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    Summary
    EudraCT Number:2020-001879-33
    Sponsor's Protocol Code Number:ESR-18-13811
    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:2021-10-07
    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 number2020-001879-33
    A.3Full title of the trial
    Efficacy study of osimertinib in treatment-naïve patients with EGFR mutant NSCLC according to TP53 mutational status (TEMPLE-2)
    Studio sull’efficacia di Osimertinib in prima linea nei pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53 (TEMPLE-2)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Efficacy study of osimertinib in treatment-naïve patients with EGFR mutant NSCLC according to TP53 mutational status (TEMPLE-2)
    Studio sull’efficacia di Osimertinib in prima linea nei pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53 (TEMPLE-2)
    A.3.2Name or abbreviated title of the trial where available
    TEMPLE 2
    TEMPLE 2
    A.4.1Sponsor's protocol code numberESR-18-13811
    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 SponsorFONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE
    B.1.3.4CountryItaly
    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 supportASTRAZENECA
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFONDAZIONE POLICLINICO UNIVERSITARIO A. GEMELLI IRCCS
    B.5.2Functional name of contact pointDIREZIONE SCIENTIFICA
    B.5.3 Address:
    B.5.3.1Street AddressLARGO A. GEMELLI 8
    B.5.3.2Town/ cityROMA
    B.5.3.3Post code00168
    B.5.3.4CountryItaly
    B.5.4Telephone number0630155701
    B.5.5Fax number0630155701
    B.5.6E-maildirezione.scientifica@policlinicogemelli.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 Yes
    D.2.1.1.1Trade name TAGRISSO
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA AIC 044729046/E
    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 nameOsimertinib
    D.3.2Product code [Osimertinib]
    D.3.4Pharmaceutical form Tablet
    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 INNOsimertinib
    D.3.9.1CAS number 1421373-65-0
    D.3.9.2Current sponsor code1421373-65-0
    D.3.9.3Other descriptive nameOsimertinib
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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
    Patients with EGFR mutant NSCLC according to TP53 mutational status
    Pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53
    E.1.1.1Medical condition in easily understood language
    Patients with EGFR mutant NSCLC according to TP53 mutational status
    Pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10051054
    E.1.2Term Lung disease
    E.1.2System Organ Class 100000004855
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To determine the efficacy in terms of PFS of osimertinib in the treatment of patients with advanced EGFR mutant NSCLC, according to the TP53 mutational status.
    Determinare l'efficacia in termini di PFS di osimertinib nel trattamento dei pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53.
    E.2.2Secondary objectives of the trial
    To determine the efficacy in terms of OS of osimertinib in the treatment of patients with advanced EGFR mutant NSCLC, according to the TP53 mutational status.
    To determine the activity in terms of ORR of osimertinib in the treatment of patients with advanced EGFR mutant NSCLC, according to the TP53 mutational status.
    Valutare indici secondari di efficacia clinica tra cui la sopravvivenza globale (OS), il tasso di risposta globale (ORR), il tasso di controllo della malattia (DCR) e la durata della risposta (DoR), gli eventi avversi (AE) sulla base dello stato mutazionale di TP53.
    Valutare l’attivtà e l’efficacia di osimertinib sul SNC
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Provision of informed consent prior to any study specific procedures.
    o Patients (male/female) must be > 18 years of age.
    o Locally advanced or metastatic EGFR mutant NSCLC, not amenable to curative surgery or radiotherapy with confirmation of the presence of EGFR exon 19 deletion or exon 21 p.L858R.
    o Mandatory provision of an unstained, archived tumour tissue sample in a quantity sufficient to allow central analysis.
    o Patients must be treatment-naïve for locally advanced or metastatic NSCLC and eligible to receive first-line treatment with osimertinib. Prior adjuvant and neo-adjuvant therapy is permitted (chemotherapy, radiotherapy) if at least 6 months has elapsed between the end of chemotherapy and enrolment.
    o World Health Organization (WHO) performance status 0-2.
    o Patients must have a life expectancy = 12 weeks.
    o Females should be using adequate contraceptive measures, should not be breast feeding and must have a negative pregnancy test prior to start of dosing if of child-bearing potential or must have evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
    • Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
    • Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with LH and FSH levels in the post-menopausal range for the institution.
    • Documentation of irreversible surgical sterilisation by hysterectomy, bilateral oophorectomy or bilateral salpingectomy but not tubal ligation.
    o Male patients should be willing to use barrier contraception.
    o Patient is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
    o At least one lesion, not previously irradiated, that can be accurately measured at baseline as = 10 mm in the longest diameter (except lymph nodes which must have short axis = 15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and which is suitable for accurate repeated measurements.
    o Fornire il consenso informato prima di qualsiasi procedura specifica dello studio.
    o I pazienti (maschio/femmina) devono avere un'età > 18 anni.
    o NSCLC con mutazione di EGFR localmente avanzato o metastatico, non suscettibile di chirurgia curativa o radioterapia con conferma della presenza della delezione dell'esone 19 di EGFR o dell'esone 21 p.L858R.
    o Fornitura obbligatoria di un campione di tessuto tumorale archiviato non colorato in una quantità sufficiente per consentire l'analisi centrale.
    o I pazienti devono essere naïve al trattamento per NSCLC localmente avanzato o metastatico e idonei a ricevere il trattamento di prima linea con Osimertinib. È consentita una precedente terapia adiuvante e neoadiuvante (chemioterapia, radioterapia) se sono trascorsi almeno 6 mesi tra la fine della chemioterapia e l'arruolamento.
    o Performance status 0-2 dell'Organizzazione mondiale della sanità (OMS).
    o I pazienti devono avere un'aspettativa di vita = 12 settimane.
    o Le donne devono utilizzare misure contraccettive adeguate, non devono allattare al seno e devono avere un test di gravidanza negativo prima di iniziare la somministrazione se potenzialmente fertili o devono avere evidenza di non fertilità soddisfacendo uno dei seguenti criteri allo screening:
    • Post-menopausa definita come di età superiore a 50 anni e amenorrea da almeno 12 mesi dopo la cessazione di tutti i trattamenti ormonali esogeni.
    • Le donne sotto i 50 anni sarebbero considerate in postmenopausa se sono state amenorreiche per 12 mesi o più dopo la cessazione dei trattamenti ormonali esogeni e con livelli di LH e FSH nell'intervallo post-menopausale per l'istituzione.
    • Documentazione di sterilizzazione chirurgica irreversibile mediante isterectomia, ovariectomia bilaterale o salpingectomia bilaterale ma non legatura delle tube.
    o I pazienti di sesso maschile dovrebbero essere disposti a utilizzare la contraccezione di barriera.
    o Il paziente è disposto e in grado di rispettare il protocollo per tutta la durata dello studio, compreso il trattamento, le visite programmate e gli esami, compreso il follow-up.
    o Almeno una lesione, non precedentemente irradiata, che può essere accuratamente misurata al basale come = 10 mm nel diametro più lungo (eccetto i linfonodi che devono avere asse corto = 15 mm) con tomografia computerizzata (TC) o risonanza magnetica (MRI) e che è adatto per misurazioni ripetute accurate.
    E.4Principal exclusion criteria
    • Subjects (sponsor and/or enrollment center staff) involved in planning and/or conducting the study
    • Previous treatment with Osimertinib or any other anti-EGFR target drug
    • Treatment with any other experimental drug in the previous 3 months of enrollment
    • Patients who are currently being treated (or are unable to stop treatment before receiving the first dose of the experimental drug) with medications or homeopathic remedies included in Annex 6.
    • Any residual toxicity from previous treatments that is grade > 1 at the time of enrollment, with the exception of alopecia. Grade 2 residual toxicity is permissible for platinum-related neuropathy
    • Concomitant uncontrolled or severe systemic disease, including hypertension or haemorrhagic diathesis, active hepatitis B infection, hepatitis C or HIV
    • Patients with spinal cord compression or symptomatic and / or unstable brain metastases. Corticosteroid therapy is allowed for the control of brain metastases as long as they are asymptomatic and treated with the same dosage for at least 14 days before starting treatment with Osimertinib
    • Personal history of pulmonary interstitial disease, actinic pneumonia requiring corticosteroid therapy, or any evidence of active interstitial disease
    • Any cardiac alteration between:
    o Correct QT interval (using Fredericia's formula)> 470 msec or the presence of risk factors that prolong the QT interval (electrolyte changes)
    o Any clinically significant alteration of the rhythm, conduction or alterations of the resting ECG (e.g., complete left branch block).
    • Inadequate blood chemistry values:
    o Absolute neutrophil count <1.5 x 109 / L.
    o Platelets <100 x 109 / L.
    o Hemoglobin <9 g / dL.
    o Alanine aminotransferase and aspartate aminotransferase> 2.5 times the upper limit (ULN) in the absence of liver metastases> 5 times ULN in the presence of liver metastases
    o Total bilirubin> 1.5 times ULN in the absence of liver metastases or> 3 times ULN in the presence of Gilbert's syndrome (indirect hyperbilirubinemia) or liver metastases
    o Creatinine> 1.5 times ULN concomitant with a creatinine clearance <50 ml / min (using the Cockcroft and Gault formula
    • Refractory nausea or vomiting, or any gastrointestinal disease that does not allow the intake / absorption of osimertinib
    • Second active neoplasms or previous treatments for other neoplasms for which at least 6 months have elapsed since the first day of Osimertinib therapy (or at least 2 years in case of bone marrow transplant)
    • Patients with other medical conditions or serious clinical conditions, including those with uncontrolled active infection.
    • History of hypersensitivity to osimertinib or to chemically similar drugs or to any excipient
    • Women who are pregnant or breastfeeding
    • Decision by the Investigator not to enroll the patient who is unable to comply with the procedures envisaged by the study.
    • Soggetti (staff dello sponsor e/o dei centri di arruolamento) coinvolti nella pianificazione e/o nella conduzione dello studio
    • Trattamento precedente con Osimertinib o qualunque altro farmaco target anti- EGFR
    • Trattamento con qualunque altro farmaco sperimentale nei precedenti 3 mesi dall’arruolamento
    • Pazienti che attualmente sono in trattamento (o sono impossibilitati a sospendere il trattamento prima di ricevere la prima dose del farmaco sperimentale) con farmaci o rimedi omeopatici inclusi nell’Allegato 6.
    • Qualunque tossicità residua da precedenti trattamenti che sia di grado >1 al momento dell’arruolamento, ad eccezione dell’alopecia. Per la neuropatia platino-relata è ammessa una tossicità residua di grado 2
    • Malattie sistemiche concomitanti non controllate o di grado severo, compresa ipertensione o diatesi emorragica, infezione attiva da epatite B, epatite C o HIV
    • Pazienti con compressione midollare o metastasi cerebrali sintomatiche e/o instabili. é consentita terapia corticosteroidea per il controllo delle metastasi cerebrali purché siano asintomatiche e trattate con lo stesso dosaggio da almeno 14 giorni prima dell’inizio del trattamento con osimertinib
    • Anamnesi personale di interstiziopatia polmonare, polmonite attinica che richieda terapia corticosteroidea o qualunque evidenza di interstiziopatia in fase attiva
    • Una qualunque alterazione cardiaca tra:
    • Intervallo QT corretto (usando formula di Fredericia) > 470 msec o presenza di fattori di rischio che prolunghino l’intervallo QT (alterazioni elettrolitiche,
    • Qualunque alterazione clinicamente significativa del ritmo, conduzione o alterazioni dell’ECG a riposo (es. blocco di branca sinistro completo).
    • Valori ematochimici inadeguati:
    • Conta assoluta di neutrofili <1.5 x 109/L.
    • Piastrine <100 x 109/L.
    • Emoglobina <9 g/dL.
    • Alanina aminotransferasi e aspartato aminotransferasi >2.5 volte il limite superiore (ULN) in assenza di metastasi epatiche >5 volte ULN in presenza di metastasi epatiche
    • Bilirubina totale >1.5 volta ULN in assenza di metastasi epatiche o >3 volte ULN in presenza di Sindrome di Gilbert (iperbilirubinemia indiretta) o metastasi epatiche
    • Creatinina >1.5 volte ULN concomitante ad una creatinina clearance <50 ml/min (utilizzando la formula di Cockcroft and Gault
    • Nausea o vomito refrattari, o qualunque malattia gastrointestinale che non permetta l’assunzione/ l’assorbimento di osimertinib
    • Seconde neoplasie attive o trattamenti pregressi per altre neoplasie per cui non siano trascorsi almeno 6 mesi dal primo giorno di terapia con osimertinib (o almeno 2 anni in caso di trapianto di midollo osseo)
    • Pazienti con altre patologie o gravi condizioni cliniche, inclusi quelli con infezione attiva non controllata.
    • Anamnesi di ipersensibilità a osimertinib o a farmaci chimicamente simili o a qualunque eccipiente
    • Donne in gravidanza o in allattamento
    • Decisione da parte dello Sperimentatore di non arruolare il paziente non in grado di rispettare le procedure previste dallo studio.
    E.5 End points
    E.5.1Primary end point(s)
    To determine the efficacy in terms of PFS of osimertinib in the treatment of patients with advanced EGFR mutant NSCLC, according to the TP53 mutational status.
    Determinare l'efficacia in termini di PFS di osimertinib nel trattamento dei pazienti con NSCLC EGFR mutati sulla base dello stato mutazionale di TP53.
    E.5.1.1Timepoint(s) of evaluation of this end point
    PFS
    PFS
    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 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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Stato mutazione TP53
    Mutation status of TP53
    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 concerned15
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    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
    LVLS
    LVLS
    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 months0
    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 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: 100
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state122
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 122
    F.4.2.2In the whole clinical trial 122
    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)
    BEST CLINICAL PRACTICE
    MIGLIORE PRATICA CLINICA
    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 Decision2021-07-30
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-12-02
    P. End of Trial
    P.End of Trial StatusOngoing
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