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    Summary
    EudraCT Number:2022-000493-26
    Sponsor's Protocol Code Number:D533BC00001
    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:2022-06-28
    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 number2022-000493-26
    A.3Full title of the trial
    A Phase III, Open-label, Randomised, Multicentre Study of Ceralasertib Plus Durvalumab versus Docetaxel in Patients With Advanced or Metastatic Non-Small Cell Lung Cancer
    Without Actionable Genomic Alterations, and Whose Disease Has Progressed On or After Prior Anti-PD- (L)1 Therapy and Platinum-based Chemotherapy: LATIFY
    Studio di fase III, in aperto, randomizzato, multicentrico di ceralasertib più durvalumab rispetto a docetaxel in pazienti con carcinoma polmonare non a piccole cellule avanzato o metastatico, senza alterazioni genomiche su cui è possibile intervenire e la cui malattia è progredita durante o dopo precedente terapia anti-PD- (L)1 e chemioterapia a base di platino: LATIFY
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of ceralasertib plus durvalumab versus docetaxel for patients with advanced or metastatic non-small cell lung cancer
    Studio su ceralasertib più durvalumab rispetto a docetaxel in pazienti con carcinoma polmonare non a piccole cellule avanzato o metastatico
    A.3.2Name or abbreviated title of the trial where available
    LATIFY
    LATIFY
    A.4.1Sponsor's protocol code numberD533BC00001
    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 SponsorASTRAZENECA AB
    B.1.3.4CountrySweden
    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 supportAstraZeneca AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNA
    B.5.3.2Town/ cityNA
    B.5.3.3Post codeNA
    B.5.3.4CountryUnited States
    B.5.6E-mailInformation.Center@astrazeneca.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 Yes
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameInfliximab
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Powder for concentrate 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 INNINFLIXIMAB
    D.3.9.2Current sponsor codeNA
    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.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.IMP: 2
    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.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameMicofenolato
    D.3.2Product code [ans]
    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 INNMICOFENOLATO MOFETILE
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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.IMP: 3
    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 nameCeralasertib 120 mg
    D.3.2Product code [AZD6738]
    D.3.4Pharmaceutical form Film-coated 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 INNCeralasertib
    D.3.9.1CAS number 1352226-88-0
    D.3.9.2Current sponsor codeAZD6738
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number120
    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.IMP: 4
    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 nameCeralasertib 80 mg
    D.3.2Product code [AZD6738]
    D.3.4Pharmaceutical form Film-coated 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 INNCeralasertib
    D.3.9.1CAS number 1352226-88-0
    D.3.9.2Current sponsor codeAZD6738
    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.IMP: 5
    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 nameDurvalumab
    D.3.2Product code [MEDI4736]
    D.3.4Pharmaceutical form Concentrate 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 INNDurvalumab
    D.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.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.IMP: 6
    D.1.2 and D.1.3IMP RoleComparator
    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 Docetaxel
    D.2.1.2Country which granted the Marketing AuthorisationPortugal
    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 nameDocetaxel
    D.3.2Product code [NA]
    D.3.4Pharmaceutical form Concentrate 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 INNDOCETAXEL
    D.3.9.1CAS number 114977-28-5
    D.3.9.2Current sponsor codeNA
    D.3.10 Strength
    D.3.10.1Concentration unit mg/m2 milligram(s)/square meter
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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 or Metastatic Non-Small Cell Lung Cancer
    Carcinoma polmonare non a piccole cellule avanzato o metastatico
    E.1.1.1Medical condition in easily understood language
    Lung Cancer
    Cancro ai polmoni
    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 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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 demonstrate superiority of ceralasertib plus durvalumab combination therapy relative to docetaxel by assessment of OS in participants with advanced NSCLC after second- or thirdline therapy and without actionable genomic alterations
    Dimostrare la superiorità della terapia di combinazione ceralasertib più durvalumab rispetto a docetaxel mediante valutazione dell’OS nei partecipanti con NSCLC in stadio avanzato dopo terapia di seconda o terza linea e senza alterazioni genomiche su cui è possibile agire
    E.2.2Secondary objectives of the trial
    - To demonstrate superiority of ceralasertib plus durvalumab (C&D) combination therapy relative to docetaxel by assessment of PFS.
    - To estimate the effectiveness of C&D combination therapy relative:
    • to docetaxel by assessment of ORR
    • to docetaxel by assessment of duration of response (DoR)
    • to docetaxel by assessment of time to response (TTR)
    • to docetaxel by assessment of disease control rate (DCR) at 18 weeks
    • to docetaxel by assessment of time to second progression or death (PFS2)
    • to docetaxel by assessment of OS at 12 months (OS12)
    -To assess participant-reported health-related quality of life (QoL)
    - To assess participant-reported physical functioning in participants treated with C&D combination therapy relative to docetaxel
    PLEASE REFER TO THE PROTOCOL FOR FURTHER DETAILS
    Dimostrare la superiorità della terapia di combinazione ceralasertib più durvalumab rispetto a docetaxel mediante valutazione della PFS
    Stimare l’efficacia della combinazione terapeutica C&D rispetto a:
    • docetaxel mediante valutazione dell’ORR
    • docetaxel mediante valutazione della durata della risposta (DoR)
    • docetaxel mediante valutazione del tempo alla risposta (TTR).
    • docetaxel mediante valutazione del tasso di controllo della malattia (DCR) a 18 settimane.
    • docetaxel mediante la valutazione del tempo alla seconda progressione o al decesso (PFS2).
    • docetaxel mediante valutazione dell’OS a 12 mesi (OS12).
    -Valutare la qualità della vita (QoL) correlata alla salute riferita dai partecipanti
    -Valutare la funzionalità fisica riferita dai partecipanti tra quelli trattati con ceralasertib più terapia di combinazione con durvalumab rispetto a docetaxel.
    SI PREGA DI FARE RIFERIMENTO AL PROTOCOLLO PER ULTERIORI DETTAGLI
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Participant must be >= 18 years at the time of screening.
    2. Histologically or cytologically documented NSCLC that is locally advanced or metastatic according to Version 8 of the IASLC Staging Manual in Thoracic Oncology.
    3. Documented EGFR and ALK wild-type status as determined at a local laboratory.
    4. Documented radiological PD whilst on or after receiving the most recent treatment regimen.
    5. Eligible for second- or third-line therapy and must have received an anti-PD-(L)1 therapy and a platinum doublet containing therapy for locally advanced or metastatic NSCLC either separately or in
    combination.
    6. ECOG/WHO performance status of 0 or 1.
    7. Adequate organ function and marrow reserve
    8. Minimum life expectancy of 12 weeks.
    9. Body weight > 30 kg and no cancer-associated cachexia.
    10. Negative pregnancy test (serum test) for WOCBP.
    1. Il partecipante deve avere più di 18 anni al momento dello screening.
    2. Tumore polmonare non a piccole cellule (NSCLC) documentato istologicamente o citologicamente che sia localmente in stadio avanzato o metastatico secondo la Versione 8 della stadiazione dell’Associazione internazionale per lo studio del carcinoma polmonare (IASLC)
    Manuale in Oncologia Toracica.
    3. Stato del recettore del fattore di crescita epiteliale (EGFR) e della chinasi del linfoma anaplastico (ALK) wild-type documentato, determinato presso un laboratorio locale.
    4. Farmacodinamica radiologica documentata durante o dopo aver ricevuto la maggior parte
    del regime di trattamento recente.
    5. Idoneità alla terapia di seconda o terza linea; inoltre il soggetto deve aver ricevuto una
    terapia anti-PD-(L)1 e una terapia contenente doppietta a base di platino per NSCLC localmente avanzato o metastatico separatamente o in combinazione.
    6. Stato di validità ECOG/OMS di 0 o 1.
    7. Adeguata funzione d’organo e riserva midollare
    8. Aspettativa di vita minima di 12 settimane.
    9. Peso corporeo > 30 kg e assenza di cachessia associata a tumore.
    10. Test di gravidanza negativo (test sul siero) per le donne in età fertile (WOCBP).
    E.4Principal exclusion criteria
    1. Participant with mixed SCLC and NSCLC histology.
    2. History of another primary malignancy except for malignancy treated with curative intent with no known active disease >= 5 years before the first dose of study intervention.
    3. Persistent toxicities (CTCAE Grade > 2) caused by previous anticancer therapy.
    4. Active or prior documented autoimmune or inflammatory disorders.
    5. Participants who have received more than one line of prior anti-PD- (L)1, either alone or in any combination.
    6. Participants:
    (a) Must not have experienced a toxicity that led to permanent discontinuation of the prior anti-PD(L)1 therapy.
    (b) All AEs while receiving prior anti-PD(L)1 therapy must have completely resolved.
    (c) Must not have experienced a Grade >= 3 imAE or an immune-related neurologic or ocular AE of any grade while receiving prior anti-PD(L)1
    therapy.
    (d) Must not have required the use of additional immunosuppression other than corticosteroids for the management of an AE, not have experienced recurrence of an AE if re-challenged, and not currently
    require maintenance doses of > 10 mg prednisone or equivalent per day.
    7. Participants who have received more than one prior line of platinum- based chemotherapy in metastatic setting.
    8. Participants who have received a prior ATR inhibitor.
    1. Partecipante con istologia mista di carcinoma polmonare a piccole cellule (SCLC) e NSCLC.
    2. Anamnesi di altra malignità primaria ad eccezione di malignità trattata con intento curativo senza malattia attiva nota >= 5 anni prima della prima dose del trattamento dello studio.
    3. Tossicità persistenti (grado >2 dei criteri terminologici comuni per gli eventi avversi [CTCAE]) causate da precedente terapia antitumorale.
    4. Disturbi autoimmuni o infiammatori documentati attivi o precedenti.
    5. Partecipanti che hanno ricevuto più di una linea di precedente terapia anti-PD-(L)1, da sola o in qualsiasi combinazione.
    6. I partecipanti:
    (a) Non devono aver manifestato una tossicità che abbia portato a interruzione permanente della precedente terapia anti-PD(L)1.
    (b) Tutti gli EA durante la precedente terapia anti-PD(L)1 devono essersi completamente risolti.
    (c) Non devono aver manifestato un evento avverso immuno-mediato (imAE) di grado >=3 o un EA neurologico immuno-correlato od oculare di qualsiasi grado durante la precedente terapia
    anti-PD(l)1.
    (d) Non devono aver richiesto l’uso di immunosoppressione aggiuntiva diversa dai corticosteroidi per la gestione di un EA, non hanno manifestato una recidiva di un EA se si è ripresentato e non richiedono attualmente dosi di mantenimento >10 mg di prednisone o equivalente al giorno.
    7. Partecipanti che hanno ricevuto più di una precedente linea di chemioterapia a base di platino in fase metastatica.
    8. Partecipanti che hanno ricevuto un precedente inibitore di ATR.
    E.5 End points
    E.5.1Primary end point(s)
    - OS is defined as time from randomisation until the date of death due to any cause.
    - The comparison will include all randomised participants, regardless of whether the participant withdraws from randomised therapy or receives another anti-cancer therapy.
    - The measure of interest is the HR of OS.
    - La OS è definita come il tempo dalla randomizzazione fino alla data di morte per qualsiasi causa.
    - Il confronto includerà tutti i partecipanti randomizzati, indipendentemente dal fatto che il partecipante si ritiri dalla terapia randomizzata o riceva un'altra terapia antitumorale.
    - La misura di interesse è l'HR di OS.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomisation until the date of death due to any cause
    Tempo dalla randomizzazione fino alla data di morte per qualsiasi causa
    E.5.2Secondary end point(s)
    - To demonstrate superiority of ceralasertib plus durvalumab relative to docetaxel by assessment of PFS, ORR, of duration of response (DoR), time to response (TTR), disease control rate (DCR) at 18 weeks, time to second progression or death (PFS2), OS at 12 months (OS12), participant-reported health-related quality of life (QoL), participant- reported physical functioning, participant-reported treatment tolerability.
    - To assess the PK of ceralasertib when administered in combination with durvalumab.
    - To assess safety and tolerability of ceralasertib plus durvalumab therapy as compared with docetaxel
    - Dimostrare la superiorità di ceralaserib plus durvalumab rispetto a docetaxel mediante la valutazione di PFS, ORR, durata della risposta (DoR), tempo alla risposta (TTR), tasso di controllo della malattia (DCR) a 18 settimane, tempo alla seconda progressione o morte ( PFS2), OS a 12 mesi (OS12), qualità di vita correlata alla salute (QoL) riferita dai partecipanti, funzionamento fisico segnalato dai partecipanti, tollerabilità al trattamento segnalata dai partecipanti.
    - Valutare la PK di ceralaserib quando somministrato in combinazione con durvalumab.
    - Per valutare la sicurezza e la tollerabilità della terapia con ceralasertib più durvalumab rispetto a docetaxel
    E.5.2.1Timepoint(s) of evaluation of this end point
    - The tumour response endpoints (PFS, ORR, DoR and TTR) will be driven from randomisation up until progression, or the last evaluable assessment in the absence of progression (up to three years).
    -Plasma concentration of ceralasertib and sparse PK parameters such as peak concentration and trough, as data allow.
    - Safety and tolerability will be evaluated in terms of TEAEs, vital signs, clinical laboratory results, and ECGs
    - Gli endpoint di risposta tumorale (PFS, ORR, DoR e TTR) saranno guidati dalla randomizzazione fino alla progressione o all'ultima valutazione valutabile in assenza di progressione (fino a tre anni).
    -Concentrazione plasmatica di ceralasertib e parametri PK sparsi come concentrazione di picco e minimo, come consentito dai dati.
    - La sicurezza e la tollerabilità saranno valutate in termini di TEAE, segni vitali, risultati clinici di laboratorio ed ECG
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    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 concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA76
    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
    Argentina
    Australia
    Brazil
    Canada
    China
    Hong Kong
    India
    Japan
    Korea, Republic of
    Taiwan
    United States
    France
    Poland
    Netherlands
    Romania
    Spain
    Germany
    Italy
    Belgium
    Hungary
    Serbia
    United Kingdom
    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 end of the study is defined as the date of the last visit of the last participant in the study or last scheduled procedure shown in the SoA for the last participant in the study globally (including OS determination).
    La fine dello studio è definita come la data dell'ultima visita dell'ultimo partecipante allo studio o all'ultima procedura programmata mostrata nella SoA per l'ultimo partecipante allo studio a livello globale (compresa la determinazione della OS).
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    E.8.9.2In all countries concerned by the trial months2
    E.8.9.2In all countries concerned by the trial days7
    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: 320
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 260
    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 state33
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 208
    F.4.2.2In the whole clinical trial 580
    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)
    None
    Nessuno
    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 Decision2022-09-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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