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    Summary
    EudraCT Number:2021-002453-28
    Sponsor's Protocol Code Number:GR-2018-12368292
    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:2021-10-12
    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 number2021-002453-28
    A.3Full title of the trial
    First line Immunotherapy-chemotherapy versus Immunotherapy-chemotherapy Combined With Stereotactic Body Radiation for Metastatic NSCLC patients:
    A Phase II Randomized, Open Label Clinical Trial.
    Immunoterapia-chemioterapia verso immunoterapia-chemioterapia più radioterapia stereotassica come trattamento di prima linea nei pazienti affetti da NSCLC metastatico: Uno studio di fase II randomizzato controllato in aperto.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Stereotactic Body Radiation in combination with immunotherapy-chemotherapy in patients with Metastatic Non-Small Cell Lung Cancer.
    Radioterapia stereotassica in associazione alla Immunoterapia-chemioterapia in pazienti affetti da Cancro Metastatico del Polmone non a Piccole Cellule.
    A.3.2Name or abbreviated title of the trial where available
    ICSMEN-Trial
    ICSMEN-Trial
    A.4.1Sponsor's protocol code numberGR-2018-12368292
    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 SponsorAZIENDA OSPEDALIERA ARCISPEDALE SANTA MARIA NUOVA/IRCCS DI REGGIO EMILIA
    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 supportMinistero della Salute
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAzienda USL IRCCS di Reggio Emilia
    B.5.2Functional name of contact pointInfrastruttura ricerca e statistica
    B.5.3 Address:
    B.5.3.1Street AddressViale Umberto I, 50
    B.5.3.2Town/ cityReggio Emilia
    B.5.3.3Post code42123
    B.5.3.4CountryItaly
    B.5.6E-mailmassimo.costantini@ausl.re.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.2.5The 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 namePemetrexed
    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 INNPEMETREXED DISODICO
    D.3.9.1CAS number 137281-23-3
    D.3.9.2Current sponsor codepemetrexed
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number500
    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: 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.2.5The 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 namePembrolizumab
    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 INNPEMBROLIZUMAB
    D.3.9.1CAS number 1374853-91-4
    D.3.9.2Current sponsor codePembrolizumab
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    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) Yes
    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: 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 Yes
    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 nameCarboplatino AHCL
    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 INNCARBOPLATINO
    D.3.9.1CAS number 41575-94-4
    D.3.9.2Current sponsor codeCarboplatino
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Yes
    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 nameCisplatino
    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 INNCISPLATINO
    D.3.9.1CAS number 15663-27-1
    D.3.9.2Current sponsor codecicplatio
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number1
    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 Yes
    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 namePaclitaxel
    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 INNPACLITAXEL
    D.3.9.1CAS number 33069-62-4
    D.3.9.2Current sponsor codepaclitaxel
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6
    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 both squamous and nonsquamous metastatic non-small cell lung cancer (NSCLC) wild type in EGFR, KRAS, ALK and ROS1.
    Pazienti con carcinoma polmonare non a piccole cellule (NSCLC) metastatico sia squamoso che non squamoso wild type in EGFR, KRAS, ALK e ROS1.
    E.1.1.1Medical condition in easily understood language
    First line metastatic non small cell lung cancer
    Carcinoma non a piccole cellule metastatico del polmone
    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 evaluate whether the ORR (Objective Response Rate) assessed at 14 weeks after the start of treatment is higher in the experimental group than in the control group.
    L'obiettivo primario è quello di valutare se l'ORR (Tasso di Risposta Oggettiva) valutato a 14 settimane dall'inizio del trattamento è più alto nel gruppo sperimentale rispetto al gruppo di controllo.
    E.2.2Secondary objectives of the trial
    Secondary objectives are to compare the two treatment arms in terms of:
    1) Safety
    2) PFS (progression-free survival)
    3) OS (overall survival)
    4) TTF (duration of response to treatment)
    5) Quality of life
    Gli obiettivi secondari consistono nel confrontare i due bracci di trattamento in termini di:
    1) Safety
    2) PFS (sopravvivenza libera da progressione)
    3) OS (sopravvivenza globale)
    4) TTF (durata di risposta al trattamento)
    5) Qualità della vita
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives

    Other types of substudies
    Specify title, date and version of each substudy with relative objectives: Title: Collateral Research (Chapter 18_ICSMEN Protocol V2 del 29.04.2021)

    The aims of this research are:
    - identify a list of predictive tumor immune-related biomarkers of response or resistance to Pembrolizumab, for the optimization of NSCLC patient selection (training set: standard arm)
    - validate these tumor-associated biomarker in the experimental arm of the study to optimize the modalities of combination with SRT (validation set: experimental arm)
    - identify the immune molecular basis of the synergistic effect of RT and immunotherapy in NSCLC patients, analyzing immune secretome and related immune cell populations

    Altre tipologie di sottostudi
    specificare il titolo, la data e la versione di ogni sottostudio con i relativi obiettivi: Titolo: Ricerca Collaterale (Capitolo 18_ICSMEN Protocol V2 del 29.04.2021)

    Gli obiettivi di questo sottostudio sono:
    - identificare biomarcatori immunitari predittivi di risposta o resistenza a Pembrolizumab, la selezione dei pazienti con NSCLC (training set: braccio standard)
    - convalidare questi biomarcatori associati al tumore per ottimizzare le modalità di combinazione con SRT (set di validazione: braccio sperimentale)
    - identificare le basi immunomolecolari dell'effetto sinergico di RT e immunoterapia nei pazienti con NSCLC, analizzando il secretoma immunitario e le relative popolazioni di cellule immunitarie
    E.3Principal inclusion criteria
    - Histologic confirmation of NSCLC by biopsy or cytology (primary cancer are eligible: squamous cell carcinoma, adenocarcinoma; no sensitizing mutation in the epidermal growth factor receptor (EGFR) gene or anaplastic lymphoma kinase (ALK) gene translocation; stage IV according to the 8th version of the IASLC system);
    - Age >= 18 years;
    - Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
    - At least two lesions measurable according to Response Evaluation Criteria in Solid Tumors (RECIST), version 1.1;
    - Life expectancy of at least 3 months;
    - Signature of informed consent form;
    - Patients must have adequate organ function.
    - Conferma istologica di NSCLC tramite biopsia o citologia (cancro primario sono ammissibili: carcinoma a cellule squamose, adenocarcinoma; nessuna mutazione sensibilizzante del gene del recettore del fattore di crescita epidermico (EGFR) o traslocazione del gene della linfoma chinasi anaplastica (ALK); stadio IV secondo l'ottava versione del sistema IASLC);
    - Età >= 18 anni;
    - Punteggio di performance status dell'Eastern Cooperative Oncology Group (ECOG) di 0-1;
    - Almeno due lesioni misurabili secondo i Response Evaluation Criteria in Solid Tumors (RECIST), versione 1.1;
    - Aspettativa di vita di almeno 3 mesi;
    - Firma del modulo di consenso informato;
    - I pazienti devono avere una funzione d'organo adeguata.
    E.4Principal exclusion criteria
    - Eastern Cooperative Oncology Group (ECOG) performance status score >2;
    - Patients scheduled to receive other concomitant local therapy (including standard fractionated radiation therapy and surgery) during this protocol, except at disease progression;
    - Mandatory detention for treatment of a psychiatric or physical illness;
    - Pregnancy or lactating (because treatment carries unpredictable risks to the embryo or fetus);
    - Previous immunotherapy with PD1 or CTLA4 antibodies;
    - Known or suspected active autoimmune disease;
    - History of antibodies to human immunodeficiency virus (HIV) -1 or -2;
    - Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection;
    - Patients who are unable to receive chemotherapy;
    - Conditions requiring systemic treatment with corticosteroids or other immunosuppressive drugs within 14 days of study drug administration;
    - Allergies or adverse drug reactions;
    - Contraindications to radiation therapy;
    - History of idiopathic pulmonary fibrosis, including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
    - Performance status dell'Eastern Cooperative Oncology Group (ECOG) >2;
    - Pazienti che hanno in programma di ricevere altra terapia locale concomitante (compresa la radioterapia frazionata standard e la chirurgia) durante questo protocollo, tranne che alla progressione della malattia;
    - Detenzione obbligatoria per il trattamento di una malattia psichiatrica o fisica;
    - Gravidanza o allattamento (perché il trattamento comporta rischi imprevedibili per l'embrione o il feto);
    - Precedente immunoterapia con anticorpi PD1 o CTLA4;
    - Malattia autoimmune attiva, nota o sospetta;
    - Anamnesi di anticorpi contro il virus dell'immunodeficienza umana (HIV) -1 o -2;
    - Test positivo per l'antigene di superficie del virus dell'epatite B (HBV sAg) o l'acido ribonucleico del virus dell'epatite C (anticorpo HCV) che indica un'infezione acuta o cronica;
    - Pazienti che non sono in grado di ricevere la chemioterapia;
    - Condizioni che richiedono un trattamento sistemico con corticosteroidi o altri farmaci immunosoppressivi entro 14 giorni dalla somministrazione del farmaco in studio;
    - Allergie o reazioni avverse ai farmaci;
    - Controindicazioni alla radioterapia;
    - La storia di fibrosi polmonare idiopatica, compresa la polmonite, la polmonite indotta da farmaci, polmonite da Pneumonia (cioè, bronchiolite obliterante, polmonite criptogenetica da Pneumonia), o l'evidenza di polmonite attiva sulla tomografia computerizzata del torace (CT) di screening
    E.5 End points
    E.5.1Primary end point(s)
    Tumor response rate will be measured by iRECIST criteria. The response categories will be complete response (CR), partial response (PR), stable disease (SD) and progressive disease (PD). Overall response rate (ORR) will be defined as the proportion of subjects with the best overall response of CR or PR. The ORR will be calculated with both confirmed and unconfirmed responses as responses.
    Il tasso di risposta tumorale sarà misurato in base ai criteri iRECIST. Le categorie di risposta saranno: risposta completa (CR), risposta parziale (PR), malattia stabile (SD) e progressione di malattia (PD). Il tasso di risposta globale (ORR) sarà valutato come la proporzione di soggetti con la migliore risposta globale di CR o PR. L'ORR sarà calcolato considerando come risposte sia le risposte confermate che quelle non confermate.
    E.5.1.1Timepoint(s) of evaluation of this end point
    This endpoint will be measured at 14 weeks after the start of treatment
    Questo endpoint verrà valutato a 14 settimane dall'inizio del trattamento
    E.5.2Secondary end point(s)
    Quality of life; Safety; TTF (Treatment response duration); PFS (progression free survival); Overall survival (OS)
    Qualità della vita; Sicurezza; TTF (Durata della risposta al trattamento); PFS (sopravvivenza libera da progressione); Sopravvivenza globale (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    It will be measured with validated questionnaires (EORTC QLQC30 & QLQ-LC13) administered at baseline, at the end of treatment and at each administration of pembrolizumab.; From start treatment since 4 weeks after the last dose of platinum-chemioteraphy; Time to Treatment Failure (TTF) will be measured as time between randomization and treatment failure defined as first date of documented progression, based on investigator assessment (as per iRECIST criteria).; Progression Free survival (PFS) will be measured from the date of randomization to the date of first documented disease progression or the date of death due to any cause.; It will be calculated as the time (days) from the date of randomization to death from any cause. Survival for subjects who will be alive or lost to follow-up at or
    Verrà misurata con questionari validati (EORTC QLQC30 & QLQ-LC13) somministrati al baseline, alla fine del trattamento ed ad ogni somministrazione di pembrolizumab.; Dall'inizio del trattamento fino a 4 settimane dopo l'ultima dose di chemioterapia a base di platino; Il tempo al fallimento del trattamento (TTF) sarà misurato come tempo tra la randomizzazione e il fallimento del trattamento definito come prima data di progressione documentata, basata sulla valutazione dello sperimentatore (secondo i criteri iRECIST).; La sopravvivenza libera da progressione (PFS) sarà misurata dalla data di randomizzazione alla data della prima progressione documentata della malattia o alla data di morte per qualsiasi causa; Sarà calcolato come il tempo (giorni) dalla data di randomizzazione alla morte per
    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 No
    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 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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Terapia da pratica clinica
    Standard care
    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 concerned4
    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 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
    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: 32
    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 state132
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 132
    F.4.2.2In the whole clinical trial 132
    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)
    At the end of their participation patients will continue therapy as per clinical practice at the discretion of the investigator.
    Al termine della loro partecipazione allo studio i pazienti proseguiranno la terapia come da pratica clinica a discrezione dello 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 Decision2021-08-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-07-06
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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