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    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   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:2018-002997-29
    Sponsor's Protocol Code Number:D9106C00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2020-03-16
    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 number2018-002997-29
    A.3Full title of the trial
    A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/adjuvant Durvalumab for the Treatment of Patients with Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)
    Międzynarodowe, wieloośrodkowe badanie fazy III, prowadzone metodą podwójnie ślepej próby z kontrolą placebo, oceniające durwalumab w terapii neoadjuwantowej/adjuwantowej w leczeniu pacjentów z niedrobnokomórkowym rakiem płuc w II i III stopniu zaawansowania (AEGEAN)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Durvalumab Before and After Surgery for Patients with Operable Non-Small Cell Lung Cancer.
    Badanie oceniające durwalumab w terapii przed oraz po operacji w leczeniu pacjentów z operacyjnym niedrobnokomórkowym rakiem płuc.
    A.3.2Name or abbreviated title of the trial where available
    AEGEAN
    AEGEAN
    A.4.1Sponsor's protocol code numberD9106C00001
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03800134
    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 AB
    B.5.2Functional name of contact pointStudy Information Center
    B.5.3 Address:
    B.5.3.1Street AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.4Telephone number+1877 7240 9479
    B.5.6E-mailInformation.center@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.3.10 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 resectable Non-small Cell Lung Cancer (Stage IIA to IIIB; either squamous or non-squamous)
    Pacjenci z operacyjnym niedrobnokomórkowym rakiem płuc (faza IIA do IIIB płaskonabłonkowym lub niepłaskonabłonkowym)
    E.1.1.1Medical condition in easily understood language
    Patients with "non-small cell lung cancer" (NSCLC) at a specific stage (Stage IIA to IIIB)
    Pacjenci z niedrobnokomórkowym rakiem płuc (NDRP) w określonej fazie (faza IIA do IIIB)
    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 10061873
    E.1.2Term 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
    To compare the efficacy of durvalumab + chemotherapy administered prior to surgery followed
    by durvalumab post-surgery compared with placebo + chemotherapy administered prior to surgery
    followed by placebo post-surgery in terms of EFS
    To compare the activity of durvalumab + chemotherapy administered prior to surgery compared with placebo + chemotherapy administered prior to surgery in terms of pCR
    E.2.2Secondary objectives of the trial
    - To compare the efficacy of perioperative durvalumab + neoadjuvant
    - chemotherapy compared with placebo + neoadjuvant chemotherapy in terms of DFS
    - To compare the efficacy of perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy in terms of MPR
    - To compare the efficacy of perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy in terms of OS
    - To compare the efficacy of perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy in patients with PD-L1 TC ≥1% tumors in terms of EFS, pCR, DFS, MPR and OS
    - To assess disease-related symptoms and HRQOL in patients treated with perioperative durvalumab + neoadjuvant chemotherapy compared with placebo + neoadjuvant chemotherapy
    - To assess the PK and immunogenicity of durvalumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Age ≥18 years
    2. Newly diagnosed and previously untreated patients with histologically or cytologically documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease
    3. World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment
    4. At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target Lesion (TL) at baseline
    5. No prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic anticancer vaccines.
    6. Adequate organ and marrow function
    7. Confirmation of a patients tumour PD-L1 status
    8. Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR and ALK status
    9. Planned surgery to be performed need to include lobectomy, sleeve resection or bilobectomy.
    10. A pre- or post-bronchodilator FEV of 1.0 L and >40% post-operative predicted value.
    1. Wiek ≥18 lat
    2. Nowo zdiagnozowani lub wcześniej nieleczeni pacjenci z udokumentowanym histologicznie lub cytologicznie operacyjnym NDRP (stopień zaawansowania IIA do wybranych przypadków [tj. N2] IIIB)
    3. Stan sprawności (PS) w skali Światowej Organizacji Zdrowia (WHO) /ECOG musi wynosić 0 lub 1 w chwili włączenia do badania
    4. Co najmniej jedna zmiana, która nie była wcześniej naświetlana i która została sklasyfikowana jako zmiana docelowa wg kryteriów RECIST 1.1 podczas oceny wyjściowej.
    5. Niestosowanie wcześniej leczenia immunologicznego, w tym w szczególności innych przeciwciał anty CTLA 4, anty PD-1, anty PD-L1 i anty PD-L2, z wyłączeniem leczniczych szczepionek przeciwnowotworowych
    6. Wydolna czynność narządów i szpiku kostnego
    7. Potwierdzony status ekspresji PD-L1
    8. Dostarczenie wystarczającej próbki biopsji do oceny i potwierdzenia statusu receptora naskórkowego czynnika wzrostu (EGFR) i kinazy chłoniaka anaplastycznego (ALK)
    9. Planowana operacja musi obejmować lobektomię, resekcję rękawową lub bilobektomię.
    10. FEV przed lub po leku rozszerzającym oskrzela o wartości 1,0 L oraz > 40% przewidywanej wartości pooperacyjnej.
    E.4Principal exclusion criteria
    1. History of allogeneic organ transplantation
    2. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome).
    3. History of another primary malignancy
    4. History of active primary immunodeficiency
    5. Active infection including tuberculosis hepatitis B and C, or human immunodeficiency virus
    6. Deemed unresectable NSCLC by multidisciplinary evaluation
    7. Patients who have pre-operative radiotherapy treatment as part of their care plan
    8. Patients who have brain metastases or spinal cord compression
    9. Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC
    10. Known allergy or hypersensitivity to any of the study drugs or excipients
    11. Existence of more than one primary tumour such as mixed small cell and NSCLC histology
    12. Patients who are candidates to undergo only pneumonectomy, segmentectomies or wedge resections.
    13. Patients with a documented test result confirming the presence of EGFRm or ALK translocation.
    1. Stan po allogenicznym przeszczepieniu narządu
    2. Udokumentowane aktywne lub wcześniej przebyte choroby autoimmunologiczne lub zapalne (w tym choroba zapalna jelit, zapalenie uchyłków, toczeń rumieniowaty układowy, sarkoidoza lub zespół Wegenera)
    3. Inny pierwotny nowotwór złośliwy w wywiadzie
    4. Aktywny pierwotny niedobór immunologiczny w wywiadzie
    5. Aktywne zakażenie, w tym gruźlica, wirusowe zapalenie wątroby typu B lub C lub ludzkim wirusem niedoboru odporności
    6. NDRP uznany za nieoperacyjny na podstawie oceny wielodyscyplinarnej
    7. Pacjenci poddawani radioterapii przedoperacyjnej w ramach planu opieki
    8. Pacjenci z przerzutami do mózgu lub uciskiem na rdzeń kręgowy
    9. NDRP w stopniu zaawansowania IIIB N3 oraz IIIC, IVA i IVB
    10. Znana alergia lub nadwrażliwość na którykolwiek z badanych leków lub substancję pomocniczą
    11. Obecność więcej niż jednego guza pierwotnego, takiego jak mieszany drobnokomórkowy i niedrobnokomórkowy rak płuca
    12. Pacjenci, którzy są kandydatami wyłącznie do przeprowadzenia pneumonektomii, segmentektomii lub resekcji klinowej
    13. Pacjenci z udokumentowanym wynikiem badania potwierdzającym obecność mutacji EGFR lub translokacji genu ALK
    E.5 End points
    E.5.1Primary end point(s)
    Event-free Survival (EFS) and pathological Complete Response (pCR) in modified intent-to-treat (mITT).
    E.5.1.1Timepoint(s) of evaluation of this end point
    approximately 7 months after last patient randomized and up to 5.5 years after FSR
    E.5.2Secondary end point(s)
    1. DFS in the modified resected population
    2. mPR (≤10% viable tumour cells in lung primary tumour after complete evaluation in the resected lung cancer specimen)
    3. OS
    4. EFS, pCR, DFS, mPR, OS in the population with PD-L1 TC ≥1%.
    5. Change from baseline in Patient reported outcomes and time to deterioration
    6. Concentration of durvalumab
    7. Presence of ADAs for durvalumab
    E.5.2.1Timepoint(s) of evaluation of this end point
    approximately 5.5 years after last patient randomized
    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 Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    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) 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 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 EEA75
    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
    Chile
    Costa Rica
    Peru
    Philippines
    Taiwan
    Brazil
    Canada
    China
    India
    Japan
    Korea, Republic of
    Mexico
    Russian Federation
    Thailand
    United States
    Viet Nam
    Austria
    Belgium
    Bulgaria
    France
    Germany
    Hungary
    Italy
    Netherlands
    Poland
    Romania
    Spain
    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
    LVLS (Last Visit Last Subject)
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years5
    E.8.9.2In all countries concerned by the trial months6
    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: 280
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 520
    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 275
    F.4.2.2In the whole clinical trial 800
    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
    Nie dotyczy
    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 Decision2020-05-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-04-22
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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