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    Summary
    EudraCT Number:2019-002869-35
    Sponsor's Protocol Code Number:CAPLAND
    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:2022-10-27
    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 number2019-002869-35
    A.3Full title of the trial
    A randomized, non-comparative, phase II study investigating the best epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sequence in advanced or metastatic non-small-cell lung cancer (NSCLC) harboring EGFR mutations
    Estudio de fase II, aleatorizado, no comparativo, en el que se investiga la mejor
    secuencia de inhibidores de la tirosina cinasa del receptor del factor de
    crecimiento epidérmico (EGFR-TKI) en el cáncer de pulmón no microcítico
    (CPNM) con mutaciones en el EGFR en estadio avanzado o metastásico
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A randomized, non-comparative, phase II study investigating the best epidermal growth factor receptor tyrosine kinase inhibitor (EGFR-TKI) sequence in advanced or metastatic non-small-cell lung cancer (NSCLC) harboring EGFR mutations
    Estudio de fase II, aleatorizado, no comparativo, en el que se investiga la mejor
    secuencia de inhibidores de la tirosina cinasa del receptor del factor de
    crecimiento epidérmico (EGFR-TKI) en el cáncer de pulmón no microcítico
    (CPNM) con mutaciones en el EGFR en estadio avanzado o metastásico
    A.4.1Sponsor's protocol code numberCAPLAND
    A.5.4Other Identifiers
    Name:CAPLANDNumber:CAPLAND
    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 SponsorFONDAZIONE RICERCA TRASLAZIONALE (FORT)
    B.1.3.4CountryItaly
    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 supportPfizer srl
    B.4.2CountryItaly
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationClinical Research Technology
    B.5.2Functional name of contact pointClinical Operations
    B.5.3 Address:
    B.5.3.1Street AddressVia San Leonardo Traversa Migliaro
    B.5.3.2Town/ citySalerno
    B.5.3.3Post code84131
    B.5.3.4CountryItaly
    B.5.4Telephone number+39089301545
    B.5.5Fax number+390897724155
    B.5.6E-mailcapland@cr-technology.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 Vizimpro 15 mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Europe MA EEIG
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product namedacomitinib
    D.3.2Product code NAP
    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 INNDacomitinib
    D.3.9.1CAS number 1110813-31-4
    D.3.9.4EV Substance CodeSUB189491
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number15
    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
    Advanced or metastatic untreated EGFR mutation positive NSCLC
    cáncer de pulmón no microcítico (CPNM) con mutaciones en el EGFR en estadio avanzado o metastásico
    E.1.1.1Medical condition in easily understood language
    Advanced or metastatic untreated EGFR mutation positive NSCLC
    cáncer de pulmón no microcítico (CPNM) con mutaciones en el EGFR en estadio avanzado o metastásico
    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 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level SOC
    E.1.2Classification code 10029104
    E.1.2Term Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    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 best drug sequencing in patients with advanced or metastatic EGFR mutation positive NSCLC. The study, including patients with classical or uncommon activating EGFR mutations, will allow to investigate the efficacy of dacomitinib or osimertinib in these patients. Patients with asymptomatic or controlled brain metastases are eligible, allowing to define efficacy of dacomitinib in this special population.
    Evaluar la mejor secuencia de medicamentos en pacientes con CPNM avanzado o metastásico y mutaciones en el gen EGFR. El estudio, en el que se incluirán pacientes con mutaciones activadores del gen EGFR, tanto habituales como poco frecuentes, permitirá investigar la eficacia de dacomitinib u osimertinib en estos pacientes. Se considerarán idóneos los pacientes con metástasis cerebrales asintomáticas o controladas, lo que permitirá definir la eficacia de dacomitinib en esta población especial.
    E.2.2Secondary objectives of the trial
    • OS in patients treated with osimertinib first followed by dacomitinib and in patients treated with dacomitinib first followed by osimertinib
    • PFS at the time of study second-line therapy failure (PFS2) in patients treated with front-line osimertinib or dacomitinib;
    • PFS in patients treated with osimertinib first or dacomitinib first;
    • Response Rate (RR) with dacomitinib or osimertinib;
    • RR, PFS and OS with osimertinib followed by dacomitinib or with the opposite sequence in patients with uncommon activating EGFR mutations;
    • RR, PFS and OS with dacomitinib given at the time of osimertinib failure;
    • Intracranial RR and intracranial PFS with dacomitinib or osimertinib
    • Safety and incidence of AEs in patients treated with osimertinib followed by dacomitinib or with the opposite sequence.
    - SG en pacientes tratados con osimertinib primero seguido de dacomitinib y en pacientes tratados con dacomitinib primero seguido de osimertinib
    - SLP en el momento del fracaso del tratamiento de segunda línea del estudio (SLP2) en pacientes tratados con osimertinib o dacomitinib en primera línea;
    - SLP en pacientes tratados con osimertinib en primera línea o dacomitinib en primera línea;
    - Tasa de respuesta (RR) con dacomitinib u osimertinib;
    - RR, SLP y SG con osimertinib seguido de dacomitinib o con la secuencia opuesta en pacientes con mutaciones activadoras del EGFR poco comunes;
    - RR, SLP y SG con dacomitinib administrado en el momento del fracaso de osimertinib;
    - RR y SLP intracraneal con dacomitinib u osimertinib
    - Seguridad e incidencia de EA en pacientes tratados con osimertinib seguido de dacomitinib o con la secuencia opuesta.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) Written informed consent;
    2) Male or female patient aged =18 years;
    3) Histologically/cytologically confirmed diagnosis of NSCLC with evidence of activating EGFR mutations including exon 19 deletion, exon 21 L858R or other activating/sensitizing EGFR mutations such as exon 21 L861Q, exon 18 G719S, G719A, G719C, exon 20 S768I and V769L; co-occurrence of de novo T790M is not an exclusion criterion; EGFR status assessed in circulating DNA is allowed;
    4) Patients with brain metastases are allowed provided they are asymptomatic and stable (i.e. without evidence of progression by imaging for at least two weeks prior to the first dose of trial treatment and without deterioration of any neurologic symptoms);
    5) No evidence of concomitant drivers including KRAS mutations, HER2 mutations, ALK or ROS1 rearrangements, MET mutations, BRAF mutations;
    6) No previous EGFR-TKI therapy; Previous palliative radiotherapy or surgery allowed.
    Previous neo/adjuvant chemotherapy is allowed as long as therapy was completed at least 6 months before diagnosis of advanced or metastatic NSCLC;
    7) At least one radiological measurable disease according to RECIST criteria version 1.1;
    8) Performance status 0-1 (ECOG PS);
    9) Patient compliance to trial procedures;
    10) Adequate bone marrow function (ANC = 1.5x109/L, platelets =100x10e9/L, haemoglobin >9 g/dl);
    11) Adequate liver function (AST (SGOT)/ALT (SGPT) =2.5 x institutional upper limit of normal unless liver metastases are present, in which case it must be =5x ULN, bilirubin < grade 2, transaminases no more than 3xULN/<5xULN in presence of liver metastases);
    12) Normal level of alkaline phosphatase, and creatinine;
    13) Female patients should be using adequate contraceptive measures, should not be breastfeeding, until 12 months after the last dose, and must have a negative pregnancy test (serum or urine) prior to first dose of study drug (within 72 hours); or female patients must have an evidence of non-child-bearing potential by fulfilling one of the following criteria at screening:
    • Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments.
    • Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution.
    • Documentation of irreversible surgical sterilisation by hysterectomy, bilateraloophorectomy, or bilateral salpingectomy but not tubal ligation.
    14) Male patients should be willing to use barrier contraception, i.e. condoms;
    15) No significant comorbidity that according to the investigator would hamper the participation on the trial;
    1) Proporcionar el consentimiento informado por escrito
    2) Pacientes de ambos sexos y al menos 18 años de edad;
    3) Diagnóstico histológico/citológico confirmado de CPNM en estadio IIIB/IV, con signos de mutaciones activadoras del EGFR, incluidas la deleción del exón 19, la mutación L858R en el exón 21 u otras mutaciones activadoras/sensibilizadoras del EGFR, como la mutación L861Q en el exón 21, la mutación G719S en el exón 18, la mutación G719A, la mutación G719C, la mutación S768I en el exón 20 y la mutación V769L; la presencia simultánea de la mutación T790M de nueva aparición no constituye un criterio de exclusión; el estado mutacional del gen EGFR puede evaluarse en el ADN circulante;
    4) Pacientes elegibles y candidatos a recibir osimertinib como tratamiento de primera o segunda línea, de acuerdo con la práctica clínica y el diseño del estudio, según determine el investigador, independientemente de la participación en el estudio;
    5) Los pacientes con metástasis cerebrales pueden participar, siempre que estén asintomáticos y estables (es decir, sin indicios de progresión de acuerdo con las pruebas de imagen al menos durante las dos semanas anteriores a la primera dosis de tratamiento del estudio, y que no presenten deterioro de ningún síntoma neurológico);
    6) Ausencia de indicios de mutaciones oncoiniciadoras concomitantes, incluidas las mutaciones en el gen KRAS, las mutaciones en el gen HER2, los reordenamientos ALK o ROS1, las mutaciones en el gen MET y las mutaciones en el gen BRAF;
    7) No haber recibido tratamiento previo con EGFR-TKI; se permite la administración previa de radioterapia o cirugía paliativa. Se permite la administración previa de radioterapia y la realización de radiocirugía estereotáctica (RCE) en el cerebro. Se permite la administración previa de quimioterapia neo/adyuvante, siempre que el tratamiento se haya completado al menos 6 meses antes del diagnóstico de CPNM avanzado o metastásico;
    8) Presentar al menos una enfermedad medible radiológicamente según los criterios RECIST, versión 1.1;
    9) Categoría funcional (ECOG) de 0 o 1;
    10) Que el paciente cumpla los procedimientos del estudio;
    11) Que el paciente presente una función adecuada de la médula ósea (RAN > o =1,5x10e9/l, plaquetas > o =100x10e9 /l, hemoglobina >9 g/dl);
    12) Que el paciente presente una función hepática adecuada (AST (SGOT)/ALT (SGPT) < o = 2,5 x límite superior de la normalidad del centro, a menos que existan metástasis hepáticas, en cuyo caso debe ser < o =5x LSN; concentración de bilirrubina < grado 2; concentración de transaminasas como máximo 3 x
    LSN / <5 x LSN en presencia de metástasis hepáticas);
    13) Concentración normal de fosfatasa alcalina y de creatinina;
    14) Las pacientes deben utilizar medidas anticonceptivas adecuadas, no deben dar el pecho hasta que hayan transcurrido 12 meses desde la última dosis, y deben presentar un resultado negativo en una prueba de embarazo (suero u orina) antes de la primera dosis del medicamento del estudio (en el transcurso de las 72 horas anteriores); o debe considerarse que las pacientes no pueden tener hijos por cumplir uno de los siguientes criterios durante la selección:
    • Mujer que haya entrado en la posmenopausia, es decir, que tenga más de 50 años y haya presentado amenorrea durante al menos 12 meses tras la interrupción de todos los tratamientos hormonales exógenos.
    • Las mujeres menores de 50 años se considerarían posmenopáusicas si han presentado amenorrea al menos durante 12 meses tras la interrupción de los tratamientos hormonales exógenos y presentan
    niveles de hormona luteinizante (LH) y de hormona folículo-estimulante (FSH) en el rango posmenopáusico de la institución.
    • Documentación de haberse sometido a una cirugía irreversible (histerectomía, ooforectomía bilateral o salpingectomía bilateral, pero no ligadura de trompas).
    15) Los pacientes masculinos deben estar dispuestos a utilizar métodos anticonceptivos de barrera, es decir, preservativo;
    16) No presentar ninguna comorbilidad significativa que, según el investigador, pueda dificultar la participación en el estudio;
    E.4Principal exclusion criteria
    1) Previous therapy with any EGFR-TKI;
    2) Previous systemic anti-cancer therapy for advanced/metastatic NSCLC including chemotherapy, biologic therapy, immunotherapy, or any investigational drug;
    3) Absence of measurable lesions;
    4) Concomitant radiotherapy or chemotherapy;
    5) Symptomatic or immediately requiring therapy brain metastases or carcinomatous meningitis. Subjects with asymptomatic and stable or treated brain metastases may participate
    6) Diagnosis of any other malignancy during the last 3 years, except for in situ carcinoma of cervix uteri and squamous cell carcinoma of the skin;
    7) History of extensive disseminated/bilateral or known presence of Grade 3 or 4 interstitial fibrosis or interstitial lung disease including a history of pneumonitis, hypersensitivity pneumonitis, interstitial pneumonia, interstitial lung disease, obliterative bronchiolitis and pulmonary fibrosis (but not history of prior radiation pneumonitis);
    8) Any evidence of severe or uncontrolled systemic diseases, including uncontrolled hypertension and active bleeding diatheses, or active infection;
    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 the study drugs;
    10) Any of the following cardiac criteria:
    • Mean resting corrected QT interval (QTc) >470 msec, obtained from 3 ECGs using local clinic ECG machine-derived QTcF value;
    • Any clinically important abnormalities in rhythm, conduction, or morphology of resting ECG, e.g., complete left bundle branch block, third-degree heart block, second degree heart block, PR interval >250 msec or history of episodes of bradycardia (<50 BPM);
    • 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;
    • Abnormal cardiac function: LVEF < 50% (assessed by MUGA or ECHO)
    11) Pregnancy or lactating female;
    12) Other serious illness or medical condition potentially interfering with the study.
    1) Haber recibido tratamiento previo con cualquier EGFR-TKI;
    2) Haber recibido un tratamiento antineoplásico sistémico para el CPNM avanzado/metastásico, incluidos quimioterapia, tratamientos biológicos, inmunoterapia o cualquier medicamento en investigación;
    3) Ausencia de lesiones medibles;
    4) Administración concomitante de radioterapia o quimioterapia;
    5) Metástasis cerebrales sintomáticas o que requieran tratamiento inmediato, o meningitis carcinomatosa. Los pacientes con metástasis cerebrales asintomáticas y estables o que hayan sido tratados podrán participar en el estudio;
    6) Diagnóstico de cualquier otra neoplasia maligna en el transcurso de los últimos 3 años, excepto el carcinoma localizado de cuello uterino y el carcinoma de células escamosas de la piel;
    7) Antecedentes de fibrosis intersticial muy diseminada/bilateral o presencia de fibrosis intersticial o de enfermedad pulmonar intersticial de grado 3 o 4, incluidos los antecedentes de neumonitis, neumonitis por hipersensibilidad, neumonía intersticial, enfermedad pulmonar intersticial, bronquiolitis obliterante y fibrosis pulmonar (no así antecedentes de neumonitis por radiación previa);
    8) Presencia de cualquier indicio de enfermedades sistémicas graves o sin controlar, incluidas la hipertensión sin controlar y la diátesis hemorrágica activa, o las infecciones activas;
    9) Náuseas y vómitos que no respondan al tratamiento, enfermedades gastrointestinales crónicas, incapacidad para deglutir el producto formulado, o resección intestinal significativa previa que impida la absorción adecuada de los medicamentos del estudio;
    10) Presentar cualquiera de los siguientes criterios cardíacos:
    • Media del intervalo QT corregido en reposo (QTc) >470 ms, determinado a partir de 3 ECG, utilizando el valor del QTcF obtenido
    con el electrocardiógrafo en una clínica local;
    • Presentar cualquier alteración clínicamente importante en el ritmo, la conducción o la morfología cardíacas de acuerdo con los resultados del ECG en reposo, por ejemplo, bloqueo completo de la rama izquierda del haz de His, bloqueo cardíaco de tercer grado, bloqueo cardíaco de
    segundo grado, intervalo PR >250 ms o antecedentes de episodios de bradicardia (<50 LPM);
    • Presentar cualquier factor que aumente el riesgo de prolongación del intervalo QTc o el riesgo de episodios arrítmicos, como insuficiencia
    cardíaca, hipopotasemia, síndrome del QT largo congénito, antecedentes familiares de síndrome de QT largo o muerte súbita
    inexplicable en familiares de primer grado menores de 40 años, o recibir de forma concomitante cualquier medicamento que se sepa que
    prolonga el intervalo QT;
    • Presentar una función cardíaca anómala: fracción de expulsión del ventrículo izquierdo (FEVI) <50 % (de acuerdo con los resultados de
    una ventriculografía nuclear o de una ecocardiografía)
    11) Mujer embarazada o en período de lactancia;
    12) Presentar otra enfermedad o problema de salud grave que pueda interferir en el estudio.
    E.5 End points
    E.5.1Primary end point(s)
    OS in patients treated with osimertinib first or dacomitinib first
    SG en pacientes que reciban tratamiento primero con osimertinib o con dacomitinib.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Continuous - Every 8 weeks
    De forma continua, cada 8 semanas
    E.5.2Secondary end point(s)
    • OS in patients treated with osimertinib first followed by dacomitinib and in patients treated with dacomitinib first followed by osimertinib
    • PFS at the time of study second-line therapy failure (PFS2) in patients treated with front-line osimertinib or dacomitinib;
    • PFS in patients treated with osimertinib first or dacomitinib first;
    • Response Rate (RR) with dacomitinib or osimertinib;
    • RR, PFS and OS with osimertinib followed by dacomitinib or with the opposite sequence in patients with uncommon activating EGFR mutations;
    • RR, PFS and OS with dacomitinib given at the time of osimertinib failure;
    • Intracranial RR and intracranial PFS with dacomitinib or osimertinib
    • Safety and incidence of AEs in patients treated with osimertinib followed by dacomitinib or with the opposite sequence.
    • SG en pacientes que reciban tratamiento primero con osimertinib y posteriormente con dacomitinib, y en pacientes que reciban tratamiento primero con dacomitinib y luego con osimertinib;
    • SSP en la fecha en la que fracase el tratamiento de segunda línea del estudio (SSP2) en pacientes que hayan recibido osimertinib o dacomitinib como tratamiento de primera línea;
    • SSP en pacientes que reciban tratamiento primero con osimertinib o con dacomitinib;
    • Tasa de respuesta (TR) con dacomitinib u osimertinib;
    • TR, SSP y SG con el tratamiento con osimertinib seguido de dacomitinib, o con la secuencia contraria, en pacientes con mutaciones activadoras del EGFR poco frecuentes;
    • TR, SSP y SG con dacomitinib, cuando este medicamento se administra cuando fracasa el tratamiento con osimertinib;
    • TR intracraneal y SSP intracraneal con dacomitinib u osimertinib;
    • Seguridad e incidencia de AA en pacientes que reciben tratamiento con osimertinib y posteriormente dacomitinib, o con la secuencia contraria.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • 24 months from LPFV
    • continuous - every 8 weeks
    • continuous - every 8 weeks
    • continuous - every 8 weeks and 24 months from LPFV
    • continuous - every 8 weeks and 24 months from LPFV
    • continuous - every 8 weeks
    • continuous
    - 24 meses de LPFV
    - continuo - cada 8 semanas
    - continuo - cada 8 semanas
    - continuo - cada 8 semanas y 24 meses a partir de LPFV
    - continuo - cada 8 semanas y 24 meses a partir de LPFV
    - continuo - cada 8 semanas
    - continuo
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    estudio no comparativo que investiga la mejor secuencia de EGFR-TKI
    non-comparative study investigating the best EGFR-TKI sequence
    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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA24
    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
    Austria
    France
    Sweden
    Spain
    Switzerland
    Germany
    United Kingdom
    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
    24 months from Last Patient First Visit
    24 meses desde la última visita del primer paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years4
    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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 89
    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
    Subject incapable of giving consent for physical reasons or reason linked to their medical condition
    Sujeto incapaz de dar su consentimiento por razones físicas o relacionadas con su condición médica
    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 170
    F.4.2.2In the whole clinical trial 189
    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)
    If a patient discontinues treatment (and/or receives a subsequent anticancer therapy) prior to radiologic progression, then the patient should still continue to be followed until confirmed objective disease progression.
    Following confirmed progression, patients should continue to be followed up for survival every 3 months (12 weeks) till 2 years from last patient first visit
    Si un paciente interrumpe el tratamiento (y/o recibe una terapia anticancerosa posterior) antes de la progresión radiológica, el paciente debe seguir siendo seguido hasta que se confirme la progresión objetiva de la enfermedad.
    Tras la confirmación de la progresión, los pacientes deben seguir siendo objeto de un seguimiento de supervivencia cada 3 meses (12 semanas) hasta 2 años después de la última visita del paciente.
    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 Decision2022-12-23
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-12-21
    P. End of Trial
    P.End of Trial StatusOngoing
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