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    Summary
    EudraCT Number:2020-003427-42
    Sponsor's Protocol Code Number:DS8201-A-U206
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2021-06-04
    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 ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-003427-42
    A.3Full title of the trial
    A Phase 2, multicenter, randomized study of trastuzumab deruxtecan in subjects with HER2-mutated metastatic Non-Small Cell Lung Cancer (NSCLC) [DESTINY-Lung02]
    Studio di fase 2, multicentrico, randomizzato su trastuzumab deruxtecan in soggetti affetti da carcinoma polmonare non a piccole cellule (NSCLC) metastatico con mutazione HER2 [DESTINY-Lung02]
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Trastuzumab deruxtecan for subjects with HER2-mutated metastatic NSCLC
    Trastuzumab deruxtecan per soggetti affetti da NSCLC metastatico con mutazione HER2
    A.3.2Name or abbreviated title of the trial where available
    [DESTINY-Lung02]
    [DESTINY-Lung02]
    A.4.1Sponsor's protocol code numberDS8201-A-U206
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT04644237
    A.5.4Other Identifiers
    Name:IND Number:Number:137009
    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 SponsorDAIICHI SANKYO INC.
    B.1.3.4CountryUnited States
    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 supportDaiichi Sankyo, Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Inc.
    B.5.2Functional name of contact pointDavid Rusnak
    B.5.3 Address:
    B.5.3.1Street Address211 Mount Airy Road
    B.5.3.2Town/ cityBasking Ridge
    B.5.3.3Post codeNJ 07920
    B.5.3.4CountryUnited States
    B.5.4Telephone number0019089927876
    B.5.5Fax number000000
    B.5.6E-maildrusnak@dsi.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.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameTrastuzumab deruxtecan for injection 100 mg
    D.3.2Product code [DS-8201a]
    D.3.4Pharmaceutical form Powder for 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 INNTrastuzumab deruxtecan
    D.3.9.1CAS number 1826843-81-5
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.4EV Substance CodeSUB188357
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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 nameTrastuzumab deruxtecan for injection 100 mg
    D.3.2Product code [DS-8201a]
    D.3.4Pharmaceutical form Powder for 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 INNTrastuzumab deruxtecan
    D.3.9.1CAS number 1826843-81-5
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.4EV Substance CodeSUB188357
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number100
    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 Information not present in EudraCT
    D.3.11.3.2Gene therapy medical product Information not present in EudraCT
    D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    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
    HER2-mutated metastatic Non-Small Cell Lung Cancer (NSCLC)
    Carcinoma polmonare non a piccole cellule metastatico (NSCLC) metastatico con HER2 mutato
    E.1.1.1Medical condition in easily understood language
    Metastatic Lung Cancer
    Carcinoma polmonare metastatico
    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 LLT
    E.1.2Classification code 10064049
    E.1.2Term Lung adenocarcinoma metastatic
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate confirmed ORR of trastuzumab deruxtecan in human epidermal growth factor receptor 2- (HER2-) mutated NSCLC subjects treated at 5.4 and 6.4 mg/kg doses.
    Per valutare l'ORR confermato di trastuzumab deruxtecan in soggetti con NSCLC mutato del recettore del fattore di crescita epidermico umano 2- (HER2-) trattati a dosi di 5,4 e 6,4 mg / kg.
    E.2.2Secondary objectives of the trial
    • To evaluate the clinical efficacy of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses by confirmed ORR by investigator assessment.
    • To evaluate the clinical efficacy of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses by Duration of Response (DoR).
    • To evaluate further the clinical efficacy of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses by Disease control rate (DCR), Progression-free survival (PFS) and Overall survival (OS).
    • To evaluate safety of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses.
    • To evaluate pharmacokinetics (PK) and immunogenicity of trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses.
    • To assess symptoms, functioning and Health-related Quality of life (HRQoL) in subjects treated with trastuzumab deruxtecan at 5.4 and 6.4 mg/kg doses.
    • Valutare l'efficacia clinica di trastuzumab deruxtecan a dosi di 5,4 e 6,4 mg / kg mediante ORR confermato dalla valutazione dello sperimentatore.
    • Valutare l'efficacia clinica di trastuzumab deruxtecan a dosi di 5,4 e 6,4 mg / kg in base alla durata della risposta (DoR).
    • Valutare ulteriormente l'efficacia clinica di trastuzumab deruxtecan a dosi di 5,4 e 6,4 mg / kg in base al tasso di controllo della malattia (DCR), alla sopravvivenza libera da progressione (PFS) e alla sopravvivenza globale (OS).
    • Valutare la sicurezza di trastuzumab deruxtecan alle dosi di 5,4 e 6,4 mg / kg.
    • Valutare la farmacocinetica (PK) e l'immunogenicità di trastuzumab deruxtecan alle dosi di 5,4 e 6,4 mg / kg.
    • Valutare i sintomi, il funzionamento e la qualità della vita correlata alla salute (HRQoL) nei soggetti trattati con trastuzumab deruxtecan alle dosi di 5,4 e 6,4 mg / kg.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Must have provided informed consent for study participation (see Section 10.1.2) before performance of any study-specific procedure or test.
    2. Men or women =18 years old. (Please follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
    3. Pathologically documented metastatic NSCLC with a known activating HER2 mutation (please refer to the list of HER2 mutations, Table 10.2). The HER2 mutation must be documented from an archival or fresh tumor tissue sample analyzed by Clinical Laboratory Improvement Amendments (CLIA) certified laboratory or equivalent laboratory performing testing to Good Laboratory Practice (GLP) standard.
    Note: HER2 mutation documented only from a liquid biopsy sample cannot be used for enrollment.
    4. Subjects who had previous treatment (2L+) including platinum therapy, not amenable to curative surgery or radiation.
    5. Presence of at least 1 measurable lesion confirmed by BICR based on RECIST version 1.1.
    6. Is willing and able to provide an adequate archival tumor tissue sample. A fresh biopsy is required if an archival tumor tissue sample cannot be supplied. Fine needle aspirates are not acceptable.
    7. Has ECOG PS of 0 to 1.
    8. Has LVEF = 50% within 28 days before randomization.
    9. Has adequate organ function within 14 days before randomization, as defined in the protocol.
    10. Has adequate treatment washout period before randomization, as defined in the protocol.
    11. Male and female subjects of reproductive/childbearing potential must agree to use a highly effective form of contraception or avoid intercourse during and upon completion of the study and for at least 7 months for females and for 4 months for males after the last dose of study drug. Please refer protocol for more details.
    12. Male subjects must not freeze or donate sperm starting at Screening and throughout the study period, and at least 4 months after the final study drug administration. Preservation of sperm should be considered prior to enrollment in this study.
    13. Female subjects must not donate, or retrieve for their own use, ova from the time of Screening and throughout the study treatment period, and for at least 7 months after the final study drug administration.
    14. Life expectancy of 3 months or more.

    1. Deve aver fornito il consenso informato per la partecipazione allo studio (vedere la Sezione 10.1.2) prima di eseguire qualsiasi procedura o test specifico per lo studio.
    2. Uomini o donne = 18 anni. (Seguire i requisiti normativi locali se l'età legale per il consenso alla partecipazione allo studio è> 18 anni).
    3. NSCLC metastatico patologicamente documentato con una mutazione HER2 attivante nota (fare riferimento all'elenco delle mutazioni HER2, Tabella 10.2). La mutazione HER2 deve essere documentata da un campione di tessuto tumorale fresco o archiviato analizzato da un laboratorio certificato CLIA (Clinical Laboratory Improvement Amendments) o da un laboratorio equivalente che esegue test secondo lo standard GLP (Good Laboratory Practice).
    Nota: la mutazione HER2 documentata solo da un campione bioptico liquido non può essere utilizzata per l'arruolamento.
    4. Soggetti che hanno avuto un precedente trattamento (2L +) inclusa la terapia con platino, non suscettibili di chirurgia curativa o radiazioni.
    5. Presenza di almeno 1 lesione misurabile confermata da BICR sulla base della versione RECIST 1.1.
    6. È disposto e in grado di fornire un adeguato campione di tessuto tumorale archivistico. Se non è possibile fornire un campione di tessuto tumorale archiviato, è necessaria una nuova biopsia. Gli aghi aspirati fini non sono accettabili.
    7. Ha ECOG PS da 0 a 1.
    8. Ha LVEF = 50% entro 28 giorni prima della randomizzazione.
    9. Ha una funzione organica adeguata entro 14 giorni prima della randomizzazione, come definito nel protocollo.
    10. Ha un adeguato periodo di washout dal trattamento prima della randomizzazione, come definito nel protocollo.
    11. I soggetti di sesso maschile e femminile in età fertile / fertile devono accettare di utilizzare una forma di contraccezione altamente efficace o di evitare i rapporti durante e al termine dello studio e per almeno 7 mesi per le femmine e per 4 mesi per i maschi dopo l'ultima dose di farmaco in studio. Fare riferimento al protocollo per maggiori dettagli.
    12. I soggetti di sesso maschile non devono congelare o donare sperma a partire dallo Screening e per tutto il periodo di studio e almeno 4 mesi dopo la somministrazione finale del farmaco in studio. La conservazione dello sperma deve essere presa in considerazione prima dell'arruolamento in questo studio.
    13. I soggetti di sesso femminile non devono donare, o recuperare per uso personale, ovuli dal momento dello screening e durante il periodo di trattamento in studio e per almeno 7 mesi dopo la somministrazione finale del farmaco in studio.
    14. Aspettativa di vita di 3 mesi o più.
    E.4Principal exclusion criteria
    1. Has a known driver mutation in the EGFR or BRAF gene or a known ALK or ROS1 fusion.
    2. Medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV). Subjects with troponin levels above ULN at screening (as defined by the manufacturer), and without any MI related symptoms should have a cardiologic consultation before enrollment to rule out MI.
    3. Has a corrected QT interval (QTcF) prolongation > 470 msec (females) or >450 msec (males) based on average of the triplicate12-lead ECG at screening.
    4. Has a history of (non-infectious) ILD/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
    5. Has spinal cord compression or clinically active CNS metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed between the end of whole brain radiotherapy and study randomization.
    6. Has multiple primary malignancies within 3 years, except adequately resected non melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated.
    7. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug product.
    8. Has a history of severe hypersensitivity reactions to other monoclonal antibodies.
    9. Has an uncontrolled infection requiring IV antibiotics, antivirals, or antifungals.
    10. Has substance abuse or any other medical conditions such as clinically significant cardiac or psychological conditions, that may, in the opinion of the investigator, interfere with the subject’s participation in the clinical study or evaluation of the clinical study results.
    11. Known human immunodeficiency virus (HIV) infection. Subjects should be tested for HIV prior to randomization if required by local regulations or institutional review board (IRB)/independent ethics committee (IEC).
    12. Known active clinically relevant liver disease (eg, active hepatitis B, or active hepatitis C), based on available blood tests, liver ultrasound, or liver biopsy results. Subjects who are HBsAg +, with HBV infection for more than 6 months, have a HBV DNA viral load < 2000 IU/mL, have normal transaminase values prior to randomization, and are willing to start and maintain antiviral treatment for the duration of the study are allowed].
    13. Unresolved toxicities from previous anticancer therapy, defined as toxicities (other than alopecia)not yet resolved to Grade = 1 or baseline. Note: Subjects may be enrolled with chronic Grade 2 toxicities (defined as no worsening to > Grade 2 for at least 3 months prior to randomization and managed with standard of care treatment) which the investigator deems related to previous nticancer therapy, comprised of:
    a. Chemotherapy-induced neuropathy
    b. Fatigue
    c. Residual toxicities from prior IO treatment: Grade 1 or Grade 2 endocrinopathies which may include:
    • Hypothyroidism/ hyperthyroidism
    • Type I diabetes
    • Hyperglycemia
    • Adrenal insufficiency
    • Adrenalitis
    • Skin hypopigmentation (vitiligo)
    14. Is pregnant, breastfeeding, or planning to become pregnant.
    15. Otherwise considered inappropriate for the study by the investigator.
    (No other space available - please refer to the protocol)
    1. Possiede una mutazione driver nota nel gene EGFR o BRAF o una fusione nota ALK o ROS1.
    2. Storia medica di infarto miocardico nei 6 mesi precedenti la randomizzazione, insufficienza cardiaca congestizia sintomatica (CHF) (Classe da II a IV della New York Heart Association). I soggetti con livelli di troponina superiori all'ULN allo screening (come definito dal produttore) e senza alcun sintomo correlato a IM dovrebbero sottoporsi a un consulto cardiologico prima dell'arruolamento per escludere IM.
    3. Ha un prolungamento dell'intervallo QT corretto (QTcF)> 470 msec (femmine) o> 450 msec (maschi) in base alla media dell'ECG a 12 derivazioni triplicato allo screening.
    4. Ha una storia di ILD / polmonite (non infettiva) che ha richiesto steroidi, ha una ILD / polmonite in corso o una sospetta ILD / polmonite non può essere esclusa mediante imaging allo screening.
    5. Presenta compressione del midollo spinale o metastasi del SNC clinicamente attive, definite come non trattate e sintomatiche, o che richiedono una terapia con corticosteroidi o anticonvulsivanti per controllare i sintomi associati. Soggetti con metastasi cerebrali clinicamente inattive possono essere inclusi nello studio. I soggetti con metastasi cerebrali trattate che non sono più sintomatiche e che non richiedono alcun trattamento con corticosteroidi o anticonvulsivanti possono essere inclusi nello studio se si sono ripresi dall'effetto tossico acuto della radioterapia. Devono essere trascorse almeno 2 settimane tra la fine della radioterapia dell'intero cervello e la randomizzazione dello studio.
    6. Presenta più tumori primari entro 3 anni, ad eccezione del carcinoma cutaneo non melanoma adeguatamente asportato, della malattia in situ trattata curativamente o di altri tumori solidi trattati curativamente.
    7. Ha una storia di gravi reazioni di ipersensibilità alle sostanze farmaceutiche o agli ingredienti inattivi nel prodotto farmaceutico.
    8. Ha una storia di gravi reazioni di ipersensibilità ad altri anticorpi monoclonali.
    9. Ha un'infezione incontrollata che richiede antibiotici IV, antivirali o antimicotici.
    10. Ha abuso di sostanze o qualsiasi altra condizione medica come condizioni cardiache o psicologiche clinicamente significative, che possono, a parere dello sperimentatore, interferire con la partecipazione del soggetto allo studio clinico o la valutazione dei risultati dello studio clinico.
    11. Infezione nota da virus dell'immunodeficienza umana (HIV). I soggetti devono essere testati per l'HIV prima della randomizzazione se richiesto dalle normative locali o dal comitato di revisione istituzionale (IRB) / comitato etico indipendente (IEC).
    12. Malattia epatica attiva nota clinicamente rilevante (ad es., Epatite B attiva o epatite C attiva), sulla base dei risultati degli esami del sangue disponibili, dell'ecografia epatica o dei risultati della biopsia epatica. I soggetti che sono HBsAg +, con infezione da HBV da più di 6 mesi, hanno una carica virale del DNA di HBV <2000 UI / mL, hanno valori normali di transaminasi prima della randomizzazione e sono disposti a iniziare e mantenere un trattamento antivirale per la durata dello studio sono ammessi].
    (Spazio a disposizione esaurito - si prega di fare riferimento al protocollo)
    E.5 End points
    E.5.1Primary end point(s)
    Primary efficacy endpoint is confirmed Objective Response Rate (ORR), defined as the proportion of subjects with Complete Response (CR) or Partial Response (PR), assessed by blinded independent central review (BICR) based on RECIST version 1.1
    L'endpoint primario di efficacia è confermato Tasso di risposta obiettiva (ORR), definito come la proporzione di soggetti con risposta completa (CR) o risposta parziale (PR), valutata da una revisione centrale indipendente in cieco (BICR) basata su RECIST versione 1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least 9 months after the last subject is randomized
    Almeno 9 mesi dopo la randomizzazione dell'ultimo soggetto
    E.5.2Secondary end point(s)
    - Objective Response Rate
    - Duration of Response (DoR)
    - Disease Control Rate (DCR)
    - Progression-free Survival (PFS)
    - Overall Survival (OS)
    - Safety parameters (AEs, ECOG PS, vital signs, clinical laboratory parameters, ECG etc.)
    - PK endpoints: Serum concentrations of trastuzumab deruxtecan, total anti-HER2 antibody, and MAAA 1181a
    - Immunogenicity endpoint: Incidence of ADA.
    - Change from baseline in European Organization for Research and Treatment of Cancer (EORTC) core quality of life questionnaire (QLQ-C30) and EORTC quality of life questionnaire for lung cancer trials (QLQ-LC13) scale scores
    - Time to deterioration in EORTC QLQ-C30 scores
    - Tasso di risposta obiettiva
    - Durata della risposta (DoR)
    - Tasso di controllo della malattia (DCR)
    - Sopravvivenza libera da progressione (PFS)
    - Sopravvivenza globale (OS)
    - Parametri di sicurezza (EA, ECOG PS, segni vitali, parametri di laboratorio clinico, ECG ecc.)
    - Endpoint PK: concentrazioni sieriche di trastuzumab deruxtecan, anticorpo anti-HER2 totale e MAAA 1181a
    - Endpoint di immunogenicità: incidenza di ADA.
    - Variazione rispetto al basale nel questionario sulla qualità della vita (QLQ-C30) e nel questionario sulla qualità della vita dell'EORTC per gli studi sul cancro del polmone (QLQ-LC13) dell'Organizzazione europea per la ricerca e il trattamento del cancro (EORTC)
    - Tempo al deterioramento dei punteggi EORTC QLQ-C30
    E.5.2.1Timepoint(s) of evaluation of this end point
    ORR, DOR, PFS, OS, Safety parameters, PK, Immunogenicity, Health-related Quality of life (HRQoL): At least 9 months after the last subject is randomized
    ORR, DOR, PFS, OS, parametri di sicurezza, PK, immunogenicità, qualità della vita correlata alla salute (HRQoL): almeno 9 mesi dopo la randomizzazione dell'ultimo soggetto
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Biomarker Analysis, Immunogenicity, clinical pharmacology, Health economics and outcomes research (HEOR), quality of life (QoL)
    Analisi dei biomarcatori, immunogenicità, farmacologia clinica, salute economia e ricerca sui risultati (HEOR), qualità della vita (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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Yes
    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 Yes
    E.8.2.3.1Comparator description
    Dose diversa dello stesso IMP
    Different dose of the same IMP
    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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA22
    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 Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Australia
    Canada
    Japan
    Korea, Republic of
    Taiwan
    United States
    France
    Italy
    Netherlands
    Spain
    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
    EOS will occur when the last subject’s last visit has occurred, all subjects have discontinued from the study or have died, an alternative study has become available where trastuzumab deruxtecan is offered to subjects continuing to derive benefit from such treatment, or the study is discontinued by the Sponsor for other reasons.
    EOS si verificherà quando si sarà verificata l'ultima visita dell'ultimo soggetto, tutti i soggetti hanno interrotto lo studio o sono morti, è diventato disponibile uno studio in cui viene offerto trastuzumab deruxtecan a soggetti che continuano a trarre beneficio da tale trattamento, o lo studio viene interrotto dallo Sponsor per altri motivi.
    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 months7
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months7
    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: 135
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 15
    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 state50
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 66
    F.4.2.2In the whole clinical trial 150
    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)
    An alternative study will be available to subjects who continues to derive benefit from trastuzumab deruxtecan treatment.
    Uno studio alternativo sarà disponibile per i soggetti che continuano a trarre beneficio dal trattamento con trastuzumab deruxtecan.
    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 Decision2021-05-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-03-18
    P. End of Trial
    P.End of Trial StatusCompleted
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