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    Summary
    EudraCT Number:2015-003447-19
    Sponsor's Protocol Code Number:AP26113-13-301
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2016-05-17
    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 number2015-003447-19
    A.3Full title of the trial
    A Phase 3 Multicenter Open-label Study of Brigatinib (AP26113) versus Crizotinib in Patients with ALK-positive Advanced Lung Cancer
    Estudio abierto y multicéntrico en fase III de brigatinib (AP26113) frente a crizotinib en pacientes con cáncer de pulmón avanzado con ALK positiva
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 3 Multicenter Open-label Study of Brigatinib versus Crizotinib in ALK-positive Advanced Lung Cancer patients
    Estudio abierto y multicéntrico en fase 3 de brigatinib frente a crizotinib en pacientes con cancer de pulmón avanzado con ALK positiva
    A.4.1Sponsor's protocol code numberAP26113-13-301
    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 SponsorARIAD Pharmaceuticals, Inc.
    B.1.3.4CountryUnited States
    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 supportARIAD Pharmaceuticals, Inc
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationARIAD Pharmaceuticals Inc.
    B.5.2Functional name of contact pointShreya Mehta
    B.5.3 Address:
    B.5.3.1Street Address26 Landsdowne Street
    B.5.3.2Town/ cityCambridge
    B.5.3.3Post codeMA 02139
    B.5.3.4CountryUnited States
    B.5.4Telephone number1911916280
    B.5.5Fax number+1617222688
    B.5.6E-mailshreya.mehta@ariad.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 No
    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 nameBrigatinib
    D.3.2Product code AP26113
    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 INNBrigatinib
    D.3.9.1CAS number 1197953-54-0
    D.3.9.2Current sponsor codeAP26113
    D.3.9.3Other descriptive nameAP26113
    D.3.9.4EV Substance CodeSUB32682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number30
    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 No
    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 nameBrigatinib
    D.3.2Product code AP26113
    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 INNBrigatinib
    D.3.9.1CAS number 1197953-54-0
    D.3.9.2Current sponsor codeAP26113
    D.3.9.3Other descriptive nameAP26113
    D.3.9.4EV Substance CodeSUB32682
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number90
    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 RoleComparator
    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 XALKORI
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 nameCrizotinib
    D.3.2Product code Crizotinib
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCrizotinib
    D.3.9.1CAS number 877399-52-5
    D.3.9.2Current sponsor codeCrizotinib
    D.3.9.3Other descriptive nameXALKORI
    D.3.9.4EV Substance CodeSUB32267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number200
    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 RoleComparator
    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 XALKORI
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    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 nameCrizotinib
    D.3.2Product code Crizotinib
    D.3.4Pharmaceutical form Capsule, hard
    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 INNCrizotinib
    D.3.9.1CAS number 877399-52-5
    D.3.9.2Current sponsor codeCrizotinib
    D.3.9.3Other descriptive nameXALKORI
    D.3.9.4EV Substance CodeSUB32267
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number250
    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
    ALK positive Locally Advanced or Metastatic Non-small Cell Lung Cancer
    Cáncer de pulmón localmente avanzado con ALK positiva o cáncer de pulmón no microcítico mestásico
    E.1.1.1Medical condition in easily understood language
    Metastatic or locally advanced non-small cell lung cancer
    Cáncer de pulmón localmente 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 19.0
    E.1.2Level PT
    E.1.2Classification code 10059515
    E.1.2Term Non-small cell lung cancer metastatic
    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
    The objective of the study is to compare the efficacy and safety of brigatinib to that of crizotinib in ALK+ locally advanced or metastatic NSCLC patients naive to ALK inhibitors, as evidenced by PFS.
    El objetivo principal del estudio es comparar la eficacia de brigatinib frente a la de crizotinib en pacientes con CPA ALK+ localmente avanzado o metastásico que no han recibido previamente inhibidores de ALK, demostrada mediante SLP
    E.2.2Secondary objectives of the trial
    1. To compare the efficacy of brigatinib to that of crizotinib, as evidenced by confirmed ORR, time to/duration of response, disease control rate (DCR), and Overall Survival (OS)
    2. To compare the efficacy in the CNS of brigatinib to that of crizotinib, as evidenced by intracranial response and intracranial PFS in those patients with intracranial CNS metastases at baseline
    3. To assess the safety and tolerability of brigatinib in comparison with crizotinib
    4. To determine pharmacokinetic (PK) parameters of brigatinib through population PK modeling
    5. To assess patient-reported symptoms and health-related quality of life (HRQoL) with the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30 (v3.0) in patients treated with brigatinib compared to those treated with crizotinib
    1. Comparar la eficacia de brigatinib con la de crizotinib, como se demuestra por la TRO confirmada, el tiempo hasta la respuesta o la duración de la misma, tasa de control de la enfermedad (TCE) y supervivencia global (SG).
    2. Comparar eficacia en el SNC de brigatinib con la de crizotinib, como se demuestra por la respuesta intracraneal y la SLP intracraneal en los casos con metástasis intracraneales en el SNC al inicio.
    3. Evaluar seguridad y tolerabilidad de brigatinib en comparación con crizotinib.
    4. Determinar parámetros farmacocinéticos (FC) de brigatinib con un modelo de FC poblacional.
    5. Evaluar síntomas descritos por el paciente y calidad de vida relacionada con la salud utilizando el cuestionario de calidad de vida QLQ-C30 (v3.0) de la Organización Europea para Investigación y Tratamiento del Cáncer (European Organisation for Research and Treatment of Cancer, EORTC) en pacientes tratados con brigatinib comparados con los tratados con crizotinib.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Have histologically or cytologically confirmed stage IIIB (and not a candidate for definitive multimodality therapy) or stage IV NSCLC.
    2. Must have prior positive test results from an ALK test.
    3. Have sufficient tumor tissue available for central analysis.
    4. Have at least 1 measurable (i.e., target) lesion per RECIST v1.1.
    5. Recovered from toxicities related to prior anticancer therapy to NCI CTCAE v 4.0 grade < or = 1.
    6. Are a male or female patient > or = 18 years old.
    7. Have adequate organ function, as defined by the study protocol.
    8. Have Eastern Cooperative Oncology Group (ECOG) performance status <2.
    9. Have normal QT interval on screening ECG evaluation, defined as QT interval corrected (Fridericia) (QTcF) of ?450 milliseconds (msec) in males or ?470 msec in females.
    10. For female patients of childbearing potential, have a negative pregnancy test documented prior to randomization.
    11. For female and male patients who are fertile, agree to use a highly effective form of contraception, as defined by the study protocol.
    12. Provide signed and dated informed consent indicating that the patient has been informed of all pertinent aspects of the study, including the potential risks, and is willingly participating.
    13. Have the willingness and ability to comply with scheduled visit and study procedures.
    1. Tener un CPA confirmado histológica o citológicamente en estadio IIIB (y no ser candidato para un tratamiento multimodal definitivo) o estadio IV.
    2. Deben tener test previo con resultado positivo para ALK.
    3. Tener tejido tumoral disponible suficiente para el análisis central.
    4. Tener al menos 1 lesión medible (es decir, objetivo) según los criterios RECIST v1.1.
    5. Estar recuperado de las toxicidades relacionada con el tratamiento antineoplásico previo de grado < o = 1 según los CTCAE del NCI v 4.0.
    6. Ser un paciente hombre o mujer > o = 18 años de edad.
    7. Presentar una función orgánica adecuada, según el protocolo.
    8. Tener un estado funcional del Eastern Cooperative Oncology Group (ECOG) < 2
    9. Tener un intervalo QT normal en el ECG de selección, definido como un intervalo QT corregido (fórmula de Fridericia) (QTcF) ? 450 milisegundos (ms) en los hombres o ? 470 ms en las mujeres.
    10. En cuanto a las mujeres en edad fértil, debe documentarse una prueba de embarazo negativa antes de la aleatorización.
    11. En cuanto a los pacientes de ambos sexos que sean fértiles, aceptarán usar un método anticonceptivo muy eficaz con sus parejas sexuales durante su participación en el estudio.
    12. Proporcionará el consentimiento informado firmado y fechado en el que se indicará que se ha informado al paciente de todos los aspectos pertinentes del estudio, incluidos los posibles riesgos, y está dispuesto a participar.
    13. Estar dispuesto y ser capaz de cumplir las visitas y procedimientos programados del estudio.
    E.4Principal exclusion criteria
    1. Previously received an investigational antineoplastic agent for NSCLC.
    2. Previously received any prior TKI, including ALK-targeted TKIs.
    3. Previously received more than 1 regimen of systemic anticancer therapy for locally advanced or metastatic disease.
    4. Received chemotherapy or radiation within 14 days of first dose of study drug, except stereotactic radiosurgery (SRS) or stereotactic body radiation therapy (SBRT).
    5. Received anti-neoplastic monoclonal antibodies within 30 days of the first dose of study drug.
    6. Had major surgery within 30 days of the first dose of study drug, minor surgical procedures such as catheter placement or minimally invasive biopsies are allowed.
    7. Have been diagnosed with another primary malignancy other than NSCLC, except for adequately treated non-melanoma skin cancer or cervical cancer in situ; definitively treated non-metastatic prostate cancer; or patients with another primary malignancy who are definitively relapse-free with at least 3 years elapsed since the diagnosis of the other primary malignancy.
    8. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or asymptomatic disease requiring an increasing dose of corticosteroids to control symptoms within 7 days prior to randomization.
    9. Have current spinal cord compression (symptomatic or asymptomatic and detected by radiographic imaging). Patients with leptomeningeal disease and without cord compression are allowed.
    10. Be pregnant, planning a pregnancy, or breastfeeding
    11. Have significant, uncontrolled, or active cardiovascular disease, as defined by the study protocol.
    12. Have uncontrolled hypertension.
    13. Have a history or the presence at baseline of pulmonary interstitial disease, drug-related pneumonitis, or radiation pneumonitis.
    14. Have an ongoing or active infection.
    15. Have a known history of human immunodeficiency virus (HIV) infection.
    16. Have a known or suspected hypersensitivity to brigatinib or its excipients and/or crizotinib or its excipients.
    17. Have malabsorption syndrome or other gastrointestinal (GI) illness or condition.
    18. Have any condition or illness that, in the opinion of the investigator, would compromise patient safety or interfere with the evaluation of the study drug.
    1. Haber recibido previamente un fármaco antineoplásico en investigación para el CPA.
    2. Haber recibido con anterioridad cualquier TKI, incluidos los TKI dirigidos a ALK.
    3. Haber recibido con anterioridad más de 1 pauta de tratamiento antineoplásico sistémico para la enfermedad localmente avanzada o metastásica.
    4. Haber recibido quimioterapia o radioterapia en los 14 días anteriores a la primera dosis de fármaco del estudio, salvo radiocirugía estereotáctica (RCE) o radioterapia corporal estereotáctica (RCTE).
    5. Haber recibido anticuerpos monoclonales antineoplásicos en los 30 días previos a la primera dosis del fármaco del estudio.
    6. Haberse sometido a una cirugía mayor en los 30 días anteriores a la primera dosis del fármaco del estudio, pero se permiten procedimientos quirúrgicos menores como implantación de un catéter o procedimientos de biopsia mínimamente invasivos.
    7. Haber sido diagnosticado de otro neoplasia maligna primaria distinto del CPA, salvo para el tratamiento adecuado del cáncer de piel no melanoma o el cáncer cervicouterino in situ, cáncer de próstata no metastásico tratado definitivamente u otro tipo de neoplasia maligna primaria que haya recidivado después de al menos 3 años desde el diagnóstico de la otra neoplasia maligna primaria.
    8. Tener metástasis sintomáticas en el SNC (parenquimatosas o leptomeníngeas) en la selección o enfermedad asintomática que requiera aumentar la dosis de corticoesteroides para controlar los síntomas en los 7 días anteriores a la aleatorización.
    9. Tener actualmente compresión de la médula espinal (sintomática o asintomática, y detectada en el estudio radiográfico). Se permite participar a pacientes con enfermedad leptomeníngea y sin compresión medular.
    10. Estar embarazada, planear estar embarazada o en período de lactancia
    11. Sufrir enfermedad cardiovascular significativa, no controlada o activa, según se indica en el protocolo.
    12. Tener hipertensión no controlada.
    13. Tener antecedentes o presencia al inicio de enfermedad intersticial pulmonar, neumonitis relacionada con el fármaco o neumonitis por radiación.
    14. Tener una infección en curso o activa.
    15. Tener antecedentes conocidos de infección por el virus de la inmunodeficiencia humana (VIH).
    16. Tener una reacción de hipersensibilidad conocida o sospechada ante brigatinib o sus excipientes.
    17. Tener una reacción de hipersensibilidad conocida o sospechada ante crizotinib o sus excipientes.
    18. Presentar síndrome de malabsorción u otra enfermedad gastrointestinal (GI) que pudiera afectar la absorción oral del fármaco del estudio.
    19. Tener una afección o enfermedad que, en opinión del investigador, podría poner en peligro la seguridad del paciente o interferir con la evaluación del fármaco del estudio.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) as assessed by a blinded Independent Review Committee (bIRC)
    Supervivencia libre de progresión (SLP) evaluada por el Comité Independiente de Revisión del estudio (CRIE)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At least up to 36 months
    Al menos hasta el mes 36
    E.5.2Secondary end point(s)
    1. ORR
    2. Intracranial ORR
    3. Intracranial PFS
    4. OS
    5. Duration of response
    6. Time to response
    7. DCR
    8. Safety and tolerability
    9. Health Related Quality of Life (HRQoL)
    1. TRO
    2. TRO intracraneal
    3. SLP intracraneal
    4. SG.
    5. Duración de la respuesta
    6. Tiempo hasta la respuesta
    7. Tasa de control de la enfermedad
    8. Seguridad y tolerabilidad
    9. Síntomas comunicados por el paciente y puntuaciones de la CdVRS
    E.5.2.1Timepoint(s) of evaluation of this end point
    1-8. At least upto 36 months

    9. Until 30 days after the last dose of study treatment.
    1-8: Al menos hasta 36 meses
    9: Hasta 30 días tras la última dosis de tratamiento
    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 Yes
    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 Yes
    E.6.13.1Other scope of the trial description
    To evaluate exploratory biomarkers
    Evaluar biomarcadores exploratorios
    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 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
    Crizotinib
    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 concerned18
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA98
    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
    Australia
    Austria
    Belgium
    Canada
    Czech Republic
    Denmark
    Finland
    France
    Germany
    Hong Kong
    Hungary
    Italy
    Korea, Republic of
    Luxembourg
    Netherlands
    Norway
    Portugal
    Singapore
    Spain
    Sweden
    Switzerland
    Taiwan
    United Kingdom
    United States
    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
    Last visit after treatment with interventional therapy is completed prior
    to entering long term follow-up for survival.
    Última visita tras el tratamiento con terapia intervencionista que se realiza antes de entrar en la fase de seguimiento de supervivencia a largo plazo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years5
    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 years5
    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: 216
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 54
    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 state36
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 164
    F.4.2.2In the whole clinical trial 270
    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)
    Patients in the Randomized Phase will continue to be dosed with brigatinib (Arm A ) or crizotinib (Arm B) until they experience BIRC-confirmed disease progression or intolerable toxicity or are discontinued for other reasons. In certain circumstances, at the discretion of the treating investigator, therapy may continue after progressive disease has been identified.
    Patients will be followed-up for survival.
    Los pacientes aleatorizados recibirán brigatinib (brazo A) o crizotinib (brazo B) hasta que presenten enfermedad progresiva (confirmada por el comité de revisión independiente del estudio) o toxicidad no intolerable o sean discontinuados por otros motivos. En ciertas circunstancias, a discreción del investigador, el tratamiento puede continuar después de la progresión. Se hara seguimiento de supervivencia de los pacientes.
    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 Decision2016-07-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-04
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-12-21
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