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    EudraCT Number:2020-000633-40
    Sponsor's Protocol Code Number:61186372NSC3001
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2021-03-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000633-40
    A.3Full title of the trial
    A Randomized, Open-label Phase 3 Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    Studio randomizzato, in aperto, di fase 3 sulla terapia di combinazione con amivantamab e carboplatino-pemetrexed rispetto a carboplatino-pemetrexed in pazienti affetti da tumore
    polmonare non a piccole cellule localmente avanzato o metastatico con mutazione esone 20ins di EGFR
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Clinical Study of Combination Amivantamab and Carboplatin-Pemetrexed Therapy, Compared with Carboplatin-Pemetrexed, in Patients with EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    Uno studio di fase 3 randomizzato, in aperto, sulla terapia combinata con amivantamab e carboplatino-pemetrexed, rispetto a carboplatino-pemetrexed, in pazienti con carcinoma polmonare non a piccole cellule metastatico o avanzato localmente con mutazione dell'esone 20 di EGFR
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code number61186372NSC3001
    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.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportJanssen Cilag S.p.A.
    B.4.1Name of organisation providing supportJanssen Research and Development
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationJanssen-Cilag International NV
    B.5.2Functional name of contact pointClinical Registry Group
    B.5.3 Address:
    B.5.3.1Street AddressArchimedesweg 29
    B.5.3.2Town/ cityLeiden
    B.5.3.3Post code2333CM
    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.2.5The 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 nameAmivantamab
    D.3.2Product code [JNJ-61186372]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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 INNamivantamab
    D.3.9.1CAS number 2171511-58-1
    D.3.9.2Current sponsor codeJNJ-61186372
    D.3.9.4EV Substance CodeSUB193051
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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. cell therapy medicinal product Information not present in EudraCT
    D. therapy medical product Information not present in EudraCT
    D. Engineered Product Information not present in EudraCT
    D. ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D. 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
    EGFR Exon 20ins-mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    tumore polmonare non a piccole cellule localmente avanzato o metastatico con mutazione esone 20ins di EGFR
    E.1.1.1Medical condition in easily understood language
    A specific type of lung cancer called "Non-Small Cell Lung Cancer"
    Un tipo specifico di cancro ai polmoni chiamato "carcinoma polmonare non a piccole cellule"
    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 10061873
    E.1.2Term Non-small cell lung cancer
    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
    The primary objective is to compare the efficacy, as demonstrated by PFS, in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone
    Confrontare l’efficacia, come dimostrata in base alla PFS, in partecipanti trattati con amivantamab in combinazione con chemioterapia rispetto alla chemioterapia da sola
    E.2.2Secondary objectives of the trial
    1. To further assess the clinical benefit achieved with amivantamab in combination with chemotherapy, versus chemotherapy alone
    2. To assess the safety in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone
    3. To assess the relationship between pharmacokinetics or immunogenicity and selected endpoints (including but not limited to efficacy, safety and/or PRO)
    4. To assess health-related quality of life and disease related symptoms in participants treated with amivantamab in combination with chemotherapy, versus chemotherapy alone
    1. Valutare ulteriormente il beneficio clinico ottenuto con amivantamab in combinazione con chemioterapia rispetto alla chemioterapia da sola
    2. Valutare la sicurezza nei partecipanti trattati con amivantamab in combinazione con chemioterapia rispetto alla chemioterapia da sola
    3. Per valutare la relazione tra farmacocinetica o immunogenicità ed endpoint selezionati (inclusi ma non limitati a efficacia, sicurezza e / o PRO)
    4. Per valutare la qualità della vita correlata alla salute e i sintomi correlati alla malattia nei partecipanti trattati con amivantamab in combinazione con la chemioterapia, rispetto alla sola chemioterapia
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be =18 years of age (or the legal age of consent in the jurisdiction in which the study is taking place).
    2. Participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous NSCLC with documented primary EGFR Exon 20ins activating mutation (a copy of the mutation analysis must be submitted during screening) performed by a Clinical Laboratory Improvement Amendments (CLIA) certified (US sites) or an accredited (outside of the US) local laboratory.
    3. Participant must have measurable disease according to RECIST v1.1. If only one measurable lesion exists, it may be used for the screening biopsy (if required for submission of tumor tissue) if the baseline tumor assessment scans are performed =14 days after the biopsy.
    4. Participant must have ECOG performance status 0 or 1.
    5. Participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream.
    6. Participant must have adequate organ and bone marrow function as follows, without history of red blood cell transfusion or platelet transfusion within 7 days prior to the date of the laboratory test.
    • Hemoglobin =10 g/dL
    • Absolute neutrophil count =1.5x109/L, without use of granulocyte colony stimulating factor (G-CSF) within 10 days prior to the date of the test
    • Platelets =100x109/L
    • ALT and aspartate aminotransferase (AST) =3×upper limit of normal (ULN)
    • Total bilirubin =1.5xULN (participants with Gilbert's syndrome can enroll if conjugated bilirubin is within normal limits)
    • Creatinine clearance >50 mL/min as measured or calculated by Cockroft Gault formula
    7. Participant must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
    8. A female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study.
    9. A female participant must be (as defined in Appendix 4: Contraceptive and Barrier Guidance) either of the following:
    a. Not of childbearing potential
    b. Of childbearing potential and
    • practicing true abstinence during the entire period of the study, including up to 6 months after the last dose of study treatment is given;
    • have a sole partner who is vasectomized;
    • or practicing 2 highly effective methods of contraception, including 1 user independent method and a second method (examples of highly effective methods of contraception are located in Appendix 4:
    Contraceptive and Barrier Guidance).
    Participant must agree to continue contraception throughout the study and through 6 months after the last dose of study treatment.
    Note: If the childbearing potential changes after start of the study (eg, woman who is not heterosexually active becomes active, premenarchal woman experiences menarche) the woman must begin 2 highly effective methods of birth control, as described above.
    10. A female participant must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the study and for 6 months after receiving the last dose of study treatment.

    for a complete description of Inclusion Criteria please refer to
    1. Età =18 anni (o l’età legale del consenso nella giurisdizione in cui si svolge lo studio).
    2. Diagnosi istologicamente o citologicamente confermata di NSCLC non squamoso in stadio localmente avanzato o metastatico con documentata mutazione attivante primaria esone 20ins di EGFR (una copia del referto relativo all’analisi mutazionale deve essere inviata durante lo screening), determinata da un laboratorio certificato secondo gli Emendamenti per il miglioramento dei laboratori clinici (Clinical Laboratory Improvement Amendments, CLIA) (centri statunitensi) o un laboratorio locale accreditato (centri al di fuori degli Stati Uniti).
    3. Malattia misurabile secondo i criteri RECIST v1.1. Se è presente una sola lesione misurabile, è possibile utilizzarla per la biopsia di screening (se necessaria ai fini dell’invio di un campione di tessuto tumorale) laddove le scansioni basali di valutazione del tumore siano eseguite =14 giorni dopo la biopsia.
    4. Performance status secondo ECOG di 0 o 1.
    5. Il/la partecipante deve acconsentire alla caratterizzazione genetica dello stato del tumore attraverso la biopsia tumorale pre-trattamento (o l’invio di materiale di archivio equivalente), nonché al prelievo basale e periodico di campioni di sangue per l’analisi delle mutazioni tumorali nel flusso sanguigno.
    6. Il/la partecipante deve avere una funzionalità d’organo e funzione del midollo osseo adeguate, come specificato di seguito, in assenza di un’anamnesi di trasfusione di globuli rossi o trasfusione piastrinica nei 7 giorni precedenti la data dell’esame di laboratorio.
    • Emoglobina =10 g/dl
    • Conta assoluta dei neutrofili =1,5x109/l, senza supporto con fattore stimolante le colonie granulocitarie (granulocyte colony-stimulating factor, G-CSF) nei 10 giorni precedenti la data dell’esame
    • Piastrine =100x109/l
    • ALT e aspartato aminotransferasi (AST) =3 × il limite superiore della norma (upper limit of normal, ULN)
    • Bilirubina totale =1,5xl’ULN (i partecipanti con sindrome di Gilbert sono ammessi all’arruolamento se la bilirubina coniugata rientra nei limiti di normalità)
    • Clearance della creatinina >50 ml/min come misurata o calcolata mediante formula di Cockroft-Gault
    7. Il/la partecipante deve sottoscrivere un Modulo di consenso informato che indichi che comprende l’obiettivo dello studio e le procedure da questo previste ed è disposto a parteciparvi.
    8. La partecipante di sesso femminile potenzialmente fertile deve presentare un test sul siero o sulle urine negativo allo screening ed entro 72 ore dalla prima dose del trattamento in studio, nonché acconsentire a sottoporsi a ulteriori test di gravidanza sul siero o sulle urine nel corso dello studio.
    9. La partecipante di sesso femminile deve soddisfare (come definito nell’Appendice 4: Guida ai metodi contraccettivi e di barriera) uno dei seguenti requisiti:
    a) Non essere potenzialmente fertili
    b) Essere potenzialmente fertili e
    • praticare l’astinenza completa durante l’intero periodo dello studio e fino a 6 mesi dopo la somministrazione dell’ultima dose del trattamento in studio;
    • avere un partner (unico) vasectomizzato;
    • oppure utilizzare 2 metodi contraccettivi altamente efficaci, tra cui 1 metodo indipendente dall’utilizzatore e un secondo metodo (esempi di metodi contraccettivi altamente efficaci sono riportati nell’Appendice 4: Guida ai metodi contraccettivi e di barriera).
    La partecipante deve acconsentire a proseguire la contraccezione per tutta la durata dello studio e fino a 6 mesi dopo l’ultima dose del trattamento in studio.
    10. La partecipante di sesso femminile deve acconsentire a non donare ovuli (ovociti, oociti) per finalità di riproduzione assistita durante lo studio e per 6 mesi dopo aver ricevuto l’ultima dose del trattamento in studio.
    E.4Principal exclusion criteria
    1. Participant has received any prior systemic treatment for locally advanced or metastatic disease, with following exceptions noted in section 5.2 of the protocol
    2. Participant has evidence of synchronous NSCLC with an EGFR mutation other than EGFR Exon 20ins.
    3. Participant has untreated brain metastases (a participant with definitively, locally treated metastases who is clinically stable, asymptomatic, and off corticosteroid treatment for at least 2 weeks prior
    to randomization is eligible). If brain metastases are diagnosed on Screening imaging, the participant may be rescreened for eligibility after definitive treatment.
    4. Participant has a history of leptomeningeal disease.
    5. Participant has history of spinal cord compression that has not been treated definitively with surgery or radiation.
    6. Participant has uncontrolled tumor-related pain (symptomatic lesions amenable to palliative radiotherapy [eg, bone metastases or metastases causing nerve impingement] should be treated prior to Screening).
    7. Participant has a medical history of ILD, including drug-induced ILD, or radiation pneumonitis.
    8. Participant has an active malignancy (ie, progressing or requiring treatment change in the last 24 months) other than the disease being treated under study. Exceptions noted in section 5.2. of the protocol.
    9. Participant has a history of clinically significant cardiovascular disease. Examples noted in section 5.2 of the protocol.
    10. Participant has at Screening:
    • Positive hepatitis B (hepatitis B virus [HBV]) surface antigen (HBsAg)
    • Positive hepatitis C (hepatitis C virus [HCV]) antibody (anti-HCV)
    • Other clinically active infectious liver disease
    11. Participant is known to be positive for human immunodeficiency virus (HIV)
    • Not receiving highly active antiretroviral therapy (ART)
    • Had a change in antiretroviral therapy within 6 months of the start of screening
    • Receiving antiretroviral therapy that may interfere with study treatment (consult Sponsor for review of medication prior to enrollment)
    • CD4 count <350 at screening
    • AIDS-defining opportunistic infection within 6 months of start of screening
    • Not agreeing to start ART and be on ART>4 weeks plus having HIV viral load <400 copies/mL at end of 4-week period (to ensure ART is tolerated and HIV controlled).
    12. Participant has an uncontrolled illness, including but not limited to the following:
    • Diabetes
    • Ongoing or active bacterial infection (includes infection requiring treatment with antimicrobial therapy [participants will be required to complete antibiotics 1 week before randomization]), symptomatic viral infection, or any other clinically significant infection
    • Active bleeding diathesis
    • Impaired oxygenation requiring supplemental oxygen
    • Psychiatric illness/social situation that would limit compliance with study requirements
    13. Participant had major surgery (eg, requiring general anesthesia) or significant traumatic injury within 4 weeks of randomization, will not have fully recovered from surgery, or has surgery planned during the time the participant is expected to participate in the study. Note: Participants with planned surgical procedures to be conducted under local anesthesia may participate.
    1. Anamnesi di qualsiasi trattamento sistemico precedente per malattia localmente avanzata o metastatica, con le seguenti eccezioni:
    2. Evidenza di NSCLC sincrono con mutazione di EGFR diversa dalla mutazione esone 20ins.
    3. Presenza di metastasi cerebrali non trattate (il partecipante con metastasi sottoposte a trattamento locale definitivo che sia clinicamente stabile e asintomatico e non abbia ricevuto un trattamento corticosteroideo per almeno 2 settimane prima della randomizzazione è considerato idoneo). Nell’eventualità di metastasi cerebrali diagnosticate agli esami di diagnostica per immagini eseguiti allo screening, il partecipante può ripetere lo screening per l’accertamento dell’idoneità dopo essersi sottoposto a trattamento definitivo.
    4. Anamnesi di malattia leptomeningea.
    5. Anamnesi di compressione del midollo spinale non trattata in modo definitivo con chirurgia o radioterapia.
    6. Dolore correlato al tumore non controllato (le lesioni sintomatiche suscettibili di radioterapia palliativa [per es., metastasi ossee o metastasi che causano conflitto nervoso] devono essere trattate prima dello screening).
    7. Anamnesi di ILD (interstitial lung disease [malattia polmonare interstiziale]), compresa l’ILD da farmaci, o polmonite da radiazioni. Per le eccezioni consentite fare riferimento alla sezione 5.2 del Protocollo.
    8. Presenza di malignità attiva (ovvero, progressione o necessità di modifica del trattamento negli ultimi 24 mesi) diversa dalla malattia trattata nell’ambito dello studio.
    9. Anamnesi di malattia cardiovascolare clinicamente significativa, tra cui, in modo non limitativo Per gli esempi fare riferimento alla sezione 5.2 del protocollo
    10. Positività allo screening per:
    • Antigene di superficie dell’epatite B (infezione da virus dell’epatite B [hepatitis B virus, HBV]) (HB surface antigen, HBsAg)
    • Anticorpi anti-epatite C (infezione da virus dell’epatite C [hepatitis C virus, HCV]) (anti-HCV)
    • Altra malattia epatica infettiva clinicamente attiva
    11. Il partecipante presenta positività nota per il virus dell’immunodeficienza umana (human immunodeficiency virus, HIV) e:
    • Non è in trattamento con una terapia antiretrovirale (antiretroviral therapy, ART) altamente attiva
    • Riceve una terapia antiretrovirale che è stata modificata entro 6 mesi dall’inizio dello screening
    • Riceve una terapia antiretrovirale che potrebbe interferire con il trattamento in studio (consultare lo Sponsor per una revisione dei farmaci prima dell’arruolamento)
    • Presenta una conta CD4 <350 allo screening
    • Ha sviluppato un’infezione opportunistica indicativa di AIDS (acquired immunodeficiency syndrome [sindrome da immunodeficienza acquisita]) entro 6 mesi dall’inizio dello screening
    • Non acconsente a iniziare e proseguire una ART per >4 settimane con dimostrazione di una carica virale HIV <400 copie/ml al termine del periodo di 4 settimane (per garantire che la ART sia tollerata e l’infezione da HIV controllata)
    12. Presenza di malattia non controllata, tra cui, in modo non limitativo:
    • Diabete
    • Infezione batterica in corso o attiva (tra cui infezioni che richiedono un trattamento con terapia antimicrobica [i partecipanti devono completare la terapia antibiotica 1 settimana prima della randomizzazione]), infezione virale sintomatica o qualsiasi altra infezione clinicamente significativa
    • Diatesi emorragica attiva
    • Deficit di ossigenazione con necessità di ossigeno supplementare
    • Malattia psichiatrica/Situazione sociale che potrebbe limitare l’aderenza ai requisiti dello studio
    13. Anamnesi di intervento chirurgico maggiore (per es., con necessità di anestesia generale) o di lesione traumatica significativa entro 4 settimane dalla randomizzazione, recupero incompleto da un intervento chirurgico o intervento chirurgico in programma nel periodo previsto di partecipazione allo studio.Nota: sono ammessi i/le partecipanti con procedure chirurgiche in programma da condurre in anestesia locale.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) (using RECIST v1.1 guidelines), as assessed by blinded independent central review (BICR)
    PFS (secondo le linee guida RECIST v1.1), come valutata mediante revisione centrale indipendente in cieco
    E.5.1.1Timepoint(s) of evaluation of this end point
    From randomization, until the date of objective disease progression based on BICR using RECIST v1.1 or death (by any cause) in the absence of progression, whichever comes first.
    Dalla randomizzazione, fino alla data di progressione oggettiva della malattia basata sul BICR utilizzando RECIST v1.1 o morte (per qualsiasi causa) in assenza di progressione, a seconda di quale evento si verifica per primo.
    E.5.2Secondary end point(s)
    1. Objective response rate
    2. Duration of response
    3. Overall survival
    4. Time to subsequent therapy
    5. PFS after first subsequent therapy
    6. Time to symptomatic progression
    7. Incidence and severity of adverse events and laboratory abnormalities, assessment of vital signs, and physical examination abnormalities
    8. a. Pharmacokinetic sample: Serum amivantamab concentrations
    • Ceoi: end of infusion serum concentration
    • Ceoi,ss: end of infusion serum concentration at steady state
    • Ctrough: serum concentration immediately prior the next study treatment administration
    • Ctrough,ss: serum concentration immediately prior the next study treatment administration at steady state
    • Cmax: maximum serum concentration
    b. Immunogenecity sample: anti-amivantamab antibodies
    9. EORTC-QLQ-C30
    10. PROMIS PF
    1. Tasso di risposta obiettiva
    2. Durata della risposta
    3. Sopravvivenza complessiva
    4. Tempo che intercorre alla terapia successiva
    5. PFS dopo la prima terapia successiva
    6. Tempo alla progressione sintomatica
    7. Incidenza e gravità di eventi avversi e anomalie di laboratorio
    8. a. Campione farmacocinetico: concentrazioni sieriche di amivantamab
    • Ceoi: concentrazione sierica di fine infusione
    • Ceoi, ss: concentrazione sierica di fine infusione allo stato stazionario
    • Ctrough: concentrazione sierica immediatamente prima della successiva somministrazione del trattamento in studio
    • Ctrough, ss: concentrazione sierica immediatamente prima della successiva somministrazione del trattamento in studio allo stato stazionario
    • Cmax: massima concentrazione sierica
    b. Campione di immunogenicità: anticorpi anti-amivantamab
    9. EORTC-QLQ-C30
    10. PROMIS PF
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. to 6.
    From randomization until the date of documented progression or death, whichever comes first
    7. Throughout study
    8.a. Day 1 (D1) of Cycle 1(C1), C2, C3, C5, C7, C9, C11, C13 and C1D2, and End of Treatment visit (ETV)
    b. D1 of C1, C2, C3, C5, C7, C9, C11, C13 and ETV
    9 and 10. EORTC-QLQ-C30: D1 of C1, C3, C5, C7, C9 etc, EOT, Follow-up every 12 weeks
    1. a 6.
    Dalla randomizzazione fino alla data di progressione o morte documentata, a seconda dell'evento che si verifica per primo
    7. Durante lo studio
    8.a. Giorno 1 (G1) del ciclo 1 (C1), C2, C3, C5, C7, C9, C11, C13 e C1D2 e visita di fine trattamento (ETV)
    b. G1 di C1, C2, C3, C5, C7, C9, C11, C13 e ETV
    9 e 10. EORTC-QLQ-C30: G1 di C1, C3, C5, C7, C9 ecc., EOT, follow-up ogni 12 settimane
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Immunogenecity, Tolerability, Biomarker evaluation, Quality of life
    Immunogenecità, tollerabilità, valutazione dei biomarcatori, qualità della vita
    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. trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA50
    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
    Hong Kong
    Korea, Republic of
    Russian Federation
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Approximately 48 months after the first participant is randomized
    Circa 48 mesi dopo il primo soggeto randomizzato
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months0
    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: 250
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 50
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 150
    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)
    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 Decision2021-01-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-06
    P. End of Trial
    P.End of Trial StatusOngoing
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