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The European Union Clinical Trials Register   allows you to search for protocol and results information on:
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    The EU Clinical Trials Register currently displays   43976   clinical trials with a EudraCT protocol, of which   7312   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    EudraCT Number:2021-003031-29
    Sponsor's Protocol Code Number:D4191C00137
    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:2023-01-16
    Trial results
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    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2021-003031-29
    A.3Full title of the trial
    ROSY-D: Roll Over StudY for Patients Who Have Completed a Previous Oncology Study with Durvalumab and Are Judged by the Investigator to Clinically Benefit From Continued Treatment
    ROSY-D: Estudio maestro de continuación en pacientes que hayan completado un estudio en oncología previo y que el investigador considere que van a beneficiarse clínicamente de continuar el tratamiento
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Roll Over Study for Patients Who Have Completed a Previous Oncology
    Study with Durvalumab
    Estudio maestro de continuación en pacientes que hayan completado un estudio en oncología previo con Durvalumab
    A.3.2Name or abbreviated title of the trial where available
    A.4.1Sponsor's protocol code numberD4191C00137
    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.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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAstraZeneca
    B.5.2Functional name of contact pointClinical Study Information Center
    B.5.3 Address:
    B.5.3.1Street AddressNot applicable
    B.5.3.2Town/ cityNot applicable
    B.5.3.3Post codeNot applicable
    B.5.3.4CountryUnited States
    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 nameDurvalumab
    D.3.2Product code MEDI4736
    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.3.9.1CAS number 1428935-60-7
    D.3.9.2Current sponsor codeMEDI4736
    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. cell therapy medicinal product No
    D. therapy medical product No
    D. Engineered Product No
    D. ATIMP (i.e. one involving a medical device) No
    D. 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
    Post-Chemotherapy Urothelial and Non-Urothelial Carcinoma of the Urinary Tract.
    First-line patients with extensive disease (Stage IV) small-cell lung cancer (SCLC).
    Advanced or Metastatic Non Small-Cell Lung Cancer (NSCLC) in treatment naive patients with epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) wild type tumor pathology.
    Locally Advanced, Unresectable Non-Small Cell Lung Cancer (Stage III)
    Various types of cancer ( dependent on parent study)
    Carcinoma urotelial y no urotelial de vías urinarias posquimioterapia
    Pacientes de primera línea con cáncer de pulmón de células pequeñas (CPCP) con enfermedad grave (etapa IV).
    Cáncer de pulmón de células no pequeñas avanzado o metastásico en pacientes sin tratamiento previo con receptor del factor de crecimiento epidérmico (EGFR) y patología tumoral de cepa silvestre de quinasa de linfoma anaplásico (ALK).
    Cáncer de pulmón de células no pequeñas no resecable, localmente avanzado (etapa III)
    E.1.1.1Medical condition in easily understood language
    Various types of cancer ( dependent on the parent study)
    Diferentes tipos de cáncer (dependiendo del estudio de origen)
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061272
    E.1.2Term Malignant urinary tract neoplasm
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10041068
    E.1.2Term Small cell lung cancer extensive stage
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10025055
    E.1.2Term Lung cancer non-small cell stage IV
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    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.1.2 Medical condition or disease under investigation
    E.1.2Version 21.0
    E.1.2Level LLT
    E.1.2Classification code 10049280
    E.1.2Term Solid tumour
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 21.1
    E.1.2Level PT
    E.1.2Classification code 10061873
    E.1.2Term Non-small cell lung cancer
    E.1.2System Organ Class 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To provide continuous study treatment to patients who continue to benefit at the end of a clinical study, while monitoring safety and tolerability.
    Proporcionar de forma continua el tratamiento del estudio a los pacientes que sigan beneficiándose de él al término de un estudio clínico, al tiempo que se vigila la seguridad y la tolerabilidad.
    E.2.2Secondary objectives of the trial
    Not applicable
    No aplica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of signed and dated, written ICF.
    2. Patient is currently deriving clinical benefit, as judged by the Investigator, from continued treatment in an AZ parent study using an AZ compound that has met its endpoints, or has otherwise stopped, or the patient has reached maximum treatment duration allowed in the parent study’s protocol.
    1. Suministro de ICF escrito, firmado y fechado.
    2. El paciente obtiene actualmente un beneficio clínico, según lo juzgado por el investigador, del tratamiento contínuo en un estudio de origen de AZ que utiliza un compuesto de AZ que alcanzó sus criterios de valoración, o se detuvo por aalgún motivo, o el paciente alcanzó la duración máxima del tratamiento permitida en el protocolo del estudio de origen.
    E.4Principal exclusion criteria
    Core Protocol exclusion criteria:
    1. Ongoing, unresolved, Grade 3 or above toxicity requiring interruption of treatment at the time of the termination of the parent study.
    2. Currently receiving treatment with any prohibited medication(s).
    3. Concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study.
    4. Permanent discontinuation from the parent study due to toxicity or disease progression.
    5. Local access to commercially-available drug at no cost to the patient as permitted by local/country regulation.

    Additional exclusion criteria for the ROSY-D sub-study:
    6. Active infection including COVID-19 (PCR confirmed and/or clinically suspected), tuberculosis, hepatitis B (known positive HBsAg result), hepatitis C, or HIV (positive HIV 1/2 antibodies).
    7. Male or female patients of reproductive potential who are not willing to employ effective birth control from study inclusion up to 90 days after the last dose of durvalumab monotherapy.
    8. Ongoing, unresolved, Grade 2 toxicity with an inability to reduce corticosteroid to a dose of </= 10 mg of prednisone per day (or equivalent) within 12 weeks after last dose of study treatment/study regimen, as per Toxicity Dose Modification and TMGs for Immune-mediated, Infusion-related, and Non-Immune-mediated Reactions Guidelines of the parent study.
    Criterios de exclusión del Protocolo principal:
    1. Toxicidad en curso, no resuelta, de Grado 3 o superior que requiera la interrupción del tratamiento en el momento de la finalización del estudio de origen.
    2. Actualmente recibie tratamiento con algún medicamento prohibido.
    3. Estar inscrito simultáneamente en cualquier otro tipo de investigación médica que no se considere científica o médicamente compatible con este estudio.
    4. Interrupción permanente del estudio de origen debido a toxicidad o progresión de la enfermedad.
    5. Acceso local a medicamentos disponibles comercialmente sin costo para el paciente según lo permita la regulación local/del país.

    Criterios de exclusión adicionales para el subestudio ROSY-D:
    6. Infección activa incluyendo COVID-19 (confirmado por PCR y/o clínicamente sospechado), tuberculosis, hepatitis B (resultado positivo conocido de HBsAg), hepatitis C o VIH (anticuerpos VIH 1/2 positivos).
    7. Pacientes masculinos o femeninos con potencial reproductivo que no estén dispuestos a emplear un método anticonceptivo eficaz desde la inclusión en el estudio hasta 90 días después de la última dosis de monoterapia con durvalumab.
    8. Toxicidad de grado 2 en curso, no resuelta, con incapacidad para reducir el corticosteroide a una dosis de </= 10 mg de prednisona por día (o equivalente) en las 12 semanas posteriores a la última dosis del tratamiento del estudio/régimen del estudio, según Modificación de la dosis de toxicidad y TMG para las guías de reacciones inmunológicas, relacionadas con la infusión y no inmunológicas del estudio de origen.
    E.5 End points
    E.5.1Primary end point(s)
    SAEs reported until 90 days after the last dose of study treatment.
    Acontecimientos adversos graves comunicados hasta 90 días después de la última dosis del tratamiento del estudio.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Throughout the study.
    Durante la duración del estudio
    E.5.2Secondary end point(s)
    Not applicable
    No aplica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Not applicable
    No aplica
    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 No
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E. 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 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 concerned8
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA53
    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
    Korea, Republic of
    United States
    Russian Federation
    United Kingdom
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    Última visita del último paciente
    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 months9
    E.8.9.1In the Member State concerned days30
    E.8.9.2In all countries concerned by the trial years3
    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: 103
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 72
    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 81
    F.4.2.2In the whole clinical trial 175
    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)
    All new SAEs and adverse events of special interest (AESIs) occurring during the 90 calendar days after the last dose of durvalumab must be reported and followed to resolution.
    Todos los nuevos SAE y eventos adversos de especial interés (AESIs) detectados durante el periodo de seguimiento de 90 días después de la última dosis de durvalumab deberán informarse y vigilarse hasta su resolución.
    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 Decision2023-02-24
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2023-01-25
    P. End of Trial
    P.End of Trial StatusOngoing
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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
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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