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    Summary
    EudraCT Number:2018-003011-22
    Sponsor's Protocol Code Number:ETOP_14-18
    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:2021-08-17
    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 number2018-003011-22
    A.3Full title of the trial
    A multicentre single arm phase II trial assessing the efficacy of immunotherapy, chemotherapy and stereotactic radiotherapy to metastases followed by definitive surgery or radiotherapy to the primary tumour, in patients with synchronous oligo-metastatic non-small cell lung cancer.
    Studio multicentrico di fase II, a braccio singolo, per valutare l’efficacia di immunoterapia, chemioterapia e radioterapia stereotassica delle metastasi seguite da chirurgia definitiva o radioterapia del tumore primario, in pazienti affetti da carcinoma polmonare non a piccole cellule sincrono e oligometastatico.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A phase II trial assessing the efficacy (how well the treatment works), safety and tolerability (side effects of treatment) of the antibody drug durvalumab, administered together with standard chemotherapy and radiotherapy for the treatment of non-small cell lung cancer.
    Studio di fase II per valutare l'efficacia e la tollerabilità di Durvalumab somministrato con la chemioterapia standard e radioterapia nel trattamento del tumore polmonare non a piccole cellule.
    A.3.2Name or abbreviated title of the trial where available
    CHESS
    CHESS
    A.4.1Sponsor's protocol code numberETOP_14-18
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT03965468
    A.5.4Other Identifiers
    Name:AZ Number ESR-17-13224Number:AZ D-code D4191C00092
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorEUROPEAN THORACIC ONCOLOGY PLATFORM
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportASTRA ZENECA
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationISTITUTO EUROPEO DI ONCOLOGIA
    B.5.2Functional name of contact pointUFFICIO STUDI CLINICI ED ATTIVITA'
    B.5.3 Address:
    B.5.3.1Street AddressVIA RIPAMONTI 435
    B.5.3.2Town/ cityMILANO
    B.5.3.3Post code20141
    B.5.3.4CountryItaly
    B.5.4Telephone number0257489848
    B.5.6E-mailufficio.studiclinici@ieo.it
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name IMFINZI - 50 MG/ML - CONCENTRATO PER SOLUZIONE PER INFUSIONE - USO ENDOVENOSO - FLACONCINO (VETRO) 10 ML - 1 FLACONCINO
    D.2.1.1.2Name of the Marketing Authorisation holderASTRAZENECA AB
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameIMFINZI
    D.3.2Product code [MEDI4736]
    D.3.4Pharmaceutical form Concentrate for solution for injection/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.3.9.2Current sponsor codeMEDI4736
    D.3.9.4EV Substance CodeSUB176342
    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.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
    Synchronous oligo-metastatic Non-Small Cell Lung Cancer (NSCLC)
    Carcinoma polmonare non a piccole cellule sincrono e oligometastatico
    E.1.1.1Medical condition in easily understood language
    A type of lung cancer that is called Non-Small Cell Lung Cancer (NSCLC) that spread in some parts of the body (oligo-metastatic)
    Un tipo di tumore polmonare non a piccole cellule che si è diffuso in alcune parti del corpo (oligometastatico)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate PFS in synchronous oligometastatic NSCLC patients treated with induction immunotherapy, chemotherapy and stereotactic body radiation therapy (SBRT) to all metastases followed by definitive surgery or radiotherapy to the locoregional primary tumour .
    Valutare la PFS in pazienti affetti da NSCLC oligometastatico sincrono trattati con immunoterapia di induzione, chemioterapia e SBRT di tutte le metastasi seguite da chirurgia definitiva o radioterapia del tumore locoregionale primario.
    E.2.2Secondary objectives of the trial
    1) To evaluate secondary measures of clinical efficacy, overall survival, pattern of disease progression, response to induction therapy, overall response and duration of response.
    2) To assess the safety and tolerability of the treatment.
    3) To evaluate symptom-specific and global quality of life.
    1) valutare l'efficacia clinica attraverso: sopravvivenza complessiva, dinamiche di progressione della patologia, sopravvivenza libera da progressione a distanza, risposta alla terapia di induzione, risposta complessiva, durata della risposta.
    2) verificare sicurezza e tollerabilità
    3) valutare qualità della vita sintomo-specifica e globale
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Histological confirmed NSCLC
    - Synchronous oligo-metastatic stage IV disease: max 3 distant metastases, one of which must be extra-cerebral for SBRT
    - Initial mediastinal staging is recommended (except for lymph nodes <1cm on CT and PET-negative) preferably by endobronchial ultrasound (EBUS)
    - Neurosurgical resection of one single CNS metastasis or laparoscopic resection of one adrenal metastasis before study inclusion is allowed (one extra-cerebral metastass must be available for SBRT)
    - Able to understand and give written informed consent and comply with study procedures
    - Age =18 years
    - NSCLC confermato istologicamente
    - Malattia oligometastatica sincrona di stadio IV: - al massimo tre metastasi distanti, una delle quali deve essere extra-cerebrale per la SBRT
    - Stadiazione mediastinica iniziale raccomandata (ad eccezione dei linfonodi <1 cm con TAC e PET negative) preferibilmente tramite ecografia endobronchiale (EBUS)
    - Sono ammesse la resezione neurochirurgica di una singola metastasi del SNC oppure la resezione laparoscopica di una metastasi surrenale prima dell’inclusione nello studio (una metastasi extra-cerebrale deve essere disponibile per la SBRT)
    - Capacità di intendere e di fornire il consenso informato scritto nonché di rispettare le procedure previste dallo studio
    - Età =18 anni
    E.4Principal exclusion criteria
    - Prior chemotherapy, radiotherapy or therapeutical surgery for NSCLC (an exception is the resection of one single CNS or adrenal metastasis)
    - Activating driver mutation: EGRF, ALK, ROS1
    - >3 distant metastases
    - Brain metastases not amendable for radiosurgery or neurosurgery - Extracranial metastatic locations such as malignant ascites, pleural or pericardial effusion, diffuse lymphangitiosis of skin or lung, diffuse bone marrow metastasis, abdominal masses/abdominal organomegaly, identified by physical examination that is not measurable by reproducible imaging techniques.
    - Primary lung cancer not suitable for radical therapy (pneumonectomy excluded)
    - History of leptomeningeal carcinomatosis
    - Major surgery or significant traumatic injury from which the patient has not recovered at least 28 days before enrolment
    - Any uncontrolled intercurrent illness, including but not limited to: ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, interstitial lung disease or serious chronic gastrointestinal conditions associated with diarrhea, which in the investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardise compliance with the protocol
    - Active infection including tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
    - Active autoimmune disorders requiring systemic treatment
    - Severe or uncontrolled cardiac disease requiring treatment
    - History of primary immunodeficiency
    - History of allogeneic organ transplant
    - Receipt of live attenuated vaccines within 30 days prior to enrolment
    - Known allergies or hypersensitivity to trial drugs or to any excipient
    - Sexually active men and women of childbearing potential who are not willing to use an effective contraceptive method during the trial and for up to 90 days after last dose of durvalumab.
    - Precedente chemioterapia, radioterapia o chirurgia terapeutica per il NSCLC (la resezione di un’unica metastasi del SNC o surrenale è eccezionalmente ammessa
    - Mutazione driver attivante: EGRF, ALK, ROS1
    - Più di tre metastasi distanti
    - Metastasi cerebrali non eleggibili per radiochirurgia o neurochirurgia
    - Siti metastatici extracranici come ascite maligna, versamento pleurico o pericardico, linfangite diffusa cutanea o polmonare, metastasi diffuse nel midollo osseo, masse addominali / organomegalia addominale, identificati tramite visita medica ma non misurabili con tecniche di diagnostica per immagini riproducibili.
    - Neoplasia polmonare primaria non idonea alla terapia radicale (esclusa la pneumonectomia)
    - Anamnesi di carcinomatosi leptomeningea
    - Chirurgia maggiore o lesione traumatica significativa da cui il/la paziente non si sia ripreso/a almeno 28 giorni dopo l’arruolamento
    - Qualsiasi malattia intercorrente non controllata, compresi, in via non limitativa: infezione in corso o attiva, scompenso cardiaco congestizio, ipertensione non controllata, angina pectoris instabile, aritmia cardiaca, malattia polmonare
    interstiziale o gravi patologie gastrointestinali croniche associate a diarrea, che a giudizio del ricercatore possono rendere la partecipazione dallo studio inopportuna per il/la paziente o che possono compromettere l’adesione al protocollo
    - Tubercolosi attiva, infezione da epatite B, epatite C o virus dell'immunodeficienza umana (HIV)
    - Malattia autoimmune attiva che necessita di un trattamento sistemico
    - Malattia cardiaca grave e non controllata che necessita di un trattamento
    - Anamnesi di immunodeficienza primaria
    - Anamnesi di trapianto d’organo allogenico
    - Somministrazione di vaccini vivi attenuati nei 30 giorni precedenti l’arruolamento
    - Allergie o ipersensibilità note ai farmaci di studio o a qualsiasi eccipiente
    - Uomini e donne sessualmente attivi e potenzialmente fertili che rifiutano di utilizzare un metodo contraccettivo efficace durante lo studio e per i 90 giorni successivi all’assunzione dell’ultima dose di durvalumab.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival at 12 months
    Sopravvivenza libera da progressione a 12 mesi
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 12 months (±2 weeks) from start of durvalumab treatment.
    dopo 12 mesi (±2 settimane) dall'inizio del trattamento.
    E.5.2Secondary end point(s)
    Duration of response; Toxicity before and after surgery/radiotherapy; Symptom-specific and global quality of life; Response to induction therapy; Overall response (OR); Overall survival (OS); Pattern of disease progression; Distant progression-free survival
    Durata della risposta; Tossicità prima e dopo l’intervento chirurgico / la radioterapia; Qualità della vita sintomo-specifica e globale; Risposta alla terapia di induzione; Risposta complessiva; Sopravvivenza complessiva; Dinamiche di progressione della patologia; Sopravvivenza libera da progressione a distanza
    E.5.2.1Timepoint(s) of evaluation of this end point
    from date of first objective response to date of first progression or relapse; from date enrolment until 90 days after treatment discontinuation; at baseline; 3 weeks and 3 months after treatment start. For patients without disease progression at restaging: before definitive local treatment and 6, 9 and 12 months after treatment start.; best overal response evaluated from start of treatment until end of induction phase (restaging at 3-month); from start of treatment until treatment discontinuation; from enrolment date until death from any cause.; site of first progression evaluated up to one year after enrollment.; development of new metastases across all timepoints
    dalla data della prima risposta obiettiva alla data della prima progressione o ricaduta; dalla data di arruolamento e fino a 90 giorni dopo la fine del trattamento; A tempo 0, a 3 settimane e a 3 mesi dall'inizio del trattamento. Per pazienti senza progressione di malattia al momento della ristadiazione, prima del trattamento locale definitivo e a 6, 9 e 12 mesi dopo l'inizio del trattamento.; migliore risposta complessiva valutata dall'inizio del trattamento fino al termine della fase di induzione; dall'inizio fino all'interruzione del trattamento; dall'arruolamento nello studio fino alla data di morte da qualsiasi causa; primo sito in progressione valutato fino a 1 anno dopo l'arruolamento; sviluppo di nuove metastasi nel corso dello studio
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    Studio a singolo braccio in aperto
    Sigle arm open trial
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA9
    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
    Italy
    Netherlands
    Spain
    Switzerland
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months5
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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: 27
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 20
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 41
    F.4.2.2In the whole clinical trial 47
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Standard assistance programs
    Programmi standard di assistenza
    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 Opinion2021-06-24
    P. End of Trial
    P.End of Trial StatusOngoing
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