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    Summary
    EudraCT Number:2020-002328-35
    Sponsor's Protocol Code Number:CANTABRICO
    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:2021-02-17
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2020-002328-35
    A.3Full title of the trial
    A Phase IIIB, Single Arm Study, of Durvalumab in Combination with Platinum-Etoposide for Untreated Patients with Extensive-Stage Small Cell Lung Cancer reflecting Real World Clinical Practice in Spain (CANTABRICO)
    Ensayo fase IIIB de un solo brazo, de Durvalumab en combinación con Platino-Etopósido para pacientes con cáncer de pulmón de célula pequeña en estadío extendido que no han recibido tratamiento, reflejando la práctica clínica real en España (CANTABRICO).
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase IIIB Study in Untreated Patients with Extensive-Stage Small Cell Lung Cancer
    Ensayo de fase IIIB en pacientes con cáncer de pulmón de célula pequeña en estadío extendido que no han recibido tratamiento
    A.4.1Sponsor's protocol code numberCANTABRICO
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorAstraZeneca Farmacéutica Spain, S.A
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportAstraZeneca Farmacéutica Spain, S.A
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca Farmacéutica Spain, S.A
    B.5.2Functional name of contact pointLuciana Baez
    B.5.3 Address:
    B.5.3.1Street AddressSerrano Galvache, 56
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28033
    B.5.3.4CountrySpain
    B.5.4Telephone number34650820299
    B.5.6E-mailana.moreno@apices.es
    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 holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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.3.9.1CAS number 1428935-60-7
    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 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.2.1.2Country which granted the Marketing AuthorisationSpain
    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
    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 INNCARBOPLATIN
    D.3.9.1CAS number 41575-94-4
    D.3.9.3Other descriptive nameCARBOPLATIN
    D.3.9.4EV Substance CodeSUB06614MIG
    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 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 No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.IMP: 3
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameCisplatin
    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 INNCisplatin
    D.3.9.1CAS number 15663-27-1
    D.3.9.4EV Substance CodeSUB07483MIG
    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 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 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.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameEtoposide
    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 INNETOPOSIDE
    D.3.9.1CAS number 33419-42-0
    D.3.9.3Other descriptive nameETOPOSIDE
    D.3.9.4EV Substance CodeSUB07337MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number20
    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 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 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
    Extensive-Stage Small Cell Lung Cancer
    Cáncer de pulmón de célula pequeña en estadío extendido
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Cáncer de pulmón
    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 10041068
    E.1.2Term Small cell lung cancer extensive stage
    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 describe safety profile of durvalumab in combination with platinum–etoposide as first-line treatment for patients with ES-SCLC
    Describir el perfil de seguridad de durvalumab en combinación con Platino-Etopósido como tratamiento de primera línea para pacientes con cáncer de pulmón de célula pequeña en estadío extendido.
    E.2.2Secondary objectives of the trial
    - To describe effectiveness of durvalumab in combination with platinum–etoposide as first-line treatment for patients with ES-SCLC.

    - To describe the impact of durvalumab in combination with platinum–etoposide as first-line treatment for patients with ES-SCLC on patients’ disease-related symptoms and Health Related Quality of Life (HRQoL) and (PROs).

    - To describe health care resources use related to management of ES-SCLC patients treated with durvalumab in combination with platinum–etoposide as first-line treatment.

    - To describe immune & biological characteristics of populations, basal, at the beginning of maintenance and at progression
    - Describir la efectividad de durvalumab en combinación con Platino-Etopósido como tratamiento de primera línea para pacientes con cáncer de pulmón de célula pequeña en estadío extendido (CPCP-EE)

    - Describir el impacto de durvalumab en combinación con Platino-Etopósido como tratamiento de primera línea para pacientes con CPCP-EE en los síntomas relacionados con la enfermedad de los pacientes y en la calidad de vida relacionada con la salud (CdVRS) y (PROs).

    - Describir el uso de los recursos para el cuidado de la salud relacionados con la gestión de pacientes con CPCP-EE tratados con durvalumab en combinación con Platinoetopósido como tratamiento de primera línea

    - Describir las características inmunológicas y biológicas de la población en visita basal, al principio del mantenimiento y a la progresión
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    1. Discovery of biomarkers to predict benefit from chemoimmunotherapy in sclc using digital spatial profiling. 04/Jan/2021, V 1.0

    Primary objective:
    To identify spatially-resolved protein and RNA markers that predict sensitivity to chemotherapy plus PD-1 axis blockade in SCLC.

    Secondary objectives:
    - To describe the composition and functional orientation of the tumor immune microenvironment of human SCLC in spatial context
    - To identify SCLC subtype-specific differences in the immune microenvironment features


    2. Determination of circulating leukocyte-platelet complexes & PD-L1 expression on circulating cells in patients with advanced SCLC patients receiving durvalumab in combination with platinum and etoposide. 04/Jan/2021, V 1.0

    OBJECTIVES
    1. To correlate toxicity and efficacy of durvalumab in combination with platinum and etoposide with circulating leukocyte-platelet complexes, soluble levels of immune checkpoints and the expression of immune checkpoints on circulating leucocytes.
    2. To analyze the presence of circulating immune modulatory leukocytes and anti-inflammatory molecules in patients with advance SCLC treated with durvalumab in combination with platinum and etoposide and their relation with the toxicity and efficacy.
    1. Descubrimiento de biomarcadores para predecir el beneficio de la quimioinmunoterapia en el CPCP utilizando perfiles espaciales digitales. 04/Ene/2021, V 1.0

    Objetivo principal:
    Identificar marcadores proteicos y de ARN de resolución espacial que predigan la sensibilidad a la quimioterapia más el bloqueo del eje PD-1 en el CPCP.

    Objetivos secundarios:
    - Describir la composición y orientación funcional del microambiente inmunológico tumoral del CPCP humano en el contexto espacial
    - Identificar las diferencias específicas del subtipo de CPCP en las características del microambiente inmunológico


    2. Determinación de los complejos leucocitarios plaquetarios circulantes y la expresión de PD-L1 en las células circulantes de pacientes con CPCP avanzado que reciben durvalumab en combinación con platino y etopósido. 04/Ene/2021, V 1.0

    OBJETIVOS
    1. Correlacionar la toxicidad y eficacia de durvalumab en combinación con platino y etopósido con los complejos leucocitarios plaquetarios circulantes, los niveles solubles de los puntos de control inmunológicos y la expresión de los puntos de control inmunológicos en los leucocitos circulantes.
    2. Analizar la presencia de leucocitos inmunomoduladores circulantes y moléculas antiinflamatorias en pacientes con CPCP avanzado tratados con durvalumab en combinación con platino y etopósido y su relación con la toxicidad y eficacia.
    E.3Principal inclusion criteria
    1. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
    2. Provision of signed and dated, written informed consent obtained from the patient/legal representative prior to performing any protocol-related procedures. The ICF process is described in Appendix A 3.
    3. Male or female ≥18 years at the time of screening.
    4. Patients must have histologically- or cytologically-documented extensive-stage SCLC (stage IV [T any, N any, M1a/b/c] or with T3-4 due to multiple lung nodules that are too extensive or have tumor/nodal volume that is too large to be encompassed in a tolerable radiation plan, according to American Joint Committee on Cancer Stage, 8th edition).
    a. Patients who had received chemoradiotherapy for LS-SCLC and have experienced a treatment-free interval of at least 6 months since last chemotherapy, radiotherapy, or chemoradiotherapy cycle, can be included under investigator criteria.
    b. Patients may be included if they either do not have brain metastases, or have brain metastases that are asymptomatic, or have brain metastases that have been treated at least 2 weeks prior to study treatment and are currently receiving 10 mg/day or less of prednisone or equivalent. Patients with suspected brain metastases at screening should have a CT/MRI of the brain prior to enrollment.
    5. Patients must be considered suitable to receive a platinum-based chemotherapy regimen as 1st line treatment for ES-SCLC. Chemotherapy must contain either cisplatin or carboplatin in combination with etoposide.
    6. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-2 at enrolment/
    a. Note: a maximun of 30% of total patients with PS2 will be allowed; once this limit is met, additional enrolled patients must have PS 0-1.
    7. At least 1 lesion, not previously irradiated, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have a short axis ≥15 mm) with computed tomography (CT) or magnetic resonance imaging (MRI) and that is suitable for accurate repeated measurements as per RECIST 1.1 guidelines.
    8. No prior exposure to immune-mediated therapy for cancer including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 (anti-PD-L2) antibodies.
    9. Adequate hematologic and organ function, defined by the following laboratory results obtained within 14 days prior to first Durvalumab dose:

    a. ANC ≥ 1500 cells/μL without granulocyte colony-stimulating factor support
    b. Platelet count ≥ 100,000/μL without transfusion
    c. Hemoglobin ≥ 9.0 g/dL
    d. INR or aPTT ≤ 1.5 × upper limit of normal (ULN); This applies only to patients who are not receiving therapeutic anticoagulation; patients receiving therapeutic anticoagulation should be on a stable dose.
    e. AST and ALT ≤ 2.5 × ULN, with the following exceptions: Patients with documented liver metastases: AST and/or ALT ≤ 5 × ULN; Patients with documented liver or bone metastases: alkaline phosphatase ≤ 5 × ULN.
    f. Serum bilirubin ≤ 1.5 × ULN; Patients with known Gilbert disease who have serum bilirubin level ≤ 3 × ULN may be enrolled.
    g. Measured or calculated creatinine clearance: >60mL/min for patients on cisplatin and >45mL/min for patients on carboplatin, as determined by Cockcroft-Gault (using actual body weight)

    10. Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 90 days after the last dose of study treatment.For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures.
    11. Life expectancy of at least 12 weeks.
    1. Ser capaz de dar el consentimiento informado firmado, el cual incluye el cumplimiento de los requerimientos y restricciones listados en el formulario de consentimiento informado (CI) y el protocolo.
    2. Obtención del consentimiento informado firmado y fechado por el paciente/representante legal antes de realizar cualquier procedimiento relacionado con el protocolo. El proceso del CI se describe en el apéndice A 3 del protocolo.
    3. Hombre o mujer ≥ 18 años en el momento del screening
    4. Los pacientes deben tener cáncer de pulmón de célula pequeña en estadío extendido confirmado por histológica o citología (estadío 4 [cualquier T, cualquier N, M1a/b/c] o con T3-4 debido a múltiples nódulos pulmonares que sean demasiado amplios o que tengan un volumen tumoral/nodular demasiado grande para ser englobados en un plan de radiación tolerable, según el American Joint Committee on Cancer Stage, 8ª edition).
    a. Pacientes que hayan recibido quimio-radioterapia para cáncer de pulmón de célula pequeña en estadío extendido y que hayan experimentado un intervalo libre de tratamiento de al menos 6 meses desde el último ciclo de quimioterapia, radioterapia o quimioradioterapia, pueden ser incluidos a criterio del investigador.
    b. Los pacientes pueden ser incluidos si no tienen metástasis cerebrales o si tienen metástasis cerebrales asintomáticas, o si tienen metástasis cerebrales que han sido tratadas al menos 2 semanas antes del tratamiento del estudio y están recibiendo actualmente 10 mg/día o menos de prednisona o equivalente. Los pacientes con sospecha de metástasis cerebrales durante el estudio deben hacerse un TC/RM cerebral antes de su participación.
    5. Los pacientes deben ser considerados adecuados para recibir un régimen de quimioterapia basada en platino como primera línea de tratamiento para CPCP-EE. La quimioterapia debe contener cisplatino o carboplatino en combinación con etopósido.
    6. Estado funcional de la Organización Mundial de la Salud (OMS)/Eastern Cooperative Oncology Group (ECOG) de 0-2 en el momento del reclutamiento
    a. Nota: se permitirá un máximo del 30% del total de pacientes con PS2; una vez que se alcance este límite, los pacientes adicionales que se recluten deberán tener PS 0-1.
    7. Al menos una lesión, no irradiada previamente, que pueda medirse con precisión en la visita basal ≥10 mm en el diámetro mayor (excepto los ganglios linfáticos, cuyo diámetro menor será ≥15 mm) con tomografía computerizada (TC) o resonancia magnética (RM) y que sea adecuada para mediciones repetidas precisas según los criterios RECIST 1.1.
    8. Que no haya habido una exposición previa a terapia inmunológica para el cáncer, incluyendo, pero no limitado a, otros anticuerpos anti-CTLA-4, antiPD-1, anti-PD-L1, y anti-PD-L2.
    9. Adecuada función hematológica y orgánica, definidas por las determinaciones de laboratorio realizadas en los 14 días previos a la administración de la primera dosis de Durvalumab:

    a. Recuento absoluto de neutrófilos ≥ 1.500/mm3 sin haber recibido factor estimulante de colonias de granulocitos.
    b. Recuento de plaquetas ≥ 100.000/mm3 sin transfusión.
    c. Hemoglobina ≥ 9 g/dL.
    d. INR o aPTT ≤ 1,5 X el límite superior normal (LSN). Esto solo aplica a aquellos pacientes que no estén recibiendo anticoagulación terapéutica; pacientes que estén recibiendo anticoagulación terapéutica deben recibir una dosis estable.
    e. ALT y AST ≤ 2.5 × LSN, con las siguientes excepciones: pacientes con afectación de metástasis hepáticas: ALT y AST ≤ 5 × LSN; Pacientes con afectación de metástasis óseas o hepáticas: Fosfatasa alcalina ≤ 5 × LSN.
    f. Bilirrubina sérica ≤ 1,5 × LSN; Pacientes con enfermedad de Gilbert conocida que tengan Bilirrubina sérica ≤ 3 × LSN pueden ser reclutados.
    g. Medición o cálculo del aclaramiento de creatinina >60mL/min para pacientes con cisplatino y >45mL/min para pacientes con carboplatino, determinado por Cockcroft-Gault (usando el peso corporal real)

    10. Evidencia de estado postmenopáusico o prueba de embarazo en orina o suero negativa para mujeres premenopáusicas. Se considerará que una mujer es postmenopáusica si ha estado amenorreica durante 12 meses sin una causa médica alternativa. Para las mujeres con potencial reproductivo: acuerdo para mantener la abstinencia (abstenerse de relaciones heterosexuales) o utilizar métodos anticonceptivos que resulten en una tasa de fracaso de < 1% por año durante el período de tratamiento y al menos 90 días después de la última dosis del tratamiento de estudio. Para los hombres: acuerdo para mantener la abstinencia (abstenerse de relaciones heterosexuales) o utilizar medidas anticonceptivas.
    11. Expectativa de vida de al menos 12 semanas.
    E.4Principal exclusion criteria
    1. History of allogeneic organ transplantation.
    2. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease). The following are exceptions to this criterion:

    a. Patients with vitiligo or alopecia
    b. Patients with hypothyroidism (e.g., following Hashimoto syndrome) stable on hormone replacement
    c. Any chronic skin condition that does not require systemic therapy
    d. Patients with celiac disease controlled by diet alone
    Note: Patients without active disease in the last 5 years may be included but only after consultation with AstraZeneca.

    3. History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
    4. 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, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with treatment requirements or compromise the ability of the patient to give written informed consent.
    5. Malignancies other than SCLC within 3 years prior to screening if the patient has no evidence of disease, with the exception of those with a negligible risk of metastasis or death (e.g., expected 5-year OS > 90%) treated with expected curative outcome.
    6. History of leptomeningeal carcinomatosis.
    7. History of active primary immunodeficiency.
    8. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result), hepatitis C, or human immunodeficiency virus (positive HIV 1 / 2 antibodies).
    a. NOTE: Patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
    9. Has a paraneoplastic syndrome (PNS) of autoimmune nature, requiring systemic treatment (systemic steroids or immunosuppressive agents) or has a clinical symptomatology suggesting worsening of PNS.
    10. Known allergy or hypersensitivity to Durvalumab (IMFINZI), etoposide, carboplatin, cisplatin, or any of their excipients.
    11. Medical contraindication to etoposide-platinum (carboplatin or cisplatin)-based chemotherapy
    12. Has received prior systemic treatment for ES-SCLC.
    13. Planned consolidation chest radiation therapy.
    14. Receipt of live attenuated vaccination within 30 days prior to the first dose of Durvalumab (IMFINZI). Note: Patients, if enrolled, should not receive live vaccine whilst receiving Durvalumab (IMFINZI) and up to 30 days after the last dose of Durvalumab (IMFINZI).
    15. Major surgical procedure (as defined by the treating physician) within 28 days prior to the first dose of Durvalumab (IMFINZI). Note: Local surgery of isolated lesions for palliative intent is acceptable.
    16. Prior exposure to any immune-mediated therapy, including, but not limited to, anti-CTLA-4, anti-PD-1, anti-PD-L1, or anti-PD-L2 antibodies, including Durvalumab/(IMFINZI).
    17. Current or prior use of immunosuppressive medication within 14 days before the first dose of Durvalumab (IMFINZI). The following are exceptions to this criterion:

    a. Intranasal, inhaled, topical steroids or local steroid injections
    b. Systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or its equivalent
    c. Systemic steroid administration required as premedication for hypersensitivity reactions (eg, CT scan premedication), or as premedication for chemotherapy is allowed.

    18. Participation in another clinical study with an IP during the last 4 weeks.
    19. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study.
    20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
    21. Female patients who are pregnant or breast-feeding, or male or female patients of reproductive potential who are not willing to employ an effective method of birth control from screening to 90 days after the last dose of Durvalumab (IMFINZI).
    22. Any condition that, in the opinion of the treating physician, would interfere with evaluation of the Program drug or interpretation of patient safety.
    1. Historial de trasplante alogénico de órganos.
    2. Desórdenes autoinmunes o inflamatorios activos o previos (incluyendo enfermedad inflamatoria intestinal).Las siguientes son excepciones a este criterio:

    a. Pacientes con vitíligo o alopecia.
    b. Pacientes con hipotiroidismo estable con remplazo hormonal (por ejemplo, después del síndrome de Hashimoto).
    c. Cualquier enfermedad crónica de la piel que no requiera terapia sistémica.
    d. Pacientes con enfermedad celiaca controlada solo con dieta.
    Nota: Pacientes sin enfermedades activas en los últimos 5 años pueden ser incluidos pero solo después de consultarlo con AstraZeneca.

    3. Historial de fibrosis idiopática pulmonar neumonía organizada (por ejemplo, bronquiolitis obliterante), neumonitis inducida por fármacos, neumonitis idiopática o evidencia de neumonitis activa en una tomografía computarizada de tórax.
    4. Enfermedades intercurrentes no controladas, incluidas, entre otras, las infecciones continuas o activas, la insuficiencia cardíaca congestiva sintomática, la hipertensión no controlada, la angina de pecho inestable, la arritmia cardíaca, la enfermedad pulmonar intersticial, las afecciones gastrointestinales crónicas graves asociadas con la diarrea o las enfermedades psiquiátricas/situaciones sociales que limitarían el cumplimiento de los requisitos de tratamiento o comprometerían la capacidad del paciente para dar su consentimiento informado por escrito.
    5. Neoplasias malignas distintas del CPCP en los tres años anteriores al estudio si el paciente no tiene pruebas de la enfermedad, con la excepción de las que tienen un riesgo mínimo de metástasis o muerte (por ejemplo, una SG esperada a los 5 años > 90% ) que han recibido tratamiento curativo.
    6. Historial de carcinomatosis leptomeníngea.
    7. Historial de inmunodeficiencia primaria activa.
    8. Infección activa incluyendo tuberculosis (evaluación clínica que incluye historia clínica, examen físico y hallazgos radiográficos, y pruebas de tuberculosis según la práctica local), hepatitis B (resultado positivo conocido del antígeno de superficie del VHB (HBsAg)), la hepatitis C, o el virus de la inmunodeficiencia humana (anticuerpos positivos del VIH 1/2).
    a. NOTA: Los pacientes con una infección de VHB pasada o resuelta (definida como la presencia de anticuerpo principal de la hepatitis B [anti-HBc] y la ausencia de HBsAg) son elegibles. Los pacientes positivos para el anticuerpo de la hepatitis C (VHC) son elegibles sólo si la reacción en cadena de la polimerasa es negativa para el ARN del VHC.
    9. Síndrome paraneoplásico (SPN) de naturaleza autoinmune, que requiera tratamiento sistémico (esteroides sistémicos o agentes inmunosupresores) o sintomatología clínica que sugiere un agravamiento del SPN.
    10. Hipersensibilidad o alergia conocida al Durvalumab (IMFINZI), etopósido, carboplatino, cisplatino o cualquiera de sus excipientes.
    11. Contraindicación médica a la quimioterapia basada en Platino-Etopósido (carboplatino o cisplatino).
    12. Tratamiento sistémico previo para Cáncer de pulmón de célula pequeña en estadío extendido.
    13. Radioterapia torácica de consolidación planificada.
    14. Recepción de la vacuna viva atenuada dentro de los 30 días anteriores a la primera dosis de Durvalumab (IMFINZI).
    15. Procedimiento quirúrgico mayor (a criterio del investigador) dentro de los 28 días previos a la primera dosis de Durvalumab (IMFINZI).
    16. Exposición previa a cualquier tratamiento inmunológico, incluyendo, pero no limitado a, anticuerpos anti-CTLA-4, anti-PD-1, anti-PD-L1, o anti-PD-L2, incluyendo Durvalumab/(IMFINZI).
    17. Uso actual o previo de medicación inmunosupresora dentro de los 14 días anteriores a la primera dosis de Durvalumab (IMFINZI). Las siguientes son excepciones a este criterio:

    a. Esteroides tópicos intranasales, inhalados o inyecciones de esteroides locales.
    b. Corticoesteroides sistémicos a dosis fisiológicas, que no deben exceder los 10 mg/día de prednisona, o su equivalente.
    c. Se requiere la administración de esteroides sistémicos como premedicación para las reacciones de hipersensibilidad (por ejemplo, premedicación para la tomografía computarizada), o como premedicación para la quimioterapia.

    18. Participación en otro estudio clínico con un medicamento en investigación durante las últimas 4 semanas.
    19. Participación simultánea en otro estudio clínico, a menos que se trate de un estudio clínico observacional.
    20. Participación en la planificación y/o realización del estudio (se aplica tanto al personal de AstraZeneca como al personal del centro participante).
    21. Mujeres embarazadas o en periodo de lactancia, o varones o mujeres con potencial reproductivo que no están dispuestos a emplear un método anticonceptivo eficaz .
    22. Cualquier condición que, en opinión del investigador, interferiría con la evaluación del medicamento del estudio o la interpretación de la seguridad del paciente.
    E.5 End points
    E.5.1Primary end point(s)
    - Incidence of grade ≥ 3 AEs
    - Incidence of imAE
    - Incidencia de acontecimientos adversos ≥ grado 3
    - Incidencia de acontecimientos adversos inmunomediados
    E.5.1.1Timepoint(s) of evaluation of this end point
    - From screening until 3 months after end of study treatment
    - From screening until 3 months after end of study treatment
    - Desde la visita basal hasta 3 meses después de la finalización del tratamiento
    - Desde la visita basal hasta 3 meses después de la finalización del tratamiento
    E.5.2Secondary end point(s)
    1. Progression Free Survival (PFS).
    2. PFS rate at 6 months and at 1 year (PFS6, PFS12).
    3. Objetive Response Rate (ORR): using site investigator assessments according to RECIST 1.1.
    4. Duration of Response (DoR).
    5. DoR at 1 year (DoR12)
    6. Time to Treatment Discontinuation (TTD).
    7. Overal Survival (OS).
    8. The OS rate at 6, 12 and 18 months.
    9. Changes in vital signs, physical findings, and clinical laboratory results during and following study treatment administration
    10. Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 items (EORTC QLQ-C30).
    11. Change from baseline in European Organisation for Research and Treatment of Cancer Quality of Life. Questionnaire-Lung Cancer 13 (EORTC QLQ-LC13).
    12. Changes from baseline in PRO-CTCAE.
    13. Biomarker analysis of tumour tissue sample at baseline and at progression to assess exploratory markers, which may include but is not limited to PD-L1 expression
    14. Biomarker analysis of blood samples at basal, at maintenance initiation and at progression, which may include but are not limited to, ctDNA, immune cell gene expression profiles within the peripheral compartment, MET, etc.
    1. Supervivencia libre de progresión (SLP).
    2. SLP a los 6 meses y al año (SLP6, SLP12).
    3. Tasa de respuesta global (TRG): Evaluada por los investigadores de los centros según el RECIST 1.1.
    4. Duración de la Respuesta (DoR).
    5. DoR al año (DoR12)
    6. Tiempo hasta la interrupción del tratamiento (TIT).
    7. Supervivencia global (SG).
    8. SG a los 6, 12 y 18 meses.
    9. Cambios en los signos vitales, hallazgos físicos y resultados de laboratorio durante y a lo largo de la administración del tratamiento de estudio.
    10. Cambio en el cuestionario de la Organización Europea para la Investigación y el Tratamiento del Cáncer desde la visita basal de 30 items (EORTC QLQ-C30).
    11. Cambio desde la visita basal en el cuestionario de la Organización Europea para la Investigación y el Tratamiento del Cáncer de Calidad de Vida. Cuestionario-Cáncer de pulmón 13 (EORTC QLQLC13).
    12. Cambios desde visita basal en el cuestionario PRO-CTCAE
    13. Análisis de biomarcadores de la muestra de tejido tumoral en la visita basal y en la progresión para evaluar los marcadores exploratorios que incluyen, entre otros, la expresión de PD-L1.
    14. Análisis de biomarcadores de muestras de sangre de la visita basal, del inicio del tratamiento y de la progresión que pueden incluir, entre otros, el ADN tumoral circulante, los perfiles de expresión génica de las células inmunitarias dentro del compartimento periférico, MET, etc.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Every 12 weeks until disease progression
    2. Every 12 weeks until disease progression.
    3. Every 12 weeks until disease progression.
    4. Every 12 weeks until disease progression.
    5. Every 12 weeks until disease progression.
    6. Every 4 weeks until end of treatment.
    7. Every 8 weeks until end of treatment.
    8. Every 8 weeks until disease progression.
    9. Day 1 of every cycle during study treatment
    10. Day 1 of every cycle during study treatment
    11. Day 1 of every cycle during study treatment
    12. Day 1 of every cycle during study treatment
    13. At Baseline and at progression.
    14. At baseline, start of maintenance treatment and at progression.
    1. Cada 12 semanas hasta progresión de la enfermedad.
    2. Cada 12 semanas hasta progresión de la enfermedad .
    3. Cada 12 semanas hasta progresión de la enfermedad.
    4. Cada 12 semanas hasta progresión de la enfermedad.
    5. Cada 12 semanas hasta progresión de la enfermedad
    6. Cada 4 semanas hasta fin del tratamiento
    7. Cada 8 semanas hasta fin del tratamiento
    8. Cada 8 semanas hasta progresión.
    9. Día 1 de cada ciclo durante el tratamiento del estudio
    10. Día 1 de cada ciclo durante el tratamiento de estudio
    11. Día 1 de cada ciclo durante el tratamiento de estudio
    12. Día 1 de cada ciclo durante el tratamiento de estudio
    13. En el inicio y en la progresión.
    14. En el inicio, al comienzo del mantenimiento del tratamiento y en la progresión.
    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) No
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 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 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 concerned33
    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 No
    E.8.7Trial has a data monitoring committee No
    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
    Last visit of the last patient
    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 years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 35
    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 state85
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 85
    F.4.2.2In the whole clinical trial 85
    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
    Ninguno
    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 Decision2020-11-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-27
    P. End of Trial
    P.End of Trial StatusOngoing
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