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    Summary
    EudraCT Number:2018-001375-21
    Sponsor's Protocol Code Number:D419AC00002
    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:2018-08-07
    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 number2018-001375-21
    A.3Full title of the trial
    A Phase III Randomized, Open-Label, Multi-Center Study of Durvalumab (MEDI4736) Versus Standard of Care (SoC) Platinum-Based Chemotherapy as First Line Treatment in Patients with PD-L1-High Expression Advanced Non Small-Cell Lung Cancer (NSCLC)
    Globalne, wieloośrodkowe badanie III fazy, prowadzone z zastosowaniem metodyki próby otwartej i randomizacji, oceniające stosowanie durwalumabu w porównaniu ze standardową chemioterapią opartą na związkach platyny, podawanych w pierwszej linii u pacjentów z rozpoznaniem zaawansowanego niedrobnokomórkowego raka płuca (NDRP) o wysokiej ekspresji PD-L1 (ligandu receptora programowanej śmierci)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Durvalumab Versus Standard of Care in Advanced Non Small-Cell Lung Cancer
    Badanie oceniające (zastosowanie) durwalumab w porównaniu ze standardową chemioterapią u pacjentów z zaawansowanym niedrobnokomórkowym rakiem płuca
    A.3.2Name or abbreviated title of the trial where available
    Pearl
    Pearl
    A.4.1Sponsor's protocol code numberD419AC00002
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03003962
    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 pointInformation Center
    B.5.3 Address:
    B.5.3.1Street AddressN/A
    B.5.3.2Town/ cityN/A
    B.5.3.3Post codeN/A
    B.5.3.4CountrySweden
    B.5.4Telephone number+18772409479
    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.3.9.3Other descriptive nameMEDI4736
    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.IMP: 2
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationPoland
    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 namePaclitaxel
    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 INNPaclitaxel
    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.IMP: 3
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameCarboplatin
    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 INNCarboplatin
    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.IMP: 4
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameGemcitabine
    D.3.4Pharmaceutical form Powder 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 INNGemcitabine
    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.IMP: 5
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationPoland
    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 nameCisplatin
    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 INNCisplatin
    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.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 namePemetrexed
    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 INNPemetrexed
    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
    First line patients with Advanced Non Small-Cell Lung Cancer (NSCLC) with PD-L1 high membrane expression in tumoral tissue and lacking activating epdermal growth factor receptor (EGFR) mutations and anaplastic lymphoma kinase (ALK) infusions.
    Wcześniej nieleczeni pacjenci z zaawansowanym niedrobnokomórkowym rakiem płuca (NDRP) bez mutacji w genach receptora naskórkowego czynnika wzrostu (EGFR) i kinazy chłoniaka anaplastycznego (ALK), z wysoką ekspresją PD L1.
    E.1.1.1Medical condition in easily understood language
    Treatment naïve patients with specific type of lung cancer called 'non-small cell lung cancer'
    Chorzy z typem raka płuca nazywanym „niedrobnokomórkowym rakiem płuca” (NDRP)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 100000004864
    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 Standard of care
    (SoC) chemotherapy in all randomized patients and in patients who are
    at low risk of early mortality (EM)
    Ocena skuteczności durwalumabu w porównaniu z terapią standardową (SoC) u wszystkich zrandomizowanych pacjentów oraz w grupie pacjentów z niskim ryzykiem wczesnej śmiertelności (early mortality (EM))
    E.2.2Secondary objectives of the trial
    To assess the efficacy of durvalumab compared to SoC in terms of Overall survival (OS) in PD-L1 high patients and in PD-L1 high with low risk of EM population
    To assess the efficacy of durvalumab compared to SoC in terms of progression free survival (PFS), objective response rate (ORR), duration
    of response (DoR), proportion of patients alive at 18 months from
    randomization (OS18), proportion of patients alive at 24 months from randomization (OS24), proportion of patients alive and progression free at 12 months from randomization (APF12), and time from randomization to second progression (PFS2)
    To assess disease-related symptoms and Health-related quality of life (HRQoL) in patients treated with durvalumab compared to SoC using the European Organisation for Research and Treatment of Cancer (EORTC)30-item core quality of life questionnaire, version 3 (QLQ-C30 v3) and the 13-item lung cancer quality of life questionnaire (LC13) module
    To investigate the immunogenicity of durvalumab
    1.Ocena skuteczności durwalumabu w porównaniu ze SoC pod względem OS u pacjentów z wysokim PD L1 oraz wysokim PD L1 i niskim ryzykiem EM;
    2. Ocena skuteczności MEDI4736 w porównaniu ze SoC pod względem: czasu przeżycia bez progresji choroby (PFS), odsetka odpowiedzi obiektywnych (ORR), czasu trwania odpowiedzi (DoR), odsetka pacjentów żyjących 18 miesięcy po randomizacji (OS18), odsetka pacjentów żyjących 24 miesiące po randomizacji (OS24), odsetka pacjentów żyjących bez progresji choroby 12 miesięcy po randomizacji (APF12) i czasu od randomizacji do drugiej progresji choroby (PFS2);
    3. Ocena związanych z chorobą objawów i jakości życia uwarunkowanej stanem zdrowia (HRQoL) u pacjentów otrzymujących leczenie MEDI4736 w porównaniu ze SoC, przy użyciu kwestionariusza EORTC - 30-punktowego standardowego kwestionariusza jakości życia, wersja 3 (QLQ C30 wer. 3) oraz modułu 13-punktowwgo kwestionariusza jakości życia u pacjentów z rakiem płuca (LC13);
    4. Ocena immunogenności MEDI4736
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Aged at least 18 years
    - Documented evidence of Stage IV NSCLC
    - No sensitizing EGFR mutation or ALK rearrangement
    - Prior to randomization, patients have PD-L1 high membrane expression in tumoral tissue with the Ventana SP263 PD-L1 IHC assay determined by a reference laboratory
    - No prior chemotherapy or any other systemic therapy for advanced or metastatic NSCLC
    - World Health Organization (WHO) Performance Status of 0 or 1
    1. Wiek ≥18 lat podczas oceny przesiewowej;
    2. Udokumentowany NDRP w stadium IV;
    3. Nowotwory u pacjentów nie mogą wykazywać obecności uwrażliwiającej mutacji genu EGFR ani rearanżacji genu ALK;
    4. Przed randomizacją u pacjenta musi występować status wysokiej ekspresji PD L1 zdefiniowany jako ekspresja błonowa PD L1 w tkance nowotworu w teście immunohistochemicznym Ventana SP263 PD L1 przeprowadzonym w laboratorium referencyjnym;
    5. Pacjenci wcześniej nieleczeni z zastosowaniem chemioterapii lub jakakolwiek innej terapii ogólnoustrojowej w zaawansowanym NDRP.
    E.4Principal exclusion criteria
    • Prior chemotherapy or any other systemic therapy for advanced NSCLC
    • Mixed small-cell lung cancer and NSCLC histology, sarcomatoid variant
    • Brain metastases or spinal cord compression unless the patient is stable (asymptomatic, no evidence of new or emerging brain metastases) and off steroids for at least 14 days prior to start of study treatment
    • Prior exposure to Immunomodulatory therapy (IMT), including, but not limited to, other anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4), anti-programmed cell death1 (PD-1), anti-programmed cell death ligand 1 (PD-L1), or anti PD-L2 antibodies, excluding therapeutic anticancer vaccines
    • Active or prior documented inflammatory bowel disease
    • Active infection
    • Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab.
    1. Wcześniejsza chemioterapia lub jakakolwiek inna terapia ogólnoustrojowa w zaawansowanym NDRP;
    2. Mieszany rak płuca o histologii drobnokomórkowej i NDRP, wariant sarkomatoidalny.
    3. Przerzuty do mózgu lub ucisk na rdzeń kręgowy, z wyjątkiem przypadków, w których stan pacjenta jest stabilny (nie występują objawy; nie występują oznaki nowych lub powstających przerzutów do mózgu) a kortykosteroidy nie są przyjmowane przez co najmniej 14 dni przed rozpoczęciem badanego leczenia;
    4. Wcześniejsze leczenie immunologiczne, w tym w szczególności z zastosowaniem innych przeciwciał anty CTLA 4, anty PD 1, anty PD L1 i przeciwko ligandowi programowanej śmierci 2 (anty PD L2), z wyłączeniem leczniczych szczepionek przeciwnowotworowych;
    5. Aktywna lub przebyta, udokumentowana zapalna choroba jelit;
    6. Aktywne zakażenie;
    7. Stosowanie leków immunosupresyjnych obecnie lub w okresie 14 dni poprzedzających przyjęcie pierwszej dawki durwalumabu.
    E.5 End points
    E.5.1Primary end point(s)
    OS
    przeżycie całkowite (OS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    This is anticipated to be 47 months from first patient randomized.
    Zakładany termin to 47 miesiąc od daty randomizacji pierwszego pacjenta
    E.5.2Secondary end point(s)
    Overall survival
    Proportion of patients alive at 18 months from randomization (OS18)
    Proportion of patients alive at 24 months from randomization (OS24)
    Progression-free survival (PFS) using investigator assessments according to RECIST 1.1
    Objective response rate (ORR) using investigator assessments according to RECIST 1.1
    Duration of response (DoR) using investigator assessments according to RECIST 1.1
    Proportion of patients alive and progression free at 12 months from randomization (APF12) using investigator assessments according to RECIST 1.1
    Progression-free survival after subsequent anticancer therapy (PFS2)
    Health-related QoL measured by EORTC QLQ-C30 v3
    Disease-related symptoms measured by EORTC QLQ-LC13
    Changes in WHO/ECOG performance status
    The immunogenicity of durvalumab as assessed by presence of anti-drug antibodies (ADAs)
    1. Przeżycie całkowite (OS);
    2. Odsetek pacjentów żyjących 18 miesięcy po randomizacji (OS18);
    3. Odsetek pacjentów żyjących 24 miesiące po randomizacji (OS24);
    4. Czas przeżycia bez progresji choroby (PFS) na podstawie oceny badacza według kryteriów RECIST 1.1;
    5. Odsetek odpowiedzi obiektywnych (ORR) na podstawie oceny badacza według kryteriów RECIST 1.1;
    6. Czas trwania odpowiedzi (DoR) na podstawie oceny badacza według kryteriów RECIST 1.1;
    7. Oodsetek pacjentów żyjących bez progresji choroby 12 miesięcy po randomizacji (APF12) na podstawie oceny badacza według kryteriów RECIST 1.1;
    8. Czas od randomizacji do drugiej progresji choroby (PFS2);
    9. Ocena jakości życia uwarunkowanej stanem zdrowia (HRQoL) na podstawie EORTC QLQ C30;
    10.Ocena objawów związanych z chorobą u pacjentów z rakiem płuca na podstawie ERTC LC1;
    11.Zmiany stanu sprawności wg Wschodniej Grupy Współpracy Onkologicznej (ECOG)Światowej Organizacji Zdrowia (WHO);
    12.Immunogeniczność durwalumabu ocenia ba podstawie obecności obecność przeciwciał przeciwko durwalumabowi (ADA).
    E.5.2.1Timepoint(s) of evaluation of this end point
    Until end of study
    Do zakończenia badania
    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 No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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) Yes
    E.8.2.2Placebo No
    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 concerned12
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA27
    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
    China
    Hungary
    Korea, Republic of
    Netherlands
    Poland
    Russian Federation
    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
    last visit of the last subject
    „LVLS” (Last Visit Last Subject)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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
    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: 430
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 90
    F.4.2.2In the whole clinical trial 650
    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 Decision2018-09-26
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-23
    P. End of Trial
    P.End of Trial StatusOngoing
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