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    Summary
    EudraCT Number:2013-005427-16
    Sponsor's Protocol Code Number:D4191C00003
    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:2014-07-04
    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 number2013-005427-16
    A.3Full title of the trial
    A Phase II, Non-comparative, Open label, Multi-centre, International Study
    of MEDI4736, in Patients with Locally Advanced or Metastatic Non-Small
    Cell Lung Cancer (Stage IIIB-IV) who have received at least Two Prior
    Systemic Treatment Regimens Including One Platinum-based
    Chemotherapy Regimen (ATLANTIC)
    Estudio de fase II, no comparativo, abierto, multicentrico e internacional de MEDI4736 en pacientes con carcinoma pulmonar no microcitico localmente avanzado o metastasico (estadio IIIB-IV), que han recibido al menos dos pautas previas de tratamiento sistemico, incluida una pauta de quimioterapia basada en platino (ATLANTIC)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Phase II Study of MEDI4736 in Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer
    Estudio de fase II de MEDI4736 en pacientes con carcinoma pulmonar no microcitico localmente avanzado o metastasico
    A.3.2Name or abbreviated title of the trial where available
    ATLANTIC
    ATLANTIC
    A.4.1Sponsor's protocol code numberD4191C00003
    A.5.2US NCT (ClinicalTrials.gov registry) numberNCT02087423
    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 pointCoral Berriochoa
    B.5.3 Address:
    B.5.3.1Street AddressSodertalje
    B.5.3.2Town/ citySodertalje
    B.5.3.3Post codeSE 151 85
    B.5.3.4CountrySweden
    B.5.4Telephone number34913019179
    B.5.6E-mailcoral.berriochoa@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 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 nameMEDI4736
    D.3.2Product code MEDI4736
    D.3.4Pharmaceutical form Lyophilisate 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 INNMEDI4736
    D.3.9.2Current sponsor codeMEDI4736
    D.3.9.3Other descriptive nameMEDI4736
    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 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
    Locally Advanced or Metastatic Non-Small Cell Lung Cancer (Stage IIIB-IV)
    Carcinoma pulmonar no microcitico localmente avanzado o metastasico (estadio IIIB-IV),
    E.1.1.1Medical condition in easily understood language
    Non-Small Cell Lung Cancer
    Carcinoma pulmonar no microcitico
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 17.0
    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 17.0
    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.1.3Condition 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 MEDI4736 treatment in terms of objective response rate (ORR)
    Evaluar la eficacia del tratamiento con MEDI4736 en terminos de Tasa de Respuesta Objetiva (TRO).
    E.2.2Secondary objectives of the trial
    To further assess the efficacy of MEDI4736 in terms of: Duration of response (DoR), Progression free survival (PFS), Disease control rate (DCR), Overall survival (OS), and Deep sustained response (DSR)
    To assess the safety, tolerability, PK and immunogenicity profile of MEDI4736
    Evaluar la eficacia de MEDI4736 en terminos de: Duracion de la respuesta (DR), Supervivencia sin Progresion (SSP), Tasa de Control de la Enfermedad (TCE), Supervivencia General (SG) y Respuesta Profunda Sostenida (RPS)
    Evaluar la seguridad, tolerabilidad, FC e inmunogenicidad de MEDI4736
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    Pharmacogenetics Research
    Investigacion Farmacocinética
    E.3Principal inclusion criteria
    1. Provision of signed, written and dated informed consent prior to any study specific procedures
    2. Male or female aged 18 years or older
    3. Patients must have EITHER
    ? Histologically- or cytologically-documented NSCLC), OR
    ? Recurrent or progressive disease following multimodal therapy for locally advanced disease)
    4. Patients must have received at least 2 prior systemic treatment regimens for treatment of NSCLC
    5. Patients must have experienced disease progression or recurrence after both a platinum-based chemotherapy regimen and at least 1 additional systemic therapy
    6. Patients must provide a tumour sample
    7. Patients must have measurable disease
    8. Life expectancy ?12 weeks
    9. World Health Organisation (WHO) Performance Status of 0 or 1
    10. Evidence of post-menopausal status, or negative urinary or serum pregnancy test for female pre-menopausal patients
    11. Adequate organ and marrow function
    1.Proporcionar un consentimiento informado firmado y fechado antes de realizar cualquier procedimiento del estudio
    2.Ser hombre o mujer de 18 años de edad o mas
    3.Los pacientes deben tener O BIEN
    ?CPNM histologicamente o citologicamente documentado de la enfermedad O
    ?Una enfermedad recurrente o progresiva despues de un tratamiento multimodal (radioterapia, reseccion quirurgica o quimiorradioterapia definitiva para la enfermedad localmente avanzada)
    4.Los pacientes deben haber recibido al menos 2 pautas de tratamiento sistemico previas para el tratamiento del CPNM
    5.Los pacientes deben haber experimentado progresion de la enfermedad o recurrencia despues de un regimen de quimioterapia a base de platino y, al menos, 1 tratamiento sistemico adicional
    6. Los pacientes deben proporcionar una muestra tumoral.
    7.Los pacientes deben tener una enfermedad medible
    8.Esperanza de vida ? 12 semanas
    9.Estado general de 0 o 1 de la Organización Mundial de la Salud (OMS)
    10. Pruebas de condición posmenopausica o prueba de embarazo en orina o suero negativa en las mujeres premenopausicas.
    11. Funcion adecuada de los organos y la medula
    E.4Principal exclusion criteria
    1. Participation in another clinical study with an investigational product (IMP) during the last 4 weeks
    2. Concurrent enrolment in another clinical study, unless it is an observational (non-interventional) clinical study or the follow-up period of an interventional study
    3. Mixed small cell and NSCLC histology
    4. Receipt of any immunotherapy, or IMP within 4 weeks prior to the first dose of study drug
    5. Prior exposure to any anti-PD-1 or anti-PD-L1 antibody
    6. Any unresolved toxicity CTCAE >Grade 2 from previous anti-cancer therapy
    7. Any prior Grade ?3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE >Grade 1
    8. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment
    9. Receipt of radiation therapy within 4 weeks prior to starting MEDI4736, or limited field of radiation for palliation within 2 weeks of the first dose of MEDI4736
    10. Recent major surgery within 4 weeks
    11. Active or prior documented autoimmune disease within the past 2 years, except for: Vitiligo, Grave's disease, or psoriasis not requiring systemic treatment
    12. Active or prior documented inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis)
    13. History of primary immunodeficiency
    14. History of organ transplant that requires therapeutic
    Immunosuppression
    15. History of hypersensitivity to MEDI4736 or any excipient
    16. Brain metastases or spinal cord compression unless asymptomatic, treated and stable off steroids and anti-convulsants for at least 1 month prior to entry into the study
    17. Uncontrolled intercurrent illness
    18. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving MEDI4736
    19. History of another primary malignancy within 5 years prior to starting MEDI4736, except for adequately treated basal or squamous cell carcinoma of the skin or cancer of the cervix in situ and the disease under study
    20. Female patients who are pregnant or breast-feeding. Male or female patients of reproductive potential who are not using an effective method of birth control
    21. Any condition that, in the opinion of the investigator, would interfere with evaluation of MEDI4736 or interpretation of patient safety or study results
    1.Participacion en otro estudio clinico con un producto en investigacion durante las ultimas 4 semanas
    2Inscripcion simultanea en otro estudio clinico, a menos que sea un estudio clinico observacional (no intervencionista) o el periodo de seguimiento de un estudio de intervencion
    3.Histologia del CPNM con celulas pequeñas mixtas
    4.Haber recibido una inmunoterapia o un farmaco en investigacion en las 4 semanas previas a la primera dosis del farmaco del estudio; y, en el caso de anticuerpos monoclonales, 6 semanas antes de la primera dosis del farmaco del estudio
    5.Exposicion previa a cualquier anticuerpo PD-1 o anti-PD-L1
    6.Cualquier toxicidad no resuelta de > grado 2 de los CTCAA derivada del tratamiento anterior contra el cancer.
    7.Cualquier acontecimiento adverso relacionado con la inmunidad (AAri) de grado ? 3 durante la recepcion de un agente de inmunoterapia previo, o cualquier AAri no resuelto > grado 1
    8.Cualquier quimioterapia, inmunoterapia, tratamiento biologico u hormonal concurrentes para el tratamiento del cancer
    9.Haber recibido una radioterapia en las 4 semanas antes de comenzar el producto en investigacion o un campo limitado de radiacion paliativo en las 2 semanas antes de la primera dosis del producto en investigacion
    10.Cirugia mayor reciente en las 4 semanas antes de la entrada en el estudio.
    11.Enfermedad autoinmune, activa o previamente documentada, en los ultimos 2 años. NOTA: no estan excluidos los pacientes con vitiligo, la enfermedad de Grave o psoriasis que no requieren un tratamiento sistemico (en los ultimos 2 años)
    12.Enfermedad intestinal inflamatoria activa o previamente documentada (p. ej. la enfermedad de Crohn o la colitis ulcerosa)
    13.Antecedentes de inmunodeficiencia primaria
    14.Antecedentes de trasplante de organos que requieran inmunosupresion terapeutica
    15.Antecedentes de hipersensibilidad a MEDI4736 o cualquier excipiente
    16.Metastasis cerebrales o compresion de la medula espinal, a menos que sea asintomatica, este tratada y estable, sin esteroides y anticonvulsivos durante, al menos, 1 mes antes de la entrada en el estudio
    17.Enfermedad intercurrente no controlada
    18.Haber recibido una vacuna viva atenuada en los 30 dias antes de la entrada en el estudio o en los 30 dias antes de recibir MEDI4736
    19.Antecedentes de otro tumor maligno primario en los 5 años antes de iniciar el producto en investigacion, con excepcion del carcinoma basocelular o el carcinoma de celulas escamosas de la piel, o del cancer de cuello uterino in situ, que se hayan tratado adecuadamente, y de la enfermedad en estudio
    20.Las pacientes que esten embarazadas o dando el pecho, o los hombres y las mujeres con potencial reproductivo que no utilicen un metodo anticonceptivo efectivo
    21.Cualquier condición que, en opinion del investigador, podria interferir en la evaluacion del producto en investigacion o la interpretacion de la seguridad del paciente o de los resultados del estudio
    E.5 End points
    E.5.1Primary end point(s)
    Objective response rate (ORR) (per RECIST 1.1)
    Tasa de respuesta objetiva (TRO) (RECIST 1.1)
    E.5.1.1Timepoint(s) of evaluation of this end point
    The data cut-off for analysis of ORR will take place approximately 8 months after recruitment ends.
    Los datos de corte para el analisis de la TRO se llevaran a cabo aproximadamente 8 meses despues del fin del reclutamiento
    E.5.2Secondary end point(s)
    - Duration of response
    - Progression free survival
    - Disease control rate
    - Overall survival
    - Deep sustained response
    - AEs
    - Duracion de la respuesta
    - Supervivencia sin progresion
    - Tasa de control de la enfermedad
    - Supervivencia General
    - Respuesta Profunda Sostenida
    - AA
    E.5.2.1Timepoint(s) of evaluation of this end point
    The data cut-off for analysis of the secondary efficacy endpoints will take place approximately 8 months after recruitment ends. The final analysis of OS (secondary endpoint) will take place 12 months after recruitment ends.
    Los datos de corte para el analisis de los criterios de valoracion de la eficacia tendran lugar aproximadamente 8 meses despues del fin de reclutamiento. El analisis final de la SG (criterio de valoracion secundario) tendra lugar 12 meses despues del fin de reclutamiento
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic 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 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 concerned6
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA57
    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
    Canada
    European Union
    Japan
    Korea, Republic of
    Malaysia
    Philippines
    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
    The end of the study is defined as ?the last visit of the last patient undergoing the study?.
    El final del estudio se define como la ultima visita del ultimo sujeto del estudio
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    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 years2
    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: 89
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 121
    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 state10
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 81
    F.4.2.2In the whole clinical trial 210
    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)
    The data cut-off for the final analysis of OS will take place 12 months after recruitment ends. Patients who are receiving treatment can either choose to discontinue from the study or where the investigator believes patients are gaining clinical benefit, patients may continue to receive investigational product. All patients will receive follow-up care in accordance with standard local clinical practice.
    Los datos de corte para el analisis final de supervivencia general (SG) tendra lugar 12 meses despues de que termine el reclutamiento. Los pacientes que estan recibiendo tratamiento pueden optar por discontinuar el estudio o cuando el investigador considere que los pacientes se estan beneficiando clinicamente, los pacientes podran continuar recibiendo el producto en investigacion. Todos los pacientes recibiran atencion de seguimiento de acuerdo con la practica clinica local estandar.
    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 Decision2014-07-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-06-03
    P. End of Trial
    P.End of Trial StatusCompleted
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    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
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