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    The EU Clinical Trials Register currently displays   42869   clinical trials with a EudraCT protocol, of which   7063   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2020-002683-31
    Sponsor's Protocol Code Number:TUD-ALPINE-077
    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:2021-03-03
    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 number2020-002683-31
    A.3Full title of the trial
    A Phase II, single-arm trial of Atezolizumab/Platinum/Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung
    Einarmige Phase II-Studie mit Atezolizumab, Platin und Etoposid zur Behandlung des fortgeschrittenen großzellig-neuroendokrinen Lungenkarzinoms

    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II, single-arm trial of addition of Atezolizumab to standard chemotherapy of Platinum and Etoposide for the treatment of advanced large-cell neuroendocrine cancer of the lung
    A.3.2Name or abbreviated title of the trial where available
    LCNEC-ALPINE
    LCNEC-ALPINE
    A.4.1Sponsor's protocol code numberTUD-ALPINE-077
    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 SponsorTechnische Universität Dresden
    B.1.3.4CountryGermany
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportROCHE Pharma AG
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationTU Dresden
    B.5.2Functional name of contact pointCoordination Investigator
    B.5.3 Address:
    B.5.3.1Street AddressFetscherstr. 74
    B.5.3.2Town/ cityDresden
    B.5.3.3Post code01307
    B.5.3.4CountryGermany
    B.5.4Telephone number00493514587566
    B.5.5Fax number0049351458 885624
    B.5.6E-mailALPINE@ukdd.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 Tecentriq®
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration GmbH
    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.3.4Pharmaceutical form Concentrate for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 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
    locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) not eligible for curative treatment
    lokal fortgeschrittenes oder metastasiertes großzellig-neuroendokrines Lungenkarzinom (LCNEC), nicht für eine kurative Behandlung geeignet
    E.1.1.1Medical condition in easily understood language
    locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung not eligible for curative treatment
    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 LLT
    E.1.2Classification code 10078184
    E.1.2Term Neuroendocrine tumor of the lung metastatic
    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 10078175
    E.1.2Term Neuroendocrine tumour of the lung metastatic
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the efficacy of Atezolizumab in addition to standard of care chemotherapy (Platinum/Etoposide) in LCNEC.
    Wirksamkeit von Atezolizumab zusätzlich zur Standard-Chemotherapie (Platinum/Etoposid) in LCNEC.
    E.2.2Secondary objectives of the trial
    To assess the safety, tolerability and efficacy of Atezolizumab in addition to standard of care (SoC; Platinum/Etoposide) in LCNEC.
    Sicherheit, Verträglicheit und Wirksamkeit von Atezolizumab zusätzlich zur Standard-Chemotherapie (Platinum/Etoposid) in LCNEC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent
    2) Patients with locally advanced or metastatic large-cell neuroendocrine carcinoma of the lung (LCNEC) without curative treatment options (patients with mixed histology are eligible if LCNEC is the predominant histology i.e. ≥50%)
    3) Previously untreated with systemic therapy (note: patients relapsing after curative radio chemotherapy or adjuvant chemotherapy are eligible if relapse occurs ≥6 months after discontinuation of curative treatment)
    4) Planned treatment with Carboplatin or Cisplatin and Etoposide (SoC)
    5) ECOG performance status: 0-2
    6) age ≥18 years
    7) measurable disease according to RECIST v1.1
    8) adequate organ function defined as:
    - ALAT/ASAT ≤2.5x ULN or ≤3.5x ULN in case of liver metastases
    - Bilirubin ≤1.5x ULN or ≤2.5x ULN in case of liver metastases
    - Creatinine ≤1.5x ULN or Creatinine clearance according to Cockroft-Gault >60 ml/min
    - Neutrophils ≥1 Gpt/l, Platelets >50 Gpt/l unless caused by bone marrow carcinosis
    1) Schriftliche Zustimmung zur Studienteilnahme (Patienteninformation)
    2) Patienten mit lokal fortgeschrittenem oder metastasiertem großzellig-neuroendokrinem Lungenkarzinom (LCNEC), die nicht für eine kurative Behandlung geeignet sind (Patienten mit gemischter Histologie sind geeignet, wenn LCNEC die vorscherrschende Histologie ≥50% ist)
    3) Keine Vorbehandlung mit systemischer Therapie (Hinweis: Patienten mit Rezidiv nach kurativer Radiochemotherapie oder adjuvanter Chemotherapie sind geeignet, wenn das Rezidiv ≥6 Monate nach Beendigung der kurativen Therapie auftrat)
    4) Geplante Behandlung mit Carboplatin oder Cisplatin und Etoposid (Standard-Chemotherapie)
    5) ECOG Status: 0-2
    6) Alter ≥18 Jahre
    7) messbare Erkrankung gemäß RECIST v1.1
    8) adäquate Organfunktionen definiert als:
    - ALAT/ASAT ≤2.5x ULN oder ≤3.5x ULN im Fall von Lebermetastasen
    - Bilirubin ≤1.5x ULN oder ≤2.5x ULN im Fall von Lebermetastasen
    - Kreatinin ≤1.5x ULN oder Kreatinin Clearance gemäß Cockroft-Gault >60 ml/min
    - Neutrophile ≥1 Gpt/l, Thrombozyten >50 Gpt/l solange nicht durch Knochenmark-Karzinose verursacht
    E.4Principal exclusion criteria
    1) Symptomatic brain metastases (patients with asymptomatic brain metastases are allowed provided they are stable without steroid treatment for at least 3 weeks)
    2) Severe autoimmune disease (patients with endocrine autoimmune disorders are allowed as long as they are on stable substitution treatment)
    3) Severe uncontrolled infection
    4) Prior treatment with either Atezolizumab or other immune checkpoint inhibitor
    5) Any prior treatment for metastatic disease
    1) Symptomatische Hirnmetastasen (Patienten mit asymptomatischen Hirnmetastasen sind erlaubt, wenn sie für mindestens 3 Wochen ohne Steroidbehandlung stabil sind)
    2) schwere Autoimmun-Erkrankungen (Patienten mit endokrinen Autoimmun-Erkrankungen sind erlaubt, solange sie in stabiler Substitutions-Behandlung sind)
    3) schwere unkontrollierte Infektion
    4) vorherige Behandlung mit entweder Atezolizumab oder einem anderen Immuncheckpoint-Inhibitor
    5) jedwede vorherige systemische Behandlung der metastasierten Erkrankung
    E.5 End points
    E.5.1Primary end point(s)
    overall survival (OS)
    Gesamtüberleben
    E.5.1.1Timepoint(s) of evaluation of this end point
    time to event endpoint
    Time-to-Event Endpunkt (bei Eintreten des Ereignisses)
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints (ORR, iORR, DCR, PFS, iPFS, DoR, PFS rate at one year, iPFS rate at one year, OS rate at one year), Safety: Incidence, nature, causality, seriousness and severity of adverse events using NCI CTCAE (v5.0)
    sekundäre Wirksamkeits-Endpunkte (ORR, iORR, DCR, PFS, iPFS, DoR, PFS 1-Jahres-Rate, iPFS 1-Jahres-Rate, OS 1-Jahres-Rate), Sicherheit: Inzidenz, Art, Kausalzusammenhang, Bedeutung und Schweregrad von unerwünschten Ereignissen gemäß NCI CTCAE Klassifizierung (v5.0)
    E.5.2.1Timepoint(s) of evaluation of this end point
    during whole study and time to event endpoints
    während der gesamten Studie und bei Eintreten des Ereignisses
    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 No
    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.8.3 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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS ( last visit of the last subject)
    letzte Visite des letzten Patienten
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months72
    E.8.9.1In the Member State concerned days
    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: 74
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 74
    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 state67
    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)
    Once study treatment is permanently discontinued any subsequent treatment is left at the discretion of the treating physician.
    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 Decision2021-05-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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