<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03030131</url>
  </required_header>
  <id_info>
    <org_study_id>IFCT-1601</org_study_id>
    <nct_id>NCT03030131</nct_id>
  </id_info>
  <brief_title>Immune Neoadjuvant Therapy Study of Durvalumab in Early Stage Non-small Cell Lung Cancer</brief_title>
  <acronym>IONESCO</acronym>
  <official_title>A Phase II Prospective Immune Neoadjuvant Therapy Study od Durvalumab (MEDI4736) in Early Stage Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Intergroupe Francophone de Cancerologie Thoracique</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Intergroupe Francophone de Cancerologie Thoracique</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall&#xD;
      all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA)&#xD;
      NSCLC is curative surgery. Although patients treated with curative surgery have a better&#xD;
      prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging&#xD;
      from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative&#xD;
      chemotherapy versus no chemotherapy have shown a significant overall survival benefit from&#xD;
      postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA.&#xD;
      Likewise other randomized trials have demonstrated preoperative chemotherapy improves&#xD;
      survival and recently the analyses also based on individual patients data of 15 randomized&#xD;
      trials showed a significant benefit of preoperative chemotherapy on survival with the same&#xD;
      survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become&#xD;
      accepted in many countries.&#xD;
&#xD;
      Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an&#xD;
      attractive therapeutic option in the early stage NSCLC, which may reactivate host immune&#xD;
      responses and enable longterm tumor control.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Definitive discontinuation according to safety monitoring of death from the 46th patient&#xD;
    onwards.&#xD;
  </why_stopped>
  <start_date type="Actual">January 12, 2017</start_date>
  <completion_date type="Actual">August 28, 2019</completion_date>
  <primary_completion_date type="Actual">August 28, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Surgical resection R0</measure>
    <time_frame>2 months</time_frame>
    <description>Patient percentage of surgical resection R0 after a maximum of 3 cycles of immune therapy</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate (recist 1.1)</measure>
    <time_frame>After 28 days (3 cycles of immune therapy maximum)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metabolic response rate on TEP-FDG</measure>
    <time_frame>After 28 days (3 cycles of immune therapy maximum)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay between surgery and start of treatment</measure>
    <time_frame>After 28 days (3 cycles of immune therapy maximum)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with treatment-related adverse events as assessed by CTCAE v4.0</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-Free Survival (DFS)</measure>
    <time_frame>1 year</time_frame>
    <description>Time from the date of inclusion to the date of first documented disease relapse or the occurrence of a new invasive primary malignancy or death from any cause</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>1 year</time_frame>
    <description>Time from the inclusion to the date of death of any cause, or censored at their last known alive date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of predictive/prognostic value of PD-1/PD-L1 expression</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of changes in plasma/serum cytokines and other biomarkers</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Pathological Response</measure>
    <time_frame>2 months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Carcinoma, Non-Small-Cell Lung</condition>
  <arm_group>
    <arm_group_label>Durvalumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>durvalumab 750 mg IV J1, J15, J29</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>durvalumab 750 mg IV Day1, 15, 29</description>
    <arm_group_label>Durvalumab</arm_group_label>
    <other_name>MEDI4736</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed diagnosis of primary non-small cell carcinoma of the lung.&#xD;
&#xD;
          -  Tissue block of diagnosis must be available for submission after inclusion (one HES&#xD;
             slide and one paraffin embedded block).&#xD;
&#xD;
          -  Patients must be classified clinically as Stage IB (only T = 4 cm in greatest&#xD;
             dimension, N0), Stage IIA (T2b,N0) and some of Stage IIB : (T1-2,N1) and (T3 : &gt; 5 cm&#xD;
             and ≤ 7 cm in greatest dimension surrounded by lung or associated with separate tumor&#xD;
             nodule(s) in the same lobe but without mediastinum or chest wall involvements, or&#xD;
             superior sulcus tumors, N0) on the basis of clinical evaluation (8th classification&#xD;
             TNM, UICC 2015). In case of invasion of the main bronchus (distance &lt; 2 cm from&#xD;
             carina), a biopsy of the carina is required. A pre-surgical PET scan of the thorax and&#xD;
             a MRI or CT scan of the brain as well as thorax abdomen pelvis CT scan must be done&#xD;
             prior to surgery and before inclusion. If preoperative CT and/or PET are suspicious&#xD;
             for mediastinal nodal involvement, invasive mediastinal staging with mediastinoscopy&#xD;
             or EBUS-TBNA must be performed. Station 5 or 6 lymph nodes may be accessed by anterior&#xD;
             mediastinotomy or VATS.&#xD;
&#xD;
          -  Pre-operative (neo-adjuvant) platinum based or other chemotherapy except the treatment&#xD;
             of the protocol is not permissible. Pre-operative radiation therapy is not permissible&#xD;
&#xD;
          -  The patient must have an ECOG performance status of 0, 1.&#xD;
&#xD;
          -  Hematology (done within 14 days prior to inclusion and with values within the ranges&#xD;
             specified below): If anemic, patients should be asymptomatic and should not be&#xD;
             decompensated. Transfusions are permissible.&#xD;
&#xD;
        Haemoglobin ≥ 9,0 g/dL Absolute neutrophil count &gt; 1.5 x 109/L or &gt; 1,500/µl Platelets &gt;&#xD;
        100 x 109/L or &gt; 100,000/µl&#xD;
&#xD;
        - Biochemistry (done within 14 days prior to inclusion and with values within the ranges&#xD;
        specified below): Total bilirubin* within normal institutional limits Alkaline phosphatase&#xD;
        &lt; 2.5 x institutional upper limit of normal AST(SGOT) and ALT(SGPT) &lt; 2.5 x institutional&#xD;
        upper limit of normal Creatinine Clearance &gt; 40 ml/min TSH within normal institutional&#xD;
        limits&#xD;
&#xD;
        * excluding Gilbert's syndrome&#xD;
&#xD;
        Creatinine clearance to be measured directly by 24 hour urine sampling or as calculated by&#xD;
        Cockcroft Formula:&#xD;
&#xD;
        Females: GFR = 1.04 x (140-age) x weight in kg serum creatinine in μmol/L Males: GFR = 1.23&#xD;
        x (140-age) x weight in kg serum creatinine in μmol/L&#xD;
&#xD;
          -  Other investigations detailed in Section 6 must have been performed within the&#xD;
             timelines indicated.&#xD;
&#xD;
          -  Patient consent must be appropriately obtained in accordance with applicable local and&#xD;
             regulatory requirements. Each patient must sign a consent form prior to inclusion in&#xD;
             the trial to document their willingness to participate.&#xD;
&#xD;
          -  Patients must be accessible for treatment and follow-up. Investigators must assure&#xD;
             themselves the patients included on this trial will be available for complete&#xD;
             documentation of the treatment, adverse events, and follow-up.&#xD;
&#xD;
          -  Protocol treatment is to begin within 7 days of patient inclusion&#xD;
&#xD;
          -  Age of at least 18 years.&#xD;
&#xD;
          -  Female subjects must either be of non-reproductive potential (ie, post-menopausal by&#xD;
             history: ≥60 years old and no menses for ≥ 1 year without an alternative medical&#xD;
             cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history&#xD;
             of bilateral oophorectomy) or must have a negative serum pregnancy test upon study&#xD;
             entry.&#xD;
&#xD;
          -  Females of childbearing potential who are sexually active with a nonsterilized male&#xD;
             partner or men who are sexually active with women of childbearing potential must use a&#xD;
             highly effective method of contraception prior the first dose of investigational&#xD;
             product, and must agree to continue using such precautions for 4 months after the&#xD;
             final dose of investigational product. Periodic abstinence, the rhythm method, and the&#xD;
             withdrawal method are not acceptable methods of contraception.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of other malignancies, except: adequately treated non-melanoma&#xD;
             skin cancer, curatively treated in-situ cancer, or other solid tumours curatively&#xD;
             treated with no evidence of disease for &gt; 5 years following the end of treatment and&#xD;
             which, in the opinion of the treating physician, do not have a substantial risk of&#xD;
             recurrence of the prior malignancy.&#xD;
&#xD;
          -  A combination of small cell and non-small cell lung cancer or pulmonary carcinoid&#xD;
             tumour.&#xD;
&#xD;
          -  History of autoimmune disease, including but not limited to myasthenia gravis,&#xD;
             myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis,&#xD;
             inflammatory bowel disease, vascular thrombosis associated with antiphospholipid&#xD;
             syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome,&#xD;
             multiple sclerosis, vasculitis, or glomerulonephritis. NOTE: patients with Grave's&#xD;
             disease and/or psoriasis not requiring systemic therapy within the last two years from&#xD;
             inclusion are not excluded.&#xD;
&#xD;
          -  History of primary immunodeficiency, history of allogenic organ transplant, use of&#xD;
             immunosuppressive agents within 28 days of inclusion* or a prior history of severe&#xD;
             (grade 3 or 4) immune mediated toxicity from other immune therapy.&#xD;
&#xD;
             * NOTE: Intranasal/inhaled corticosteroids or systemic steroids that do not to exceed&#xD;
             10 mg/day of prednisone or equivalent dose of an alternative corticosteroid are&#xD;
             permissible.&#xD;
&#xD;
          -  Live attenuated vaccination administered within 30 days prior to inclusion.&#xD;
&#xD;
          -  History of hypersensitivity to durvalumab or any excipient.&#xD;
&#xD;
          -  Patients who have experienced untreated and/or uncontrolled cardiovascular conditions&#xD;
             and/or have symptomatic cardiac dysfunction (unstable angina, congestive heart&#xD;
             failure, myocardial infarction within the previous year or cardiac ventricular&#xD;
             arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular&#xD;
             conduction defects). Patients with a significant cardiac history, even if controlled,&#xD;
             should have a LVEF &gt; 50% within 12 weeks prior to inclusion.&#xD;
&#xD;
          -  Concurrent treatment with other investigational drugs or anti-cancer therapy.&#xD;
&#xD;
          -  Patients with active or uncontrolled infections or with serious illnesses or medical&#xD;
             conditions which would not permit the patient to be managed according to the protocol.&#xD;
             This includes but is not limited to:&#xD;
&#xD;
               -  known prior history of tuberculosis;&#xD;
&#xD;
               -  known acute hepatitis B or C by serological evaluation;&#xD;
&#xD;
               -  known Human immunodeficiency virus infection.&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 28 days before the first&#xD;
             dose of durvalumab, with the exceptions of intranasal and inhaled corticosteroids or&#xD;
             systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of&#xD;
             prednisone, or an equivalent corticosteroid&#xD;
&#xD;
          -  Any previous treatment with a PD1 or PD-L1 inhibitor, including durvalumab&#xD;
&#xD;
          -  Active or prior documented inflammatory bowel disease (e.g., Crohn's disease,&#xD;
             ulcerative colitis)&#xD;
&#xD;
          -  Known history of previous clinical diagnosis of tuberculosis&#xD;
&#xD;
          -  Female subjects who are pregnant, breast-feeding or male or female patients of&#xD;
             reproductive potential who are not employing an effective method of birth control&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would interfere with&#xD;
             evaluation of study treatment or interpretation of patient safety or study results&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Amiens - Clinique de l'Europe</name>
      <address>
        <city>Amiens</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Argenteuil - CH</name>
      <address>
        <city>Argenteuil</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bayonne - CH</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bordeaux - Institut Bergonié</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caen - CHU</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Caen - CRLCC</name>
      <address>
        <city>Caen</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chauny - CH</name>
      <address>
        <city>Chauny</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clermont-Ferrand - CHU</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cornebarrieu - Clinique des Cèdres</name>
      <address>
        <city>Cornebarrieu</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Grenoble - CHU</name>
      <address>
        <city>Grenoble</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Le Mans - CHG</name>
      <address>
        <city>Le Mans</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Limoges - CHU</name>
      <address>
        <city>Limoges</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mantes La Jolie - CH</name>
      <address>
        <city>Mantes La Jolie</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AP-HM Hopital Nord</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Marseille - Hôpital Européen</name>
      <address>
        <city>Marseille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metz - Hôpital Robert Schuman</name>
      <address>
        <city>Metz</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mulhouse - CH</name>
      <address>
        <city>Mulhouse</city>
        <zip>68000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nancy - Polyclinique Gentilly</name>
      <address>
        <city>Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nantes - CRLCC</name>
      <address>
        <city>Nantes</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paris - Hopital Tenon</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paris - HEGP</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paris - Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paris - Montsouris</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paris - Saint Joseph</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Paris Bichat</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pau - CHG</name>
      <address>
        <city>Pau</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre René Huguenin</name>
      <address>
        <city>Saint-Cloud</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cancérologie de l'Ouest - site René Gauducheau</name>
      <address>
        <city>Saint-Herblain</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint-Quentin - CH</name>
      <address>
        <city>Saint-Quentin</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Strasbourg - NHC</name>
      <address>
        <city>Strasbourg</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toulouse - CHU Larrey</name>
      <address>
        <city>Toulouse</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.ifct.fr/index.php/fr/la-recherche/item/2041-ifct-1601-ionesco</url>
    <description>Site web</description>
  </link>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>March 10, 2023</last_update_submitted>
  <last_update_submitted_qc>March 10, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>IFCT</keyword>
  <keyword>neodjuvant</keyword>
  <keyword>immune therapy</keyword>
  <keyword>Non small cell lung cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Durvalumab</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>February 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/31/NCT03030131/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03030131
org study id: IFCT-1601
nct id: NCT03030131
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Lung cancer is still the leading cause of cancer related-deaths worldwide, with an overall
      all-stage 5-year survival of approximately 17%. The primary treatment of early stage (I-IIIA)
      NSCLC is curative surgery. Although patients treated with curative surgery have a better
      prognosis, the 5-year survival for patients treated with surgery alone remains low, ranging
      from 67% (stage IA) to 23% (stage IIIA). Several randomized trials comparing postoperative
      chemotherapy versus no chemotherapy have shown a significant overall survival benefit from
      postoperative chemotherapy in completely resected patients with NSCLC stage II and IIIA.
      Likewise other randomized trials have demonstrated preoperative chemotherapy improves
      survival and recently the analyses also based on individual patients data of 15 randomized
      trials showed a significant benefit of preoperative chemotherapy on survival with the same
      survival improvement of 5% at 5 years. Then, neoadjuvant chemotherapy has also become
      accepted in many countries.

      Targeting of PD-1 receptors and its ligand PD-L1, and inhibiting their engagement is an
      attractive therapeutic option in the early stage NSCLC, which may reactivate host immune
      responses and enable longterm tumor control.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Surgical resection R0
time frame: 2 months
description: Patient percentage of surgical resection R0 after a maximum of 3 cycles of immune therapy
measure: Response Rate (recist 1.1)
time frame: After 28 days (3 cycles of immune therapy maximum)
measure: Metabolic response rate on TEP-FDG
time frame: After 28 days (3 cycles of immune therapy maximum)
measure: Delay between surgery and start of treatment
time frame: After 28 days (3 cycles of immune therapy maximum)
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
time frame: 1 month
measure: Disease-Free Survival (DFS)
time frame: 1 year
description: Time from the date of inclusion to the date of first documented disease relapse or the occurrence of a new invasive primary malignancy or death from any cause
measure: Overall survival (OS)
time frame: 1 year
description: Time from the inclusion to the date of death of any cause, or censored at their last known alive date
measure: Evaluation of predictive/prognostic value of PD-1/PD-L1 expression
time frame: 1 month
measure: Evaluation of changes in plasma/serum cytokines and other biomarkers
time frame: 1 month
measure: Major Pathological Response
time frame: 2 months
arm group label: Durvalumab
arm group type: Experimental
description: durvalumab 750 mg IV J1, J15, J29
intervention type: Drug
intervention name: Durvalumab
description: durvalumab 750 mg IV Day1, 15, 29
arm group label: Durvalumab
other name: MEDI4736
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
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country: France
url: http://www.ifct.fr/index.php/fr/la-recherche/item/2041-ifct-1601-ionesco
description: Site web
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Durvalumab
provided document: 