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    Summary
    EudraCT Number:2018-002220-16
    Sponsor's Protocol Code Number:D4194C00006
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2018-12-13
    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 ConcernedGermany - PEI
    A.2EudraCT number2018-002220-16
    A.3Full title of the trial
    A Phase II, Open-Label, Multi-Centre, International Safety Study of Durvalumab Following Sequential Chemotherapy and Radiation Therapy in Patients with Stage III, Unresectable Non-Small Cell Lung Cancer (PACIFIC 6)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    This is a Phase II, open-label, multi-centre study to determine the safety of a fixed dose of durvalumab in patients with Non-Small Cell Lung Cancer who have not progressed after sequential chemoradiation therapy.
    A.3.2Name or abbreviated title of the trial where available
    PACIFIC 6
    A.4.1Sponsor's protocol code numberD4194C00006
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03693300
    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
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressForskargatan 18
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@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.3.9.4EV Substance CodeSUB176342
    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 unresectable Stage III non-small cell lung cancer (NSCLC), who have not progressed following platinum-based sequential chemoradiation therapy (sCRT)
    E.1.1.1Medical condition in easily understood language
    A specific type of lung cancer
    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 10029519
    E.1.2Term Non-small cell lung cancer stage III
    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 safety and tolerability profile of durvalumab (MEDI4736) as defined by Grade 3 and Grade 4 TRAEs within 6 months from the initiation of durvalumab (MEDI4736) treatment.
    E.2.2Secondary objectives of the trial
    - To assess the efficacy of durvalumab (MEDI4736) treatment in terms of PFS and OS.
    - To further assess the efficacy of durvalumab (MEDI4736) treatment in terms of ORR and DoR.
    - To assess the efficacy of durvalumab (MEDI4736) treatment in terms of lung cancer mortality.
    - To further assess the safety and tolerability profile of durvalumab (MEDI4736) treatment, including all AEs.
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Genetic research (Appendix D of study protocol, dated 16 Jul 2018)

    Rationale and Objectives
    Genetic variation may impact a patient’s response to therapy, susceptibility to, and severity and PD. Variable response to therapy may be due to genetic determinants that impact drug absorption, distribution, metabolism, and excretion; MOA of the drug; disease aetiology; and/or molecular subtype of the disease being treated. Therefore, where local regulations and IRB/IEC allow, a blood sample will be collected for DNA analysis from consenting patients.
    AstraZeneca intends to collect, analyse, and store DNA for genetic research to explore how genetic variations may affect clinical parameters, risk and prognosis of diseases, and the response to medications. Genetic research may lead to better understanding of diseases, better diagnosis of diseases or other improvements in health care and to the discovery of new diagnostics, treatments or medications.
    In addition, collection of DNA samples from populations with well described clinical characteristics may lead to improvements in the design and interpretation of clinical studies and, possibly, to genetically guided treatment strategies.

    All patients will be asked to participate in this genetic research. Participation is voluntary and if a patient declines to participate there will be no penalty or loss of benefit. The patient will not be excluded from any aspect of the main study.
    E.3Principal inclusion criteria
    - Informed consent as detailed in the protocol.
    - 18 years or older at the time of signing the ICF.
    - Histologically-or cytologically-documented NSCLC with locally-advanced, unresectable Stage III disease (according to the IASLC Staging Manual Version 8 [IASLC 2016]). Positron emission tomography (PET)/CT, MRI of the brain, and endobronchial ultrasound with biopsy are highly encouraged at diagnosis.
    - Receipt of sCRT which must have been completed within 28 days prior to first IP dose administration in the study as defined in the protocol.
    - Patients must not have progressed following platinum-based sCRT, as per Investigator-assessed RECIST 1.1 criteria as defined in the protocol.
    - Must have a life expectancy of at least 12 weeks at enrolment.
    - WHO/ECOG PS ≤2.
    - Adequate organ and marrow function at enrolment as defined in the protocol.
    - Body weight >30 kg at enrolment and first IP dose administration.
    - Male or female.
    - Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. Age-specific requirements are detailed in the protocol.
    E.4Principal exclusion criteria
    - Patients with locally-advanced NSCLC whose disease has progressed following platinum-based sCRT.
    - Patients who have disease considered for surgical treatment as part of their care plan, such as Pancoast or superior sulcus tumours.
    - Mixed small-cell lung cancer and NSCLC histology.
    - History of allogeneic organ transplantation.
    - Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). Exceptions to this criterion are defined in the protocol.
    - Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, ILD, serious chronic GI conditions associated with diarrhoea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent.

    - History of another primary malignancy except for:
    -- Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence.
    -- Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.
    -- Adequately treated carcinoma in situ without evidence of disease.

    - History of leptomeningeal carcinomatosis.
    - History of active primary immunodeficiency.
    - Active infection including tuberculosis, hepatitis B, hepatitis C virus (HCV), or human immunodeficiency virus (HIV). Patients with a past or resolved hepatitis B virus (HBV) infection are eligible. Patients positive for hepatitis C antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
    - Any unresolved toxicity of NCI CTCAE Grade ≥2 from previous anticancer therapy with the exception of alopecia, vitiligo, and the laboratory values defined in the inclusion criteria. More details to be found in the protocol.
    - Known allergy or hypersensitivity to durvalumab (MEDI4736) or any of the IP excipients.
    - Patients who have received cCRT for locally-advanced NSCLC, or who received sCRT with at least 2 concomitant CRT cycles. Prior surgical resection (ie, Stage I or II) is permitted.
    - Receipt of live attenuated vaccine within 30 days prior to the first dose of IP.
    - Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
    - 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.
    - Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. Exceptions to this criterion are detailed in the protocol.
    - Previous IP assignment in the present study.
    - Concurrent enrolment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study.
    - Participation in another clinical study with an IP during the 4 weeks prior to the first IP dose administration.
    - Prior randomisation or treatment in a previous durvalumab (MEDI4736) ± tremelimumab clinical study regardless of treatment arm assignment.
    - Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of IP.
    - Judgment by the Investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements.

    - Genetic research study (optional): Exclusion criteria for participation in the optional (DNA) genetic research component of the study include:
    -- Previous allogeneic bone marrow transplant.
    -- Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection.
    E.5 End points
    E.5.1Primary end point(s)
    Grade 3 or Grade 4 TRAEs
    E.5.1.1Timepoint(s) of evaluation of this end point
    Patients will receive IMP every 4 weeks (q4w) for a maximum of 24 months.

    Efficacy for all patients will be assessed every 8 weeks (q8w) for the first 12 months and every 12 weeks (q12w) thereafter, until disease progression; plus an additional follow-up scan is performed if clinically feasible. Additional scans can be completed per standard practice post disease progression.

    Patients who have discontinued treatment will be followed up for 90 days after IP discontinuation, and thereafter followed up with tumour assessments until RECIST 1.1-defined radiological PD plus an additional follow-up scan or until death (whichever comes first).
    E.5.2Secondary end point(s)
    - Median PFS according to RECIST 1.1 as assessed by the Investigator.
    - PFS12 and PFS24 according to RECIST 1.1 as assessed by the Investigator.
    - Median OS, OS12, OS24, and OS36.
    - ORR according to RECIST 1.1 as assessed by the Investigator.
    - DoR according to RECIST 1.1 as assessed by the Investigator.
    - Lung cancer mortality.
    - AEs, SAEs, AESIs, imAEs, physical examinations, vital signs including BP, pulse, ECGs, and laboratory findings including clinical chemistry, haematology and urinalysis.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Patients will receive IMP every 4 weeks (q4w) for a maximum of 24 months.

    Efficacy for all patients will be assessed every 8 weeks (q8w) for the first 12 months and every 12 weeks (q12w) thereafter, until disease progression; plus an additional follow-up scan is performed if clinically feasible. Additional scans can be completed per standard practice post disease progression.

    Patients who have discontinued treatment will be followed up for 90 days after IP discontinuation, and thereafter followed up with tumour assessments until RECIST 1.1-defined radiological PD plus an additional follow-up scan or until death (whichever comes first).

    All patients in the study should be followed up for survival every 12 weeks until death, withdrawal of consent, or the end of the study.
    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 Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker; Quality of life
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised Information not present in EudraCT
    E.8.1.2Open Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Information not present in EudraCT
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Information not present in EudraCT
    E.8.2.2Placebo Information not present in EudraCT
    E.8.2.3Other Information not present in EudraCT
    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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    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
    France
    Germany
    Italy
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    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 the study is defined as the last visit of the last patient undergoing the study, i.e. LPLV.
    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 months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months1
    E.8.9.2In all countries concerned by the trial days0
    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: 45
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 105
    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 state34
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 141
    F.4.2.2In the whole clinical trial 150
    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)
    If the Investigator determines that the patient still benefits from treatment with the IMP, AstraZeneca will continue to supply the IMP to patients up to the time that they discontinue the treatment for whatever reason (see protocol section 7.1 „Discontinuation of study drug“).
    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 Decision2018-12-13
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-22
    P. End of Trial
    P.End of Trial StatusOngoing
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