Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43861   clinical trials with a EudraCT protocol, of which   7284   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2014-004824-22
    Sponsor's Protocol Code Number:I4T-MC-JVCY
    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:2021-06-17
    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 number2014-004824-22
    A.3Full title of the trial
    A Multicenter, Randomized, Double-Blind Study of Erlotinib in Combination with Ramucirumab or Placebo in Previously Untreated Patients with EGFR
    Mutation-Positive Metastatic Non-Small Cell Lung Cancer
    Studio Multicentrico, Randomizzato in Doppio Cieco di Erlotinib in Combinazione con Ramucirumab o con Placebo, in Pazienti con Carcinoma Metastatico del Polmone Non a Piccole Cellule con Mutazione EGFR positiva, mai Trattati Precedentemente
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study of Ramucirumab (LY3009806) in Combination With Erlotinib in Participants With EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer (NSCLC)
    Studio di Ramucirumab (LY3009806) in combinazione con erlotinib, in soggetti affetti da Carcinoma Metastatico del Polmone Non a Piccole Cellule con Mutazione EGFR positiva
    A.3.2Name or abbreviated title of the trial where available
    RELAY
    RELAY
    A.4.1Sponsor's protocol code numberI4T-MC-JVCY
    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 SponsorELI LILLY & COMPANY, LILLY CORPORATE CENTER
    B.1.3.4CountryUnited States
    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 supportEli Lilly and Company
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationEli Lilly
    B.5.2Functional name of contact pointClinical Trial Registry Office
    B.5.3 Address:
    B.5.3.1Street AddressLilly Corporate Center, DC 1526
    B.5.3.2Town/ cityIndianapolis
    B.5.3.3Post code46285
    B.5.3.4CountryUnited States
    B.5.4Telephone number00390554257386
    B.5.5Fax number00390554257348
    B.5.6E-mailEU_Lilly_Clinical_Trials@lilly.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.2.1.1.1Trade name Tarceva
    D.2.1.1.2Name of the Marketing Authorisation holderRoche Registration Limited
    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 nameErlotinib
    D.3.2Product code [Erlotinib]
    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 INNErlotinib
    D.3.9.2Current sponsor codeNA
    D.3.9.4EV Substance CodeSUB16423MIG
    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.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.2.1.1.1Trade name Cymranza
    D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V.
    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 nameCyramza
    D.3.2Product code [LY3009806]
    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 INNramucirumab
    D.3.9.1CAS number 947687-13-0
    D.3.9.2Current sponsor codeLY3009806
    D.3.9.4EV Substance CodeSUB32795
    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 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.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    EGFR Mutation-Positive Metastatic Non-Small Cell Lung Cancer
    Carcinoma metastatico del polmone non a piccole cellule con mutazione EGFR positiva
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Tumore 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 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 Yes
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of Part B is to compare the PFS of ramucirumab administered in combination with erlotinib versus placebo in combination with erlotinib in previously untreated patients with EGFR
    mutation-positive metastatic NSCLC.
    L¿obiettivo primario della Parte B ¿ quello di confrontare la Sopravvivenza libera da Progressione (PFS) di ramucirumab somministrato in combinazione con erlotinib rispetto a placebo in combinazione con erlotinib nei pazienti affetti da NSCLC metastatico con mutazione EGFR positiva mai trattati precedentemente.
    E.2.2Secondary objectives of the trial
    Secondary objectives of Part B are to compare ramucirumab administered in combination with erlotinib versus placebo administered in combination with erlotinib for:
    ¿ safety and toxicity profile
    ¿ overall survival (OS)
    ¿ objective response rate (ORR) (complete response [CR] + partial
    response [PR])
    ¿ disease control rate (DCR) (CR + PR + stable disease [SD])
    ¿ duration of response (DOR)
    ¿ pharmacokinetics (PK) and immunogenicity of ramucirumab
    ¿ patient-reported outcomes (using Lung Cancer Symptom Scale [LCSS] and EuroQol 5 dimension, 5-level questionnaire [EQ 5D-5L])
    Gli obiettivi secondari della Parte B sono confrontare ramucirumab somministrato in combinazione con erlotinib rispetto a placebo in combinazione con erlotinib in relazione ai seguenti parametri:
    ¿ profilo di sicurezza e di tossicit¿
    ¿ sopravvivenza globale (OS)
    ¿ tasso di risposta obiettiva (ORR) (risposta completa [CR] + risposta parziale [PR])
    ¿ tasso di controllo della malattia (DCR) (CR + PR + malattia stabile [SD])
    ¿ durata della risposta (DOR)
    ¿ farmacocinetica (PK) e immunogenicit¿ di ramucirumab
    ¿ outcome riferiti dai pazienti (mediante Lung Cancer Symptom Scale [LCSS] e questionario EuroQol a 5 dimensioni e 5 livelli [EQ-5D-5L]).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    * Cytologically or histologically confirmed diagnosis of Stage IV NSCLC as defined by the American Joint Committee on Cancer Staging Criteria for Lung Cancer (AJCC 7th edition 2009)
    * Eligible for first-line treatment with erlotinib based on previously documented evidence of tumor that has EGFR exon 19 deletion or exon 21 (L858R) substitution mutation.
    * Mandatory provision of adequate archived stage IV NSCLC tissue sample.
    * At least one or more measurable lesion attributed to NSCLC, documented by computed tomography (CT) scan or magnetic resonance imaging (MRI), as defined by the Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
    * Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1
    * Prior radiation therapy is allowed
    * Adequate hematologic and organ function
    * Eligible patients of reproductive potential (both sexes) must agree to use adequate contraceptive methods (hormonal or barrier methods) during the study period and for at least 12 weeks after the last dose of study therapy.
    * Resolution to Grade =1 (except alopecia), by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), v4.0, of all clinically significant toxic effects of prior locoregional
    therapy, surgery, or other anticancer therapy.
    * Life expectancy of at least 3 months and, in the judgment of the investigator, will be able to complete at least 2 cycles of treatment.
    * Diagnosi confermata istologicamente o citologicamente di NSCLC allo stadio IV in base ai criteri di stadiazione dell’American Joint Committee per il carcinoma polmonare (AJCC 7a edizione 2009)
    * Idoneità al trattamento di prima linea con erlotinib sulla base di evidenze precedentemente documentate di tumore con delezione dell’esone 19 o mutazione di sostituzione dell’esone 21 (L858R) nel gene EGFR
    * Disponibilità obbligatoria di un campione tissutale del NSCLC di stadio IV adeguatamente archiviato
    * Almeno una o più lesioni misurabili attribuite al NSCLC, documentate tramite tomografia computerizzata (TC) o risonanza magnetica (RM), come definito dalla versione 1.1 dei criteri RECIST (Response Evaluation Criteria in Solid Tumors)
    * Performance status ECOG (Eastern Cooperative Oncology Group) di 0 o 1
    * Il trattamento precedente con radioterapia è concesso
    * Funzionalità d’organo ed ematologica adeguata
    * Consenso da parte dei pazienti eleggibili e potenzialmente fertili (entrambi i sessi) all’uso di metodi contraccettivi adeguati (metodi ormonali o di barriera) durante lo studio e per almeno 12 settimane dopo l’ultima somministrazione dei farmaci in studio
    * Risoluzione di tutti gli effetti tossici clinicamente significativi (eccetto l’alopecia) di eventuali terapie pregresse locoregionali, chirurgiche o antitumorali di altro tipo al grado =1 dei criteri CTCAE (Common Terminology Criteria for Adverse Events) dell’NCI (National Cancer Institute), versione 4.0
    * Aspettativa di vita di almeno 3 mesi e, in base al giudizio dello sperimentatore, possibilità di completare almeno 2 cicli di trattamento
    E.4Principal exclusion criteria
    * Known T790M EGFR mutation
    * Known leptomeningeal carcinomatosis, uncontrolled/unstable spinal cord compression, or brain metastases
    * Major surgery within 28 days or subcutaneous venous access device placement within 7 days prior to enrollment. Any patient with postoperative bleeding complications or wound complications from a surgical procedure performed in the last 2 months will be excluded
    * Pleural effusion, pericardial fluid, or ascites requiring drainage every other week or more frequently
    * Superior vena cava syndrome
    * Clinically relevant congestive heart failure [NYHA] II-IV; or symptomatic or poorly controlled cardiac arrhythmia
    * Serious illness or medical condition including Cirrhosis at a level of Child-Pugh Class B (or worse) or cirrhosis (any degree) and a history of hepatic encephalopathy or clinically meaningful ascites resulting from cirrhosis and requiring ongoing treatment with diuretics and/or paracentesis. Patients with a history of hepatorenal syndrome should also be excluded.
    * Uncontrolled hypertension
    * Ongoing treatment with CYP3A4 inducers or strong/moderate inhibitors
    * Ongoing therapy with nonsteroidal anti-inflammatory drugs for more than 2 months or other antiplatelet agents. Aspirin use at doses up to 325 mg/day is permitted
    * History of gross hemoptysis within 2 months
    * Significant bleeding disorders, vasculitis, or experienced Grade 3/4 GI bleeding within 3 months
    * Radiologically documented evidence of major blood vessel invasion or encasement by cancer
    * Radiographic evidence of intratumor cavitation, regardless of tumor histology
    * History of gastrointestinal perforation, peptic ulceration, diverticular disease, and/or fistulae within 6 months
    * History of bowel obstruction, history or presence of inflammatory enteropathy or extensive intestinal resection, Crohn's disease, ulcerative colitis, or chronic diarrhea
    * History of any arterial thrombotic event, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack, within 6 months
    * The patient has any known significant ophthalmologic abnormalities of the surface of the eye
    * The patient requires daily use of prescription or over-the-counter proton pump inhibitors
    * Any prior anticancer therapy for Stage IIIB/IV NSCLC
    * Any evidence of clinically active interstitial lung disease. Asymptomatic patients with chronic, stable, radiographic changes are eligible
    * Preexisting idiopathic pulmonary fibrosis as evidenced by CT scan/Xray at baseline; have or had any disease of acute lung injury, idiopathic pulmonary fibrosis, or pneumoconiosis evident on an X-ray; have or had any disease of radiation pneumonia or drug-induced pneumonia
    * The patient has SPO2 < 94 (room air)
    * Mutazione T790M del EGFR nota
    * Carcinomatosi leptomeningea, compressione del midollo spinale non controllata/instabile o metastasi cerebrali note
    * Intervento chirurgico maggiore nei 28 giorni precedenti o impianto di un dispositivo di accesso venoso sottocutaneo nei 7 giorni precedenti l’arruolamento. Tutti i pazienti che hanno riportato complicanze emorragiche postoperatorie o correlate alla ferita in seguito a procedure chirurgiche eseguite nei 2 mesi precedenti saranno esclusi
    * Versamento pleurico, liquido pericardico o ascite tali da richiedere un drenaggio quindicinale (o più frequente)
    * Sindrome della vena cava superiore
    * Insufficienza cardiaca congestizia clinicamente rilevante di classe II-IV [NYHA] o aritmia cardiaca sintomatica o scarsamente controllata
    * Patologia o condizione medica grave, quale cirrosi di classe Child-Pugh B (o peggiore) o cirrosi (in qualsiasi stadio) e storia di encefalopatia epatica o ascite clinicamente significativa secondaria a cirrosi con necessità di trattamento continuo con diuretici e/o paracentesi. Anche i pazienti con anamnesi positiva per la sindrome epatorenale devono essere esclusi
    * Ipertensione non controllata
    * Trattamento in corso con farmaci induttori o inibitori forti o moderati del CYP3A4
    * Terapia in corso da oltre 2 mesi con farmaci anti-infiammatori non steroidei o altri agenti antiaggreganti. È consentito l’uso di aspirina con dosaggi fino a 325 mg/die
    * Anamnesi positiva per emottisi macroscopica negli ultimi 2 mesi
    * Disturbi emorragici significativi, vasculite o episodi di emorragia GI di grado 3/4 negli ultimi 3 mesi
    * Evidenze documentate radiologicamente di invasione vascolare maggiore o inglobamento neoplastico
    * Evidenze radiografiche di cavitazione intratumorale, indipendentemente dall’istologia del tumore
    * Anamnesi positiva per perforazione gastrointestinale, ulcera peptica, malattia diverticolare e/o fistole negli ultimi 6 mesi
    * Anamnesi positiva per occlusione intestinale, presenza o storia di enteropatia infiammatoria o resezione intestinale estesa, morbo di Crohn, colite ulcerosa o diarrea cronica
    * Anamnesi positiva per qualsiasi evento trombotico arterioso, inclusi infarto del miocardio, angina instabile, ictus cerebrovascolare o attacco ischemico transitorio, negli ultimi 6 mesi
    * Presenza di anomalie oftalmologiche significative note con coinvolgimento della superficie oculare
    * Terapia quotidiana con inibitori della pompa protonica da banco o con prescrizione medica
    * Qualsiasi terapia antitumorale pregressa per il NSCLC di stadio IIIB/IV
    * Qualsiasi evidenza di malattia interstiziale polmonare clinicamente attiva. Sono invece eleggibili i pazienti asintomatici con alterazioni croniche stabili apprezzabili all’esame radiografico
    * Fibrosi polmonare idiopatica preesistente evidenziata da TC/radiografie al basale; presenza o storia di patologia dovuta a lesioni polmonari acute, fibrosi polmonare idiopatica o pneumoconiosi apprezzabile all’esame radiografico; presenza o storia di polmonite da radiazioni o secondaria a farmacoterapia
    * Concentrazione di ossigeno nel sangue (SPO2) <94 (in aria ambiente)
    E.5 End points
    E.5.1Primary end point(s)
    Part B: Progression Free Survival (PFS)
    Parte B: Sopravvivenza libera da progressione (PFS)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Part B: After 320 PFS events for approximately 450 patients have been reported.
    PFS is measured from the date of randomization to the date of radiographic documentation of progression (as defined by RECIST v. 1.1) based on investigator assessment, or the date of death due to any cause, whichever is earlier.
    Parte B: dopo la rilevazione di 320 eventi di PFS per circa 450 pazienti.
    La PFS è calcolata dalla data della randomizzazione alla data della documentazione radiografica di una progressione (secondo la definizione del RECIST, versione 1.1) in base alla valutazione dello sperimentatore o alla data di morte per qualsiasi causa (a seconda di quale evento si verifichi per primo).
    E.5.2Secondary end point(s)
    ¿ overall survival (OS) defined as the time from the date of randomization until the date of death from any cause
    ¿ objective response rate (ORR) (complete response [CR] + partial response [PR]) defined as the proportion of randomized patients achieving a best overall response of PR or CR, from randomization to
    disease progression.
    ¿ disease control rate (DCR) (CR + PR + stable disease [SD]) defined as the proportion of randomized patients achieving a best overall response of PR or CR or SD, from randomization to disease progression.
    ¿ duration of response (DOR) defined from the date of first documented CR or PR (responder) to the date of objective progression or the date of death due to any cause, whichever is earlier.
    ¿ pharmacokinetics (PK) of ramucirumab: Cmin from Cycle 2 predose through Cycle 14 predose
    ¿ Number of patients with Anti-Ramucirumab antibodies from Cycle 1 predose through follow-up
    ¿ Change from baseline on the Lung Cancer Symptom Scale [LCSS] - time to deterioration (TtD) for each of the 9 items
    ¿ Change from baseline on the EuroQoL 5-dimension, 5-Level Questionnaire (EQ-5D-5L): -Descriptive statistics for the 5 dimensions, index, and VAS calculated for each assessment period
    ¿ Resource Utilization - Hospitalizations, transfusions, and concomitant medications during the study treatment period or during the 30-day
    short-term follow-up period
    ¿ Sopravvivenza Globale (OS) definita come tempo intercorrente tra la data della randomizzazione e la data della morte per qualsiasi causa
    ¿ Tasso di risposta obiettiva (ORR) (risposta completa [CR] + risposta parziale [PR]) definito come percentuale di pazienti randomizzati che raggiungono una migliore risposta globale in termini di PR o CR dalla randomizzazione alla
    progressione della patologia
    ¿ Tasso di controllo della malattia (DCR) (CR + PR + malattia stabile [SD]) definito come percentuale di pazienti randomizzati che raggiungono una migliore risposta globale in termini di PR, CR o SD dalla randomizzazione alla progressione della patologia
    ¿ Durata della risposta (DOR) definita a partire dalla data della prima documentazione di CR o di PR (pazienti responder) fino alla data di progressione obiettiva o alla data di morte per qualsiasi causa (a seconda di quale evento si verifichi per primo)
    ¿ Farmacocinetica (PK) di ramucirumab: Cmin dal ciclo 2 (prima della somministrazione) al ciclo 14 (prima della somministrazione)
    ¿ Numero di pazienti con anticorpi anti-ramucirumab dal ciclo 1 (prima della somministrazione) fino al follow-up
    ¿ Variazioni rispetto al basale dei parametri valutati dalla Lung Cancer Symptom Scale [LCSS]; tempo al deterioramento (TtD) per ciascuno dei 9 elementi
    ¿ Variazione rispetto al basale del questionario EuroQol a 5 dimensioni e 5 livelli (EQ-5D-5L): - Statistiche descrittive sulle 5 dimensioni, indici e calcolo della scala visuo-analogica (VAS) per ogni periodo di valutazione
    ¿ Utilizzo delle risorse: - Ricoveri, trasfusioni e farmacoterapie concomitanti durante il periodo di trattamento dello studio o durante il periodo di follow-up di breve termine della durata di 30 giorni
    E.5.2.1Timepoint(s) of evaluation of this end point
    After at least 300 OS events have been reported
    Dopo la rilevazione di almeno 300 eventi di OS
    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 Yes
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others Yes
    E.6.13.1Other scope of the trial description
    Patients reported outcomes
    Immunogenicity
    Other translational research not reported above: Immunohistochemistry
    Esiti riferiti dai pazienti
    Immunogenicit¿
    Altra ricerca traslazionale non riportata sopra: Immunoistochimica
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Yes
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other Yes
    E.7.1.3.1Other trial type description
    Phase Ib (part A of the protocol) does not take place in Italy
    La fase Ib (parte A del protocollo) non si svolge in Italia
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 Yes
    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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA29
    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
    Canada
    China
    Hong Kong
    Japan
    Korea, Republic of
    United States
    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 years5
    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 years5
    E.8.9.2In all countries concerned by the trial months4
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 330
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 220
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 105
    F.4.2.2In the whole clinical trial 550
    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 Decision2016-04-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-02-17
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Thu Apr 25 22:05:42 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA