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    Summary
    EudraCT Number:2017-004781-94
    Sponsor's Protocol Code Number:DS8201-A-U204
    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:2018-07-17
    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 number2017-004781-94
    A.3Full title of the trial
    A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC)
    ESTUDIO EN FASE II, MULTICÉNTRICO, ABIERTO, DE 2 COHORTES DE TRASTUZUMAB DERUXTECÁN (DS-8201A), UN CONJUGADO ANTICUERPO-FÁRMACO (CAF) ANTI-HER2 PARA EL CÁNCER DE PULMÓN NO MICROCÍTICO (CPNM) IRRESECABLE Y/O METASTÁSICO CON MUTACIÓN O SOBREEXPRESIÓN DE HER2
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase 2, Multicenter, Open-Label, 2-Cohort Study of Trastuzumab Deruxtecan (DS-8201a), an Anti-HER2 Antibody Drug Conjugate (ADC), for HER2-Over-Expressing or -Mutated, Unresectable and/or Metastatic Non Small Cell Lung Cancer (NSCLC)
    ESTUDIO EN FASE II, MULTICÉNTRICO, ABIERTO, DE 2 COHORTES DE TRASTUZUMAB DERUXTECÁN (DS-8201A), UN CONJUGADO ANTICUERPO-FÁRMACO (CAF) ANTI-HER2 PARA EL CÁNCER DE PULMÓN NO MICROCÍTICO (CPNM) IRRESECABLE Y/O METASTÁSICO CON MUTACIÓN O SOBREEXPRESIÓN DE HER2
    A.4.1Sponsor's protocol code numberDS8201-A-U204
    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 SponsorDAIICHI SANKYO, 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 supportDaiichi Sankyo Inc.
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationDaiichi Sankyo Inc.
    B.5.2Functional name of contact pointnot applicable
    B.5.3 Address:
    B.5.3.1Street Address211 Mount Airy Road
    B.5.3.2Town/ cityBasking Ridge
    B.5.3.3Post codeNJ 07920
    B.5.3.4CountryUnited States
    B.5.4Telephone number+34916307447
    B.5.6E-maileu_cta@dsi.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 nameDS-8201a
    D.3.4Pharmaceutical form Powder for solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNtrastuzumab deruxtecan
    D.3.9.2Current sponsor codeDS-8201a
    D.3.9.3Other descriptive nameAnti-HER2 antibody-drug conjugate
    D.3.9.4EV Substance CodeSUB188940
    D.3.10 Strength
    D.3.10.1Concentration unit mg/kg milligram(s)/kilogram
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number6.4
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    HER2-over-expressing or -mutated, unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC)
    Cáncer de pulmón no microcítico (CPNM) no epidermoide irresecable y/o metastásico con mutación o sobreexpresión de HER2
    E.1.1.1Medical condition in easily understood language
    Certain types of lung cancer
    Ciertos tipos de cáncer de pulmón
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001246
    E.1.2Term Adenosquamous cell lung cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10029514
    E.1.2Term Non-small cell lung cancer NOS
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001255
    E.1.2Term Adenosquamous cell lung cancer stage unspecified
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001253
    E.1.2Term Adenosquamous cell lung cancer stage IIIB
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10001252
    E.1.2Term Adenosquamous cell lung cancer stage IIIA
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10066490
    E.1.2Term Progression of non-small cell lung cancer
    E.1.2System Organ Class 100000004864
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10079440
    E.1.2Term Non-squamous non-small cell lung cancer
    E.1.2System Organ Class 100000004864
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective is to evaluate the objective response rate (ORR) of trastuzumab deruxtecan in HER2-over-expressing and/or –HER2 mutated advanced NSCLC subjects.
    El objetivo principal es evaluar la tasa de respuesta objetiva (TRO) de trastuzumab deruxtecán en sujetos con CPNM avanzado con sobreexpresión o mutación de HER2.
    E.2.2Secondary objectives of the trial
    Secondary Objectives:
    The secondary objectives are:
    • To evaluate duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS)
    • To further evaluate the safety of trastuzumab deruxtecan
    • To determine the pharmacokinetics (PK) of trastuzumab deruxtecan
    Exploratory Objective:
    The exploratory objectives are:
    • To evaluate time to response (TTR) and best percent change in the sum of the diameters for all target lesions
    • To evaluate potential biomarkers
    • To evaluate exposure-response relationships for efficacy and safety endpoints
    Objetivos secundarios:
    Los objetivos secundarios son:
    • evaluar la duración de la respuesta (DR), la tasa de control de la enfermedad (TCE), la supervivencia sin progresión (SSP) y la supervivencia general (SG).
    • evaluar en mayor profundidad la seguridad de trastuzumab deruxtecán.
    • determinar la farmacocinética (FC) de trastuzumab deruxtecán.

    Objetivo exploratorio:
    Los objetivos exploratorios son:
    • evaluar el tiempo hasta la respuesta (TR) y el mejor cambio porcentual en la suma de los diámetros de todas las lesiones diana.
    • evaluar biomarcadores potenciales.
    • evaluar las relaciones exposición-respuesta de los criterios de valoración de la eficacia y la seguridad.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Inclusion Criteria:
    1. Age ≥20 y old in Japan, ≥18 y old in other countries.
    2. Pathologically documented unresectable and/or metastatic non-squamous NSCLC.
    3. Has relapsed from or is refractory to standard treatment or for which no standard treatment is available.
    4. For Cohort 1 only: HER2-overexpression (IHC 2+ or 3+) status must be assessed and confirmed by Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory or equivalent, from an archival tumor sample.
    5. For Cohort 2 only: Documented any known activating HER2 mutation from an archival tumor sample analyzed by CLIA laboratory or equivalent, specifically exon 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), single base pair substitutions L755S, V777L, or S310F or another HER2 mutation approved by the Principal Investigator and the Sponsor.
    6. Presence of at least 1 measurable lesion assessed by the investigator based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1.
    7. Is willing and able to provide an adequate archival tumor sample.
    8. Is willing to undergo a tissue biopsy, after the completion of the most recent treatment regimen.
    9. Has Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1.
    Criterios de inclusión:
    1. Edad ≥20 años en Japón, ≥18 años en los demás países.
    2. CPNM no epidermoide irresecable y/o metastásico anatomopatológicamente documentado.
    3. Haber recaído con el tratamiento de referencia o ser resistente al mismo, o no disponer de tratamiento de referencia.
    4. Para la cohorte 1 solamente: El estado de sobreexpresión de HER2 (IHQ 2+ o 3+) debe evaluarse y confirmarse por un laboratorio certificado con CLIA (Clinical Laboratory Improvement Amendments) o equivalente, a partir de una muestra tumoral de archivo.
    5. Para la cohorte 2 solamente: Se deberá documentar cualquier mutación activadora de HER2 conocida a partir de una muestra tumoral de archivo analizada por el laboratorio CLIA o equivalente, específicamente el exón 20 insYVMA (Y772_A775dup), insGSP (G778_P780dup), insTGT (G776delinsVC), sustituciones de pares de bases únicos L755S, V777L o S310F u otra mutación de HER2 aprobada por el investigador principal y el promotor.
    6. Presencia de al menos 1 lesión medible según la evaluación del investigador en base a los Criterios de Evaluación de la Respuesta en Tumores Sólidos (RECIST) versión 1.1.
    7. Estar dispuesto a y ser capaz de proporcionar una muestra tumoral de archivo adecuada.
    8. Estar dispuesto a someterse a una biopsia de tejido tras la finalización de la pauta de tratamiento más reciente.
    9. Presentar un estado funcional (EF) según la escala del Grupo Oncológico Cooperativo del Este (Eastern Cooperative Oncology Group, EF ECOG) de 0 a 1.
    E.4Principal exclusion criteria
    Exclusion Criteria:
    1. Previously treated with HER2-targeted therapies, except for pan-HER class tyrosine kinase inhibitors.
    2. For Cohort 1 only: Has known HER2 mutation.
    3. Uncontrolled or significant cardiovascular disease, including any of the following:
    a. Medical history of myocardial infarction within 6 mo before registration
    b. Symptomatic congestive heart failure (CHF) (New York Heart Association Class II to IV) 28 d prior to registration
    c. Troponin levels consistent with myocardial infarction (as defined by the Sponsor) 28 d prior to registration
    d. History of unstable angina, or serious cardiac arrhythmia requiring treatment
    e. Left ventricular ejection fraction (LVEF) < 50% within 28 d prior to registration
    f. Has a corrected QT interval (QTcF) prolongation to > 470 ms (females) or >450 ms (males) based on average of the screening triplicate12-lead electrocardiogram (ECG).
    4. Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis cannot be ruled out by imaging at screening.
    5. Has clinically significant corneal disease in the opinion of the Investigator.
    6. Has spinal cord compression or clinically active central nervous system metastases, defined as untreated and symptomatic, or requiring therapy with corticosteroids or anticonvulsants to control associated symptoms. Subjects with clinically inactive brain metastases may be included in the study. Subjects with treated brain metastases that are no longer symptomatic and who require no treatment with corticosteroids or anticonvulsants may be included in the study if they have recovered from the acute toxic effect of radiotherapy. A minimum of 2 wk must have elapsed between the end of whole brain radiotherapy and study registration.
    7. Has multiple primary malignancies within 3 y, except adequately resected non-melanoma skin cancer, curatively treated in-situ disease, or other solid tumors curatively treated.
    Criterios de exclusión:
    1. Tratamiento previo con terapias dirigidas a HER2, excepto los inhibidores de la tirosina quinasa de clase pan-HER.
    2. Para la cohorte 1 solamente: Presentar una mutación de HER2 conocida.
    3. Enfermedad cardiovascular no controlada o significativa, incluida cualquiera de las siguientes:
    a. Antecedentes médicos de infarto de miocardio en los 6 meses anteriores al registro.
    b. Insuficiencia cardíaca congestiva (ICC) sintomática (clase II a IV según la New York Heart Association) 28 días antes del registro.
    c. Niveles de troponina indicativos de infarto de miocardio (según determinación del promotor) 28 días antes del registro.
    d. Antecedentes de angina inestable o arritmia cardíaca grave que requiere tratamiento.
    e. Fracción de eyección ventricular izquierda (FEVI) < 50 % en los 28 días anteriores al registro.
    f. Presentar una prolongación del intervalo QT corregido (QTcF) hasta > 470 ms (mujeres) o >450 ms (hombres) en base a la media del electrocardiograma (ECG) de 12 derivaciones realizado por triplicado en la selección.
    4. Tener antecedentes de enfermedad pulmonar intersticial (EPI) (no infecciosa)/neumonitis que requiere corticoesteroides, EPI/neumonitis recurrente o sospecha de EPI/neumonitis que no puede descartarse mediante diagnóstico por imagen en la selección.
    5. Presentar enfermedad corneal clínicamente significativa, en opinión del investigador.
    6. Presentar compresión de la médula espinal o metástasis en el sistema nervioso central clínicamente activas, definidas como no tratadas y sintomáticas, o que requieren tratamiento con corticoesteroides o antiepilépticos para controlar los síntomas asociados. Los sujetos con metástasis cerebrales clínicamente inactivas podrán ser incluidos en el estudio. Los sujetos con metástasis cerebrales tratadas que ya no sean sintomáticas y que no requieran tratamiento con corticoesteroides o antiepilépticos podrán ser incluidos en el estudio si se han recuperado del efecto tóxico agudo de la radioterapia. Deberán haber transcurrido al menos 2 semanas entre el final de la radioterapia total del cerebro y el registro en el estudio.
    7. Presentar múltiples neoplasias malignas primarias en los últimos 3 años, excepto el cáncer de piel no melanoma adecuadamente resecado, enfermedad in situ tratada de forma curativa u otros tumores sólidos tratados de forma curativa.
    E.5 End points
    E.5.1Primary end point(s)
    Primary Efficacy Endpoint:
    The primary efficacy endpoint (primary outcome measure) is ORR assessed by independent central review (ICR) based on RECIST version 1.1 for each cohort.
    Criterio de valoración principal de la eficacia:
    El criterio de valoración principal de la eficacia (medida de resultado principal) es la TRO evaluada mediante revisión central independiente (RCI) en base a RECIST versión 1.1 para cada cohorte.
    E.5.1.1Timepoint(s) of evaluation of this end point
    every 6 weeks
    cada 6 semanas
    E.5.2Secondary end point(s)
    Secondary Efficacy Endpoints:
    - DoR based on investigator assessment and ICR
    - DCR based on investigator assessment and ICR
    - PFS based on investigator assessment and ICR
    - OS
    - ORR based on investigator assessment
    Secondary outcome measures include: ORR, DoR, and PFS, and OS.
    Criterios de valoración secundarios de la eficacia:
    - DR en base a la evaluación del investigador y RCI
    - TCE en base a la evaluación del investigador y RCI
    - SSP en base a la evaluación del investigador y RCI
    - SG
    - TRO en base a la evaluación del investigador
    Los criterios de valoración secundarios incluyen: TRO, DR, SSP y SG.
    E.5.2.1Timepoint(s) of evaluation of this end point
    every 6 weeks for efficacy, every 3 months for OS for until death or last contact with subject
    cada 6 semanas para la eficacia, cada 3 meses para SG hasta la muerte o el último contacto con el sujeto
    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 Yes
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA8
    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
    Japan
    United States
    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
    End of OS follow-up
    Fin del seguimiento SG
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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: 70
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    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 state8
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 32
    F.4.2.2In the whole clinical trial 80
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    none
    ninguno
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2018-10-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2018-10-04
    P. End of Trial
    P.End of Trial StatusOngoing
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