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    Summary
    EudraCT Number:2016-005225-37
    Sponsor's Protocol Code Number:16-12301
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-10
    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 ConcernedFinland - Fimea
    A.2EudraCT number2016-005225-37
    A.3Full title of the trial
    The ASTEROID trial - Ablative STEreotactic RadiOtherapy wIth Durvalumab
    (MEDI4736). An open label randomized phase II trial with durvalumab
    following Stereotactic Body radiotherapy (SBRT) in patients with stage I
    Non-small Cell Lung Cancer (NSCLC)
    Avoin satunnaistettu vaiheen II tutkimus, jossa durvalumabia annetaan stereotaktisen sädehoidon jälkeen ei-pienisoluisen, asteen I keuhkosyövän liitännäishoitona.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized trial assessing the addition of the immunotherapeutic drug
    durvalumab after high dose radiation in patients with localized early stage
    Non-small cell lung cancer
    Avoin satunnaistettu vaiheen II tutkimus, jossa durvalumabia annetaan stereotaktisen sädehoidon jälkeen ei-pienisoluisen, asteen I keuhkosyövän liitännäishoitona.
    A.3.2Name or abbreviated title of the trial where available
    Asteroid
    Asteroid
    A.4.1Sponsor's protocol code number16-12301
    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 SponsorSahlgrenska University Hospital
    B.1.3.4CountrySweden
    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 supportAstra Zeneca
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSahlgrenska university hospital
    B.5.2Functional name of contact pointClinical trial unit
    B.5.3 Address:
    B.5.3.1Street AddressBlå stråket 2, Dept of Oncology
    B.5.3.2Town/ cityGothenburg
    B.5.3.3Post code41345
    B.5.3.4CountrySweden
    B.5.4Telephone number46313421000
    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 Imfinzi
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.9.4EV 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 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 I Non-small cell lung cancer (NSCLC) that has been treated with
    Stereotactic Body Radiotherapy (SBRT).
    asteen I ei-pienisoluinen keuhkosyöpä, jonka sopivaksi hoitomuodoksi on arvioitu stereotaktinen sädehoito
    E.1.1.1Medical condition in easily understood language
    Early stage, i.e. localized Non-small cell lung cancer that has been
    treated with high dose radiotherapy.
    asteen I ei-pienisoluinen keuhkosyöpä, jonka sopivaksi hoitomuodoksi on arvioitu stereotaktinen sädehoito
    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
    To assess whether adjuvant immunotherapy with durvalumab
    administered after curatively intended SBRT in stage I NSCLC will
    increase time to progression
    voidaanko liitännäishoitona annettavalla durvalumabilla vähentää taudin uusiutumisriskiä tai viivyttää aikaa joka kuluu taudin etenemiseen.
    E.2.2Secondary objectives of the trial
    To assess whether adjuvant immunotherapy with durvalumab
    administered after curatively intended SBRT in stage I NSCLC will:
     Increase overall survival (1-, 2- 3-years)
     Increase disease free survival (DFS)
     Increase cause specific survival (1-, 2- 3-years)
     Increase time to progression depending on PDL1 expression
     Impact on relapse pattern
     Impact on local control
     Impact on Quality of life
     Impact on toxicity
    verrataan aikaa, joka kuluu hoidon aloituksesta siihen, että syöpä alkaa taas edetä ja arvioidaan haittavaikutuksia sekä toimintakykyä ja elämän laatua.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Written informed consent obtained from the subject prior to
    performing any protocol-related procedures, including screening
    evaluations
    • Histological or cytological diagnosis of NSCLC
    • Stage I tumours ≤ 5 cm
    • Peripheral tumours suitable for a fractionation schedule of 15 Gy x 3
    • Medically inoperable patients or patients refusing surgery
    • Received no prior chemotherapy or radiation therapy for NSCLC
    • Age > 18 years at time of study entry, no upper age limit
    • WHO performance status 0-2
    • Adequate normal organ and marrow function
    • Female subjects must either be of non-reproductive potential or must have a negative serum pregnancy test upon study entry
    • Subject is willing and able to comply with the protocol for the
    duration of the study including undergoing treatment and scheduled
    visits and examinations including follow up
    E.4Principal exclusion criteria
    • Centrally located tumours
    • Oxygen usage or a FEV1 < 0.7 L and CO diffusion capacity < 30%
    • Participation in another clinical study with an investigational product
    during the last 4 weeks
    • Any previous treatment with a PD1 or PD-L1 inhibitor, including
    durvalumab
    • Second primary residual malignancy. Other malignancy diagnosed
    and treated > 5 years ago without relapse is allowed. (Carcinoma in situ
    of the cervix or adequately treated basal cell carcinoma of the skin < 5
    years are allowed)
    • Mean QT interval corrected for heart rate (QTc) ≥470 ms calculated
    from 3 electrocardiograms (ECGs) using Frediricia's Correction
    • Current or prior use of immunosuppressive medication within 28 days
    before the first dose of durvalumab, with the exceptions of intranasal
    and inhaled corticosteroids or systemic corticosteroids at physiological
    doses, which are not to exceed 10 mg/day of prednisone, or an
    equivalent corticosteroid
    • Active or prior documented autoimmune disease within the past 2
    years
    • Active or prior documented inflammatory bowel disease, history of
    primary immunodeficiency, history of allogenic organ transplant, history
    of tuberculosis
    • Uncontrolled intercurrent Receipt of live attenuated vaccination
    within 30 days prior to study entry or within 30 days of receiving
    durvalumab
    • Any condition that, in the opinion of the investigator, would interfere
    with evaluation of study treatment or interpretation of patient safety or study results
    E.5 End points
    E.5.1Primary end point(s)
    Time to Progression (TTP)
    aika etenemiseen
    E.5.1.1Timepoint(s) of evaluation of this end point
    TTP is measured from the date of randomization to date of progression
    and will be assessed after 53 events (i.e. progression) have been
    recorded which is estimated to happen one year after the inclusion of the last subject.
    E.5.2Secondary end point(s)
    Overall survival (1-, 2- 3-years)
    - measured from date of randomization to death.
    Disease free survival (DFS)
    - measured from date of randomization to relapse or death.
    Cause specific survival (1-, 2- 3-years)
    - measured from date of randomization to death due to NSCLC.
    TTP by PDL1 expression
    - TTP analysed according to PDL1 expression on biopsy taken before
    study entry. Relapse pattern, Local, regional or distant relapse (organ
    specific).
    Local control
    -defined as no local progression at 36 months follow up
    Quality of life, Lung cancer symptom scale - LCSS at 6, 12, and 20
    months
    Toxicity, according to CTC version 4.0 at every follow up
    E.5.2.1Timepoint(s) of evaluation of this end point
    Toxicity with AE's and SAE's and will be followed continuously. In
    addition in-depths toxicity analyses are planned after inclusion of 50
    and 100 patients. As for the other secondary endpoints they will be
    assessed when the number of events for the primary analysis have been reached, see E.5.1.1.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Ei liitännäishoitoa
    No adjuvant therapy
    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 concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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 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 years4
    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 years6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 166
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 216
    F.4.2.2In the whole clinical trial 216
    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
    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 Swedish lung cancer study group
    G.4.3.4Network Country Sweden
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-08-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-10
    P. End of Trial
    P.End of Trial StatusOngoing
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