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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   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).

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    Summary
    EudraCT Number:2020-000958-98
    Sponsor's Protocol Code Number:2017-1-39-007
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-08-07
    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 ConcernedFrance - ANSM
    A.2EudraCT number2020-000958-98
    A.3Full title of the trial
    A phase II trial evaluating conformational intensity modulated radiotherapy with concomitant nivolumab followeb by nivolumab for patients with locally advanced non-small cell lung cancer
    Essai de phase II évaluant l'association d'une radiothérapie conformationnelle avec modulation d'intensité-Nivolumab suivi d'une maintenance par Nivolumab dans les cancers pulmonaires non à petites cellules localement avancés
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Accelerated radiotherapy and Nivolumab (immunotherapy) treatment for pulmonary cancer
    Traitement par radiothérapie accélérée et Nivolumab (Immunothérapie) dans le cancer du poumon
    A.3.2Name or abbreviated title of the trial where available
    AIRING
    AIRING
    A.4.1Sponsor's protocol code number2017-1-39-007
    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 SponsorCentre Régional de lutte contre le Cancer Eugène Marquis
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportBristol Meyers Squibb
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportCentre Régional de Lutte Contre le Cancer Eugène Marquis
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCentre Régional de lutte contre le cancer Eugène Marquis
    B.5.2Functional name of contact pointCellule Promotion de la DRC
    B.5.3 Address:
    B.5.3.1Street AddressAvenue de la Bataille Flandres-Dunkerque
    B.5.3.2Town/ cityRennes
    B.5.3.3Post code35042
    B.5.3.4CountryFrance
    B.5.4Telephone number33(0)2 99 25 30 36
    B.5.5Fax number33(0)2 99 25 32 34
    B.5.6E-mailpromotion@rennes.unicancer.fr
    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 Yes
    D.2.1.1.1Trade name Opdivo (TM)
    D.2.1.1.2Name of the Marketing Authorisation holderBristol-Meyers Squibb Pharma EEIG
    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 nameNivolumab- CLINICAL
    D.3.2Product code BMS-936558
    D.3.4Pharmaceutical form Solution for injection
    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 INNNivolumab
    D.3.9.1CAS number 946414-94-4
    D.3.9.2Current sponsor codeBMS936558
    D.3.9.3Other descriptive nameBMS936558; Nivolumab
    D.3.9.4EV Substance CodeSUB32944
    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.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
    Patient having locally Advanced Non-Small Cell Lung Cancer
    Patients présentant un cancer du poumon Non à Petites Cellules Localement Avancé
    E.1.1.1Medical condition in easily understood language
    Lung cancer
    Cancer du poumon
    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 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 the efficacy (disease control rate) of accelerated IMRT combined with nivolumab for patients with a locally advanced non-small cell lung cancer unfit for concomitant or sequential chemoradiotherapy.
    Evaluer l’efficacité (taux de contrôle de la maladie) d’une radiothérapie conformationnelle avec modulation d’intensité accélérée en combinaison avec du nivolumab pour des patients avec un cancer pulmonaire non à petites cellules localement avancé contre indiqués pour une radiochimiothérapie concomitante ou séquentielle
    E.2.2Secondary objectives of the trial
    To evaluate the efficacy (recurrence free survival, overall survival, objective response rate) of accelerated IMRT combined with nivolumab for patients with a locally advanced non-small cell lung cancer unfit for concomitant or sequential chemoradiotherapy.

    To evaluate the tolerance of accelerated IMRT combined with nivolumab for patients with a locally advanced non-small cell lung cancer unfit for concomitant or sequential chemoradiotherapy
    Evaluer l’efficacité (survie sans progression, survie globale, taux de réponse objectif) d’une radiothérapie conformationnelle avec modulation d’intensité accélérée en combinaison avec du nivolumab pour des patients avec un cancer pulmonaire non à petites cellules localement avancé contre indiqués pour une radiochimiothérapie concomitante ou séquentielle

    Evaluer la tolérance d’une radiothérapie conformationnelle avec modulation d’intensité accélérée en combinaison avec du nivolumab pour des patients avec un cancer pulmonaire non à petites cellules localement avancé contre indiqués pour une radiochimiothérapie concomitante ou séquentielle
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    To evaluate the immune effect of accelerated-hypofractionated RT in patients treated in the context of the AIRING trial to obtain high quality immunomonitoring data to design future prospective trials.
    Evaluer l'effet immunologique de la radiothérapie accélérée-hypofractionnée chez des patients traités dans le cadre de l'essai AIRING afin d'obtenir des données immunologiques de qualité pour l'élaboration de futurs essais prospectifs.
    E.3Principal inclusion criteria
    • Stage III non-small lung cancer (AJCC 8th edition);
    • Non-eligible to chemoradiotherapy, defined by multidisciplinary tumor board;
    • Eligible to radiotherapy, defined by multidisciplinary tumor board;
    • Performance Status ECOG 0-2;
    • Age ≥ 18 years;
    • M0 based on clinical, MRI of brain and FDG/PET-CT examinations;
    • Written informed consent
    • Cancer pulmonaire non à petites cellules de stade III (AJCC 8ème édition) ;
    • Contre indiqué à la radiochimiothérapie par un comité pluridisciplinaire (RCP) ;
    • Eligible à la radiothérapie, selon l’avis d’un comité pluridisciplinaire ;
    • Performance Status ECOG 0-2 ;
    • Age ≥ 18 ans ;
    • M0 après examen clinique, IRM cérébrale et TEP scanner ;
    • Consentement écrit
    E.4Principal exclusion criteria
    • Patients eligible to surgery
    • Any prior or current treatment for invasive lung cancer
    • History of other malignancy within the last 3 years (exception of skin carcinomas, localized prostate carcinoma Gleason
    6 and in situ breast carcinoma)
    • Significant disease which, in the judgment of the investigator, as a result of the medical interview, physical examinations, or screening investigations would make the patient inappropriate for entry into the trial
    • Known hypersensitivity reaction to nivolumab
    • Prior organ transplantation including allogenic stem-cell transplantation
    • Any social, personal, medical and/or psychologic factor(s) that could interfere with the observance of the patient to the protocol and/or the follow-up and/or the signature of the informed consent
    • Patients pouvant bénéficier d’une chirurgie
    • Antécédent de traitement ou traitement en cours pour un cancer pulmonaire invasif
    • Antécédent d’autres cancers dans les 3 dernières années (à l’exclusion de carcinome cutané, cancer de prostate localisé de Gleason 6 et cancer du sein in situ)
    • Pathologie pouvant potentiellement, selon le jugement de l’investigateur après interrogatoire, examen clinique ou à l’issue des examens de sélection, constituée une contre-indication à la participation à l’essai
    • Hypersensibilité connue au nivolumab
    • Antécédent de transplantation d’organe incluant les greffes allogéniques de cellules souches
    • Tout facteur social, personnel, médical et/ou psychologique qui pourrait interférer avec l’observance du patient au protocole et/ou avec le suivi et/ou la signature du formulaire de consentement
    E.5 End points
    E.5.1Primary end point(s)
    Disease control
    Taux de contrôle de la maladie
    E.5.1.1Timepoint(s) of evaluation of this end point
    12 months after treatment start
    12 mois après le début de traitement
    E.5.2Secondary end point(s)
    Overall survival time
    Progression free survival time
    Tumor response
    Early and late treatment-related adverse events of grade ≥ 2 according to the NCI CTCAE V5.0
    Durée de survie globale
    Durée de survie sans progression
    Réponse tumorale
    Toxicités aigues et tardives de grade ≥ 2 reliées au traitement selon la classification NCI CTCAE V5.0
    E.5.2.1Timepoint(s) of evaluation of this end point
    Overall survival time : up to 12 months after start treatment initiation of the last patient
    Progression free survival time : 12 months after treatment start
    Tumor response : 12 months after treatment start
    Early and late treatment-related adverse events of grade ≥ 2 : 3 months after treatment (early) start and 5 months (late) after treatment stop
    Durée de survie globale : jusqu'à 12 mois après le début de traitement du dernier patient inclus
    Durée de survie sans progression : 12 mois après le début de traitement
    Réponse tumorale : 12 mois après le début de traitement
    Toxicités aigues et tardives de grade ≥ 2 reliées au traitement selon la classification NCI CTCAE V5.0 : 3 mois après le début de traitement pour les toxicités aigues et 5 mois après la fin de traitement pour les toxicités retardées.
    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 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.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 Yes
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned5
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    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
    LVLS
    Dernière visite du dernier patient
    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 months1
    E.8.9.1In the Member State concerned days
    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: 20
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 40
    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 No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    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 state60
    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
    Aucun
    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 Decision2020-08-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-07-02
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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