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    The EU Clinical Trials Register currently displays   44144   clinical trials with a EudraCT protocol, of which   7325   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:2014-005096-85
    Sponsor's Protocol Code Number:XM22-ONC-40041
    National Competent Authority:Hungary - National Institute of Pharmacy
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-04-10
    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 ConcernedHungary - National Institute of Pharmacy
    A.2EudraCT number2014-005096-85
    A.3Full title of the trial
    Safety and Efficacy of LONQUEX® (Lipegfilgrastim) in Comparison to Pegfilgrastim (Neulasta®, Amgen Inc.) and Placebo in Patients with Non-Small-Cell Lung Cancer Receiving First-Line Chemotherapy
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase 4 clinical study to compare the safety and efficacy of LONQUEX® with NEULASTA® and Placebo in patients with Non-Small-Cell Lung Cancer treated with first-line chemotherapy
    A.4.1Sponsor's protocol code numberXM22-ONC-40041
    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 SponsorMerckle GmbH
    B.1.3.4CountryGermany
    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 supportTeva Pharmaceutical Industries Limited
    B.4.2CountryIsrael
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerckle GmbH
    B.5.2Functional name of contact pointBiosimilar Clinical Group
    B.5.3 Address:
    B.5.3.1Street AddressGraf-Arco-Strasse 3
    B.5.3.2Town/ cityUlm
    B.5.3.3Post code89079
    B.5.3.4CountryGermany
    B.5.4Telephone number+497314023890
    B.5.5Fax number+497314027656
    B.5.6E-mailanton.buchner@ratiopharm.de
    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 LONQUEX
    D.2.1.1.2Name of the Marketing Authorisation holderSicor Biotech, UAB
    D.2.1.2Country which granted the Marketing AuthorisationGermany
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNLIPEGFILGRASTIM
    D.3.9.1CAS number 1117844-87-7
    D.3.9.2Current sponsor codeXM22
    D.3.9.4EV Substance CodeSUB33778
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.2.1.1.1Trade name NEULASTA
    D.2.1.1.2Name of the Marketing Authorisation holderAmgen Europe B.V.
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPEGFILGRASTIM
    D.3.9.1CAS number 208265-92-3
    D.3.9.4EV Substance CodeSUB16451MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboSubcutaneous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced squamous or non-squamous non-small-cell lung cancer (NSCLC) Stage IIIB/IV
    E.1.1.1Medical condition in easily understood language
    Advanced Lung Cancer (non-small-cell)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    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 19.0
    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 collect comparative data for LONQUEX®, Neulasta® and placebo in patients with advanced squamous or non-squamous NSCLC Stage IIIB/IV, including full details of disease progression (whether or not leading to death) and mortality, for detailed clinical review.
    E.2.2Secondary objectives of the trial
    To explore the potential correlation between genetic polymorphisms in germline DNA specimens and response to LONQUEX® (eg, efficacy, pharmacokinetics, tolerability, and safety features) compared with placebo/comparator.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Signed and dated written informed consent is obtained

    -The patient is a man or woman, aged 18 to 75 years

    - Patients must have a histologically or cytologically confirmed, unresectable, advanced or metastatic (Stage IIIB/IV per American Joint Committee on Cancer [AJCC] 7th edition of tumors, nodes, and metastases classification of malignant tumors [TNM] staging) squamous or non-squamous (adenocarcinoma plus large cells) NSCLC

    - The patient has at least non-measurable but evaluable disease lesion per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1.

    - The patient is planned and eligible to receive a maximum of 6 cycles of the predefined cisplatin/pemetrexed, or cisplatin/docetaxel, or paclitaxel/cisplatin CTX

    - Have a life-expectancy of at least 18 weeks, according to the investigator’s assessment

    - The patient is CTX naïve. Patients who received CTX in neoadjuvant or adjuvant setting, treated >12 months ago, will be eligible

    - Eastern Cooperative Oncology Group (ECOG) performance status ≤2

    - Absolute neutrophil count (ANC) ≥1.5 × 109/L

    - Platelets ≥100 × 109/L

    - Adequate hepatic, cardiac, bone marrow and renal function (creatinine clearance ≥45 mL/min per the standard Cockroft Gault formula) for the chosen CTX (cisplatin/pemetrexed, or cisplatin/docetaxel, or paclitaxel/cisplatin) regimen.

    - Women of childbearing potential (not surgically sterile or 2 years postmenopausal) must use a medically accepted method of contraception and must agree to continue use of this method for the duration of the 6 CTX cycles and for 30 days after discontinuation of study drug. Acceptable methods of contraception include intrauterine device (IUD), steroidal contraceptive (oral, implanted, transdermal, or injected), barrier method with spermicide, partner vasectomy, and abstinence throughout the study (ie, true abstinence: when this is in line with the preferred and usual lifestyle of the subject. [periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception]).

    - The patient, if a man, is surgically sterile, or, if capable of producing offspring, is currently using an approved method of birth control and agrees to continued use of this method for the duration of the 6 CTX cycles (and for 90 days after taking the last dose of study drug because of the possible effects on spermatogenesis). Acceptable methods of contraception include abstinence (ie, true abstinence as detailed above), female partner’s use of an acceptable method of contraception (as described above), or if female partner is surgically sterile or 2 years post-menopausal. In addition, male patients may not donate sperm for the duration of the 6 CTX cycles and for 90 days after taking study drug.

    - The patient must be willing and able to comply with study restrictions and to remain at the clinic for the required duration during the study period, and willing to return to the clinic for the follow-up evaluation as specified in this protocol.
    E.4Principal exclusion criteria
    - Previous exposure to filgrastim, pegfilgrastim or lenograstim or other granulocyte colony stimulating factors (G-CSFs) in clinical development less than 6 months before randomization

    - Participation in a clinical trial within 30 days or 5 half-lives of the investigational product before randomization, whichever is longer

    - Known hypersensitivity to filgrastim, pegfilgrastim, lenograstim, cisplatin, pemetrexed, docetaxel or paclitaxel

    - Patient meeting any contraindication for the chosen CTX regimen

    - Patient to be treated with combined CTX/radiotherapy during the foreseen participation in this study

    - Prior radiation therapy for lung cancer if not recovered from all toxicities related to this therapy

    - Tumor surgery within 4 weeks before randomization

    - Prior bone marrow or stem cell transplantation

    - Progressive brain metastases

    - Prior malignancy (other than NSCLC) within the preceding 5 years other than non-melanoma skin cancer or in situ cervical carcinoma

    - The patient is a pregnant or lactating woman. (Any woman becoming pregnant during the study will be withdrawn from the study.)
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the progression-free survival (PFS) time (Kaplan-Meier curves, medians and hazard rates).
    E.5.1.1Timepoint(s) of evaluation of this end point
    After completion of the follow-up period
    E.5.2Secondary end point(s)
    Secondary safety measures are:
    • PFS as assessed by the investigator
    • Objective response rate (ORR)
    • Overall survival (OS)

    Secondary Efficacy measures/endpoints:
    • Duration of severe neutropenia (DSN) in cycle 1.
    • Febrile neutropenia (FN) in cycle 1, defined as occurrence of at least 1 of the following conditions:
    − Oral body temperature >38.5°C for at least 1 hour (2 consecutive measurements on the same day, at least 60 minutes apart) and an observed severe neutropenia (ie, ANC value <0.5 x 109/L) on the day before, on the same day or on the day after the elevated temperature readings.
    − Documentation of neutropenic sepsis, ie, a sepsis in combination with an ANC value <0.5 × 109/L.
    − Documentation of serious or life-threatening neutropenic infection, ie, a life-threatening infection in combination with an ANC value <0.5 × 109/L.
    • Incidence of very severe neutropenia (ANC <0.1 × 109/L) in cycle 1
    • Incidence of severe neutropenia (grade 4: ANC <0.5 × 109/L) in cycle 1
    E.5.2.1Timepoint(s) of evaluation of this end point
    Safety endpoints: After completion of the follow-up period

    Efficacy endpoints: cycle 1
    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 No
    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 Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    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 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 EEA52
    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
    Argentina
    Belarus
    Bosnia and Herzegovina
    Brazil
    Bulgaria
    Chile
    Croatia
    Greece
    Hungary
    Latvia
    Poland
    Romania
    Russian Federation
    Serbia
    Slovakia
    South Africa
    Spain
    Turkey
    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
    End of study occurs after 225 deaths are observed overall.
    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 months
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    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: 225
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 75
    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 state23
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 162
    F.4.2.2In the whole clinical trial 300
    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)
    Standard treatment of care
    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 Decision2015-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-05-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2018-02-09
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