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   43858   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:2018-001061-16
    Sponsor's Protocol Code Number:D5160C00048
    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:2018-06-21
    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 number2018-001061-16
    A.3Full title of the trial
    A Phase III, randomized, double-blind, placebo-controlled, multicenter, international study of Osimertinib as maintenance therapy in patients with locally advanced, unresectable EGFR mutation-positive Non-Small Cell Lung Cancer (Stage III) whose disease has not progressed following definitive platinum-based chemoradiation therapy (LAURA).
    Ensayo Fase III, randomizado, doble ciego, controlado con placebo, multicéntrico, internacional con Osimertinib como tratamiento de mantenimiento en pacientes con cáncer de pulmón no microcítico (estadio III) localmente avanzado e irresecable, con mutación de EGFR positiva, cuya enfermedad no ha progresado después de tratamiento definitivo con quimioradioterapia basada en platino (LAURA)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A global study to assess the effects of osimertinib following chemoradiation in patients with Stage III unresectable non-small cell lung cancer (LAURA).
    Ensayo internacional para evaluar los efectos de Osimertinib tras quimioradioterapia en pacientes con cáncer de pulmón no microcítico irresecable (LAURA)
    A.3.2Name or abbreviated title of the trial where available
    LAURA
    LAURA
    A.4.1Sponsor's protocol code numberD5160C00048
    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 AB
    B.1.3.4CountrySweden
    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 AB
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca AB
    B.5.2Functional name of contact pointClinical Trial Transparency
    B.5.3 Address:
    B.5.3.1Street AddressSödertälje
    B.5.3.2Town/ citySödertälje
    B.5.3.3Post code151 85
    B.5.3.4CountrySweden
    B.5.6E-mailClinicalTrialTransparency@astrazeneca.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 Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameAZD9291 80 mg film-coated tablet
    D.3.2Product code AZD9291
    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 INNOsimertinib mesylate
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number80
    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: 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 Tagrisso
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    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 nameAZD9291 40 mg film-coated tablet
    D.3.2Product code AZD9291
    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 INNOsimertinib mesylate
    D.3.9.1CAS number 1421373-66-1
    D.3.9.2Current sponsor codeAZD9291 mesylate
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number40
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Histologically documented non-small cell lung cancer of predominantly non-squamous pathology who present with locally advanced, unresectable (Stage III) disease, whose tumor tissue has EGFR exon 19 deletions or exon 21 (L858R) substitution mutations, either alone or in combination with other EGFR mutations, as detected by cobas® EGFR Mutation Test v2 (Roche Diagnostics) and whose disease has not progressed following definitive platinum-based chemoradiation.
    Cáncer de pulmón no microcítico histológicamente documentado de patología predominantemente no escamosa que presenta enfermedad localmente avanzada, irresecable (estadio III), cuyo tejido tumoral tiene deleciones de EGFR exón 19 o mutaciones de sustitución del exón 21 (L858R), solo o en combinación con otras mutaciones de EGFR, detectadas por cobas® EGFR Mutation Test v2 (Roche Diagnostics) y cuya enfermedad no ha progresado después de la quimioradiación definitiva basada en platino.
    E.1.1.1Medical condition in easily understood language
    Stage III EGFR mutation-positive Non-Small Cell Lung Cancer that cannot be removed by surgery (unresectable) whose disease has not worsened (progressed) following chemoradiation treatment.
    Cáncer de pulmón no microcítico positivo para la mutación en EGFR en estadio III que no puede eliminarse mediante cirugía cuya enfermedad no ha empeorado después del tratamiento de quimioradiación.
    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 10029519
    E.1.2Term Non-small cell lung cancer stage III
    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 assess the efficacy of osimertinib treatment compared with placebo as measured by progression free survival (PFS).
    Evaluar la eficacia del tratamiento con Osimertinib en comparación con un placebo, determinada mediante la supervivencia libre de progresión (SLP)
    E.2.2Secondary objectives of the trial
    1. To assess the efficacy of osimertinib treatment compared with placebo by assessment of PFS in patients with:
    EGFR Ex19del or L858R mutation
    EGFRm+ Ex19del or
    L858R detectable in plasma-derived ctDNA
    2. To assess the efficacy of osimertinib versus placebo on CNS PFS
    3. To further assess the efficacy of osimertinib compared with placebo as measured by OS, ORR, DoR, DCR and tumor shrinkage, time to death or distant metastases ( TTDM) and Time to treatment discontinuation (TTD)
    4. To further assess the efficacy of osimertinib compared to placebo post progression (as measured by Second progression free survival on a subsequent treatment (PFS2), Time to first subsequent therapy (TFST) and Time to second subsequent therapy (TSST)
    5. To assess disease-related symptoms and health-related QoL in patients treated with osimertinib compared with placebo
    6. To assess the safety and tolerability profile of osimertinib compared with placebo
    7. To assess the PK of osimertinib
    Evaluar:
    -eficacia del tratamiento con Osimertinib (Os) comparado con placebo evaluando la SLP en pacientes con Mutación Ex19del o L858R del gen del EGFR /Mutación Ex19del o L858R del gen del EGFR detectable en ADNtc derivado de plasma
    -eficacia de Os frente a placebo en relación con SLP en SNC
    - eficacia más a fondo de Os comparado con placebo medida por SGTRO, DR, TCE yreducción del tumor, Tiempo hasta muerte o hasta metástasis a distancia (THMM) yTiempo hasta suspensión del tratamiento (TST)
    -eficacia más a fondo de Os en comparación con placebo después de progresión medidos por Segunda supervivencia libre de progresión con un tratamiento subsiguiente (SLP2),Tiempo hasta primer tratamiento subsiguiente (TPTS)yTiempo hasta segundo tratamiento subsiguiente (TSTS)
    -síntomas relacionados con la enfermedad y la CdV relacionada con la salud en pacientes tratados con Os en comparación con placebo
    - perfil de seguridad y tolerabilidad de Os en comparación con placebo yFC de Os
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Male or female aged at least 18 years
    2. Patients with histologically documented NSCLC of predominantly non-squamous Pathology who present with locally advanced, unresectable (Stage III) disease (according to Version 8 of the International Association for the Study of Lung Cancer [IASLC] Staging Manual in Thoracic Oncology)
    3. The tumor harbours one of the two common EGFR mutations known to be associated with EGFR-TKI sensitivity (Ex19del, L858R), either alone or in combination with other EGFR mutations, assessed by cobas® EGFR Mutation Test v2 (Roche Diagnostics) in a CLIA certified (USA sites) or an accredited local laboratory (sites outside of the USA) or by central testing.
    4. Patients must have received either concurrent chemoradiation or sequential chemoradiation including at least 2 cycles of platinum based chemotherapy and a total dose of radiation of 60 Gy ±10% (54 to 66 Gy)
    5. Chemoradiation must be completed ≤6 weeks prior to randomization.
    6. Patients must not have had disease progression during or following definitive platinum-based, chemoradiation therapy
    7. World Health Organization (WHO) performance status of 0 or 1
    8. Life expectancy >12 weeks at Day 1
    9. Female patients who are not abstinent (in line with the preferred and usual lifestyle choice) must be using adequate contraceptive measures, must not be breast feeding, and must have a negative pregnancy test prior to first dose of study drug; or female patients must have an evidence of non-childbearing potential
    1. Hombres o mujeres de al menos 18 años
    2. Pacientes con NSCLC documentado histológicamente de patología predominantemente no escamosa que presentan enfermedad localmente avanzada, irresecable (estadio III) (según la Versión 8 de la Asociación Internacional para el Estudio del Cáncer de Pulmón [IASLC] Manual de estadificación en Oncología Torácica)
    3. El tumor alberga una de las dos mutaciones de EGFR comunes que se sabe que están asociadas con la sensibilidad a EGFR-TKI (Ex19del, L858R), ya sea solo o en combinación con otras mutaciones de EGFR, evaluadas por cobas® EGFR Mutation Test v2 (Roche Diagnostics) en un certificado de CLIA (sitios de EE. UU.) o un laboratorio local acreditado (sitios fuera de EE. UU.) o mediante pruebas centrales.
    4. Los pacientes deben haber recibido quimioradiación concurrente o quimiorradiación secuencial que incluya al menos 2 ciclos de quimioterapia basada en platino y una dosis total de radiación de 60 Gy ± 10% (54 a 66 Gy)
    5. La quimioradiación debe completarse ≤ 6 semanas antes de la aleatorización.
    6. Los pacientes no deben haber tenido progresión de la enfermedad durante o después de la terapia de quimiorradiación definitiva basada en platino
    7. Estado funcional de la Organización Mundial de la Salud (OMS) de 0 o 1
    8. Esperanza de vida> 12 semanas en el día 1
    9. Las pacientes femeninas que no son abstinentes (de acuerdo con la opción de estilo de vida preferida y habitual) deben usar medidas anticonceptivas adecuadas, no deben amamantar y deben tener una prueba de embarazo negativa antes de la primera dosis del medicamento del estudio; o pacientes femeninas deben evidenciar no tener capacidad de gestación.
    E.4Principal exclusion criteria
    1. Mixed small cell and non-small cell lung cancer histology

    2. History of interstitial lung disease (ILD) prior to chemoradiation

    3. Symptomatic pneumonitis following chemoradiation

    4. Any unresolved toxicity Common Terminology Criteria for Adverse Events (CTCAE) > Grade 2 from the prior chemoradiation therapy

    5. Any of the following cardiac criteria:
    • Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG
    • Patient with any factors that increase the risk of QTc prolongation or risk of arrhythmic events such as heart failure, hypokalaemia, congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death under 40 years of age in first-degree relatives or any concomitant medication known to prolong the QT interval and cause Torsades de Pointes

    6. Inadequate bone marrow reserve or organ function

    7. History of other malignancies, except: adequately treated non-melanoma skin cancer or lentigo maligna , curatively treated in-situ cancer, or other solid tumors curatively treated with no evidence of disease for > 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.

    8. Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses; or active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV).

    9. Refractory nausea and vomiting, chronic gastrointestinal diseases, inability to swallow the formulated product, or previous significant bowel resection that would preclude adequate absorption of osimertinib

    10. Prior treatment with any prior chemotherapy, radiation therapy, immunotherapy or investigational agents for NSCLC outside of that received in the definitive setting for Stage III disease (chemotherapy and radiotherapy in SCRT and CCRT regimens is allowed for treatment of Stage III disease).

    11. Prior treatment with EGFR-TKI therapy

    12. Major surgery as defined by the investigator within 4 weeks of the first dose of study drug.

    13. Patients currently receiving (unable to stop use prior to receiving the first dose of study treatment) medications or herbal supplements known to be strong inducers of CYP3A4 (at least 3 weeks prior to receiving the first dose of study drug).

    14. Contraindication to MRI, including but not limited to, claustrophobia, pace makers, metal implants, intracranial surgical clips and metal foreign bodies
    1. Histología mixta de cáncer de pulmón de células microcíticas y células no microcíticas

    2. Antecedentes de enfermedad pulmonar intersticial (EPI) antes de la quimiorradiación

    3. Neumonitis sintomática después de la quimiorradiación

    4. Cualquier toxicidad no resuelta Criterios de terminología común para eventos adversos (CTCAE)> Grado 2 de la terapia de quimiorradiación anterior

    5. Cualquiera de los siguientes criterios cardíacos:
    • Intervalo QT corregido en reposo (QTc)> 470 mseg, obtenido de 3 ECG
    • Cualquier anomalía clínicamente importante en el ritmo, la conducción o la morfología del ECG en reposo
    • Paciente con factores que aumentan el riesgo de prolongación del intervalo QTc o riesgo de eventos arrítmicos como fallo cardíaco, hipocalemia, síndrome congénito de QT prolongado, antecedentes familiares de síndrome de QT prolongado o muerte súbita inexplicada en parientes de primer grado menores de 40 años o cualquier medicamento concomitante que se conozca que prolonga el intervalo QT y causa Torsades de Pointes

    6. Inadecuada reserva medular ósea o función del órgano

    7. Historial de otros tumores malignos, excepto: cáncer de piel no-melanoma adecuadamente tratado o lentigo maligno, cáncer in situ tratado con intención curativa u otros tumores sólidos tratados con intención curativa sin evidencia de enfermedad durante más de 5 años después del final del tratamiento y que, en la opinión del médico tratante, no tiene un riesgo sustancial de recurrencia de la malignidad previa.

    8. Cualquier evidencia de enfermedades sistémicas graves o no controladas, incluyendo hipertensión no controlada y diatesis hemorrágicas activas; o infección activa incluyendo hepatitis B, hepatitis C y virus de inmunodeficiencia humana (VIH).

    9. Náuseas y vómitos refractarios, enfermedades gastrointestinales crónicas, incapacidad para tragar la formulación del producto o resección intestinal previa significativa que pueda impedir la absorción adecuada de Osimertinib

    10. Tratamiento previo con cualquier quimioterapia previa, radioterapia, inmunoterapia o agentes de investigación para NSCLC fuera del que se recibió en el escenario definitivo para la enfermedad en Etapa III (la quimioterapia y la radioterapia en los regímenes SCRT y CCRT están permitidos para el tratamiento de la enfermedad en Etapa III).

    11. Tratamiento previo con terapia EGFR-TKI

    12. Cirugía mayor según lo definido por el investigador dentro de las 4 semanas posteriores a la primera dosis del medicamento del estudio.

    13. Pacientes que actualmente reciben (no pueden dejar de usar antes de recibir la primera dosis del tratamiento del estudio) medicamentos o suplementos herbales conocidos por ser inductores potentes del CYP3A4 (al menos 3 semanas antes de recibir la primera dosis del medicamento del estudio).

    14. Contraindicaciones a la resonancia magnética, que incluyen pero no se limitan a claustrofobia, marcapasos, implantes metálicos, clips quirúrgicos intracraneales y cuerpos extraños metálicos.
    E.5 End points
    E.5.1Primary end point(s)
    PFS using BICR assessment according to RECIST v1.1

    Sensitivity analysis of PFS using Investigator assessment according to RECIST v1.1
    SLP utilizando la evaluación mediante RCIE conforme a los criterios RECIST v1.1
    Análisis de sensibilidad de la SLP basado en los datos evaluados por el investigador para todos los pacientes conforme a los criterios RECIST v1.1
    E.5.1.1Timepoint(s) of evaluation of this end point
    Q4 2021
    Q4 2021
    E.5.2Secondary end point(s)
    1. PFS in patients with EGFR Ex19del or L858R mutation and Patients with EGFRm+ Ex19del or L858R detectable in plasma-derived ctDNA using BICR assessment according to RECIST v1.1; Sensitivity analysis of PFS using Investigator assessment according to RECIST v1.1.
    2. Time to CNS PFS (time to the earliest of CNS progression or death) using BICR assessments according to RECIST v1.1; Cumulative incidence rate of CNS PFS by BICR at 12 and 24 months.
    3. OS, ORR, DoR, DCR and tumor shrinkage, TTDM using BICR assessments according to RECIST v1.1, Time to treatment discontinuation (TTD).
    4. Second progression free survival on a subsequent treatment (PFS2), Time to first subsequent therapy (TFST), Time to second subsequent therapy (TSST).
    5. Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 items (EORTC QLQ-C30): Change from baseline in European Organization for Research and Treatment of Cancer Quality of Life Questionnaire – Lung Cancer 13 items (EORTC QLQ-LC13).
    6. Adverse Events (graded by CTCAE v5); Clinical chemistry, hematology and urinalysis; Vital signs (pulse and blood pressure), physical examination, weight; ECG parameters; Left ventricular ejection fraction; WHO Performance Status.
    7. Trough plasma concentrations of osimertinib, and its metabolite AZ5104 If conducted, PK Parameters (CLss/F, Css, min and Css, max, AUCss) may be derived using population PK analysis and reported separately to the CSR. Data from this study may form part of a pooled analysis with data from other studies.
    1. SLP en pacientes con mutación EGFR Ex19del o L858R y pacientes con EGFRm + Ex19del o L858R detectables en ctDNA derivado de plasma mediante evaluación por RCIE conforme a los criterios RECIST v1.1
    Análisis de sensibilidad de la SLP basado en los datos evaluados por el investigador para todos los pacientes conforme a los criterios RECIST v1.1
    2. Tiempo hasta la SLP del SNC (tiempo hasta la progresión más temprana del SNC o la muerte) usando evaluaciones RCIE conforme a los criterios RECIST v1.1; Tasa de incidencia acumulada de SNC del SNC por RCIE a los 12 y 24 meses.
    3. OS, ORR, DoR, DCR y reducción tumoral, TTDM usando evaluaciones RCIE conforme a los criterios RECIST v1.1, Tiempo hasta la interrupción del tratamiento (TTD).
    4. Segunda supervivencia libre de progresión en un tratamiento posterior (PFS2), tiempo hasta la primera terapia posterior (TFST), tiempo hasta la segunda terapia subsiguiente (TSST).
    5. Cambio en el valor basal en el Cuestionario de Calidad de Vida de la Organización Europea para la Investigación y Tratamiento del Cáncer - Módulo básico, 30 items (EORTC QLQ-C30): Cambio en el valor basal en el Cuestionario de Calidad de Vida de la Organización Europea para la Investigación y Tratamiento del Cáncer .Cáncer de Pulmón 13 items (EORTC QLQ-LC13).
    6. Eventos adversos (calificados por CTCAE v5); Química clínica, hematología y análisis de orina; Signos vitales (pulso y presión arterial), examen físico, peso; Parámetros de ECG; Fracción de eyección del ventrículo izquierdo; Estado funcional de la OMS.
    7. Concentraciones plasmáticas de osimertinib y su metabolito AZ5104 Si se realizan, los parámetros PK (CLss / F, Css, min y Css, max, AUCss) pueden derivarse utilizando el análisis de PK de la población yreportarse por separado al CSR. Los datos de este estudio pueden formar parte de un análisis combinado con datos de otros estudios.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall Survival: Q4, 2025
    The rest of secondary endpoints: Q4, 2021
    Supervivencia global: Q4, 2025
    El resto de puntos finales secundarios: Q4, 2021
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Yes
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic Yes
    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 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 concerned6
    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 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
    Argentina
    China
    India
    Japan
    Korea, Republic of
    Spain
    Taiwan
    Thailand
    Turkey
    United States
    Vietnam
    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
    The end of the study is defined as the last expected visit/contact of the last patient undergoing the study.
    El final del estudio se define como la última visita / contacto esperado del último paciente que se somete al estudio.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    E.8.9.1In the Member State concerned months9
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years7
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 110
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 90
    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 Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    legally acceptable representative will provide consent on behalf of patient
    un representante legalmente aceptable dará su consentimiento en nombre del paciente
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state9
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 9
    F.4.2.2In the whole clinical trial 200
    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)
    Following discontinuation of study medication standard of care therapy as judged by the study doctor will be given. After study completion AstraZeneca will tell the study doctor which treatment those patients still receiving study medication are taking. Patients receiving osimertinib may continue to receive osimertinib at the discretion of the study doctor. Patients receiving placebo will discontinue placebo treatment and will be given standard of care therapy, as judged by the study doctor.
    Tras interrumpir la medicación del estudio,se administrará tratamiento estándar según juzgue el médico del estudio.Finalizado el estudio AstraZeneca informará al médico del estudio qué tratamiento están tomando los pacientes que aún reciben medicación del estudio.Aquellos que reciben Osimertinib (Os) pueden continuar recibiendo Os a discreción del médico del estudio.Los que reciben placebo discontinuarán el tratamiento y recibirán terapia de atención estándar, según juzgue el médico del estudio.
    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 Decision2018-09-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-08-06
    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 11:32:12 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA