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    The EU Clinical Trials Register currently displays   41200   clinical trials with a EudraCT protocol, of which   6743   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2016-002579-83
    Sponsor's Protocol Code Number:54767414LUC2001
    National Competent Authority:Poland - Office for Medicinal Products
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2017-09-20
    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 ConcernedPoland - Office for Medicinal Products
    A.2EudraCT number2016-002579-83
    A.3Full title of the trial
    A Phase 1b/2, Open-Label, Randomized Study of Daratumumab Administered in Combination with Atezolizumab Compared with Atezolizumab Alone in Subjects with Previously Treated Advanced or Metastatic Non-Small Cell Lung Cancer
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A study of Daratumumab combined with Atezolizumab versus Atezolizumab in Previously Treated Subjects with Advanced Non-Small Cell Lung Cancer.
    A.3.2Name or abbreviated title of the trial where available
    CALLISTO
    A.4.1Sponsor's protocol code number54767414LUC2001
    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 SponsorJanssen-Cilag International NV
    B.1.3.4CountryBelgium
    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 supportJanssen Research & Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationPAREXEL International LLC
    B.5.2Functional name of contact point
    B.5.6E-mailclinicaltrial.enquiries@PAREXEL.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 Yes
    D.2.1.1.1Trade name DARZALEX
    D.2.1.1.2Name of the Marketing Authorisation holderJanssen-Cilag International NV
    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 nameDaratumumab
    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 INNDARATUMUMAB
    D.3.9.1CAS number 945721-28-8
    D.3.9.2Current sponsor codeJNJ-54767414 (Daratumumab)
    D.3.9.3Other descriptive nameHUMAX-CD38
    D.3.9.4EV Substance CodeSUB175772
    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 Yes
    D.3.11.13.1Other medicinal product typehuman monoclonal antibody
    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.2.1.1.1Trade name TECENTRIQ
    D.2.1.1.2Name of the Marketing Authorisation holderGenentech
    D.2.1.2Country which granted the Marketing AuthorisationUnited States
    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 nameAtezolizumab
    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 INNATEZOLIZUMAB
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.4EV Substance CodeSUB178312
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1200
    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 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
    Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
    E.1.1.1Medical condition in easily understood language
    A specific type of lung cancer called "Non-Small Cell 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 20.0
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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 compare the overall response rate (ORR) in subjects treated with daratumumab in combination with atezolizumab versus atezolizumab alone.
    E.2.2Secondary objectives of the trial
    - To assess the safety of the combination of daratumumab and atezolizumab
    - To compare the duration of response (DoR) in subjects treated with daratumumab in combination with atezolizumab versus atezolizumab alone
    - To compare the clinical benefit rate (CBR) in subjects treated with daratumumab in combination with atezolizumab versus atezolizumab alone
    - To compare progression-free survival (PFS) in subjects treated with daratumumab in combination with atezolizumab versus atezolizumab alone
    - To compare overall survival (OS) in subjects treated with daratumumab in combination with atezolizumab versus atezolizumab alone
    - To evaluate the pharmacokinetic and immunogenicity profile of daratumumab when given in combination with atezolizumab
    - To evaluate the pharmacokinetic and immunogenicity profile of atezolizumab when given in combination with daratumumab
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. ≥18 years of age
    2. ECOG performance status of 0 or 1.
    3. Have histologically or cytologically confirmed advanced or metastatic
    NSCLC (Stage IIIb or greater).
    4. Measurable disease, as defined by RECIST 1.1.
    5. Known PD-L1 tumor status as determined by an IHC assay performed by the central laboratory on tissue obtained at Screening.
    6. Specific laboratory results obtained within 14 days prior to first administration of study drug.
    7. A woman of childbearing potential must have a negative highly sensitive serum (b-human chorionic gonadotropin [b-hCG]) at Screening within 14 days prior to study drug administration.
    8. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for subject participating in clinical studies.
    9. During the study and for a minimum of approximately 3 months after the last dose of daratumumab or 5 months after the last dose of atezolizumab, in addition to the highly effective method of contraception, a man
    - who is sexually active with a woman of childbearing potential must agree to use a barrier method of contraception (eg, condom with spermicidal foam/gel/film/cream/suppository)
    - who is sexually active with a woman who is pregnant must use a condom
    - must agree not to donate sperm.
    10. Willing and able to adhere to the prohibitions and restrictions specified in this protocol.
    11. Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    E.4Principal exclusion criteria
    1. Received any of the following prescribed medications or therapies in the past:
    - Anti-CD38 therapy, including daratumumab
    - CD137 agonists, immune checkpoint inhibitors including but not limited to anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapies
    2. Received any of the following prescribed medications or therapies within the specified period:
    - Approved anti-cancer therapy, including chemotherapy, within 3 weeks prior to first administration of study drug.
    - Other investigational agent or participation in another clinical study with therapeutic intent within 28 days or 5 half-lives of the investigational agent (whichever is longer) prior to first administration of study drug.
    -Whole brain radiation within 28 days or other radiotherapy within 14 days prior to first administration of study drug.
    -Use of systemic corticosteroids >10 mg/day prednisone equivalent within 14 days prior to first administration of study drug.
    3. Has any of the following conditions:
    - Active or untreated CNS metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation.
    - Leptomeningeal disease or spinal cord compression not definitively treated with surgery or
    radiation, or requiring corticosteroid treatment at first administration of study drug.
    - Uncontrolled tumor-related pain
    4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently); indwelling catheters are allowed.
    5. Malignancies other than NSCLC within 2 years prior to first administration of study drug, with
    the exception of carcinoma in situ of the cervix or breast, basal or squamous-cell skin cancer, or other malignancy that in the opinion of the investigator and Sponsor is considered cured with a minimal risk of recurrence within 5 years.
    6. History of autoimmune disease.
    7. History of pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan; history of radiation pneumonitis in the radiation field (fibrosis) is permitted.
    8. Known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in
    1 second (FEV1) <50% of predicted normal. Note that spirometry is required during the screening
    period for subjects suspected of having COPD and subjects must be excluded if FEV1 <50% of
    predicted normal.
    9. Known to be seropositive for human immunodeficiency virus (HIV)
    10. Active hepatitis B, defined by a positive test for hepatitis B surface antigen (HBsAg) or prior
    history of hepatitis B, defined by presence of antibodies to hepatitis B core antigen [anti-HBc],
    regardless of hepatitis B surface antibody [anti-HBs] status; active hepatitis C or prior history of
    hepatitis C (anti-HCV positive), except in the setting of a sustained virologic response (SVR),
    defined as aviremia 12 weeks after completion of antiviral therapy.
    11. Severe infections (including active tuberculosis) within 1 week prior to first administration of study drug.
    12. Clinically significant cardiac disease, including myocardial infarction within 6 months before first administration of study drug, or unstable or uncontrolled disease/condition related to or affecting cardiac function,uncontrolled cardiac arrhythmia or clinically significant ECG abnormalities,a baseline corrected QT interval (QTc) >470 msec
    13. Prior allogeneic bone marrow transplantation or solid organ transplant.
    14. Administration of a live, attenuated vaccine within 4 weeks before first administration of study drug.
    15. Women who are pregnant, lactating, or intending to become pregnant during the study or within at least 3 months after last dose of daratumumab or 5 months after the last dose of atezolizumab; men who intend to father a child during the study or within at least 3 months after the last dose of daratumumab or 5 months after the last dose of atezolizumab.
    16. History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.
    17. Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the daratumumab or atezolizumab formulation.
    18. Any other concurrent medical or psychiatric condition, diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the subject at high risk from treatment complications.
    19. Major surgery (eg, requiring general anesthesia) within 2 weeks before Screening, not fully
    recovered from surgery, or surgery planned during the time the subject is expected to participate in
    the study or within 2 weeks after the last dose of study treatment.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is ORR: the proportion of subjects with a partial
    response (PR) or complete response (CR) as defined by RECIST 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the whole study.
    E.5.2Secondary end point(s)
    - Incidence of adverse events
    - DoR: the duration from the date of the initial documentation of a response to the date of the first objectively documented evidence of recurrence or progressive disease or death, whichever status is recorded first.
    - CBR: the proportion of subjects who achieve disease control (CR, PR, or SD with duration of at least 16 weeks).
    - PFS: the duration from the date of randomization to the date of objectively documented progression or death due to any cause, whichever status is recorded first.
    - OS: the duration from the date of randomization to the date of death due to any cause.
    - Serum daratumumab concentration (Cmin, Cmax) and incidence of anti-daratumumab antibodies
    - Serum atezolizumab concentration (Cmin, Cmax) and incidence of anti-atezolizumab antibodies
    E.5.2.1Timepoint(s) of evaluation of this end point
    Throughout the whole 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 Yes
    E.6.7Pharmacodynamic Yes
    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) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Satefy run-in cohort to assess safety/tolerability of atezolizumab administered with daratumumab
    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 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 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) 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 concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA42
    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
    Hungary
    Poland
    Spain
    United States
    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 patient last visit.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months10
    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: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 58
    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 state11
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 96
    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)
    No post-trial medication will be provided, the further treatment of patients after end of trial will be carried out according to their physicians' decision.
    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 Decision2017-12-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-06
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-26
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