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    Summary
    EudraCT Number:2017-002063-17
    Sponsor's Protocol Code Number:ETOP12-17ALERT-lung
    National Competent Authority:Italy - Italian Medicines Agency
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-05-24
    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 number2017-002063-17
    A.3Full title of the trial
    A single arm phase II trial evaluating the activity of alectinib for the treatment of pretreated RET-rearranged advanced NSCLC
    Studio clinico di fase II a braccio unico finalizzato a valutare l'attività di Alectinib nel trattamento del carcinoma polmonare non a piccole cellule (NSCLC) avanzato e pre-trattato con RET riarrangiato
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A research study to evaluate the activity of alectinib for the Treatment of pretreated patients with advanced NSCLC that have confirmed RETrearrangement.
    Studio di ricerca per valutare l'attività di Alectinib nel trattamento di pazienti con carcinoma polmonare non a piccole cellule (NSCLC) che hanno già ricevuto un trattamento e presentano un riarrangiamento del gene RET.
    A.3.2Name or abbreviated title of the trial where available
    ALERT-lung: ALEctinib for the treatment of pre-treated RET-rearranged advanced non-small cell lung c
    ALERT-lung: ALEctinib for the treatment of pre-treated RET-rearranged advanced non-small cell lung c
    A.4.1Sponsor's protocol code numberETOP12-17ALERT-lung
    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 SponsorEUROPEAN THORACIC ONCOLOGY PLATFORM
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportHOFFMANN LA ROCHE
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO EUROPEO DI ONCOLOGIA
    B.5.2Functional name of contact pointUfficio Studi Clinici e Attività Re
    B.5.3 Address:
    B.5.3.1Street AddressVia Ripamonti 435
    B.5.3.2Town/ cityMilano
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number0257489848
    B.5.5Fax number0257489781
    B.5.6E-mailufficio.studiclinici@ieo.it
    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 nameALECTINIB
    D.3.2Product code [RO5424802/F03]
    D.3.4Pharmaceutical form Capsule, hard
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALECTINIB HYDROCHLORIDE
    D.3.9.1CAS number 1256589-74-8
    D.3.9.2Current sponsor codeRo542-4802 / F03, Ro5-42-4802 / F16
    D.3.9.4EV Substance CodeSUB177048
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Advanced stage RET-rearranged NSCLC
    Carcinoma polmonare non a piccole cellule avanzato, pre-trattatato con RET riarrangiato
    E.1.1.1Medical condition in easily understood language
    Lung cancer called "non-small cell lung cancer (NSCLC)" that has spread to other parts of the Body (metastatic) and that has a rearrangment in the RET gene
    Pazienti affetti da NSCLC di stadio avanzato con RET riarrangiato, trattati con almeno un regime chemioterapico sistemico a base di platino.
    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 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    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 assess the efficacy of alectinib in terms of best overall response (OR) assessed by RECIST 1.1.
    L'obiettivo primario è valutare l'efficacia di Alectinib in termini di miglior risposta complessiva (OR) valutata da RECIST v1.1.
    E.2.2Secondary objectives of the trial
    The secondary objectives are to evaluate secondary measures of clinical efficacy including disease control, progression-free survival (PFS), and overall survival (OS) as well as to assess safety and
    tolerability of the treatment and to describe the
    association of primary and secondary outcomes with tumour characteristics.
    Gli obiettivi secondari consistono nel valutare parametri secondari in termini di efficacia clinica, compreso il controllo della malattia, la sopravvivenza libera da progressione (PFS) e la sopravvivenza complessiva (OS) oltre a valutare la sicurezza e la tollerabilità del trattamento e a descrivere l'associazione degli outcome primari e secondari con le caratteristiche del tumore
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histologically or cytologically-documented non-small cell lung
    carcinoma
    - Advanced disease defined as recurrent stage IV (according to 8th TNM
    classification) or recurrent or progressive disease following multimodal
    therapy (radiation therapy, surgical
    resection, or definitive chemo-radiation therapy for locally advanced
    disease)
    - RET rearrangement detected by FISH, Nanostring or by parallelsequencing
    on FFPE tumour tissue (biopsy, resection or cytoblock)
    assessed locally.
    - Availability of FFPE tumour material for central confirmation of RETrearrangement
    - At least one prior platinum-based systemic regimen: Adjuvant or
    neoadjuvant or definitive platinum-based chemo-radiotherapy
    treatments are considered as a line of treatment only if completed lesthan 6 months before enrolment. Maintenance therapy following
    platinum doublet-based chemotherapy is not considered a separate
    regimen of therapy.
    - Measurable or non-measurable, but radiologically evaluable (except for
    skin lesions) disease according to RECIST v1.1 criteria
    - Adequate haematological, renal and liver function
    - ECOG Performance Status 0-2
    ¿ Carcinoma polmonare non a piccole cellule documentato istologicamente o citologicamente.
    ¿ La patologia avanzata è definita come stadio IV ricorrente (ai sensi dell'ottava classificazione TNM) oppure una patologia ricorrente o progressiva a seguito di una terapia multimodale (radioterapia, resezione chirurgica o chemio-radioterapia definitiva per la patologia localmente avanzata).
    ¿ Riarrangiamento del RET individuato tramite FISH, nanostring o sequenziamento parallelo su tessuto tumorale FFPE (biopsia, resezione o citoblocco) valutato localmente.
    ¿ Disponibilità di materiale tumorale FFPE per la conferma centrale del riarrangiamento del RET.
    ¿ Almeno un precedente regime sistemico a base di platino: i trattamenti chemio-radioterapici a base di platino adiuvanti, neoadiuvanti o definitivi sono considerati come linea di trattamento solo se completati meno di 6 mesi prima dell'arruolamento. La terapia di mantenimento successiva alla chemioterapia con due agenti al platino non è considerata un regime terapeutico separato.
    ¿ Malattia misurabile o non misurabile, ma valutabile radiologicamente (ad eccezione delle lesioni cutanee) in base ai criteri RECIST v1.1.
    ¿ Funzione ematologica, renale ed epatica adeguata.
    ¿ ECOG Performance Status 0-2
    E.4Principal exclusion criteria
    - Untreated, active CNS metastases
    - Carcinomatous meningitis
    - Baseline symptomatic bradycardia
    - Prior treatment with any RET TKI or RET targeted therapy
    - Known EGFR, ALK, ROS, and BRAF mutation (in addition to RET
    rearrangement)
    - Any GI disorder that may affect absorption of oral medications, such as
    malabsorption syndrome or status post-major bowel resection
    - History of hypersensitivity to any of the additives in the alectinib drug
    formulation
    - Pregnant or lactating women
    - Known HIV positivity or AIDS-related illness
    - Any concurrent systemic anticancer therapy
    Nessun trattamento precedente, metastasi attive del sistema nervoso centrale.
    ¿ Meningite carcinomatosa.
    ¿ Bradicardia sintomatica alla baseline.
    ¿ Trattamento pregresso con qualsiasi TKI per il RET o terapia mirata per il RET.
    ¿ Conosciuta mutazione EGFR, ALK, ROS e BRAF (oltre a riarrangiamento di RET)
    ¿ Qualsiasi disturbo gastrointestinale che potrebbe influenzare l'assorbimento dei farmaci orali, come la sindrome da malassorbimento oppure una precedente resezione intestinale estesa.
    E.5 End points
    E.5.1Primary end point(s)
    Best overall response (OR = CR or PR), per investigator assessment,
    according to RECIST 1.1.
    Miglior risposta complessiva (OR = CR o PR), in base alla valutazione dei ricercatori, secondo RECIST 1.1.
    E.5.1.1Timepoint(s) of evaluation of this end point
    from the start of trial treatment across all time points until the end of
    trial treatment.
    dall'avvio del trattamento oggetto dello studio clinico e per tutta la sua durata, fino alla conclusione del trattamento
    E.5.2Secondary end point(s)
    Best Overall (OR) response per independent review; disease control ; Progression-free survival (PFS); overall survival ; Safety and tolerability
    Miglior risposta complessiva secondo una revisione indipendente; controllo della malattia; intervallo libero da progressione ; sopravvivenza complessiva; sicurezza e tollerabilità
    E.5.2.1Timepoint(s) of evaluation of this end point
    from the start of trial treatment across all time points until the end of trial Treatment; at 24 weeks; time from the date of enrolment until documented progression or death, if progression is not documented; time from the date of enrolment until death from any cause; from the date of signature of informed consent
    until 30 days after all trial treatment discontinuation, regardless of whether it is considered related to a medication
    dall'inizio del trattamento, attraverso tutti i punti di controlli previsti, fino al termine del trattamento; a 24 settimane; dall'inizio dello studio fino a progressione documentata oppure morte, se la progressione non è documentata; dall'arruolamento fino al decesso per qualsiasi causa; dalla firma del consenso informato fino a 30 giorni dopo l'interruzione del trattamento, a prescindere dal fatto che sia connesso o meno al trattamento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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 concerned3
    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
    Belgium
    Ireland
    Netherlands
    Spain
    Switzerland
    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
    The trial ends when both of the following criteria are satisfied:
    - The trial is mature for the analysis of the primary endpoint, according
    to protocol specifications.
    - The cleaning procedure of the database is completed and database is
    'frozen'.
    The total duration of the trial is expected to be 5 years, including a runin
    period of 6 months and an additional 6 months for the final analysis
    report.
    Lo studio si concluderà quando verranno soddisfatti i seguenti criteri:
    - lo studio è giunto a maturazione per quanto riguarda la valutazione dell'obiettivo primario come specificato nel protocollo
    - il data base è stato controllato, controllato e "chiuso"
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 22
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 22
    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 state16
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 39
    F.4.2.2In the whole clinical trial 44
    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)
    standard assistance trough the national health system
    normale assistenza nell'ambito del SSN
    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 Decision2018-09-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-05-23
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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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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