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    The EU Clinical Trials Register currently displays   43628   clinical trials with a EudraCT protocol, of which   7211   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:2020-000556-35
    Sponsor's Protocol Code Number:D910LC00001
    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:2020-06-30
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2020-000556-35
    A.3Full title of the trial
    A Phase III, Randomized, Multicenter, Double-blind, Placebo-controlled Study to Determine the Efficacy of Adjuvant Durvalumab in Combination with Platinum-based Chemotherapy in Completely Resected Stage II-III NSCLC (MeRmaiD-1)
    Wieloośrodkowe badanie fazy III prowadzone metodą podwójnie ślepej próby z kontrolą placebo, oceniające skuteczność terapii adjuwantowej z wykorzystaniem durwalumabu w połączeniu z chemioterapią opartą na pochodnych platyny w leczeniu pacjentów z niedrobnokomórkowym rakiem płuc w II i III stopniu zaawansowania po kompletnej resekcji (MeRmaiD-1)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase III study to determine the efficacy of Durvalumab in combination with chemotherapy in completely resected stage II-III non-small cell lung cancer.
    Badanie fazy III oceniające skuteczność terapii durwalumabem w połączeniu z chemioterapią opartą na pochodnych platyny w leczeniu pacjentów z niedrobnokomórkowym rakiem płuc w II i III stopniu zaawansowania po kompletnej resekcji
    A.3.2Name or abbreviated title of the trial where available
    MeRmaiD-1
    A.4.1Sponsor's protocol code numberD910LC00001
    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 Ltd
    B.4.2CountryUnited Kingdom
    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 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 injection/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 (NDRP) w II i III stadium zaawansowania po kompletnej resekcji
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called “Non-Small Cell Lung Cancer” at specific stage (stage II/III)
    Specyficzny typ raka płuc o nazwie „niedrobnokomórkowy rak płuca” na szczególnym etapie zaawansowania choroby (stadium II/III)
    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 + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in MRD+ patients
    Ocena skuteczności durwalumabu w skojarzeniu z chemioterapią SoC w porównaniu z placebo w skojarzeniu z chemioterapią SoC, mierzona długością czasu przeżycia wolnego od choroby (DFS), na podstawie oceny badacza, u pacjentów z chorobą resztkową (MRD+)
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy as measured by DFS using investigator assessment according to RECIST 1.1 in all patients
    2. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC
    chemotherapy as measured by DFS using BICR assessments according to RECIST 1.1 in MRD+ patients and in all patients
    3. To assess the efficacy of durvalumab + SoC chemotherapy compared to placebo + SoC
    chemotherapy as measured by OS in MRD+ patients and in all patients
    4. To assess patient-reported symptoms, functioning, and HRQoL in MRD+ patients treated with
    durvalumab + SoC chemotherapy compared to placebo + SoC chemotherapy
    5. To assess the PK of durvalumab
    6. To investigate the immunogenicity of durvalumab
    1. Ocena skuteczności durwalumabu w skojarzeniu z chemioterapią SoC w porównaniu do placebo w skojarzeniu z chemioterapią SoC, mierzona długością DFS, na podstawie oceny badacza, u wszystkich pacjentów
    2. Ocena skuteczności durwalumabu w skojarzeniu z chemioterapią SoC w porównaniu z placebo w skojarzeniu z chemioterapią SoC, mierzona długością DFS z użyciem ocen BICR wg kryteriów RECIST 1.1 u pacjentów MRD+ oraz u wszystkich pacjentów
    3. Ocena skuteczności durwalumabu w skojarzeniu z chemioterapii SoC w porównaniu z placebo w skojarzeniu z chemioterapią SoC, mierzona długością ogólnego czasu przeżycia (OS) u pacjentów MRD+ oraz u wszystkich pacjentów.
    4. Ocena objawów zgłaszanych przez pacjenta, funkcjonowania i jakości życia związanej ze zdrowiem fizycznym (HRQoL) u pacjentów MRD+ leczonych durwalumabem w skojarzeniu z chemioterapią SoC, w porównaniu z placebo w skojarzeniu z chemioterapią SoC.
    5. Ocena farmakokinetyki (PK) durwalumabu.
    6. Badanie immunogenności durwalumabu.
    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. Pacjenci muszą być w stanie wyrazić świadomą zgodę obejmującą obowiązkową świadomą zgodę na badanie genetyczne i zobowiązanie do przestrzegania wymagań oraz ograniczeń ujętych w treści formularzy świadomej zgody (ICF – z ang. Informed Consent Form) oraz protokołu badania
    2. Wiek ≥18 lat w okresie przesiewowym
    3. Osoby z rozpoznaniem histologicznie potwierdzonego NDRP (klasyfikacja WHO 2015) z kwalifikującą się do resekcji chorobą (stadium II-III)
    4. Całkowita resekcja pierwotnego NDRP jest obowiązkowa
    E.4Principal exclusion criteria
    1. Postoperative imaging demonstrating unequivocal evidence of disease recurrence or
    tissue biopsy-proven disease recurrence
    2. EGFR-mutant and/or ALK-translocation
    3. Mixed small cell and NSCLC histology
    4. Received any prior adjuvant therapy for NSCLC or any prior exposure to durvalumab
    1. Pooperacyjne badanie obrazowe jednoznacznie świadczące o wznowie choroby lub wznowa choroby potwierdzona wynikiem biopsji tkanki
    2. Mutacja genu EGFR i/lub translokacja genu ALK
    3. Cechy mieszane raka drobnokomórkowego i NDRP
    4. Jakiekolwiek wcześniejsze leczenie adjuwantowe pod kątem NDRP lub wcześniejsza ekspozycja na durwalumab
    E.5 End points
    E.5.1Primary end point(s)
    DFS in MRD+ analysis set (using Investigator assessments according to RECIST 1.1)
    Analiza DFS u pacjentów MRD+ (na podstawie oceny badacza wg RECIST 1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Approximately 4 years
    około 4 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 MRD+ analysis set and in FAS
    3. OS in MRD+ analysis set and in FAS
    4. Change from baseline and time to deterioration in EORTC QLQ-C30 and EORTC QLQ-LC13
    5.Concentration of durvalumab
    6. Presence of ADAs for durvalumab
    1. Analiza DFS w populacji objętej analizą (FAS) (na podstawie oceny badacza wg RECIST 1.1)
    2. Analiza DFS (z użyciem ocen BICR wg kryteriów RECIST 1.1) u pacjentów MRD+ i w FAS
    3. Analiza OS u pacjentów MRD+ i w FAS
    4. Zmiana od punktu początkowego i czas do pogorszenia w kwestionariuszach EORTC QLQ-C30 i EORTC QLQ-LC13
    5. Stężenie durwalumabu
    6. Obecność przeciwciał przeciwlekowych (ADA) w odniesieniu do durwalumabu
    E.5.2.1Timepoint(s) of evaluation of this end point
    Approximately 6 years
    około 6 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 Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA79
    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
    Australia
    Belgium
    Brazil
    Bulgaria
    Canada
    Czechia
    Denmark
    France
    Germany
    Hungary
    India
    Israel
    Italy
    Japan
    Korea, Republic of
    Mexico
    Netherlands
    Peru
    Poland
    Romania
    Russian Federation
    Spain
    Sweden
    Switzerland
    Taiwan
    Thailand
    Turkey
    United Kingdom
    United States
    Vietnam
    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 patient undergoing the
    study.
    Zakończenie badania zdefiniowano jako ostatnią zakładaną wizytę/kontakt ostatniego pacjenta uczestniczącego w badaniu.
    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 months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years4
    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: 232
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 160
    F.4.2.2In the whole clinical trial 332
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-09-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-09-10
    P. End of Trial
    P.End of Trial StatusOngoing
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