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    EudraCT Number:2020-000730-17
    Sponsor's Protocol Code Number:U31402-A-U201
    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:2021-06-15
    Trial results View results
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    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2020-000730-17
    A.3Full title of the trial
    HERTHENA-Lung01: A Phase 2 Randomized Open-Label Study of Patritumab Deruxtecan (U3-1402) in Subjects with Previously Treated Metastatic or Locally Advanced EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)
    HERTHENA-Lung01: Studio randomizzato, in aperto, di fase II su patritumab deruxtecan (U3-1402) in soggetti affetti da carcinoma polmonare non a piccole cellule (NSCLC) metastatico o localmente avanzato, con mutazione di EGFR, trattato in precedenza
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    (Patritumab Deruxtecan in Subjects with Metastatic or Locally Advanced EGFR-mutated NSCLC)
    Patritumab deruxtecan in soggetti affetti da NSCLC metastatico o localmente avanzato, con mutazione di EGFR
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberU31402-A-U201
    A.5.4Other Identifiers
    Name:IND NumberNumber:133343
    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 organisationSyneos Health LLC
    B.5.2Functional name of contact pointShruti Aggarwal
    B.5.3 Address:
    B.5.3.1Street Address1 Pinehurst Road Farnborough
    B.5.3.2Town/ cityHampshire
    B.5.3.3Post codeGU14 7BF
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number00441276481091
    B.5.5Fax number00441276713000
    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 namePatritumab Deruxtecan for Injection 100 mg
    D.3.2Product code [U3-1402]
    D.3.4Pharmaceutical form Powder 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 INNPatritumab deruxtecan
    D.3.9.2Current sponsor codeU3-1402
    D.3.9.4EV Substance CodeSUB204104
    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. 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
    Metastatic or Locally Advanced EGFR mutated Non-Small Cell Lung Cancer (NSCLC)
    carcinoma polmonare non a piccole cellule (NSCLC) metastatico o localmente avanzato, con mutazione di EGFR
    E.1.1.1Medical condition in easily understood language
    Metastatic or Locally Advanced Lung Cancer
    carcinoma polmonare metastatico o localmente avanzato
    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
    To investigate the antitumor activity of patritumab deruxtecan in subjects with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    Indagare l’attività antitumorale di patritumab deruxtecan in soggetti affetti da NSCLC metastatico o localmente avanzato con mutazione attivante dell’EGFR (delezione dell’esone 19 o L858R)
    E.2.2Secondary objectives of the trial
    - To investigate the durability of patritumab deruxtecan antitumor activity in subjects with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    - To further investigate the antitumor activity of patritumab deruxtecan in subjects with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    - To assess the safety and tolerability of patritumab deruxtecan in subjects with metastatic or locally advanced NSCLC with an activating EGFR mutation (exon 19 deletion or L858R)
    - To evaluate HER3 protein expression in tumor tissue and its relationship with efficacy
    - To assess the immunogenicity incidence against patritumab deruxtecan
    - Indagare la durata dell’attività antitumorale di patritumab deruxtecan in soggetti con NSCLC metastatico o localmente avanzato con mutazione attivante dell’EGFR (delezione dell’esone 19 o L858R)
    - Indagare ulteriormente l’attività antitumorale di patritumab deruxtecan in soggetti con NSCLC metastatico o localmente avanzato con mutazione attivante dell’EGFR (delezione dell’esone 19 o L858R)
    - Valutare la sicurezza e la tollerabilità di patritumab deruxtecan in soggetti affetti da NSCLC metastatico o localmente avanzato con mutazione attivante dell’EGFR (delezione dell’esone 19 o L858R)
    - Valutare l’espressione della proteina HER3 nel tessuto tumorale e la sua relazione con l’efficacia
    - Valutare l’incidenza dell’immunogenicità diretta contro patritumab deruxtecan
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Sign and date the tissue ICF and the main ICF, prior to the start of any study-specific qualification procedures.
    2. Male or female subjects aged =18 years (follow local regulatory requirements if the legal age of consent for study participation is >18 years old).
    3. Histologically or cytologically documented locally advanced or metastatic NSCLC not amenable to curative surgery or radiation.
    4. Documentation of radiological disease progression while on/after receiving most recent treatment regimen for locally advanced or metastatic disease. Subjects must have received both of the following:
    a. =1 prior line(s) of EGFR TKI treatment (erlotinib, gefitinib, afatinib, dacomitinib or simertinib). Subjects receiving an EGFR TKI at the time of signing informed consent should continue to take the EGFR TKI until 5 days prior to Cycle 1 Day 1. EGFR T790M mutation-positive subjects
    (previously treated with erlotinib, gefitinib, afatinib or dacomitinib) must have received and have documentation of radiological disease progression following treatment with osimertinib.
    b. Systemic therapy with at least 1 platinum-based chemotherapy regimen.
    5. Documentation of an EGFR-activating mutation detected from tumor tissue or blood sample: exon 19 deletion or L858R.
    6. At least 1 measurable lesion confirmed by BICR as per RECIST v1.1
    7. Consented and willing to provide required tumor tissue of sufficient quantity (as defined in the Laboratory Manual) and of adequate tumor tissue content (as confirmed by H&E staining at the central laboratory). Required tumor tissue can be provided as either:
    a. Pretreatment tumor biopsy from at least 1 lesion not previously irradiated and amenable to core biopsy
    b. Archival tumor tissue collected from a biopsy performed within 3 months prior to signing of the tissue consent and since progression while on or after treatment with the most recent cancer therapy regimen.
    AND consent to provide a required on-study tumor biopsy. After approximately 15 on-study tumor biopsies in each arm have been collected, the Sponsor will notify the Investigator of a change to the requirement.
    8. Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1 at Screening.
    9. Has adequate bone marrow reserve and organ function, based on local laboratory data within 14 days prior to Cycle 1 Day 1 as defined in the protocol.
    10. If the subject is a female of childbearing potential, she must have a negative serum pregnancy test at Screening and must be willing to use highly effective birth control, upon enrollment, during the Treatment Period, and for 7 months following the last dose of study drug.
    11. 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.
    12. If male, the subject must be surgically sterile or willing to use highly effective birth control upon enrollment, during the treatment period, and for at least 4 months following the last dose of study drug.
    13. 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.
    14. Is willing and able to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
    1. Consenso informato per lo studio principale e consenso per il prelievo di tessuto firmati e datati prima di iniziare qualsiasi procedura specifica dello studio.
    2. Soggetti di sesso maschile o femminile =18 anni (attenersi ai requisiti normativi locali se l'età legale per il consenso alla partecipazione allo studio è >18 anni).
    3. NSCLC localmente avanzato o metastatico documentato istologicamente o citologicamente non trattabile mediante chirurgia curativa o radiazioni.
    4. Documentazione di progressione radiologica della malattia durante l'assunzione/dopo aver ricevuto il regime di trattamento più recente per la malattia localmente avanzata o metastatica. I soggetti devono aver ricevuto entrambi i seguenti trattamenti:
    a) =1 linea precedente di TKI dell’EGFR (erlotinib, gefitinib, afatinib, dacomitinib o osimertinib). I soggetti che ricevono un TKI dell’EGFR al momento della firma del consenso informato devono continuare ad assumerlo fino a 5 giorni prima del giorno 1 del ciclo 1. I soggetti positivi alla mutazione T790M dell’EGFR (precedentemente trattati con erlotinib, gefitinib, afatinib o dacomitinib) devono aver ricevuto e possedere la documentazione di progressione radiologica della malattia a seguito del trattamento con osimertinib.
    b) Terapia sistemica con almeno 1 regime chemioterapico a base di platino.
    5. Documentazione di mutazione attivante dell’EGFR rilevata da campione di tessuto tumorale o sangue: delezione dell’esone 19 o L858R.
    6. Almeno 1 lesione misurabile confermata mediante BICR secondo i criteri RECIST v1.1
    7. Consenso e volontà di fornire il tessuto tumorale richiesto in quantità sufficiente (definita nel manuale di laboratorio) e con contenuto di tessuto tumorale adeguato (confermato mediante colorazione con ematossilina-eosina [H&E] presso il laboratorio centrale). Il tessuto tumorale richiesto può essere fornito come:
    a) Biopsia del tumore pre-trattamento da almeno 1 lesione non precedentemente irradiata e sottoponibile ad agobiopsia OPPURE
    b) Tessuto tumorale di archivio prelevato da una biopsia effettuata nei 3 mesi precedenti la firma del consenso al prelievo di tessuto e dopo progressione della malattia durante o dopo il trattamento con il regime terapeutico antitumorale più recente.
    E consenso a fornire una biopsia del tumore durante lo studio. Quando saranno state acquisite all’incirca 15 biopsie tumorali in ogni braccio durante lo studio, lo Sponsor avvertirà lo sperimentatore della modifica del requisito.
    8. Stato di validità dell’Eastern Cooperative Oncology Group (ECOG PS) pari a 0 o 1 allo Screening (vedere la Sezione 10.3.3).
    9. Presenza di una riserva di midollo osseo e funzionalità d’organo sufficienti sulla base dei dati del laboratorio locale nei 14 giorni precedenti il giorno 1 del ciclo 1 come definito nel protocollo
    10. Test di gravidanza negativo allo screening per il soggetto di sesso femminile potenzialmente fertile che deve acconsentire ad usare un metodo contraccettivo dall’arruolamento, durante il trattamento e per 7 mesi successivamente all’ultima dose del farmaco in studio
    11. I soggetti di sesso femminile non devono donare, o recuperare per uso personale, ovuli dal momento dello screening e per tutto il periodo di trattamento in studio, e per almeno 7 mesi dopo la somministrazione finale del farmaco in studio
    12. Se di sesso maschile il soggetto deve essere chirurgicamente sterile o deve acconsentire ad usare un metodo contraccettivo all'arruolamento, durante il periodo di trattamento, e per almeno 4 mesi dopo l'ultima dose del farmaco in studio.
    13. I soggetti maschi non devono congelare o donare lo sperma a partire dallo Screening e per tutto il periodo di studio e almeno 4 mesi dopo l’ultima somministrazione del farmaco in studio.
    14. disposto e in grado di rispettare le visite programmate, il piano di amministrazione del farmaco, test di laboratorio, altre procedure di studio e restrizioni.
    E.4Principal exclusion criteria
    1. previous or current histologic or cytologic evidence of small cell OR combined small cell/non-small cell disease in the archival tumor tissue or pretreat. tumor biopsy.
    2. Any history of interstitial lung disease (incl. pulmonary fibrosis or radiation pneumonitis), current interstitial lung disease (ILD), or is suspected to have such disease by imaging during screen.
    3. Clinically severe respiratory compromise (based on PI assess.) result. from intercurrent pulmonary illnesses including, but not limited to:
    a. Any underlying pulm. disorder (eg, pulmonary emboli within 3 mths of the study enroll., severe asthma, severe chronic obstructive pulm. disease [COPD], restrictive lung disease, pleural effusion);
    b. Any autoimmune, connective tissue or inflamm. disorders with pulmonary involvement (e.g., rheumatoid arthritis, Sjogren's syndrome, sarcoidosis); OR prior pneumonectomy.
    4. Is receiving chronic systemic corticosteroids dosed at >10 mg prednisone or equivalent or any form of immunosuppressive therapy prior to enrollm. Subj. who require use of bronchodilators, inhaled steroids, or local steroid injections may be included in the study.
    5. Evid. of any leptomeningeal disease
    6. Evidence of clinic. active spinal cord compress. or brain metastases, defined as untreated and symptomatic, or requiring ther. with corticosteroids or anticonvulsants to control associated sympt. Subj. with clinic. inactive or treated brain metastases who are asymptomatic (i.e., without neurologic signs or symptoms and not requir. Treat. with corticosteroids or anticonvulsants) may be included in the study. Subj. must have a stable neurologic status for at least 2 wks prior to Cycle 1 D1.
    7. Inadeq. washout period prior to Cycle 1 D1 as defined in the protocol points a/b/c/d/e/f (pag 53).
    8. Prior treat. with an anti-HER3 antibody or single-agent topoisomerase I inhibitor.
    9. Prior treatment with an ADC that consists of any topoisomerase I inhibitor
    10. unresolved toxicities from prev. anticancer therapy, defined as toxicities (other than alopecia) not yet resol. to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) v5.0, Grade =1 or baseline. Subj. with chronic Grade 2 toxicities may be eligible at the discretion of the PI after consult. with the Sponsor Medical Monitor or designee.
    11. Has history of other active malignancy within 3 yrs prior to enroll., except:
    a. Adequately treated non-melanoma skin cancer;
    b. Superficial bladder tumors (Ta, Tis, T1);
    c. Adequately treated intraepithelial carcinoma of the cervix uteri;
    d. Low risk non-metastatic prostate cancer (with Gleason score <7, and follow. local treatment or ongoing active surveill.);
    e. Any other curatively treated in situ disease.
    12. Uncontr. or sign. Cardiovasc. disease prior to Cycle 1 Day 1 as defined in the prot. points a/b/c/d/e/f/g (page 54).
    13. Active hepatitis B and/or hepatitis C infection, such as those with serologic evidence of viral infect within 28 days of Cycle 1 Day 1 as defined in the prot. points a/b (page 54).
    14. Subject with HIV infection.
    15. Any evidence of severe or uncontrolled diseases includ. active bleeding diatheses, active infection, psychiatric illness/social situations, geograph. factors, substance abuse, or other factors which in the PI's opinion makes it undesirable for the subject to participate in the study or which would jeopardize compliance with the protocol.
    screening for chronic conditions is not required.
    16. History of hypersens. to either the drug substance or any excipients in patritumab deruxtecan.
    17. Fem. who is pregnant or breast-feeding or intends to bec. preg during the study.
    18. Prior or ongoing clinically relev. illness, medical cond., surgical history, physical finding, or labor. abnormality that, in the PI's opinion, could affect the safety of the subj.
    19. sign. corneal disease.
    1.Evidenza istologica o citologica preced. di carcinoma a piccole cellule OPP di carcinoma combinato a piccole cellule/non a piccole cellule nel tessuto tumorale di archivio o nella biopsia del tumore pre-trattam.
    2.Anamnesi di malattia polmon. interstiziale (tra cui fibrosi polmon o polmonite da radiazioni), pneumopatia interstiziale (ILD) in atto, o sospetto della malattia suggerito da immagini acquisite durante lo screen.
    3.Compromiss. respiratoria clinic. grave (in base alla valutaz. del PI) deriv. da pneumopatie intercorrenti, tra cui anche:
    a)Disturbi polmon sottostanti (es. embolia polmon nei 3 mesi preced. l’arruol. nello studio, asma grave, broncopneumopatia cronica ostruttiva [BPCO]) grave, malattia polmonare restrittiva, versamento pleurico);
    b)Disturbi autoimmuni, del tessuto connettivo o infiammat. con interess. polmon (es., artrite reumat., sindrome di Sjögren, sarcoidosi);
    OPP. Preced. pneumonectomia.
    4.Trattam. cronico con corticosteroidi sistemici, dosati a >10 mg di prednisone o equiv. o qls forma di terapia immunos. preced. all’arruolam.. I sogg. che necess. dell’uso di broncodilatatori, steroidi per inalaz. o iniezioni locali di steroidi possono essere inclusi.
    5.Evid. di malattia leptomeningea.
    6.Evidenza di compress. del midollo spinale o metastasi cerebr. clinic. attive, definite come non trattate e sintom, o che necess di terapia con corticosteroidi o anticonvulsivanti per controll. i sintomi associati. I sog. con metastasi cerebrali clinic. inattive o trattate che sono asintom (senza segni o sintomi neurol e che non necess. del tratt. con corticosteroidi o anticonvulsivanti) possono essere inclusi. I sogg. devono avere una condiz. neurol. stabile da alm. 2 sett. prima del G1 del ciclo 1.
    7.Periodo di sospens. Insuff. prima del g 1 del ciclo 1, definito come nei punti a/b/c/d/e/f prot. (p.53)
    8.Tratt. prec. con un antic anti-recettore del fattore di crescita epiderm. umano 3 (HER3) o singolo inibitore della topoisomerasi I.
    9.Tratt. prec. con un coniugato farmaco-anticorpo (ADC) costituito da un qls inibitore della topoisomerasi I.
    10.Tossicità non risolte da preced. terapie antitum., definite come tossicità (diverse dall’alopecia) non ancora risolte al grado =1 o al basale dei criteri comuni di terminol. per gli eventi avversi del National Cancer Institute (NCI-CTACE) v 5.0. I sog. con tossicità croniche di grado 2 possono essere idonei a discrez del PI, previa consultaz. con il monitor medico dello Sponsor o un suo incaricato.
    11.Anamnesi di altre neoplasie attive maligne nei 3 anni prec. l’arruol., tranne:
    a) Carcinoma cutaneo non melanoma adeg. trattato;
    b) Tumori superfic della vescica (Ta, Tis, T1);
    c) Carcinoma intraepiteliale della cervice uterina in situ trattato adeg.;
    d) Carcinoma prostatico non metastatico a basso rischio (con punteggio di Gleason <7, in seguito a trattam locale o monitor. attivo in corso);
    e) Altra malattia in situ trattata in modo curativo.
    12.Malattia cardiovasc. non controll o signific. prima del g 1 del ciclo 1, come definito nel prot. punti a/b/c/d/e/f/g del prot (pag.54)
    13.Infez da epatite B e/o epatite C attiva, es. con eviden sierologica di infez virale nei 28 gg prima del g 1 del ciclo 1 come defin. nel prot punti a/b/ del prot. (pag.54)
    14. Sogg. con infez. da HIV.
    15. Qls evidenza di malattia grave o non controll., comprese diatesi emorr attive, infezioni attive, malattie psichiatr/situazioni sociali, fattori geograf, abuso di sostanze o altri fattori che, a parere del PI, rendono non desiderabile per il sogg. partec. allo studio o che comprom. la compliance al prot. Lo screen. non è richiesto per le condiz. croniche.
    16. ipersensibilità a farmaco o altri eccip.
    17. Donna in gravid o in allattam o che intende rimanere incinta durante lo studio.
    18. Malattia clinic. rilevante preced. o in corso, condiz medica, storia chirurg, problemi fisici o anomalia di lab. che, nell'opinione del PI, potrebbe influire su sicur. del sogg;
    19.malattia corneale clinic. signific.
    E.5 End points
    E.5.1Primary end point(s)
    Objective Response Rate (ORR) as assessed by Blinded Independent Central Review (BICR) per RECIST v1.1
    ORR valutato mediante BICR secondo i criteri RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    ORR: Data are collected at baseline, then from the start of study treatment until documented disease progression or other protocol defined reason.
    I dati sono acquisiti al basale e, successivamente, dall’inizio del trattamento in studio fino a progressione documentata della malattia o altra ragione specificata nel protocollo.
    E.5.2Secondary end point(s)
    - Duration of Response (DoR)
    - Progression-free Survival (PFS)
    - Objective Response Rate (ORR)
    - Disease Control Rate (DCR)
    - Time to Response (TTR)
    - Best percentage change in the sum of diameters (SoD) of measurable
    - Overall Survival (OS)
    - Safety parameters (AEs, ECOG PS, vital signs, clinical laboratory
    parameters, ECG etc.)
    - Correlation between HER3 protein expression and efficacy
    - Anti-drug antibody (ADA) status at baseline and post-baseline
    - durata della risposta (DoR)
    - sopravvivenza libera da progressione (PFS) ORR = ; OS = sopravvivenza globale;
    - tasso di risposta obiettiva (ORR)
    - tasso di controllo della malattia (DCR)
    - tempo alla risposta (TTR)
    - Migliore variazione percentuale nella SoD dei tumori misurabili
    - sopravvivenza globale (OS)
    - Parametri di sicurezza (AEs, ECOG PS, segni vitali, parametri clinici standard di laboratorio, ECG ecc)
    - Correlazione tra l’espressione della proteina HER3 ed efficacia
    - Stato ADA al basale e nel post-basale
    E.5.2.1Timepoint(s) of evaluation of this end point
    DoR, PFS, ORR, DCR, TTR, Changes in SoD: Data are collected at baseline, then from the start of study treatment until documented disease progression, death, lost to follow-up, or withdrawal by subject or other protocol defined reason. Tumor response as assessed by BICR per RECIST v1.1 and death date reported by investigator.
    OS: Death date is collected until the subject discontinues the study.
    Safety parameters: From the time the subject signs the main study ICF and up to 40 (+ 7) days after the last dose of study drug HER3 data are collected at baseline (biopsy), at Cycle 2, and EOT (optional)
    ADA Status: Data are collected from the start of study treatment until documented disease progression.
    DoR, PFS, ORR, DCR, TTR, variazioni nella SoD: I dati sono acquisiti al basale e, success., dall’inizio del trattamen. in studio fino a progressione documentata della malattia, decesso, perdita al follow-up o ritiro del soggetto, o altra ragione specificata nel protoc. Risposta tumorale valutata mediante BICR secondo i criteri RECIST v1.1 e la data del decesso riportata dallo Sperim.
    OS: data del decesso acquisita finché il sogg non interrompe lo studio.
    Parametri di sicurezza: Dal momento in cui il sogg firma ICF dello studio principale fino a 40 (+ 7) gg dopo l’ultima dose del farmaco in studio.
    I dati su HER3 sono acquisiti al basale (biopsia), al ciclo 2 e a EOT (facoltativo)
    Stato ADA: dati sono acquisiti da inizio trattamento in studio fino alla progress. documentata della malattia
    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 No
    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 assessment (HER3 expression data), Immunogenicity
    valutazione Biomarker (HER3 expression data), immunogenicità
    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) 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 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) 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 concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA16
    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
    Korea, Republic of
    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
    Overall End of Study (EOS) will occur when:
    - after the last subject last visit;
    - all subjects have discontinued treatment and discontinued long-term survival follow-up or have died;
    - an alternative study becomes available, for subjects continuing to derive benefit from treatment with patritumab deruxtecan, where the study drug is offered to these subjects;
    - the study is discontinued by the Sponsor for other reasons
    Fine complessiva dello studio (EOS) avverrà quando:
    - dopo la LSLV
    - tutti i soggetti avranno interrotto il trattamento e interrotto il follow-up per la sopravvivenza a lungo termine o saranno morti
    - sarà stato reso disponibile uno studio alternativo per i soggetti che continuano a trarre beneficio dal trattamento con patritumab deruxtecan in cui il farmaco in studio sarà offerto a tali soggetti
    - lo studio sarà 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 months2
    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 months2
    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: 15
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 285
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 78
    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)
    After end of study, an alternative study will be available for subjects continuing to derive benefit from treatment with patritumab deruxtecan.
    Dopo la fine dello studio, uno studio alternativo sarà disponibile per i soggetti che continuano a trarre beneficio dal trattamento con patritumab 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 Decision2021-01-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-11-25
    P. End of Trial
    P.End of Trial StatusOngoing
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