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    The EU Clinical Trials Register currently displays   43974   clinical trials with a EudraCT protocol, of which   7311   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:2016-001202-42
    Sponsor's Protocol Code Number:D419QC00002
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-08-22
    Trial results View 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 number2016-001202-42
    A.3Full title of the trial
    A Phase II, Open-Label, Multi-Arm Study to Determine the Preliminary
    Efficacy of Novel Combinations of Treatment in Patients with Platinum
    Refractory Extensive-Stage Small-Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II, open label, multiarm study to assess the efficay of new drugs in patients with Small Cell Lung Cancer whose cancer worsened during or within after 90 days of platinum based chemotherapy
    A.4.1Sponsor's protocol code numberD419QC00002
    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 AddressKarlebyhus, Astraallén
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailinformationcenter@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.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 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 nametremelimumab
    D.3.2Product code MEDI1123
    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 INNtremelimumab
    D.3.9.1CAS number 745013-19-6
    D.3.9.2Current sponsor codeMEDI1123
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 extensive-stage small-cell lung cancer (ED-SCLC) who have refractory or resistant
    disease from prior platinum-based chemotherapy.
    E.1.1.1Medical condition in easily understood language
    patients with Small Cell Lung Cancer whose cancer worsened during or within after 90 days of platinum based chemotherapy
    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 10041068
    E.1.2Term Small cell lung cancer extensive stage
    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 preliminary efficacy of each treatment arm in terms of Overall Response Rate. ORR will be evaluated using Investigator assessments according to RECIST 1.1
    E.2.2Secondary objectives of the trial
    1. To further assess the preliminary efficacy of each treatment arm in terms of DoR, DCR,
    TTR, PFS, and overall survival (OS)
    2. To assess the pharmacokinetics (PK) of novel combination treatments
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion criteria (applicable to all arms)
    - Adults with ED SCLC who have have demonstrated progressive disease either during first-line platinum-based chemotherapy (platinum
    refractory) or within 90 days of completing platinum basedchemotherapy (platinum resistant) and have not received further treatment.
    - Brain metastases must be asymptomatic or treated and stable off steroids and anti-convulsants for at least 1 month prior to study treatment.
    - At least 1 lesion, not previously irradiated, that can be accurately measured at baseline.
    - Life expectancy of at least 8 weeks.
    - Adequate organ and marrow function
    - WHO/ECOG PS of 0-1 at enrollment

    Inclusion criteria (Arm A specific)
    - Body weight >30 kg.
    - No prior exposure to immune mediated therapy, excluding therapeutic anticancer vaccines.

    Inclusion criteria (Arm B specific)
    - Able and willing to swallow oral medication

    Inclusion Criteria (Arm C specific)
    -Able and willing to swallow oral medication
    E.4Principal exclusion criteria
    Exclusion criteria (applicable to all arms)
    - Participation in another clinical study, major surgery, radiation therapy within 28 days.
    - Any condition that, in the opinion of the Investigator, would interfere with the evaluation of the IP or interpretation of patient safety or study
    results.
    - History of ILD, another primary malignancy, leptomeningeal carcinomatosis or spinal cord compression

    Exclusion criteria (Arm A specific)
    - Any concurrent cancer treatment.
    - Live vaccines within 30 days.
    - Known hypersensitivity to IP or excipient.
    - Prior randomization or treatment in a previous durvalumab and/or tremelimumab clinical study.
    - Active autoimmune disease, including a paraneoplastic syndrome of autoimmune nature.
    - Active or prior documented autoimmune or inflammatory disorders.
    - Any unresolved toxicity (CTCAE Grade >2) from previous anticancer therapy.
    - History of allogenic organ transplantation or active primary immunodeficiency.
    - Active infection.
    - Current or prior use of immunosuppressive medication within 14 days before the first dose of durvalumab or tremelimumab.

    Exclusion criteria (Arm B specific)
    - Prior exposure to any WEE1 inhibitors.
    - Products known to be sensitive to CYP3A4 substrates or CYP3A4 substrates with a narrow therapeutic index, or to be moderate to strong
    inhibitors/inducers of CYP3A4. Coadministration of rosuvastatin, aprepitant or fosaprepitant or any herbal preparations.. Grapefruit and
    Seville oranges should be avoided while taking AZD1775.
    - Any known hypersensitivity or contraindication to IP or CBDP.
    - QTcF > 470 msec or congenital long QT syndrome.
    - Any current or within 6 months cardiac diseases NYHA ≥ Class 2:
    unstable angina pectoris, congestive heart failure, acute MI, conduction abnormality not controlled with pacemaker or medication, significant ventricular or supraventricular arrhythmias.
    - A recent history of Torsades de pointes

    Exclusion criteria (Arm C specific)
    - Cytotoxic chemotherapy within 21 days of Cycle 1 Day 1 is not permitted
    - Previous treatment with a PARP inhibitor (including olaparib) or ATR inhibitor
    - Concomitant use of known strong CYP3A inhibitors or moderate CYP3A inhibitors
    - Concomitant use of known strong or moderate CYP3A inducers
    - Persisting (> 4 weeks) severe pancytopenia due to previous therapy
    - Cardiac dysfunction
    - Refractory nausea and vomiting, chronic gastrointestinal diseases or previous significant bowel resection
    - Patients with uncontrolled seizures
    - Intestinal obstruction or CTCAE grade 3 or grade 4 upper GI bleeding within 4 weeks before the dosing.
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response rate evaluated by using Investigator assessments according to RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    The primary analysis of ORR will occur approximately 12 weeks after the last patient has initiated treatment.
    E.5.2Secondary end point(s)
    1. To further assess the preliminary efficacy of each treatment arm in terms of DoR, DCR,
    TTR, PFS, and overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    The primary analysis of ORR will occur approx. 12 weeks after the last patient has initiated treatment. This is planned to ensure the data cut off for ORR analysis follows the 12 week RECIST assessment for the last subject to be treated. However, in the situation where this scan does not occur due to this subject having experienced another progression event (e.g. death) the primary analysis DCO will be when all subjects have been followed for at least 12 weeks or until death if this is earlier. All study endpoints will be analyzed at this time includingincluding OS. The Sponsor will determine at that time whether any further follow up for OS would be required.
    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 Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    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) 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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    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 No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA15
    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
    Ukraine
    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."
    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 months2
    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 months2
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 45
    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 state4
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 30
    F.4.2.2In the whole clinical trial 60
    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)
    For details regarding particular plans for treatment or care after the subject has ended the participation in the trial please check Appendix applicable for particular cohort
    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 Decision2017-02-09
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-12-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2023-11-27
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