncología Torácica) y previamente no tratados

    2. El tumor debe considerarse resecable antes del ingreso al estudio por un equipo multidisciplinario

    3. Estado de rendimiento de 0 o 1 si utiliza ECOG / Zubrod

    4. Los valores del laboratorio de cribado deben cumplir los siguientes criterios y deben obtenerse dentro de los 14 días previos al registro / inclusión
    yo. WBC ≥ 2000 / μL
    Ii. Neutrófilos ≥ 1500 / μL
    Iii. Plaquetas ≥ 100 x 103 / μl
    Iv. Hemoglobina> 9,0 g / dl
    V. Creatinina sérica ≤ 1,5 x ULN o aclaramiento de creatinina (CrCl) ≥ 40 mL / min (si se usa la fórmula de Cockcroft-Gault a continuación):
    a. Femenino CrCl = (140 - edad en años) x peso en kg x 0,85
    Vi. AST / ALT ≤ 3 x LSN
    Vii. Bilirrubina total ≤ 1,5 x ULN (excepto los sujetos con síndrome de Gilbert, que pueden tener bilirrubina total <3,0 mg / dL)
    Viii. Los pacientes necesitan tener un volumen espiratorio forzado (FEV1) ≥ 1,2 litros
    Ix. INR / APTT dentro de los límites normales

    5. Todos los pacientes son notificados de la naturaleza investigativa de este estudio y firmaron un consentimiento informado por escrito de acuerdo con las directrices institucionales y nacionales, incluida la Declaración de Helsinki antes de cualquier intervención relacionada con el ensayo

    Edad y estado reproductivo

    6. Pacientes mayores de 18 años

    7. Las mujeres en edad fértil (WOCBP) deben utilizar métodos apropiados de anticoncepción. WOCBP debe utilizar un método adecuado para evitar el embarazo durante 23 semanas (30 días más el tiempo requerido para que el nivolumab se someta a cinco vidas medias) después de la última dosis de fármaco en investigación
    Las mujeres en edad fértil deben tener una prueba de embarazo en suero o orina negativa (sensibilidad mínima de 25 UI / L o unidades equivalentes de HCG) dentro de las 24 horas previas al inicio del nivolumab
    8. Las mujeres no deben estar amamantando
    9. Los hombres que son sexualmente activos con WOCBP deben usar cualquier método anticonceptivo con una tasa de fracaso de menos del 1% por año. Los hombres que reciben nivolumab y que son sexualmente activos con WOCBP serán instruidos para adherirse a la anticoncepción durante un período de 31 semanas después de la última dosis del producto en investigación. Las mujeres que no son potencialmente fértiles (es decir, que son postmenopáusicas o quirúrgicamente estériles, así como los hombres azoospérmicos no requieren anticoncepción)
    E.4Principal exclusion criteria
    1. All patients carrying activating mutations in the TK domain of EGFR or any variety of alterations in the ALK gene.

    2. Patients with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune thyroiditis only requiring hormone replacement, or unexpected conditions of recurrence in the absence of an external trigger are allowed to be included.

    3. Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of randomization. Inhaled or topical steroids, and adrenal replacement steroid doses > 10 mg daily prednisone equivalent, are permitted in the absence of active autoimmune disease.

    4. Patients with a history of interstitial lung disease cannot be included if they have sympthomatic ILD (Grade 3-4) and/or poor lung function. In case of doubt please contact trial team.

    5. Patients with other active malignancy requiring concurrent intervention and/or concurrent treatment with other investigational drugs or anti-cancer therapy

    6. Patients with previous malignancies (except non-melanoma skin cancers, and the following in situ cancers: bladder, gastric, colon, endometrial, cervical/dysplasia, melanoma, or breast) are excluded unless a complete remission was achieved at least 2 years prior to study entry AND no additional therapy is required during the study period.

    7. Any medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information

    8. Patients who have had prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell costimulation or immune checkpoint pathways

    9. Patients with positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
    10. Patients with known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
    11. Patients with history of allergy to study drug components excipients
    1. Todos los pacientes portadores de mutaciones activadoras en el dominio TK de EGFR o cualquier variedad de alteraciones en el gen ALK.

    2. Pacientes con enfermedad autoinmune activa, conocida o sospechada. Los sujetos con vitiligo, diabetes mellitus tipo I, hipotiroidismo residual debidos a tiroiditis autoinmune que sólo requieren reemplazo hormonal, o condiciones inesperadas de recurrencia en ausencia de un desencadenante externo pueden incluirse.

    3. Pacientes con una condición que requiera tratamiento sistémico con corticosteroides (> 10 mg diarios de prednisona equivalente) u otros medicamentos inmunosupresores dentro de los 14 días de la aleatorización. Los esteroides inhalados o tópicos y las dosis de esteroides de sustitución suprarrenal> 10 mg diarios de prednisona equivalente, se permiten en ausencia de enfermedad autoinmune activa.

    4. Los pacientes con antecedentes de enfermedad pulmonar intersticial no pueden ser incluidos si tienen enfermedad de ILD sintomática (grado 3-4) y / o función pulmonar deficiente. En caso de duda, comuníquese con el equipo de prueba.

    5. Los pacientes con otra neoplasia activa que requieran intervención simultánea y / o tratamiento concurrente con otros fármacos en investigación o terapia anticancerosa

    Se excluyen los pacientes con neoplasias malignas previas (excepto los cánceres de piel no melanoma y los siguientes cánceres in situ: vejiga, gástrico, colon, endometrio, cervical / displasia, melanoma o mama) a menos que se haya logrado una remisión completa al menos 2 años Antes de la entrada al estudio Y no se requiere terapia adicional durante el período de estudio.

    7. Cualquier condición médica, mental o psicológica que, en opinión del investigador, no permita al paciente completar el estudio o comprender la información del paciente

    8. Pacientes que han tenido tratamiento previo con un anticuerpo anti-PD-1, anti-PD-L1, anti-PD-L2, anticuerpo anti-CTLA-4 o cualquier otro anticuerpo o fármaco dirigido específicamente a la coestimulación de células T o punto de control inmunológico caminos

    9. Pacientes con prueba positiva de antígeno de superficie del virus de la hepatitis B (HBV sAg) o ácido ribonucleico del virus de la hepatitis C (anticuerpo del VHC) que indica infección aguda o crónica
    10. Los pacientes con antecedentes conocidos de pruebas positivas para el virus de la inmunodeficiencia humana (VIH) o el síndrome de inmunodeficiencia adquirida (SIDA)
    11. Pacientes con antecedentes de alergia a los excipientes de los componentes del fármaco del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) at 24 months from diagnosis
    Supervivencia libre de enfermedad a los 24 meses desde el diagnóstico
    E.5.1.1Timepoint(s) of evaluation of this end point
    at 24 months from diagnosis
    a los 24 meses desde el diagnóstico
    E.5.2Secondary end point(s)
    -toxicity profile of the combination, the down-staging rate, complete resection rate, time to progression and overall survival, surgical outcome and surgical complications.

    - Explore the expression of other biomarkers, such as PD-L1, in tumor tissue: at screening and after surgery (resected tumor sample), free DNA and circulating tumor cells in liquid biopsy, describe whether PD-L1 expression is a predictive biomarker for ORR

    - Describe Progression Free Survival (PFS) in PD-L1+ (>=1%) population

    - Report imaging response vs pathological response rate
    El perfil de toxicidad de la combinación, la tasa de estadificación descendente, la tasa de resección completa, el tiempo hasta la progresión y la supervivencia global, el resultado quirúrgico y las complicaciones quirúrgicas.

    - Explorar la expresión de otros biomarcadores, como PD-L1, en el tejido tumoral: en el cribado y después de la cirugía (muestra de tumor resecada), el ADN libre y las células tumorales circulantes en biopsia líquida, describen si la expresión de PD-L1 es un biomarcador predictivo para ORR

    - Describa la supervivencia libre de progresión (PFS) en la población PD-L1 + (> = 1%)

    - Informe de la respuesta de imagen vs tasa de respuesta patológica
    E.5.2.1Timepoint(s) of evaluation of this end point
    - Toxicity profile of the combination, the down-staging rate, complete resection rate, time to progression, overall survival, surgical outcome and surgical cmomplications at 3 years

    -Explore the expression of other biomarkers, such as PD-L1, in tumor tissue: at screening and after surgery, free DNA and circulating tumor cells in liquid biopsy, describe whether PD-L1 expression, at the end of the study (LPLV)
    - Describe Progression Free Survival (PFS) in PD-L1+ (>=1%) population at 24 months
    - Report imaging response vs pathological response rate at the end of the trial (LPLV)
    - El perfil de toxicidad de la combinación, la tasa de estadificación descendente, la tasa de resección completa, el tiempo hasta la progresión, la supervivencia global, el resultado quirúrgico y las complicaciones quirúrgicas a los 3 años

    -Explorar la expresión de otros biomarcadores, como PD-L1, en el tejido tumoral: en el cribado y después de la cirugía, el ADN libre y las células tumorales circulantes en biopsia líquida, describen si la expresión de PD-L1, al final del estudio (LPLV)
    - Describa la Supervivencia Libre de Progresión (PFS) en la población PD-L1 + (> = 1%) a los 24 meses
    - Informe de la respuesta de imagen vs tasa de respuesta patológica al final del ensayo (LPLV)
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned24
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee 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 years5
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    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: 46
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 46
    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 No
    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 state46
    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
    No
    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 Decision2017-01-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-19
    P. End of Trial
    P.End of Trial StatusOngoing
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