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    Summary
    EudraCT Number:2019-004336-31
    Sponsor's Protocol Code Number:D4194C00009
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2020-06-18
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2019-004336-31
    A.3Full title of the trial
    A Phase II, Open-label, Multicenter, International Study of Durvalumab Following Radiation Therapy in Patients with Stage III, Unresectable Non-Small Cell Lung Cancer Who Are Ineligible for Chemotherapy (DUART)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a phase II, open-label, multi-centre study to determine the safety and tolerability of durvalumab in patients with non-small cell lung cancer who were treated with radiation therapy but are ineligible for chemotherapy
    A.3.2Name or abbreviated title of the trial where available
    DUART
    A.4.1Sponsor's protocol code numberD4194C00009
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04249362
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca AB
    B.1.3.4CountrySweden
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressForskargatan 18
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameDurvalumab
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNDURVALUMAB
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with Stage III unresectable Non-small cell lung cancer (NSCLC), who have an Eastern Cooperative Oncology Group (ECOG) PS of 0 to 2 and who are treated with radiotherapy but are ineligible for chemotherapy
    E.1.1.1Medical condition in easily understood language
    A specific type of 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 10029519
    E.1.2Term Non-small cell lung cancer stage III
    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 the safety and tolerability profile of durvalumab as defined by Grade 3 and Grade 4 PRAEs within 6 months from the initiation of durvalumab treatment
    E.2.2Secondary objectives of the trial
    -To assess the efficacy of durvalumab treatment in terms of PFS and OS
    -To further assess the efficacy of durvalumab treatment in terms of ORR and DoR
    -To assess the efficacy of durvalumab treatment in terms of lung cancer mortality
    -To further assess the safety and tolerability profile of durvalumab treatment, including all AEs
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genetic research.

    Blood sample will also be taken to allow for future exploratory research of genes/genetic factors that may influence response of durvalumab.
    E.3Principal inclusion criteria
    - Informed consent as detailed in the protocol.
    - 18 years or older at the time of signing the ICF.
    - Histologically-or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 [IASLC 2016]).
    (a) Imaging to rule out distant metastasis is required.
    (b) Endobronchial ultrasound with biopsy is encouraged in patients with suspected lymph node involvement.
    - Deemed ineligible for chemotherapy per Investigator assessment (eg, comorbidities, poor PS, etc).
    - Receipt of radiation therapy that was completed within 42 days prior to first IP dose administration in the study.
    - Patients must have received a total dose of radiation of 40 to 66 Gy (standard or hypofractionated BED). Further details are provided in the protocol.
    - Patients must not have progressed following radiation therapy, as per Investigator assessed RECIST 1.1 criteria as defined in the protocol.
    - WHO/ECOG PS of ≤ 2.
    - No prior exposure to immune-mediated therapy including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, and antiprogrammed cell death ligand 2 (anti-PD-L2) antibodies, excluding therapeutic anticancer vaccines.
    - Adequate organ and marrow function as defined in the protocol.
    - Must have a life expectancy of at least 12 weeks.
    - Body weight > 30 kg at enrollment and first IP dose administration
    - Male or female
    E.4Principal exclusion criteria
    - Patients with locally-advanced NSCLC whose disease has progressed following radiation therapy.
    - Mixed small cell lung cancer and NSCLC histology.
    - History of allogeneic organ transplantation.
    - Active or prior documented autoimmune or inflammatory disorders as defined in the protocol.
    - Uncontrolled intercurrent illness as defined in the protocol.
    - History of another primary malignancy except for (1) Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of durvalumab and of low potential risk for recurrence (2) Adequately treated nonmelanoma skin cancer or lentigo maligna without evidence of disease (3) Adequately treated carcinoma in situ without evidence of disease.
    - History of leptomeningeal carcinomatosis
    - History of active primary immunodeficiency
    - Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus (HIV; positive HIV 1/2 antibodies).
    - Any unresolved toxicity NCI CTCAE Grade ≥ 2 from previous anticancer therapy with the exception of alopecia, vitiligo, lymphopenia, and the laboratory values defined in the inclusion criteria
    -Patients with Grade ≥ 2 neuropathy will be evaluated on a case-by-case basis after consultation with the Study Physician.
    -Patients with irreversible toxicity not reasonably expected to be exacerbated by treatment with durvalumab may be included only after consultation with the Study Physician.
    - Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
    Prior/concomitant therapy
    - Receipt of live attenuated vaccine within 30 days prior to the first dose of durvalumab.
    - Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of durvalumab.
    - Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab. Please refer to protocol for exceptions.
    - Participation in another clinical study with an IP administered in the last 4 weeks
    - Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
    - Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment arm assignment

    Please refer to the protocol pages 38-39 for further criteria.
    E.5 End points
    E.5.1Primary end point(s)
    Grade 3 and Grade 4 PRAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Within 6 months after the initiation of durvalumab treatment.
    E.5.2Secondary end point(s)
    Median PFS according to RECIST 1.1 as assessed by the Investigator
    PFS6 and PFS12 according to RECIST 1.1 as assessed by the Investigator
    Median OS and OS12
    ORR according to RECIST 1.1 as assessed by the Investigator
    DoR according to RECIST 1.1 as assessed by the Investigator
    Lung cancer mortality
    AEs, SAEs, AESIs, imAEs, physical examinations, vital signs including BP, pulse, ECGs, and laboratory findings including clinical chemistry, hematology, and urinalysis
    E.5.2.1Timepoint(s) of evaluation of this end point
    Median PFS; proportion of patients progression-free at 6 and 12 months. Median OS; proportion of patients alive at 12 months.
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Patients will be enrolled into 2 cohorts according to the dose of radiotherapy received
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA46
    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
    France
    Italy
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 years3
    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 years3
    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: 30
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 120
    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 state45
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 139
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    After the final analysis, AstraZeneca will continue to supply open-label drug to patients receiving durvalumab up to completion of a patient's 12 month treatment.
    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 Decision2020-07-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-02
    P. End of Trial
    P.End of Trial StatusOngoing
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