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    Summary
    EudraCT Number:2018-003265-34
    Sponsor's Protocol Code Number:MS200647_0005
    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:2019-06-28
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2018-003265-34
    A.3Full title of the trial
    A Multicenter, Double Blind, Randomized, Controlled Study of M7824 with Concurrent Chemoradiation Followed by M7824 versus Concurrent Chemoradiation Plus Placebo Followed by Durvalumab in Participants with Unresectable Stage III Non-small Cell Lung Cancer
    Estudio multicéntrico, doble ciego, aleatorizado y controlado de M7824 con quimiorradioterapia concurrente seguida de M7824 en comparación con quimiorradioterapia concurrente más placebo seguida de durvalumab en participantes con cáncer de pulmón no microcítico irresecable en estadio III
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    M7824 with cCRT in Unresectable Stage III NSCLC
    M7824 con QRTc en el CPNM irresecable en estadio III
    A.4.1Sponsor's protocol code numberMS200647_0005
    A.5.4Other Identifiers
    Name:INDNumber:124757
    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 SponsorMerck KGaA
    B.1.3.4CountryGermany
    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 supportMerck KGaA
    B.4.2CountryGermany
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationMerck KGaA
    B.5.2Functional name of contact pointCommunication Center Merck KGaA
    B.5.3 Address:
    B.5.3.1Street AddressFrankfurter Strasse 250
    B.5.3.2Town/ cityDarmstadt
    B.5.3.3Post code64293
    B.5.3.4CountryGermany
    B.5.4Telephone number+34900810844
    B.5.5Fax number+496151 72 2000
    B.5.6E-mailservice@merckgroup.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 nameM7824
    D.3.4Pharmaceutical form Concentrate 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 INNbintrafusp alfa (proposed INN)
    D.3.9.2Current sponsor codeMSB0011359C
    D.3.9.3Other descriptive nameM7824
    D.3.9.4EV Substance CodeSUB179957
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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.IMP: 2
    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 IMFINZI 50 mg/mL concentrate for solution for infusion
    D.2.1.1.2Name of the Marketing Authorisation holderAstraZeneca AB
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Concentrate 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 INNDURVALUMAB
    D.3.9.3Other descriptive nameIMFINZI
    D.3.9.4EV Substance CodeSUB176342
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number50
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboConcentrate for solution for infusion
    D.8.4Route of administration of the placeboIntravenous use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Unresectable Stage III Non-small Cell Lung Cancer
    cáncer de pulmón no microcítico irresecable en estadio III
    E.1.1.1Medical condition in easily understood language
    Unresectable Stage III Non-small Cell Lung Cancer
    cáncer de pulmón no microcítico irresecable en estadio III
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10029519
    E.1.2Term Non-small cell lung cancer stage III
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate PFS in participants treated with cCRT plus M7824
    followed by M7824 or cCRT plus placebo followed by
    durvalumab
    Evaluar la SSP en los participantes tratados con QRTc más
    M7824 seguida de M7824 o QRTc más placebo seguida de
    durvalumab
    E.2.2Secondary objectives of the trial
    To evaluate the safety in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab
    To evaluate OS in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab
    To evaluate changes in lung function in participants treated with
    cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab
    To evaluate the association of PD-L1 expression at Baseline with efficacy in participants treated with cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab
    To evaluate objective tumor response in participants treated with
    cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab
    To evaluate duration of response in participants treated with
    cCRT plus M7824 followed by M7824 or cCRT plus placebo followed by durvalumab
    To characterize PK profile of M7824 plus cCRT and after cCRT
    To characterize the immunogenicity of M7824 plus cCRT and after cCRT
    -Evaluar la seguridad en los participantes tratados con QRTc más M7824 seguida de M7824 o QRTc + placebo seguida de durvalumab
    Evaluar la SG en los participantes tratados con QRTc más M7824 seguida de M7824 o QRTc + placebo seguida de durvalumab
    Evaluar los cambios en la func. pulmonar en los participantes tratados con QRTc más M7824 seguida de
    M7824 o QRTc + placebo seguida de durvalumab
    Evaluar la asociación de la expresión de PD-L1 en el inicio con la eficacia en los participantes tratados con QRTc + M7824 seguida de M7824 o QRTc + placebo seguida de durvalumab
    Evaluar la respuesta objetiva del tumor en los participantes tratados con QRTc + M7824 seguida de M7824 o QRTc +placebo seguida de durvalumab
    Evaluar la duración de la respuesta en los participantes tratados con QRTc + M7824 seguida de M7824 o QRTc + placebo seguida de durvalumab
    Caracterizar el perfil FC de M7824 + QRTc y después de la QRTc
    Caracterizar la inmunogenicidad de M7824 + QRTc y después de la QRTc
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Investigator Participants must have histologically documented NSCLC who present with Stage III locally advanced, unresectable disease (International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology [IASLC Staging Manual in Thoracic Oncology], v8).

    2. Participants with tumor harboring an EGFR sensitizing (activating) mutation, ALK translocation, ROS-1 rearrangement are eligible. These tests are not required for enrollment in the study.

    3. Participants must have adequate pulmonary function defined as a forced expiratory volume in 1 second (FEV1) ≥ 1.2 liters or ≥ 50% of predicted normal volume measured within 3 weeks prior to randomization. If participants do not meet the above criteria, treatment with inhaled steroids and bronchodilators can be initiated if clinically indicated and eligibility can be reassessed after 1-2 weeks.

    4. Adequate hematological, hepatic and renal function as defined in the protocol
    Contraceptive use by males or females will be consistent with local regulations on contraception methods for those participating in clinical studies

    5. Other protocol defined inclusion criteria could apply
    1. Los participantes en el estudio de investigación deben presentar CPNM localmente avanzado irresecable en estadio III histológicamente documentado (versión 8 del Manual de Estadificación en Oncología Torácica de la Asociación Internacional para el Estudio del Cáncer de Pulmón [International Association for the Study of Lung Cancer, IASLC]).
    2. Los participantes con tumores que alberguen una mutación sensibilizante (activadora) del EGFR, translocación de ALK, reordenación de ROS-1, son aptos. Estas pruebas no son necesarias para la inclusión en el estudio.
    3. Los participantes deben presentar una función pulmonar adecuada definida como un volumen espiratorio forzado en 1 segundo (FEV1) ≥ 1,2 litros o ≥ 50 % del volumen normal previsto medido en un plazo de 3 semanas antes de la aleatorización. Si los participantes no cumplen los criterios anteriores, puede iniciarse el tratamiento con esteroides inhalados y broncodilatadores, si está clínicamente indicado, y se puede evaluar de nuevo la idoneidad después de 1-2 semanas.
    4. Funciones hematológica, hepática y renal adecuadas según se define en el protocolo.
    El uso de anticonceptivos por hombres o mujeres debe ser coherente con las normativas locales relativas a los métodos anticonceptivos para los participantes en estudios clínicos.
    5. Podrán aplicarse otros criterios de inclusión definidos en el protocolo.
    E.4Principal exclusion criteria
    1. Participants with Mixed small cell with non-small cell lung cancer histology

    2. Recent major surgery within 4 weeks prior to entry into the study

    3. Significant acute or chronic infections

    4. Chronic Obstructive Pulmonary Disease exacerbation or other respiratory illness requiring hospitalization

    5. Active autoimmune disease that has required systemic treatment in past 1 year (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs)
    Other protocol defined exclusion criteria could apply
    1. Participantes con histología de cáncer de pulmón mixto microcítico y no microcítico.
    2. Cirugía mayor reciente en las 4 semanas anteriores a la inclusión en el estudio.
    3. Infecciones agudas o crónicas significativas.
    4. Exacerbación de la enfermedad pulmonar obstructiva crónica o de otra enfermedad respiratoria que requiera hospitalización.
    5. Enfermedad autoinmune activa que ha necesitado tratamiento sistémico en el último año (es decir, con agentes modificadores de la enfermedad, corticosteroides o fármacos inmunodepresores).
    Podrían aplicarse otros criterios de exclusión definidos en el protocolo.
    E.5 End points
    E.5.1Primary end point(s)
    Progression-free survival (PFS) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) assessed by Independent Review Committee (IRC)
    Supervivencia sin progresión (SSP) según los criterios de evaluación de la respuesta en tumores sólidos, versión 1.1 (RECIST 1.1) evaluada por un Comité de revisión independiente (CRI)
    E.5.1.1Timepoint(s) of evaluation of this end point
    Time from randomization to final assessment at 8 years and 10 months
    Tiempo desde la aleatorización hasta la evaluación final a los 8 años y 10 meses
    E.5.2Secondary end point(s)
    1. Occurrence of Treatment-emergent Adverse Events (TEAEs) and treatment-related Adverse Events (AEs)

    2. Overall Survival

    3. Changes from Baseline in pulmonary function

    4. Programmed death-ligand 1 (PD-L1) expression in tumors at Baseline

    5. Objective response according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)

    6. Duration of response

    7. Pharmacokinetics profile of M7824 in terms of Ceoi and Ctrough

    8. Immunogenicity of M7824
    1. Aparición de acontecimientos adversos surgidos durante el tratamiento (AAST) y acontecimientos adversos graves surgidos durante el tratamiento (AAGST).
    2. Supervivencia general
    3. Los cambios desde el inicio en la función pulmonar.
    4. Expresión del ligando 1 de muerte programada (PD-L1) en los tumores en el inicio.
    5. Respuesta objetiva según los criterios de evaluación de la respuesta en tumores sólidos (RECIST), versión 1.1.
    6. Duración de la respuesta
    7. Perfil FC de M7824 en términos de Cfdi y Cmín
    8. Inmunogenicidad de M7824
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Time from randomization to final assessment at 8 years and 10 months

    2. Time from randomization to final assessment at 8 years and 10 months

    3. Time from randomization to final assessment at 14 months

    4. Randomization

    5. Time from randomization to final assessment at 8 years and 10 months

    6. Time from randomization to final assessment at 8 years and 10 months

    7. Time from randomization to final assessment at 17 months

    8. Time from randomization to final assessment at 17 months
    1. Tiempo desde la aleatorización hasta la evaluación final a los 8 años y 10 meses
    2. Tiempo desde la aleatorización hasta la evaluación final a los 8 años y 10 meses
    3. Tiempo desde la aleatorización hasta la evaluación final a los 14 meses
    4. Aleatorización
    5. Tiempo desde la aleatorización hasta la evaluación final a los 8 años y 10 meses
    6. Tiempo desde la aleatorización hasta la evaluación final a los 8 años y 10 meses
    7. Tiempo desde la aleatorización hasta la evaluación final a los 17meses
    8. Tiempo desde la aleatorización hasta la evaluación final a los 17 meses
    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 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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned16
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA41
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Argentina
    Australia
    Brazil
    Canada
    China
    European Union
    Japan
    Korea, Republic of
    Russian Federation
    Taiwan
    Turkey
    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
    The end of the study is defined as the date of primary OS analysis when 254 participants have died.
    El final del estudio se define como la fecha del análisis principal de la SG cuando 254 los participantes han muerto.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years8
    E.8.9.1In the Member State concerned months8
    E.8.9.1In the Member State concerned days21
    E.8.9.2In all countries concerned by the trial years8
    E.8.9.2In all countries concerned by the trial months8
    E.8.9.2In all countries concerned by the trial days21
    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: 175
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 175
    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 state53
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 142
    F.4.2.2In the whole clinical trial 350
    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)
    After a participant has completed the study or has withdrawn early,
    participants may receive the care they and their physicians agree upon.
    Participants will be followed for survival and AEs as specified in the
    protocol
    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 Decision2019-06-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-03
    P. End of Trial
    P.End of Trial StatusOngoing
    As of 1.2.2020, the UK is no longer an EU Member State. However, EU law still applies to the UK during the transition period
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