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    The EU Clinical Trials Register currently displays   43850   clinical trials with a EudraCT protocol, of which   7282   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:2014-004946-83
    Sponsor's Protocol Code Number:BR.31
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2015-03-30
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-004946-83
    A.3Full title of the trial
    A phase III prospective double blind placebo controlled randomized study of adjuvant MEDI4736 in completely resected non-small cell lung cancer
    III. FÁZISÚ PROSPEKTÍV, KETTŐS VAK, PLACEBOKONTROLLOS, RANDOMIZÁLT VIZSGÁLAT AZ ADJUVÁNS MEDI4736 ÉRTÉKELÉSÉRE TELJESEN RESZEKÁLT NEM KISSEJTES TÜDŐRÁKBAN SZENVEDŐ BETEGEKNÉL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of adjuvant MEDI4736 in completely resected cell lung cancer patients
    A.3.2Name or abbreviated title of the trial where available
    NA
    A.4.1Sponsor's protocol code numberBR.31
    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 SponsorClinipace Global Ltd.
    B.1.3.4CountryUnited Kingdom
    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 supportCCTG
    B.4.2CountryCanada
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinipace Global Ltd.
    B.5.2Functional name of contact pointEU Contact Point
    B.5.3 Address:
    B.5.3.1Street AddressAston Court, Kingsmead Business Park, Frederick Place
    B.5.3.2Town/ cityHigh Wycombe, Buckinghamshire
    B.5.3.3Post codeHP11 1JU
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+49 163 7855 983
    B.5.5Fax number +49 6196 7709 983
    B.5.6E-mailEUClinicalTrials@clinipace.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.3.2Product 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 INNNot Assigned
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameDurvalumab
    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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Completely resected non-small cell lung cancer
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    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 21.1
    E.1.2Level PT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess in comparison to placebo, the impact of adjuvant therapy with MEDI4736 given by intravenous infusion for one year on the disease free survival (DFS) of patients with completely resected (stage IB ≥ 4cm, stage II or IIIA), non-small cell lung cancer that is PD-L1 expression TC ≥ 25%, in patients with PD-L1 expression TC ≥ 1% and in all randomized patients.
    E.2.2Secondary objectives of the trial
    - OS in the MEDI4736 arm vs the placebo arm in patients with PD-L1 ≥ 25%, PD-L1 ≥ 1%, and in all randomized patients
    - Lung cancer specific survival in the MEDI4736 arm vs the placebo arm for patients with PD-L1 ≥ 25%, PD-L1 ≥ 1% as well as all randomized patient
    - Evaluate the nature, severity, and frequency of toxicities, between arms
    - Evaluate QoL between the two arms in PD-L1≥ 25%, PD-L1 ≥ 1% patients and in all randomized patients
    - To determine the survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile, and the factors influencing their preferences
    - Determine the incremental cost effectiveness and cost utility ratios for MEDI4736
    - To evaluate the prognostic and predictive significance of PD-L1 expression
    - To evaluate changes in blood and tissue based biomarkers after treatment with MEDI4736 and at the first disease event
    - To explore polymorphisms that may be associated with outcomes
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Economics (EQ-5D, Resource Utilization Assessment)
    - Patient reported outcome
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung according to WHO Classification of Tumours (WHO Classification of Tumours of the Lung, Pleura, Thymus and Heart. WHO/IARC Classification of Tumours, 4th Edition, Volume 7). Patients with large-cell neuroendocrine carcinomas are not eligible. Patients must have an adequate histopathology, must consent to release of an adequate histological specimen and the tissue blocks must be available for submission after registration. Patients with synchronous primary tumors will not be elegible
    - Patients must be classified post-operatively as Stage IB (≥ 4cm in the longest diameter), II or IIIA on the basis of pathologic criteria.
    - A pre-surgical PET scan of the thorax and a MRI or CT scan of the brain is considered standard of care and thus must be done prior to surgery. Patients in whom this was not done prior to surgery may still be enrolled providing that appropriate imaging is performed prior to randomization.
    - Complete surgical resection of the primary NSCLC is also mandatory.
    - Surgeons are strongly encouraged to dissect or sample all accessible nodal levels in accordance with the European Society of Thoracic Surgeons guidelines. It is recommended that a minimum of three lobe specific mediastinal nodal stations (N2), one of which should include station 7, and at least one N1 station - inclusive of the ones removed with the pulmonary specimen have been sampled at the end of the procedure.
    - If preoperative CT and/or PET are suspicious for mediastinal nodal involvement, it is recommended that invasive mediastinal staging with mediastinoscopy or EBUS-TBNA is performed.
    - Surgery may consist of lobectomy, sleeve resection, bilobectomy or pneumonectomy as determined by the attending surgeon based on the intraoperative findings. Patients who have had only segmentectomies or wedge resections are not eligible for this study.
    - Pre-operative (neo-adjuvant) platinum based or other chemotherapy is not permissible.
    - Patients may have received prior post-operative platinum based chemotherapy as per standard of care.
    - Patients who have not received adjuvant chemotherapy, and meet all other eligibility criteria, may be eligible under the circumstances specified in the protocol.
    - No prior anticancer therapy for treatment of NSCLC other than standard post-operative adjuvant chemotherapy is permissible.
    - Patients with N2 disease only who receive adjuvant post-operative radiation therapy are eligible provided they meet the protocol specified timing criteria for surgery, adjuvant chemotherapy and randomization. Pre-operative radiation therapy is not permissible.
    - Timing between surgery and adjuvant chemotherapy and randomization according to the protocol
    - The patient must have an ECOG performance status of 0, 1.
    - Hematology done within 14 days prior to randomization and with values within the ranges specified in the protocol
    - Biochemistry done within 14 days prior to randomization and with values within the ranges specified in the protocol
    - Other investigations detailed in the section 6 of the protocol must have been performed within the timelines indicated.
    - Patient able (i.e. sufficiently fluent) and willing to complete the questionnaires
    - Patient consent must be appropriately obtained
    - Patients must be accessible for treatment and follow-up
    - Protocol treatment is to begin within 2 working days of patient randomization.
    - Age of at least 18 years
    E.4Principal exclusion criteria
    - Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other malignancies curatively treated with no evidence of disease for ≥ 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
    - A combination of small cell and non-small cell lung cancer, pulmonary carcinoid tumour or large-cell neuroendocrine carcinoma (LCNEC)
    - History of autoimmune disease
    - History of primary immunodeficiency, history of allogenic organ transplant, use of immunosuppressive agents within 28 days of randomization or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
    - Live attenuated vaccination administered within 30 days prior to randomization.
    - History of hypersensitivity to MEDI4736 or any excipient.
    - Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction. Patients with a significant cardiac history, even if controlled, must have a LVEF > 50% within 12 weeks prior to randomization.
    - Concurrent treatment with other investigational drugs or anti-cancer therapy.
    - Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol.
    - Pregnant or lactating women.
    E.5 End points
    E.5.1Primary end point(s)
    DFS for patients with NSCLC that is PD-L1 expression TC ≥ 25%, in patients with PD-L1 expression TC ≥ 1%.
    Disease free survival (DFS) in all randomized patients
    E.5.1.1Timepoint(s) of evaluation of this end point
    Follow-up for disease event and survival (q12 weeekly until 2 years from randomization, then q6 months in year 3 then annualy until disease event). After disease event follow-up for survival (q6 months until 3 years from randomization, then annualy).
    E.5.2Secondary end point(s)
    - OS for patients with with PD-L1≥ 25%, PD-L1 ≥ 1%, and in all randomized patients.
    - Lung cancer specific survival for patients with PD-L1 ≥ 25%, PD-L1 ≥1% and all randomized patients.
    - Adverse effects and tolerability of MEDI4736.
    - Quality of life in PD-L1 ≥ 25%, PD-L1 ≥ 1% patients and in all randomized patients.
    - Survival benefits participants judge necessary to make adjuvant immunotherapy worthwhile.
    - Economic evaluation (cost effectiveness and cost utility).
    - Evaluation of predictive/prognostic significance of PD-L1 expression.
    - Evaluation of changes in plasma/serum cytokines and other blood and tissue based biomarkers after treatment with MEDI4736 and at disease event.
    - Exploratory pharmacogenomic assays (baseline only).
    E.5.2.1Timepoint(s) of evaluation of this end point
    According to protocol schedules
    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 Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA149
    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
    Canada
    China
    France
    Hungary
    Italy
    Japan
    Korea, Republic of
    Netherlands
    New Zealand
    Poland
    Singapore
    Spain
    Taiwan
    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
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years11
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years11
    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: 748
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 612
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 500
    F.4.2.2In the whole clinical trial 1360
    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)
    The patient will be followed according to standard of care
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation Canadian Cancer Trials Group
    G.4.3.4Network Country Canada
    G.4 Investigator Network to be involved in the Trial: 2
    G.4.1Name of Organisation Intergroupe Francophone de Cancerologie Thoracique (IFCT)
    G.4.3.4Network Country France
    G.4 Investigator Network to be involved in the Trial: 3
    G.4.1Name of Organisation Central and East European Oncology Group (CEEOG)
    G.4.3.4Network Country Poland
    G.4 Investigator Network to be involved in the Trial: 4
    G.4.1Name of Organisation National Cancer Institute, Naples (NCI-Naples)
    G.4.3.4Network Country Italy
    G.4 Investigator Network to be involved in the Trial: 5
    G.4.1Name of Organisation Dutch Society for Pulmonology and Tuberculosis (NVALT)
    G.4.3.4Network Country Netherlands
    G.4 Investigator Network to be involved in the Trial: 6
    G.4.1Name of Organisation Korean Cancer Study Group
    G.4.3.4Network Country Korea, Republic of
    G.4 Investigator Network to be involved in the Trial: 7
    G.4.1Name of Organisation Australasian Lung cancer Trials Group (ALTG) & NHMRC Clinical Trials Centre (CTC)
    G.4.3.4Network Country Australia
    G.4 Investigator Network to be involved in the Trial: 8
    G.4.1Name of Organisation Spanish Lung Cancer Group (SLCG)
    G.4.3.4Network Country Spain
    G.4 Investigator Network to be involved in the Trial: 9
    G.4.1Name of Organisation Western Japan Oncology Group (WJOG)
    G.4.3.4Network Country Japan
    G.4 Investigator Network to be involved in the Trial: 10
    G.4.1Name of Organisation Chinese Thoracic Oncology Group (CTONG)
    G.4.3.4Network Country China
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2015-06-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-28
    P. End of Trial
    P.End of Trial StatusOngoing
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