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    Summary
    EudraCT Number:2018-003011-22
    Sponsor's Protocol Code Number:ETOP_14-18
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-07-05
    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 ConcernedSpain - AEMPS
    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 nonsmall cell lung cancer
    Estudio de fase II, multicéntrico, con un solo grupo que evalúa la eficacia de la inmunoterapia, la quimioterapia y la radioterapia estereotáctica en las metástasis seguida de cirugía o radioterapia definitiva en el tumor primario, en pacientes con cáncer de pulmón no microcítico con oligometástasis sincrónicas
    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
    Ensayo de fase II que evalúa la eficacia (qué tan bien funciona el tratamiento), seguridad y tolerabilidad (efectos secundarios del tratamiento) del anticuerpo durvalumab, administrado junto con quimioterapia y radioterapia estándar.
    A.3.2Name or abbreviated title of the trial where available
    CHESS
    A.4.1Sponsor's protocol code numberETOP_14-18
    A.5.4Other Identifiers
    Name:AstraZeneca Number:Number:ESR-17-13224
    Name:AstraZeneca D-code:Number: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 SponsorETOP (European 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 supportAstraZeneca
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationETOP
    B.5.2Functional name of contact pointETOP Coordinating Office
    B.5.3 Address:
    B.5.3.1Street Addressc/o IBCSG, Effingerstrasse 40
    B.5.3.2Town/ cityBern
    B.5.3.3Post code3008
    B.5.3.4CountrySwitzerland
    B.5.4Telephone number413131 511 94 00
    B.5.5Fax number413131 511 94 01
    B.5.6E-mailCHESS@etop-eu.org
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAstra Zeneca
    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 namedurvalumab
    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.3.9.3Other descriptive nameIMFINZI
    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 No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    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)
    Cáncer de pulmón no microcítico sincrónico oligometastásico
    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 de cáncer de pulmón que se llama cáncer de pulmón no microcítico (CPNM) que se disemina en algunas partes del cuerpo (oligo-metastásico)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level 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 .
    Para evaluar la SLP en pacientes con cáncer de pulmón no microcítico oligometastático sincrónico tratados con inmunoterapia de inducción, quimioterapia y radioterapia estereotáctica corporal (SBRT) a todas las metástasis, seguido de cirugía definitiva o radioterapia al tumor primario locorregional.
    E.2.2Secondary objectives of the trial
    1) To evaluate secondary measures of clinical efficacy including distant progression-free survival, 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) Evaluar medidas secundarias de eficacia clínica, incluida la supervivencia libre de progresión a distancia, la supervivencia global, el patrón de progresión de la enfermedad, la respuesta a la terapia de inducción, la respuesta general y la duración de la respuesta.
    2) Evaluar la seguridad y tolerabilidad del tratamiento.
    3) Evaluar la calidad de vida global y específica de los síntomas.
    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)
    - 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
    - ECOG 0-1
    - Availability of tumour tissue for translational research
    - Adequate haematological, renal and liver function
    - Cáncer de pulmón no microcítico histológicamente confirmado
    - Enfermedad sinagónica oligo-metastásica en estadio IV (máx. 3 metástasis a distancia, una de las cuales debe ser extra-cerebral para SBRT)
    - Resección neuroquirúrgica de una sola metástasis del SNC o laparoscópica.
    se permite la resección de una metástasis suprarrenal antes de la inclusión en el estudio (una
    metástasis extra-cerebrales deben estar disponibles para SBRT)
    - Capaz de entender y dar consentimiento informado por escrito y cumplir con los procedimientos del estudio
    - Edad ≥ 18 años.
    - ECOG 0-1
    - Disponibilidad de tejido tumoral para investigación traslacional.
    - Adecuada función hematológica, renal y hepática.
    E.4Principal exclusion criteria
    - Prior chemotherapy, radiotherapy or surgery for NSCLC
    - 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 exam 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 tuberculosis, hepatitis B, hepatitis C or human immunodeficiency virus (HIV)
    infection
    - Active autoimmune disease 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.
    - Quimioterapia previa, radioterapia o cirugía para cáncer de pulmón no microcítico
    - Activación de la mutación del driver: EGRF, ALK, ROS1.
    -> 3 metástasis a distancia
    - Metástasis cerebrales no modificables para radiocirugía o neurocirugía
    - Ubicaciones metastásicas extracraneales como ascitis maligna, pleural o pericárdica.
    derrame, linfangitiosis difusa de la piel o pulmón, metástasis difusa de la médula ósea, masas abdominales / organomegalia abdominal, identificadas mediante examen físico que no es
    Medible mediante técnicas de imagen reproducibles.
    - Cáncer de pulmón primario no adecuado para terapia radical (excluida la neumonectomía)
    - Antecedentes de carcinomatosis leptomeníngea.
    - Cirugía mayor o lesión traumática significativa de la que el paciente no ha
    Recuperado al menos 28 días antes de la inscripción.
    - Cualquier enfermedad intercurrente no controlada, que incluye pero no se limita a: en curso o activa infección, insuficiencia cardíaca congestiva sintomática, hipertensión no controlada, inestable angina de pecho, arritmia cardíaca, enfermedad pulmonar intersticial o afecciones gastrointestinales crónicas graves asociadas con diarrea, que en la investigación del investigador
    Esta opinión hace que sea indeseable que el paciente participe en el ensayo o que pone en peligro el cumplimiento del protocolo.
    - Tuberculosis activa, hepatitis B, hepatitis C o virus de inmunodeficiencia humana (VIH)
    infección
    - Enfermedad autoinmune activa que requiere tratamiento sistémico.
    - Enfermedad cardíaca grave o incontrolada que requiere tratamiento
    - Historia de la inmunodeficiencia primaria.
    - Historia del trasplante alogénico de órganos.
    - Recepción de vacunas atenuadas vivas dentro de los 30 días anteriores a la inscripción.
    - Alergias conocidas o hipersensibilidad a fármacos de prueba o a cualquier excipiente.
    - Hombres y mujeres sexualmente activos en edad fértil que no estén dispuestos a usar un método anticonceptivo eficaz durante el ensayo y hasta 90 días después de la última dosis de durvalumab.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) at 12 months
    supervivencia libre de enfermedad a los 12 meses
    E.5.1.1Timepoint(s) of evaluation of this end point
    after 12 months (±2 weeks) from start of durvalumab treatment.
    Después de 12 meses (± 2 semanas) desde el inicio del tratamiento con durvalumab.
    E.5.2Secondary end point(s)
    1) Overall survival (OS)
    2) Pattern of disease progression
    3) Response to induction therapy
    4) Distant progression-free survival
    5) Overall response (OR)
    6) Duration of response (DOR)
    7) Symptom-specific and global quality of life
    8) Toxicity before and after surgery/radiotherapy
    1) Supervivencia global (OS)
    2) Patrón de progresión de la enfermedad.
    3) Respuesta a la terapia de inducción.
    4) Supervivencia libre de progresión distante
    5) Respuesta general (OR)
    6) Duración de la respuesta (DOR)
    7) Calidad de vida global y específica de los síntomas.
    8) Toxicidad antes y después de la cirugía / radioterapia.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1) from enrolment date until death from any cause. Censoring occurs at the last follow-up date.
    2) site of first progression evaluated up to one year after enrollment.
    3) best overal response evaluated from start of treatment until end of induction phase (restaging at 3-month)
    4) development of new metastases across all timepoints
    5) from start of treatment across all time points until treatment discontinuation
    6) from date of first objective response to date of first progression or relapse
    7) at baseline; 3 weeks and 3 months after treatment start (at the time point of restaging). For patients without disease progression at restaging: before definitive local treatment and 6, 9 and 12 months after treatment start
    8) from date enrolment until 90 days after treatment discontinuation
    1) desde la fecha de inclusión hasta la muerte
    2) sitio de primera progresión evaluado hasta un año después de la inclusión
    3) la mejor respuesta general evaluada desde el inicio del tratamiento hasta el final de la fase de inducción
    4) desarrollo de nuevas metástasis
    5) desde el inicio del tratamiento en todos los puntos de tiempo hasta la interrupción del tratamiento
    6) desde la fecha de la primera respuesta objetiva hasta la fecha de la primera progresión
    7) en basal; 3 semanas y 3 meses después del inicio del tto (en el momento del reajuste). Para pacientes sin progresión de la enfermedad en el reingreso: antes del tratamiento local definitivo y 6, 9 y 12 meses después del inicio del tto
    8) desde la fecha de inclusión hasta 90 días después de la interrupción del tto
    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 Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    brazo único
    single-arm
    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.8.3 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 Yes
    E.8.5.1Number of sites anticipated in the EEA6
    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 No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Netherlands
    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
    database lock (90 days after LVLS)
    bloqueo de base de datos (90 días después de la última visita del último paciente)
    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 months11
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months11
    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 state25
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    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)
    none
    No
    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 Decision2019-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-09-26
    P. End of Trial
    P.End of Trial StatusOngoing
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