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    The EU Clinical Trials Register currently displays   43857   clinical trials with a EudraCT protocol, of which   7284   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:2015-003390-15
    Sponsor's Protocol Code Number:IFCT-1503
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2015-12-14
    Trial results View 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 number2015-003390-15
    A.3Full title of the trial
    Phase II study evaluating the combination of cetuximab with afatinib as first-line treatment for patients with EGFR mutated Non Small Cell Lung Cancer
    Etude de phase II évaluant l’association de cetuximab à l’afatinib en première ligne de traitement des cancers bronchiques non à petites cellules porteurs d’une mutation du récepteur à l’Epidermal Growth Factor (EGFR)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study evaluating the combination of cetuximab with afatinib for patient with EGFR mutated lung cancer
    Etude évaluant l'association de cetuximab à afatinib pour les cancers bronchiques porteurs d'une mutation du récepteur de l'Epidermal Growth Factor (EGFR)
    A.3.2Name or abbreviated title of the trial where available
    ACE : Afatinib plus Cetuximab for EGFR Mutant Lung Cancers
    A.4.1Sponsor's protocol code numberIFCT-1503
    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 SponsorIFCT
    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 supportIFCT
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportLigue contre le cancer
    B.4.2CountryFrance
    B.4.1Name of organisation providing supportBMS
    B.4.2CountryUnited States
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIFCT
    B.5.2Functional name of contact pointIFCT
    B.5.3 Address:
    B.5.3.1Street Address10 rue de la Grange-Batelière
    B.5.3.2Town/ city75009
    B.5.3.3Post codePARIS
    B.5.3.4CountryFrance
    B.5.4Telephone number+33156811045
    B.5.5Fax number+33144830151
    B.5.6E-mailcontact@ifct.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 Erbitux
    D.2.1.1.2Name of the Marketing Authorisation holderMerck KGaA
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 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 INNCETUXIMAB
    D.3.9.1CAS number 205923-56-4
    D.3.9.4EV Substance CodeSUB01178MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number5
    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 No
    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 Yes
    D.3.11.13.1Other medicinal product typeMonoclonal antibody
    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 Giotrif
    D.2.1.1.2Name of the Marketing Authorisation holderBoehringer Ingelheim International GmbH
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNAfatinib
    D.3.9.1CAS number 850140-72-6
    D.3.9.3Other descriptive nameAFATINIB
    D.3.9.4EV Substance CodeSUB32268
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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 No
    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
    Advanced Non Small Cell Lung Cancer with EGFR mutation
    CBNPC avancé porteur d’une mutation EGFR
    E.1.1.1Medical condition in easily understood language
    Advanced Lung cancer with EGFR mutation
    Cancer du poumon muté EGFR de stade avancé
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level PT
    E.1.2Classification code 10029520
    E.1.2Term Non-small cell lung cancer stage IIIA
    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 18.1
    E.1.2Level PT
    E.1.2Classification code 10029522
    E.1.2Term Non-small cell lung cancer 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 18.1
    E.1.2Level PT
    E.1.2Classification code 10029521
    E.1.2Term Non-small cell lung cancer stage IIIB
    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
    Evaluating efficacy and toxicity of the combination of afatinib with cetuximab versus afatinib alone, in first-line treatment of patient with a EGFR mutated NSCLC
    Evaluer l’efficacité et la toxicité de l’association d’afatinib et cetuximab en comparaison à l’afatinib seul, en première ligne de traitement des CBNPC avec mutation EGFR
    E.2.2Secondary objectives of the trial
    Progression free survival
    Overall survival
    Response rate
    Progression free survival for patient with classical EGFR mutation (exon 19 deletion and L858R mutation)
    Toxicities (CTCAE 4.0 criteria)
    Quality of life (EQ-5D)
    • Survie sans progression
    • Survie globale
    • Taux de réponse objective et de contrôle de la maladie
    • Survie sans progression, survie globale et taux de réponse objective pour les patients porteurs de mutations EGFR classiques (délétions dans l’exon 19 et mutation L858R)
    • Toxicité (critères CTCAE 4.0)
    • Qualité de vie (EQ-5D)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    BIO-IFCT-1503 (same protocol), objective : evaluating if detection and quantification of EGFR mutations in circulating DNA permit to appreciate the treatment response and the apparition of resistance.
    BIO-IFCT-1503 (voir protocole) : objectif : évaluer si la détection et la quantification des altérations d’EGR dans l’ADN circulant est un moyen non invasif d’apprécier la réponse au traitement et l’apparition de résistance avant les signes radiologiques.
    E.3Principal inclusion criteria
    Stage III or IV NSCLC, non irradiable non operable
    Non squamous NSCLC histologically or cytologically confirmed
    No previous treatment of NSCLC
    EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q orS768I mutations or exon 19 insertion)
    Presence of at least one lesion that can be measured
    PS 0 or 1
    CBNPC de stade IV ou III, inaccessible à un traitement local (chirurgie ou radiothérapie)
    Diagnostic histologique ou cytologique de CBNPC non épidermoïde
    Absence de traitement anti-néoplasique antérieur systémique pour le CBNPC
    Présence d’une mutation EGFR détectée sur une plateforme INCa (délétions dans l’exon 19, mutation L858R, mutations G719X, L861Q, S768I ou insertions dans l’exon 19).
    Présence d’au moins une lésion mesurable
    PS 0 ou 1
    E.4Principal exclusion criteria
    Symptomatic brain metastasis or requiring immediate radiotherapy
    T790M mutation or exon 20 insertion
    Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
    Interstitial pneumopathy
    Métastases cérébrales symptomatiques ou nécessitant une radiothérapie immédiate
    Présence d’une mutation EGFR T790M ou insertion dans l’exon 20
    Radiothérapie datant de moins de 2 semaines, incluant la radiothérapie réalisée à titre symptomatique
    Présence d’une pneumopathie interstitielle diffuse sous-jacente
    E.5 End points
    E.5.1Primary end point(s)
    Time to treatment failure
    Treatment failure is defined as treatment withdrawal regardless of the reason.
    Survie sans échec du traitement
    L’échec du traitement est défini par l’arrêt du traitement quelle qu’en soit la cause (incluant notamment les arrêts dus à une progression, un décès ou une toxicité).
    E.5.1.1Timepoint(s) of evaluation of this end point
    9 months
    9 mois
    E.5.2Secondary end point(s)
    Progression free survival
    Overall survival
    Response rate
    Progression free survival for patient with classical EGFR mutation (exon 19 deletion and L858R mutation)
    Toxicities (CTCAE 4.0 criteria)
    Quality of life (EQ-5D)
    E.5.2.1Timepoint(s) of evaluation of this end point
    9 months
    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 Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    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 No
    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 concerned35
    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 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
    2 years after registration of the last subject to determine overall survival
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned 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: 100
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 70
    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 state170
    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
    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 Decision2015-11-16
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-11-20
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2020-05-30
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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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