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    Summary
    EudraCT Number:2018-001772-38
    Sponsor's Protocol Code Number:M14-239
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Trial now transitioned
    Date on which this record was first entered in the EudraCT database:2021-06-14
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedItaly - Italian Medicines Agency
    A.2EudraCT number2018-001772-38
    A.3Full title of the trial
    Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell
    Lung Cancer
    Studio Clinico di Fase 2 In Aperto per Valutare Sicurezza ed Efficacia di Telisotuzumab Vedotin (ABBV-399) in Soggetti Affetti da Carcinoma Polmonare Non a Piccole Cellule c-Met+ precedentemente trattato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Phase 2, Open-Label Safety and Efficacy Study of Telisotuzumab Vedotin (ABBV-399) in Subjects with Previously Treated c-Met+ Non-Small Cell
    Lung Cancer
    Studio Clinico di Fase 2 In Aperto per Valutare Sicurezza ed Efficacia di Telisotuzumab Vedotin (ABBV-399) in Soggetti Affetti da Carcinoma Polmonare Non a Piccole Cellule c-Met+ precedentemente trattato
    A.3.2Name or abbreviated title of the trial where available
    na
    na
    A.4.1Sponsor's protocol code numberM14-239
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03539536
    A.5.4Other Identifiers
    Name:naNumber:na
    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 SponsorABBVIE DEUTSCHLAND GMBH & CO. KG
    B.1.3.4CountryGermany
    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 supportAbbVie Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAbbVie Ltd
    B.5.2Functional name of contact pointEU Clinical Trials Helpdesk
    B.5.3 Address:
    B.5.3.1Street AddressAbbVie House, Vanwall Business Park, Vanwall Road
    B.5.3.2Town/ cityMaidenhead, Berkshire
    B.5.3.3Post codeSL6 4UB
    B.5.3.4CountryUnited Kingdom
    B.5.4Telephone number+441628561090
    B.5.5Fax number+441628461153
    B.5.6E-maileu-clinical-trials@abbvie.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.2.5The 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 nameTelisotuzumab Vedotin
    D.3.2Product code [ABBV-399]
    D.3.4Pharmaceutical form Lyophilisate for solution for injection
    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 INNTelisotuzumab Vedotin
    D.3.9.2Current sponsor codeABBV-399
    D.3.9.4EV Substance CodeSUB169047
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) 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
    Non-Small Cell Lung Cancer
    Cancro del polmone non a piccole cellule
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Lung Cancer
    Cancro del polmone 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 determine the overall response rate (ORR) of telisotuzumab vedotin in subjects with c-Met+ NSCLC.
    L’obiettivo primario è quello di determinare il tasso di risposta globale (overall response rate, ORR) per telisotuzumab vedotin in soggetti con NSCLC c-Met+.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to determine Duration of response (DoR), Disease control rate (DCR), Duration of disease control (DDC), Progression Free Survival (PFS), Overall Survival (OS), Safety and Tolerability.
    Gli obiettivi secondari intendono determinare la Durata della risposta (duration of response, DoR), il Tasso di controllo della malattia (disease control rate, DCR), la Durata del controllo della malattia (duration of disease control, DDC), la Sopravvivenza libera da progressione (Progression Free Survival, PFS), la Sopravvivenza globale (Overall Survival, OS), la Sicurezza e tollerabilità
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Histologically confirmed non-small cell lung cancer (NSCLC) with known epidermal growth factor receptor (EGFR) status (wild type or mutant; with site documented status), or histologically documented squamous cell NSCLC.
    • Has locally advanced or metastatic NSCLC.
    • Has c-Met+ NSCLC as assessed by an AbbVie designated immunohistochemistry (IHC) laboratory.
    • If a subject meets eligibility criteria for c-Met protein expression level based on archival tissue material, subject must agree to submit fresh tumor material for assessment of c-Met protein expression level prior to first dose of telisotuzumab vedotin
    • Subjects who have progressed on systemic cytotoxic chemotherapy (or ineligible) and an immune checkpoint inhibitor (as monotherapy or in
    combination with systemic cytotoxic chemotherapy, or ineligible), and prior anti-cancer therapies targeting driver gene alterations (if applicable).
    • Subject must have received no more than 2 lines of prior systemic therapy (including no more than 1 line of prior systemic cytotoxic chemotherapy) in the metastatic setting.
    • Subjects should not have received prior cMET-targeted antibody-based therapies.
    • Has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1.
    • Soggetto con conferma istologica di carcinoma polmonare non a piccole cellule (NSCLC) di cui sia conosciuto lo status relativo al recettore del fattore di crescita dell’epidermide (EGFR) (wild type oppure mutante; secondo determinazione eseguita presso il centro), oppure con conferma istologica di NSCLC squamocellulare
    • Soggetti con NSCLC localmente avanzato oppure metastatico
    • Soggetto affetto da NSCLC c-Met+ in base alla valutazione di un laboratorio immunoistochimico (IHC) designato da AbbVie.
    • Qualora un soggetto soddisfi i criteri di eleggibilità relativi al livello di espressione della proteina c-Met in base al campione di tessuto conservato, il soggetto dovrà acconsentire a fornire un campione di tessuto tumorale ottenuto da nuova biopsia per la valutazione dei livelli di espressione della proteina c-Met prima di ricevere la prima dose di telisotuzumab vedotin.
    • Soggetto che ha presentato progressione in corso di chemioterapia citotossica sistemica (o che sia non idoneo a tale terapia) e con un inibitore del checkpoint immunitario (in monoterapia oppure in combinazione con chemioterapia citotossica sistemica, oppure che sia non idoneo a tale terapia), e pregresse terapie antineoplastiche mirate alle anomalie di gene driver (se applicabile).
    • Il soggetto deve aver ricevuto non più di 2 linee di terapia sistemica pregressa (compresa non più di 1 linea di chemioterapia citotossica sistemica pregressa) per malattia metastatica.
    • I soggetti non devono aver ricevuto terapie pregresse a base di anticorpi anti-c-MET.
    • Soggetto con punteggio ECOG (Eastern Cooperative Oncology Group) 0 -1.
    E.4Principal exclusion criteria
    • Has adenosquamous histology.
    • Has received anti-cancer therapy including chemotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy as described in the protocol.
    • Has known uncontrolled metastases to the central nervous system (CNS). Subjects with brain metastases are eligible if they meet requirements described in the protocol.
    • Has a clinically significant condition(s) described in the protocol.
    • Has unresolved clinically significant adverse events >= grade 2 from prior anticancer therapy, except for alopecia or anemia.
    • Had major surgery within 21 days prior to the first dose of telisotuzumab vedotin.
    • Subject must not have a history of interstitial lung disease or pneumonitis that required treatment with systemic steroids.
    • Soggetto con evidenza istologica di carcinoma adenosquamoso.
    • Soggetto che ha ricevuto terapia antineoplastica fra cui chemioterapia, radioterapia, immunoterapia, terapia con biologici o qualsiasi terapia sperimentale secondo quanto descritto nel protocollo
    • Soggetto che presenta note metastasi non controllate a carico del sistema nervoso centrale (SNC). I soggetti con metastasi cerebrali sono idonei se soddisfano i requisiti previsti dal protocollo.
    • Soggetto che presenta uno o più condizioni clinicamente significative secondo quanto descritto nel protocollo
    • Soggetto che presenta eventi avversi clinicamente significativi di grado = 2 non risolti e causati da pregressa terapia antitumorale, ad eccezione di alopecia o anemia.
    • Soggetto sottoposto a interventi chirurgici maggiori nei 21 giorni precedenti la prima dose di telisotuzumab vedotin
    • Soggetto non deve avere storia di malattia polmonare interstiziale oppure di polmonite per cui sia stato necessario il trattamento con steroidi sistemici
    E.5 End points
    E.5.1Primary end point(s)
    Overall Response Rate (ORR)
    Tasso di risposta globale (ORR)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Overall response rate assessed by an independent central review according to RECIST, version 1.1.10 ORR will be defined as the proportion of subjects with a confirmed complete response (CR) or confirmed partial response (PR) based on RECIST, version 1.1.
    Tasso globale di risposta valutato da un servizio centrale indipendente di valutazione in base ai criteri RECIST versione 1.1.10 ORR sarà come la percentuale di soggetti con risposta completa (CR) confermata oppure con risposta parziale (PR) confermata in base ai criteri RECIST, versione 1.1.
    E.5.2Secondary end point(s)
    1. Duration of Response (DoR)
    2. Disease Control Rate (DCR)
    3. Duration of Disease Control (DDC)
    4. Progression-Free Survival (PFS)
    5. Overall Survival (OS)
    1. Durata della risposta (DoR)
    2. Tasso di controllo della malattia (DCR)
    3. Durata del controllo della malattia (DDC)
    4. Sopravvivenza libera da progressione (PFS)
    5. Sopravvivenza globale (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time from the subject's initial response (CR or PR) to the first occurrence of radiographic progression determined by an independent central review or death from any cause for the responders.
    2. Percentage of subjects with best overall response of confirmed CR or
    PR, or stable disease (SD) for at least 12 weeks (2 tumor assessments)
    following enrollment, based on RECIST version 1.1.
    3. Time from initial subject's response of SD, PR or CR to the first
    occurrence of radiographic progression determined by an ICR or death
    from any cause.
    4. Time from subject's first dose of study drug until first occurrence of
    radiographic progression determined by an independent central review
    or death from any cause.
    5. Time from subject's first dose of study drug until death from any
    cause.
    1. Tempo dalla risposta iniziale (CR o PR) fino al primo manifestarsi di progressione radiografica accertata da valutazione indipendente centralizzata o al decesso per qualsiasi causa per i soggetti responders.
    2. Percentuale di soggetti con la migliore risposta globale di CR confermata, PR confermata o malattia stabile (stable disease, SD) per almeno 12 settimane (2 valutazioni del tumore) dopo l'arruolamento in base ai criteri RECIST, versione 1.1
    3. Tempo dall’iniziale risposta SD, PR o CR fino al primo manifestarsi di progressione radiografica accertata da valutazione indipendente centralizzata o al decesso
    4. Tempo dalla prima dose fino al primo manifestarsi di progressione radiografica accertata da una valutazione indipendente centralizzata
    5. Tempo dalla prima dose fino al decesso
    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 No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA32
    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
    China
    Israel
    Japan
    Korea, Republic of
    Puerto Rico
    Russian Federation
    Taiwan
    Turkey
    United States
    Switzerland
    E.8.7Trial has a data monitoring committee No
    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
    The end-of-study is defined as the date of the last subject's last visit or date of last follow-up contact with the subject, whichever is later.
    La fine dello studio clinico è definita come la data dell’ultima visita dell’ultimo soggetto oppure la data dell’ultimo contatto di follow-up con il soggetto, quale dei due si verifichi per ultimo
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months4
    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: 155
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 155
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 110
    F.4.2.2In the whole clinical trial 310
    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)
    Upon the completion of the study, the subjects will be treated in accordance with the investigator's best clinical judgement.
    Una volta conclusa la partecipazione allo studio, i soggetti saranno trattati secondo il miglior giudizio clinico del medico sperimentatore
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2019-02-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-01-16
    P. End of Trial
    P.End of Trial StatusTrial now transitioned
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
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