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    Summary
    EudraCT Number:2018-002572-41
    Sponsor's Protocol Code Number:D9103C00001
    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:2018-12-18
    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 number2018-002572-41
    A.3Full title of the trial
    A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab with Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515)
    Międzynarodowe, wieloośrodkowe badanie III fazy, prowadzone z zastosowaniem metodyki podwójnie ślepej próby i randomizacji, kontrolowane placebo, z durwalumabem z radioterapią stereotaktyczną (SBRT) w leczeniu pacjentów z nieoperowanym niedrobnokomórkowym rakiem płuc w stopniu I/II bez zajęcia węzłów chłonnych (PACIFIC-4/RTOG-3515)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of durvalumab or placebo administered with radiation therapy for patients with early stage non-small cell lung cancer
    Badanie oceniające durwalumab lub placebo podawane z radioterapią pacjentom z wczesnym stadium niedrobnokomórkowego raka płuca
    A.3.2Name or abbreviated title of the trial where available
    PACIFIC-4/RTOG-3515
    A.4.1Sponsor's protocol code numberD9103C00001
    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 AddressNot applicable
    B.5.3.2Town/ cityNot applicable
    B.5.3.3Post codeNot applicable
    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.3.9.3Other 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 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 TAGRISSO
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameOsimertinib 80 mg
    D.3.2Product code AZD9291
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOsimertinib
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291
    D.3.9.4EV Substance CodeSUB176340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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 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 TAGRISSO
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameOsimertinib 40 mg
    D.3.2Product code AZD9291
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNOsimertinib
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD92921
    D.3.9.4EV Substance CodeSUB176340
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution 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
    Patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer
    Pacjenci z nieoperowanym niedrobnokomórkowym rakiem płuc w stopniu I/II bez zajęcia węzłów chłonnych
    E.1.1.1Medical condition in easily understood language
    Specific type of lung cancer called “Non-Small Cell Lung Cancer”
    Określony rodzaj raka płuc zwany “Niedrobnokomórkowym Rakiem Płuca"
    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 LLT
    E.1.2Classification code 10029514
    E.1.2Term Non-small cell lung cancer NOS
    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
    Applicable to main cohort:
    To assess the efficacy of durvalumab with SoC SBRT compared to placebo with SoC SBRT in terms of PFS in patients with subset of T1T1 to T3N0M0 NSCLC

    Applicable to osimertinib cohort:
    To assess the efficacy of osimertinib following SoC SBRT in patients with T1 to T3N0M0 in terms of 4-year PFS
    E.2.2Secondary objectives of the trial
    Applicable to main cohort:
    To assess the efficacy of durvalumab with SBRT (Stereotactic Body Radiation Therapy) compared to placebo with SBRT in terms of:
    - PFS in patients with T1 to T3N0M0 NSCLC
    - Overall Survival
    - PFS24, TTP, TTDM, and PFS2

    To assess the PK of durvalumab
    To investigate the immunogenicity of durvalumab
    To assess symptoms and health-related quality of life in patients treated with durvalumab with SBRT compared to placebo with SBRT using the EORTC QLQ-C30
    To assess the safety and tolerability profile of durvalumab with SoC
    SBRT compared to placebo with SoC SBRT

    Applicable to osi cohort:
    -PFS by ICR according to RECIST 1.1
    -OS, TTP, Time to CNS progression, PFS2
    To assess the safety, tolerability, and compliance of a maximum of 3 years of osimertinib following SoC SBRT
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Applicable to both cohorts:
    1. Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling and analyses
    2. Age ≥18 years
    3. Histologically or cytologically documented Stage I to II NSCLC, with clinical T1 to T3N0M0 Stage I/II disease and planned to receive definitive treatment with SBRT (Stereotactic Body Radiation Therapy). Patients may be medically inoperable or are medically operable and refusing surgery or choosing to have SBRT (Stereotactic Body Radiation Therapy) as definitive therapy
    4. Planned SoC SBRT as definitive treatment
    5. World Health Organization (WHO)/ECOG PS of 0, 1, or 2
    6. Patients with central or peripheral lesions are eligible
    7. Patients with a history of metachronous NSCLC and synchronous lesions are eligible with some exceptions
    8. Staging studies must be done during screening (PET-CT within 10 weeks)
    9. Submission of available tumor tissue or cell block samples from FNA

    Main cohort (durvalumab) specific:
    1. Life expectancy of at least 12 weeks
    2. Body weight >30 kg
    3. Adequate organ and marrow function required
    4. Pulmonary Function Testing within 16 weeks of randomization

    Osimertinib cohort specific:
    1. Confirmation by local laboratory that the tumor harbours one of the 2 common EGFR mutations known to be associated with EGFR-TKI
    sensitivity (Ex19del, L858R)
    2. Adequate bone marrow reserve or organ function required
    E.4Principal exclusion criteria
    Applicable to both cohorts:
    1. Mixed small cell and non-small cell cancer
    2. History of another primary malignancy with exceptions

    Main cohort specific:
    1. Patients with a tumor harboring an EGFRm per local testing will be excluded from the main cohort
    2. History of allogeneic organ transplantation
    3. History of active primary immunodeficiency or autoimmune disorders
    4. History of non-infectious pneumonitis requiring steroids
    5. Active infection including tuberculosis, hepatitis B virus, hepatitis C virus, or human immunodeficiency virus
    6. Prior exposure to immune-mediate therapy

    Osimertinib cohort specific:
    1. Patients currently receiving potent inducers of CYP3A4
    2. Patients with known or increased risk factor for QTc prolongation
    3. Treatment with any of the following:
    -Preoperative or adjuvant platinum-based or other chemotherapy for the disease under investigation
    -Prior treatment with neoadjuvant or adjuvant EGFR TKI
    -Patients currently receiving (or unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be potent inducers of CYP3A4
    -Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib
    4. Any of the following cardiac criteria
    -Mean resting corrected QT interval >470 msec, obtained from 3 ECGs
    -Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG.
    -Any factors that increase the risk of QTc prolongation or risk of arrhythmic events, or unexplained -sudden death under 40 years of age
    in first-degree relatives or any concomitant medication known to prolong the QT interval
    -Past medical history of ILD, drug-induced ILD, radiation pneumonitis which required steroid treatment, or any evidence of clinically active ILD
    E.5 End points
    E.5.1Primary end point(s)
    Applicable to main cohort:
    PFS in patients with subset of T1 to T3N0M0 by BICR

    Applicable to osimertinib cohort:
    4-years PFS by ICR using RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    On-study tumor assessments occur 8 weeks after randomization (after start of SBRT for osimertinib cohort), then every 12 weeks through week 116, then every 16 weeks through 3 years after randomization (after start of SBRT for osimertinib cohort), then every 6 months thereafter until objective disease progression.
    E.5.2Secondary end point(s)
    Applicable to main cohort:
    PFS in patients with T1 to T3N0M0 NSCLC
    Overall Survival
    PFS24, TTP, and TTDM using BICR assessments according to RECIST 1.1
    PFS2 using local assessment
    PK of durvalumab in serum
    Presence of ADA for durvalumab
    EORTC QLQ-C30: Change in symptoms, functioning, and global health status/quality of life
    Safety and tolerability: AEs, physical examinations, vital signs, electrocardiograms, and laboratory findings

    Applicable to osimertinib cohort:
    AEs (graded by CTCAE version 5)
    Laboratory studies: chemistry, hematology, and urinalysis
    Clinical evaluations
    ECG parametres
    LVEF
    WHO performance status
    PFS using RECIST 1.1
    OS
    Site(s) of disease progression
    Time to CNS progression
    TTP
    PFS2
    E.5.2.1Timepoint(s) of evaluation of this end point
    Both cohorts:
    OS: date of death
    Lung cancer mortality: date of death due to lung cancer
    TTP: date of progression (excluding deaths)
    PFS2: the earliest of progression event subsequent to first subsequent therapy or death

    Main cohort:
    PFS24: 24 months
    TTDM: date of death or distant metastasis
    Safety and tolerability: from randomization until 3 months after treatment discontinuation

    Osimertinib Cohort:
    Time to CNS progression: date of progression
    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 No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Tolerability
    Symptoms and health-related quality of life
    Healthcare resource utilization
    tolerancja
    objawy i jakość życia związane z chorobą
    wykorzystanie zasobów służby zdrowia
    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 Yes
    E.8.1.7.1Other trial design description
    Powyższe odnosi się do kohorty głównej. Kohorta z ozymertynibem jest kohortą otwartą (jedno ramię)
    Above are applicable to main cohort. Osimertinib cohort is an open-label cohort (single arm)
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Powyższe odnosi się do kohorty głównej. Kohorta z ozymertynibem ma jedno ramię (nie jest kontrolowan
    Above are applicable to main cohort. Osimertinib cohort is a single arm (not placebo controlled)
    E.8.2.4Number of treatment arms in the trial3
    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 EEA55
    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
    Canada
    China
    Israel
    Japan
    Korea, Republic of
    Russian Federation
    United Kingdom
    United States
    Belgium
    France
    Germany
    Italy
    Netherlands
    Poland
    Spain
    Türkiye
    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 expected visit/contact of the last patient undergoing the study (last subject last visit)
    Ostatnia planowana wizyta/kontakt z ostanim pacjentem uczestniczącym w badaniu (Last Visit Last Subject)
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years9
    E.8.9.1In the Member State concerned months3
    E.8.9.1In the Member State concerned days11
    E.8.9.2In all countries concerned by the trial years9
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days29
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 633
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A legal representative may provide consent on behalf of a subject incapable of giving consent personally, where permitted by local regulations.
    Zgodnie z lokalnymi przepisami - prawny przedstawiciel pacjenta może wyrazić zgodę na udział w badaniu pacjenta, który nie jest zdolny do jej samodzielnego wyrażenia.
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state47
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 148
    F.4.2.2In the whole clinical trial 690
    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)
    Patients randomized to durvalumab monotherapy may undergo up to 24 months of retreatment
    Patients who discontinue treatment after RECIST 1.1-defined PD will be followed up for survival
    Patients who have discontinued treatment due to toxicity or symptomatic deterioration, or who have commenced subsequent anticancer therapy, will be followed up with tumor assessments until RECIST 1.1-defined PD plus 1 or more follow-up scans or until death (whichever comes first) and followed for survival
    Pacjenci otrzymujący monoterapię durwalumabem mogą otrzymać leczenie do 24 miesięc.
    Pacjenci, którzy przerwą leczenie z powodu PD po ocenie RECIST 1.1 wejdą w okres obserwacji przeżycia.
    Pacjenci, którzy przerwą leczenie z powodu tooksyczności, nasilenia objawów lub klinicznej PD, bądź rozpoczną kolejne leczenie przeciwnowotworowe, będą obserwowani i poddawani ocenie nowotworu do PD wg RECIST 1.1 i + 1, lub więcej kontrolnych badań obrazowych lub do zgonu (którekolwiek nastąpi wcześniej)
    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 Decision2019-03-08
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-29
    P. End of Trial
    P.End of Trial StatusOngoing
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