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    The EU Clinical Trials Register currently displays   43845   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:2020-000612-30
    Sponsor's Protocol Code Number:D910MC00001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-09-07
    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 number2020-000612-30
    A.3Full title of the trial
    A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study of Durvalumab for the Treatment of Stage II-III NSCLC Patients with Minimal Residual Disease Following Surgery and Curative Intent Therapy (MERMAID-2)
    Randomizowane, wieloośrodkowe badanie fazy III prowadzone metodą podwójnie ślepej próby z kontrolą placebo, oceniające durwalumab w leczeniu pacjentów z niedrobnokomórkowym rakiem płuc w II i III stopniu zaawansowania z minimalną chorobą resztkową po zabiegu chirurgicznym i terapii z intencją wyleczenia (MeRmaiD-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III study to evaluate the efficacy and safety of durvalumab compared to placebo in patients with NSCLC who have minimal residual disease after surgery +/- additional therapy before or after surgery.
    Badanie kliniczne fazy III oceniające skuteczność i bezpieczeństwo leczenia durwalumabem w porównaniu z placebo u pacjentów z niedrobnokomórkowym rakiem płuc z minimalną chorobą resztkową po zabiegu chirurgicznym z/bez dodatkowego leczenia przed lub po zabiegu operacyjnym
    A.3.2Name or abbreviated title of the trial where available
    MERMAID-2
    MERMAID-2
    A.4.1Sponsor's protocol code numberD910MC00001
    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 supportMedImmune
    B.4.2CountryUnited Kingdom
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstra Zeneca
    B.5.2Functional name of contact pointInformation 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.5.6E-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
    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 stage II-III NSCLC
    Niedrobnokomórkowy rak płuca w stadium II-III po doszczętnej resekcji
    E.1.1.1Medical condition in easily understood language
    Patients with NSCLC who have minimal residual disease after surgery +/- additional therapy before or after surgery.
    Pacjenci z niedrobnokomórkowym rakiem płuc z minimalną chorobą resztkową po zabiegu chirurgicznym z/bez dodatkowego leczenia przed lub po zabiegu operacyjnym
    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 assess the efficacy of durvalumab compared to placebo as measured by DFS (using Investigator assessment according to RECIST 1.1.) in the PD-L1 TC≥1% analysis set
    Ocena skuteczności durwalumabu w porównaniu z placebo na podstawie pomiaru czasu przeżycia wolny od choroby (DFS) (z użyciem oceny badacza wg kryteriów RECIST 1.1) w badanej populacji o ekspresji PD-L1 TC>1%
    E.2.2Secondary objectives of the trial
    1.To assess the efficacy of durvalumab compared to placebo as measured by DFS in all randomized
    patients (using investigator assessment according to RECIST 1.1);
    2.To assess the efficacy of durvalumab compared to placebo as measured by DFS in the PD-L1 TC≥1% analysis set and in all randomized patients (using BICR assessment according to RECIST 1.1);
    3.To assess the efficacy of durvalumab compared to placebo on post-recurrence outcomes;
    4.To assess the efficacy of durvalumab compared to placebo as measured by OS in the PD-L1 TC≥1%
    analysis set and in all randomized patients;
    5.To assess patient-reported symptoms, functioning, and HRQoL in patients treated with durvalumab
    compared to placebo;
    6.To investigate the relationship between a patient’s baseline PD-L1 TC expression and efficacy of study treatments
    1.Ocena skuteczności durwalumabu w porównaniu z placebo mierzona długością DFS u wszystkich zrandomizowanych pacjentów (z użyciem oceny badacza wg kryteriów RECIST 1.1)
    2.Ocena skuteczności durwalumabu w porównaniu z placebo na podstawie pomiaru DFS w badanej populacji o ekspresji PD-L1 TC>1% i u wszystkich zrandomizowanych pacjentów (z użyciem oceny BICR wg kryteriów RECIST 1.1)
    3.Ocena skuteczności durwalumabu w porównaniu z placebo na podstawie wyników badań wykonywanych po wznowie
    4.Ocena skuteczności durwalumabu w porównaniu z placebo na podstawie pomiaru ogólnego czasu przeżycia (OS) w badanej populacji o ekspresji PD-L1 TC>1% i u wszystkich zrandomizowanych pacjentów
    5.Ocena objawów zgłaszanych przez pacjenta, funkcjonowania i jakości życia związanej ze zdrowiem fizycznym (HRQoL) u pacjentów leczonych durwalumabem w porównaniu z placebo
    6.Zbadanie relacji pomiędzy wyjściową ekspresją PD-L1 na komórkach guza (TC) pacjenta a skutecznością badanych form leczenia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent, which includes a mandatory genetic informed consent and compliance with the requirements and restrictions listed in the informed consent forms (ICFs) and study protocol
    2. Age ≥18 years at the time of screening
    3. Diagnosis of histologically confirmed NSCLC (WHO 2015 classification) with resectable (stage II-III) disease
    4. Complete resection of the primary NSCLC
    1.Zdolność do udzielenia świadomej zgody, która zakłada obowiązkową zgodę na badania genetyczne oraz przestrzeganie wymogów i ograniczeń wskazanych w formularzach świadomej zgody i protokole badania
    2.Co najmniej 18 lat w momencie rozpoczęcia okresu przesiewowego
    3.Histologicznie potwierdzony, resekcyjny NDRP w II–III stadium zaawansowania (zgodnie z klasyfikacją WHO 2015)
    4.Całkowita resekcja pierwotnego NDRP
    E.4Principal exclusion criteria
    1.EGFR and/or ALK mutant as assessed either from the tumor biopsy taken prior to surgery or the resected tumor tissue. Testing must be performed using a well-validated, local regulatory approved test;
    2.Require re-resection or are deemed to have unresectable NSCLC by a multidisciplinary
    evaluation that must include a thoracic surgeon who perform lung cancer surgery as a
    significant part of their practice;
    3.History of allogeneic organ or bone marrow transplantation;
    4.Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection;
    1.Mutacja genu EGFR i/lub ALK stwierdzona na podstawie biopsji guza pobranej przed operacją lub na podstawie resekowanej tkanki guza. Badanie musi być wykonane z zastosowaniem Badanie musi zostać wykonane z zastosowaniem procedur odpowiednio zweryfikowanych i zatwierdzonych przez lokalny organ nadzorujący
    2.Konieczność wykonania powtórnej resekcji lub stwierdzenie nieresekcyjności NDRP przez zespół multidyscyplinarny, w skład którego wchodzi torakochirurg, którego istotną część praktyki stanowią operacje raka płuc
    3.Allogeniczny przeszczep narządu lub szpiku kostnego w wywiadzie
    4.Przetaczanie krwi pełnej bezleukocytarnej w okresie 120 dni od pobrania próbki krwi do badań genetycznych
    E.5 End points
    E.5.1Primary end point(s)
    DFS in PD-L1 TC≥1% (using Investigator assessments according to RECIST 1.1)
    Analiza DFS w PD-L1 TC≥1% (z użyciem oceny badacza wg kryteriów RECIST 1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 3 years
    około 3 lat
    E.5.2Secondary end point(s)
    1. DFS in FAS (using Investigator assessments according to RECIST 1.1)
    2. DFS (using BICR assessments according to RECIST 1.1) in PD-L1 TC≥1% and in FAS
    3. PFS (using local standard practice)
    4. Time to first subsequent therapy (TFST)
    5. Time to second subsequent therapy (TSST)
    6. OS in PD-L1 TC≥1% and in FAS
    7. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13
    8. IHC analysis of PD-L1 TC expression and spatial distribution within the tumor microenvironment
    relative to efficacy outcomes (ie, DFS, OS)
    1.Analiza czasu przeżycia wolnego od choroby ( DFS) w populacja objętej analizą (FAS) (z użyciem oceny badacza wg kryteriów RECIST 1.1)
    2.Analiza DFS (z użyciem oceny BICR wg kryteriów RECIST 1.1) u pacjentów PD-L1 TC≥1% i w FAS
    3.Długość czasu przeżycia bez progresji (PFS) (z zastosowaniem lokalnej praktyki)
    4.Czas do pierwszej kolejnej terapii (TFST)
    5.Czas do drugiej kolejnej terapii (TSST)
    6.Analiza OS u pacjentów PD-L1 TC≥1% i w FAS
    7.Zmiana od punktu początkowego i czas do pogorszenia w kwestionariuszach EORTC QLQ-C30 i EORTC QLQ-LC13
    8.Analiza IHC ekspresji PD-L1 na TC i dystrybucji przestrzennej w mikrośrodowisku guza w stosunku do wyników skuteczności (tj. DFS, OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 5 years
    około 5 lat
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    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 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 concerned9
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA78
    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
    Hong Kong
    Peru
    Turkey
    Argentina
    Belgium
    Brazil
    Bulgaria
    Czechia
    Denmark
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Netherlands
    Romania
    Russian Federation
    Spain
    Sweden
    Switzerland
    Taiwan
    United States
    Vietnam
    France
    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
    The end of study is defined as the last expected visit/contact of the last subject undergoing the study.
    Zakończenie badania zdefiniowano jako ostatnią przewidzianą wizytę/kontakt z ostatnim pacjentem biorącym udział w badaniu
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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: 200
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 84
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 104
    F.4.2.2In the whole clinical trial 284
    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 Decision2020-10-15
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-12-10
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-15
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