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    Summary
    EudraCT Number:2019-001707-21
    Sponsor's Protocol Code Number:AIO-TRK-0119
    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:2019-08-21
    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 number2019-001707-21
    A.3Full title of the trial
    Single-Arm Phase II-Study in Patients with extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status receiving Atezolizumab-Carboplatin-Etoposide
    Eine einarmige Phase-II-Studie zur Behandlung mit Atezolizumab, Carboplatin und Etoposid bei Patienten mit kleinzelligem Lungenkarzinom im extensiven Stadium (ES-SCLC) und eingeschränktem Allgemeinzustand
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Single-Arm Phase II-Study in Patients with extensive stage small cell lung cancer (ES-SCLC) with Poor Performance Status receiving Atezolizumab-Carboplatin-Etoposide
    Untersuchung einer Atezolizumab-Carboplatin-Etoposid-Behandlung in Patienten mit weit fortgeschrittenem kleinzelligen Lungenkarzinom mit eingeschränktem Gesundheitszustand
    A.3.2Name or abbreviated title of the trial where available
    SPACE
    A.4.1Sponsor's protocol code numberAIO-TRK-0119
    A.5.4Other Identifiers
    Name:Roche study numberNumber:ML40893
    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 SponsorAIO-Studien-gGmbH
    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 supportF. Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAIO-Studien-gGmbH
    B.5.2Functional name of contact pointAIO-Studien-gGmbH
    B.5.3 Address:
    B.5.3.1Street AddressKuno-Fischer-Straße 8
    B.5.3.2Town/ cityBerlin
    B.5.3.3Post code14057
    B.5.3.4CountryGermany
    B.5.4Telephone number004930814534431
    B.5.5Fax number004930322932926
    B.5.6E-mailinfo@aio-studien-ggmbh.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 (R)
    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.3.1Product nameAtezolizumab
    D.3.2Product code L01XC32
    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.3.9.1CAS number 1380723-44-3
    D.3.9.2Current sponsor codeRO5541267
    D.3.9.3Other descriptive nameAtezolizumab
    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) Yes
    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.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.2.1.2Country 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 nameCarboplatin
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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.IMP: 3
    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.2.1.2Country 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 nameEtopsid
    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 Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    treatment-naive, extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status with or without asymptomatic brain metastases (stage IV, ECOG=2)
    nicht vorbehandelte, weit fortgeschrittene kleinzellige Lungenkarzinome mit eingeschränktem Gesundheitszustand (Stadium IV mit ECOG PS = 2) mit oder ohne asymptomatische Hirnmetastasen
    E.1.1.1Medical condition in easily understood language
    extensive stage small-cell lung cancer (ES-SCLC) with Poor Performance Status
    nicht vorbehandelte, weit fortgeschrittene kleinzellige Lungenkarzinome mit eingeschränktem Gesundheitszustand
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10059514
    E.1.2Term Small cell lung cancer 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 No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To explore the efficacy of carboplatin+etoposide in combination with atezolizumab in treatment-naïve, stage IV SCLC patients with ECOG PS=2 with or without asymptomatic brain metastases
    Untersuchung der Wirksamkeit von Carboplatin + Etoposid in Kombination mit Atezolizumab bei nicht vorbehandelten SCLC-Patienten im Stadium IV mit ECOG PS = 2 mit oder ohne asymptomatische Hirnmetastasen
    E.2.2Secondary objectives of the trial
    - To assess additional efficacy parameters, e.g. PFS, ORR;
    - to assess the safety and feasibility of adding atezolizumab to
    carboplatin+etoposide in this patient population;
    - to assess quality of life and symptom burden in study
    subjects;
    - to assess PRO-CTCAE(TM)
    - Untersuchung zusätzlicher Wirksamkeitsparameter, z.B. Progressionsfreies Überleben (PFS), objektive Ansprechrate (ORR);
    - Untersuchung der Sicherheit und Durchführbarkeit der Zugabe von Atezolizumab zu Carboplatin + Etoposid bei dieser Patientenpopulation;
    - Untersuchung der Lebensqualität und der Symptombelastung von Studienteilnehmern (EORTC QLQ-C30);
    - Durchführung und Auswertung vom Patientenfragebogen (PRO-CTCAE(TM))
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Written informed consent including participation in translational research obtained from the subject prior to performing any protocol-related procedures, including screening evaluations that are not SOC
    2. Age ≥ 18 years
    3. ECOG 2
    4. At least one measurable tumor lesion (according to RECIST1.1)
    5. Histologically confirmed small cell lung cancer (SCLC)
    6. Stage IV disease (according to UICC8)
    7. No active autoimmune disease
    8. Adequate organ function defined as:
    - neutrophil count > 1.5 x 10^9/L
    - thrombocytes ≥ 100 x 10^9/L
    - hemoglobin ≥ 9 g/dL
    - INR ≤ 1.4 or aPTT ≤ 40 sec during the last 7 days before therapy [Subjects under therapeutic anticoagulation are permitted.]
    - bilirubin < 1.5 x ULN
    - AST (SGOT)/ALT (SGPT) < 3 x institutional ULN (< 5 x ULN in case of liver metastases)
    - creatinine ≤ 1.5 x ULN or creatinine clearance ≥ 45 mL/min
    9. Availability of tumor tissue/block
    10. Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the first dose of IMP.
    11. Women of childbearing potential (WOCBP) must use appropriate method(s) of contraception. [WOCBP should use an adequate method to avoid pregnancy for 6 months after the last dose of IMP.]
    12. Men who are sexually active with WOCBP must use any contraceptive method with a failure rate of less than 1% per year. Men receiving IMP and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 6 months after the last dose of IMP. Women who are not of childbearing potential (ie, who are postmenopausal or surgically sterile) and men who are azoospermic do not require contraception.
    13. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
    1. Vorliegen einer unterschriebenen Einwillungungserklärung des Patienten vor Beginn jeder studienspezifischen Maßnahme (einschließlich Screeninguntersuchungen, die nicht zum Behandlungsstandard zählen) entsprechend aller lokal bestehenden Regelungen (z.B. EU-DSGVO), die die Teilnahme an translationaler Forschung mit einschließt.
    2. Alter ≥ 18 Jahre
    3. Allgemeinzustand nach ECOG = 2
    4. Mindestens eine messbare Läsion nach RECIST 1.1
    5. Histologisch bestätigtes kleinzelliges Lungenkarzinom (SCLC)
    6. Stadium IV der Erkrankung (nach UICC8)
    7. Nichtvorliegen aktiver Autoimmunerkrankungen
    8. Adäquate Organfunktionen:
    • Anzahl Neutrophile > 1,5 x 10^9/l
    • Anzahl Blutplättchen ≥ 100 x 10^9/l
    • Hämoglobin ≥ 9,0 g/dl
    • INR ≤ 1,4 oder aPTT ≤ 40 Sek. innerhalb der letzten sieben Tage vor Therapiebeginn [Patienten unter therapeutischer Antikoagulation sind einschlussfähig]
    • Gesamt-Bilirubin < 1,5 x ULN
    • AST (SGOT)/ALT (SGPT) < 3 x ULN (< 5 x ULN im Falle von Lebermetastasen)
    • Serum-Kreatinin ≤ 1,5 x ULN oder Kreatinin-Clearance (CrCl) ≥ 45 ml/min
    9. Vorliegen einer Tumor-Gewebeprobe / Gewebeblock
    10. Frauen im gebärfähigen Alter müssen einen negativen Schwangerschaftstest (Serum oder Urin) innerhalb von 72 Stunden vor Studienbehandlung vorweisen (minimale Sensitivität 25 IU/l oder äquivalente Einheiten des HCG).
    11. Frauen im gebärfähigen Alter müssen (eine) geeignete Methode(n) zur Empfängnisverhütung anwenden. [Frauen im gebärfähigen Alter sollten eine geeignete Schwangerschafts-verhütungsmethode für 6 Monate nach der letzten Gabe der Studienmedikation anwenden.]
    12. Männliche Patienten, die mit einer gebärfähigen Frau sexuell aktiv sind, müssen eine geeignete Empfängnis-verhütungsmethode anwenden (Fehlerrate < 1% pro Jahr). Sexuell aktive männliche Patienten, die Studienmedikation erhalten, werden angewiesen, die Empfängnisverhütung für einen Zeitraum von 6 Monaten nach der letzten Gabe der Studienmedikation anzuwenden. Nicht-gebärfähige Frauen (z.B. postmenopausal oder durch operative Sterilisation) und Männer mit Azoospermie benötigen keine Empfängnisverhütung.
    13. Patient ist willens und in der Lage an Visiten, Untersuchungen und der Behandlung inklusive der Nachbeobachtung gemäß Prüfplan samt aller damit verbundenen Anforderungen teilzunehmen.
    E.4Principal exclusion criteria
    Methodological criteria:
    1. Any preceding systemic anticancer therapy for SCLC. [Up to one full-cycle-dosing of carboplatin+etoposide chemotherapy within the context of SOC is permitted prior to study treatment.] (Note: Prior treatment for limited stage disease allowed).
    2. Participation in another clinical study with an investigational product during the last 30 days before inclusion or 7 half-lives of previously used trial medication, whichever is longer
    3. Prior therapy with an anti-Programmed cell death protein 1 (anti-PD-1), anti-Programmed cell death-ligand 1 (anti-PD-L1), anti-Programmed cell death-ligand 2 (anti-PD-L2), anti-CD137 (4-1BB ligand, a member of the Tumor Necrosis Factor Receptor [TNFR] family), or anti-Cytotoxic T-lymphocyte-associated antigen-4 (anti-CTLA-4) antibody (including ipilimumab or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways).
    4. Previous treatment in the present study (does not include screening failure).
    Medical criteria:
    5. Symptomatic CNS metastases. [Patients with asymptomatic brain metastases may be included.]
    6. Major surgery ≤ 28 days before first dose of study treatment
    7. Any uncontrolled systemic disease, condition or comorbidity that, in the opinion of the investigator, would interfere with evaluation of study treatment or interpretation of patient safety or study results, including but not limited to:
    a. known active HBV, HCV or HIV infection [Patients who are HIV-positive are allowed in the trial, so long as they are stable on anti-retroviral therapy, have a CD4 count ≥ 200 cells/μL, and have an undetectable viral load at the time of screening.]
    b. active tuberculosis
    c. any other active infection requiring systemic therapy
    d. history of allogeneic tissue/solid organ transplant
    e. diagnosis of immunodeficiency or patient is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of IMP.
    f. other active malignancy requiring treatment
    g. clinically significant or symptomatic cardiovascular/cerebrovascular disease in (incl. myocardial infarction, unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac arrhythmia) within 6 months before enrolment
    Safety criteria:
    8. Female subjects who are pregnant, breast-feeding or male/female patients of reproductive potential who are not employing an effective method of birth control (failure rate of less than 1% per year).
    9. Known hypersensitivity to carboplatin, etoposide or atezolizumab or any of the constituents of the product.
    10. Medication that is known to interfere with any of the agents applied in the trial.
    11. Any condition or disease which might interfere with the subject´s ability to comply with the study procedures (e.g., dementia)
    Regulatory and ethical criteria:
    12. Patient who has been incarcerated or involuntarily institutionalized by court order or by the authorities [§ 40 Abs. 1 S. 3 Nr. 4 AMG].
    13. Patients who are unable to consent because they do not understand the nature, significance and implications of the clinical trial and therefore cannot form a rational intention in the light of the facts [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
    Methodische Kriterien:
    1. Jede vorhergehende systemische Anti-Tumor-Behandlung für SCLC [bis zu ein vollständiger Dosierzyklus von Carboplatin + Etoposid gemäß Behandlungsstandard vor Studienbehandlung ist zulässig.] (Beachte: Vorangehende Behandlung für Limited Stage-Disease ist zulässig.)
    2. Teilnahme an einer weiteren klinischen Studie mit einem Prüfpräparat innerhalb von 30 Tagen oder der 7-fachen Halbwertszeit der jeweiligen Studienmedikation (gültig ist die längere Frist) vor Studieneinschluss.
    3. Vorhergehende Therapie mit einem der folgenden Antikörper: anti-PD-1 (anti-Programmed cell death protein 1), anti-PD-L1 (anti-Programmed cell death-ligand 1), anti-PD-L2 (anti-Programmed cell death-ligand 2), anti-CD137 (4-1BB-Ligand, ein Mitglied der TNFR- (Tumor Necrosis Factor Receptor) Familie) oder anti-CTLA-4 (anti-Cytotoxic T-lymphocyte-associated antigen-4). Dies schließt sowohl Ipilimumab ein als auch jeden anderen Antikörper und jeden Wirkstoff mit T-Zell-Kostimulation oder Checkpoint-Pathways als spezifischem Target.
    4. Vorherige Teilnahme an dieser Studie (Screening Failure gilt nicht als Teilnahme.)
    Medizinische Kriterien:
    5. Symptomatische ZNS-Metastasen. [Patienten mit asymptomatischen Hirnmetastasen sind einschlussfähig]
    6. Größerer operativer Eingriff ≤ 28 Tagen vor Beginn der Studienbehandlung
    7. Jede unkontrollierte systemische Erkrankung / Zustand / Komorbidität, die, nach Urteil des Prüfarztes, die Erhebung oder Interpretation der Studienergebnisse behindern oder ein Risiko für den Patienten darstellen könnte. Dazu gehören:
    a) Bekannte aktive Infektion mit HBV, HCV oder HIV [Patienten, die HIV-positiv sind, dürfen an der Studie teilnehmen, sofern sie unter einer antiretroviralen Therapie stabil sind, eine CD4-Zahl von ≥ 200 Zellen/μl und zum Zeitpunkt des Screenings keine detektierbare Viruslast aufweisen.]
    b) Aktive Tuberkulose
    c) Jede andere aktive Infektion, die einer systemischen Therapie bedarf
    d) Vorgeschichte einer allogenen Gewebe- oder Organtransplantation
    e) Diagnose einer Immundefizienz oder systemische Langzeittherapie mit Steroiden oder jede andere Form einer immunsuppressiven Therapie innerhalb von 7 Tagen vor der ersten Gabe der Studienmedikation
    f) Andere behandlungsbedüftige aktive maligne Erkrankung
    g) Klinisch bedeutende oder symptomatische Herzkreislauferkrankung oder zerebrovaskuläre Erkrankungen (inkl. Myokardinfart, instabile Angina pectoris, symptomatische Herzinsuffizienz, schwere unkontrollierte Arrhythmie) innerhalb der letzten 6 Monate vor Studieneinschluss
    Sicherheitskriterien:
    8. Schwangere oder stillende Frauen oder gebärfähige Frauen bzw. zeugungsfähige Männer, die keine hocheffektive Empfängnisverhütungsmethode anwenden (Fehlerrate von weniger als 1 % pro Jahr).
    9. Bekannte Hypersensibilität gegenüber Carboplatin, Etoposid oder Atezolizumab oder einem der Bestandteile der Zubereitungen
    10. Medikation, für die eine Interaktion mit einem in der Studie angewendeten Wirkstoff bekannt ist
    11. Jeder Zustand oder jede Erkrankung, die die Fähigkeit des Patienten beeinträchtigen könnte, die Studienverfahren einzuhalten (z. B. Demenz).
    Regulatorische und ethische Kriterien:
    12. Patienten, die inhaftiert sind oder unfreiwillig auf gerichtliche oder behördliche Anordnung in einer Anstalt untergebracht sind (§ 40 Abs. 1 S. 3 Nr. 4 AMG).
    13. Patienten, die nicht in der Lage sind, Wesen, Bedeutung und Tragweite der klinischen Prüfung zu erkennen und daher unfähig sind, ihren Willen hiernach auszurichten [§ 40 Abs. 1 S. 3 Nr. 3a AMG].
    E.5 End points
    E.5.1Primary end point(s)
    • Overall survival (OS) incl. milestone 1-year OS rate
    • Gesamtüberleben (OS) inklusive Überlebensrate @ 12 Monate
    E.5.1.1Timepoint(s) of evaluation of this end point
    after approx. 36 months after first patient in
    after approx. 12 months after last patient in
    Studienende ca. 36 Monaten nach Einschluss des ersten Patienten
    E.5.2Secondary end point(s)
    • Objective response rate (ORR) (RECIST 1.1)
    • Progression-free survival (PFS)
    • Safety and tolerability
    • Quality of life:
    o EORTC-QLQ-C30
    o PRO CTCAE
    • Objektive Ansprechrate (ORR) nach RECIST v1.1
    • Progressionsfreies Überleben (PFS)
    • Sicherheit und Verträglichkeit
    • Lebensqualität (QoL):
    o EORTC QLQC30
    o PRO-CTCAE
    E.5.2.1Timepoint(s) of evaluation of this end point
    after approx. 36 months after first patient in
    after approx. 12 months after last patient in
    Studienende ca. 36 Monaten nach Einschluss des ersten Patienten
    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 Yes
    E.6.13.1Other scope of the trial description
    Quality of Life (QoL)
    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 trial1
    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 concerned17
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    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
    End of Study (EoS) is defined as the time point when the last study subject has completed a 6 month follow-up period after individual EoT.
    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 months36
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months30
    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: 35
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state60
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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)
    Patients will be treated according to standard-of-care at the discretion of the investigator.
    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 Decision2019-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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