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    Summary
    EudraCT Number:2016-001849-15
    Sponsor's Protocol Code Number:IFCT-1601
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2016-10-19
    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 number2016-001849-15
    A.3Full title of the trial
    A PHASE II PROSPECTIVE IMMUNE NEOADJUVANT THERAPY STUDY OF DURVALUMAB (MEDI4736) IN EARLY STAGE NON-SMALL CELL LUNG CANCER
    Etude de phase II évaluant une immunothérapie néoadjuvante, le durvalumab, chez les patients présentant un Cancer du Poumon Non à Petites cellules de stade limité
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    STUDY OF IMMUNE THERAPY (DURVALUMAB) BEFORE SURGERY IN EARLY STAGE NON SMALL CELL LUNG CANCER
    Etude évaluant une immunothérapie, le durvalumab, avant chirurgie chez les patients présentant un Cancer du Poumon Non à Petites cellules de stade limité
    A.4.1Sponsor's protocol code numberIFCT-1601
    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.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIFCT
    B.5.2Functional name of contact pointContact
    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 number33156811045
    B.5.5Fax number33944830151
    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 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.3.11 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
    Stage IB (> 4 cm), II Non Small Cell Lung Cancer resectable
    E.1.1.1Medical condition in easily understood language
    Lung Cancer resectable
    E.1.1.2Therapeutic area Diseases [C] - Cancer [C04]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level PT
    E.1.2Classification code 10029517
    E.1.2Term Non-small cell lung cancer stage I
    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 19.0
    E.1.2Level PT
    E.1.2Classification code 10029518
    E.1.2Term Non-small cell lung cancer stage II
    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 assess the impact of neo-adjuvant therapy with durvalumab given by intravenous infusion for one month on the complete resection.
    E.2.2Secondary objectives of the trial
    - Tolerance, adverse effects and tolerability of durvalumab.
    - Delay between start of treatment and surgery.
    - Response Rate (RECIST 1.1).
    - Metabolic response rate on TEP-FDG on pre-treatment PET-CT and pre-operative PET-CT after 3 durvalumab infusions, on both primary tumor and eventual nodes.
    - Post-operative adverse events (AE).
    - Pathological response (as assessed by microscopic histological examination, with at least one slide assessed by cm of tumor in the greatest diameter, i.e. 5 to 30 slides assessed). Major Pathological Response on surgical tissue (tumor + nodes) as centrally reviewed by a panel of IFCT Pathologists, on both tumor and resected nodes, and defined as semi-quantitative evaluation of less than 10% or remaining tumor cells, in surgical primary tumor and nodes samples.
    - Disease Free Survival (DFS)
    - Overall survival (OS)
    E.2.3Trial contains a sub-study Yes
    E.2.3.1Full title, date and version of each sub-study and their related objectives
    - Evaluation of predictive/prognostic significance of PD-1/PD-L1 expression (using at least SP263 antibody) on both pre-operative and surgical samples, and both tumor and infiltrating immune cells
    - Evaluation of changes in plasma/serum cytokines and other biomarkers before and after treatment
    E.3Principal inclusion criteria
    - Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.
    - Tissue block of diagnosis must be available for submission after inclusion (one HES slide and one paraffin embedded block).
    - Patients must be classified clinically as Stage IB (> 4cm in the longest diameter), II on the basis of clinical evaluation of 2009 TNM criteria. A pre-surgical PET scan of the thorax and a MRI or CT scan of the brain as well as thorax abdomen pelvis CT scan must be done prior to surgery and before inclusion. If preoperative CT and/or PET are suspicious for mediastinal nodal involvement, invasive mediastinal staging with mediastinoscopy or EBUS-TBNA must be performed. Station 5 or 6 lymph nodes may be accessed by anterior mediastinotomy or VATS.
    - Pre-operative (neo-adjuvant) platinum based or other chemotherapy except the treatment of the protocol is not permissible. Pre-operative radiation therapy is not permissible
    - The patient must have an ECOG performance status of 0, 1.
    E.4Principal exclusion criteria
    - Patients with a history of other malignancies, except: adequately treated non-melanoma skin cancer, curatively treated in-situ cancer, or other solid tumours curatively treated with no evidence of disease for > 5 years following the end of treatment and which, in the opinion of the treating physician, do not have a substantial risk of recurrence of the prior malignancy.
    - A combination of small cell and non-small cell lung cancer or pulmonary carcinoid tumour.
    - History of autoimmune disease, including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener’s granulomatosis, Sjögren’s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave’s disease and/or psoriasis not requiring systemic therapy within the last two years from inclusion are not excluded.
    - History of primary immunodeficiency, history of allogenic organ transplant, use of immunosuppressive agents within 28 days of inclusion* or a prior history of severe (grade 3 or 4) immune mediated toxicity from other immune therapy.
    * NOTE: Intranasal/inhaled corticosteroids or systemic steroids that do not to exceed 10 mg/day of prednisone or equivalent dose of an alternative corticosteroid are permissible.
    - Live attenuated vaccination administered within 30 days prior to inclusion.
    - History of hypersensitivity to durvalumab or any excipient.
    - Mean QTc correction > 470msec using standard institutional method or history of familial long QT syndrome.
    - Patients who have experienced untreated and/or uncontrolled cardiovascular conditions and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart failure, myocardial infarction within the previous year or cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects). Patients with a significant cardiac history, even if controlled, should have a LVEF > 50% within 12 weeks prior to inclusion.
    - Concurrent treatment with other investigational drugs or anti-cancer therapy.
    - Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol. This includes but is not limited to:
    • known prior history of tuberculosis;
    • known acute hepatitis B or C by serological evaluation;
    • known Human immunodeficiency virus infection.
    - Current or prior use of immunosuppressive medication within 28 days before the first dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid
    - Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab
    - Active or prior documented inflammatory bowel disease (e.g., Crohn’s disease, ulcerative colitis)
    - Known history of previous clinical diagnosis of tuberculosis
    E.5 End points
    E.5.1Primary end point(s)
    All gross disease must have been removed at the end of surgery. All surgical margins of resection must be negative for tumour.
    Margins are classified by the pathologist as:
    R0 - no cancerous cells seen microscopically; this is the desired result
    R1 - cancerous cells can be seen microscopically
    R2 - even gross examination by the naked eye shows tumor tissue on the margin, indicating more remains on the patient.
    E.5.1.1Timepoint(s) of evaluation of this end point
    After surgery
    E.5.2Secondary end point(s)
    - Number of adverse effects and tolerability of durvalumab.
    - Delay between start of treatment and surgery.
    - Response Rate (RECIST 1.1).
    - Metabolic response rate on TEP-FDG on pre-treatment PET-CT and pre-operative PET-CT after 3 durvalumab infusions, on both primary tumor and eventual nodes.
    - Post-operative adverse events (AE).
    - Pathological response (as assessed by microscopic histological examination, with at least one slide assessed by cm of tumor in the greatest diameter, i.e. 5 to 30 slides assessed). Major Pathological Response on surgical tissue (tumor + nodes) as centrally reviewed by a panel of IFCT Pathologists, on both tumor and resected nodes, and defined as semi-quantitative evaluation of less than 10% or remaining tumor cells, in surgical primary tumor and nodes samples.
    - Disease Free Survival (DFS)
    - Overall survival (OS)
    E.5.2.1Timepoint(s) of evaluation of this end point
    - 4 weeks after surgery, 6 months and one year.
    - Before surgery
    - Before surgery
    - Before surgery
    - 4 weeks after surgery
    - After surgery
    - 6 months and one year after surgery then yearly
    - 6 months and one year after surgery then yearly
    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.8.2.4Number of treatment arms in the trial1
    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 concerned20
    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
    LVLS
    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 months6
    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: 48
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 33
    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 state81
    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 Decision2016-08-10
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-07-06
    P. End of Trial
    P.End of Trial StatusOngoing
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