<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/NCT03800134</url>
  </required_header>
  <id_info>
    <org_study_id>D9106C00001</org_study_id>
    <secondary_id>2018-002997-29</secondary_id>
    <nct_id>NCT03800134</nct_id>
  </id_info>
  <brief_title>A Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Non-small Cell Lung Cancer</brief_title>
  <acronym>AEGEAN</acronym>
  <official_title>A Phase III, Double-blind, Placebo-controlled, Multi-center International Study of Neoadjuvant/Adjuvant Durvalumab for the Treatment of Patients With Resectable Stages II and III Non-small Cell Lung Cancer (AEGEAN)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AstraZeneca</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international&#xD;
      study assessing the activity of durvalumab and chemotherapy administered prior to surgery&#xD;
      compared with placebo and chemotherapy administered prior to surgery in terms of pathological&#xD;
      complete response.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 6, 2018</start_date>
  <completion_date type="Anticipated">September 11, 2028</completion_date>
  <primary_completion_date type="Actual">November 10, 2022</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pathological Complete Response (pCR) in modified intent-to-treat (mITT)</measure>
    <time_frame>From screening pathology to an average of 15 weeks after first dose.</time_frame>
    <description>Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Event-Free Survival (EFS)</measure>
    <time_frame>Up to 5.5 years after first patient randomized.</time_frame>
    <description>An event defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease-free survival (DFS) in modified resected population</measure>
    <time_frame>From date of randomization to 5.5 years after date of resection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Pathological Response (mPR)</measure>
    <time_frame>From screening pathology to an average of 15 weeks after first dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From date of randomization to 5.5 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Event-free survival (EFS) in PD-L1-TC ≥1% positive patients</measure>
    <time_frame>From date of randomization to 5.5 years after randomization</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pCR in PD-L1-TC ≥1% positive patients</measure>
    <time_frame>From screening pathology to an average of 15 weeks after first dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients</measure>
    <time_frame>From date of randomization to 5.5 years after date of resection</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients</measure>
    <time_frame>From screening pathology to an average of 15 weeks after first dose.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) in PD-L1-TC ≥1% positive patients</measure>
    <time_frame>From date of randomization to 5.5 years after randomization.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery</measure>
    <time_frame>From date of screening to 6 months after last dose of IP</time_frame>
    <description>To assess disease-related symptoms, functioning, and global health status/quality of life in patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery</measure>
    <time_frame>From date of screening to 6 months after last dose of IP</time_frame>
    <description>To assess disease-related symptoms, functioning, and global health status/quality of life in patients.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess the PK of durvalumab in blood (through concentration)</measure>
    <time_frame>From date of randomization to 2 months after resection</time_frame>
    <description>To assess concentration of durvalumab in bloodstream.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of ADA for durvalumab</measure>
    <time_frame>From date of randomization to 3 months after last dose of IP</time_frame>
    <description>To evaluate the presence of antibodies following treatment with study medications.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Number of participants with all adverse events as assessed by CTCAE v5.0</measure>
    <time_frame>64 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">826</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Arm 1: Durvalumab + platinum-based chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy.&#xD;
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:&#xD;
carboplatin/paclitaxel&#xD;
cisplatin/gemcitabine&#xD;
pemetrexed/cisplatin&#xD;
pemetrexed/carboplatin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2: Placebo + platinum-based chemotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo in concurrence with platinum-based chemotherapy.&#xD;
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:&#xD;
carboplatin/paclitaxel&#xD;
cisplatin/gemcitabine&#xD;
pemetrexed/cisplatin&#xD;
pemetrexed/carboplatin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>Durvalumab IV (intravenous infusion)</description>
    <arm_group_label>Arm 1: Durvalumab + platinum-based chemotherapy</arm_group_label>
    <other_name>MEDI4736</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo IV (intravenous infusion)</description>
    <arm_group_label>Arm 2: Placebo + platinum-based chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin/Paclitaxel</intervention_name>
    <description>Carboplatin/Paclitaxel, as per standard of care</description>
    <arm_group_label>Arm 1: Durvalumab + platinum-based chemotherapy</arm_group_label>
    <arm_group_label>Arm 2: Placebo + platinum-based chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin/Gemcitabine</intervention_name>
    <description>Cisplatin/Gemcitabine, as per standard of care</description>
    <arm_group_label>Arm 1: Durvalumab + platinum-based chemotherapy</arm_group_label>
    <arm_group_label>Arm 2: Placebo + platinum-based chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed/Cisplatin</intervention_name>
    <description>Pemetrexed/Cisplatin, as per standard of care</description>
    <arm_group_label>Arm 1: Durvalumab + platinum-based chemotherapy</arm_group_label>
    <arm_group_label>Arm 2: Placebo + platinum-based chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed/Carboplatin</intervention_name>
    <description>Pemetrexed/Carboplatin, as per standard of care</description>
    <arm_group_label>Arm 1: Durvalumab + platinum-based chemotherapy</arm_group_label>
    <arm_group_label>Arm 2: Placebo + platinum-based chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years&#xD;
&#xD;
          -  Newly diagnosed and previously untreated patients with histologically or cytologically&#xD;
             documented NSCLC with resectable (Stage IIA to select [ie, N2] Stage IIIB) disease&#xD;
&#xD;
          -  World Health Organization (WHO)/ECOG PS of 0 or 1 at enrollment&#xD;
&#xD;
          -  At least 1 lesion, not previously irradiated, that qualifies as a RECIST 1.1 Target&#xD;
             Lesion (TL) at baseline&#xD;
&#xD;
          -  No prior exposure to immune-mediated therapy including, but not limited to, other&#xD;
             anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-PD-L2 antibodies, excluding therapeutic&#xD;
             anticancer vaccines&#xD;
&#xD;
          -  Adequate organ and marrow function&#xD;
&#xD;
          -  Confirmation of a patient's tumour PD-L1 status&#xD;
&#xD;
          -  Provision of sufficient tumour biopsy sample for evaluation and confirmation of EGFR&#xD;
             and ALK status&#xD;
&#xD;
          -  Planned surgery must comprise lobectomy, sleeve resection, or bilobectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of allogeneic organ transplantation&#xD;
&#xD;
          -  Active or prior documented autoimmune or inflammatory disorders (including&#xD;
             inflammatory bowel disease, diverticulitis, systemic lupus erythematosus, Sarcoidosis&#xD;
             syndrome, or Wegener syndrome)&#xD;
&#xD;
          -  History of another primary malignancy&#xD;
&#xD;
          -  History of active primary immunodeficiency&#xD;
&#xD;
          -  Active infection including tuberculosis hepatitis B and C, or human immunodeficiency&#xD;
             virus&#xD;
&#xD;
          -  Deemed unresectable NSCLC by multidisciplinary evaluation&#xD;
&#xD;
          -  Patients who have pre-operative radiotherapy treatment as part of their care plan&#xD;
&#xD;
          -  Patients who have brain metastases or spinal cord compression&#xD;
&#xD;
          -  Stage IIIB N3 and Stages IIIC, IVA, and IVB NSCLC&#xD;
&#xD;
          -  Known allergy or hypersensitivity to any of the study drugs or excipients&#xD;
&#xD;
          -  Existence of more than one primary tumour such as mixed small cell and NSCLC histology&#xD;
&#xD;
          -  Patients whose planned surgery at enrollment includes any of the following procedures:&#xD;
             pneumonectomy, segmentectomies, or wedge resections&#xD;
&#xD;
          -  Patients with a documented test result confirming the presence of EGFRm or ALK&#xD;
             translocation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Heymach, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT MD Anderson Cancer Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orange</city>
        <state>California</state>
        <zip>92868</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80012</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32256</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ashland</city>
        <state>Kentucky</state>
        <zip>41101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Silver Spring</city>
        <state>Maryland</state>
        <zip>20910</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Towson</city>
        <state>Maryland</state>
        <zip>21204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07962</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10028</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Port Jefferson Station</city>
        <state>New York</state>
        <zip>11776</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bend</city>
        <state>Oregon</state>
        <zip>97701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Medford</city>
        <state>Oregon</state>
        <zip>97504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29424</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kirkland</city>
        <state>Washington</state>
        <zip>98034</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Buenos Aires</city>
        <zip>C1118AAT</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caba</city>
        <zip>C1012AAR</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Caba</city>
        <zip>C1280AEB</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Plata</city>
        <zip>1900</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pergamino</city>
        <zip>B2700CPM</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rosario</city>
        <zip>S2000DEJ</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>San Salvador de Jujuy</city>
        <zip>4600</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Viedma</city>
        <zip>R8500ACE</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Graz</city>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rankweil</city>
        <zip>6830</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Wien</city>
        <zip>1210</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
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      <address>
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  </location>
  <location>
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      <address>
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  <location>
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      <name>Research Site</name>
      <address>
        <city>Verona</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Habikino-shi</city>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
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  <location>
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  <location>
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  <location>
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  <location>
    <facility>
      <name>Research Site</name>
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  <location>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
      <address>
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  <location>
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      <name>Research Site</name>
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  <location>
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      <name>Research Site</name>
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  <location>
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      <name>Research Site</name>
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      <name>Research Site</name>
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    <facility>
      <name>Research Site</name>
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  <location>
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      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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    <facility>
      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
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      <name>Research Site</name>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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  <location>
    <facility>
      <name>Research Site</name>
      <address>
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      <address>
        <city>Alicante</city>
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    </facility>
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      <address>
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        <zip>10330</zip>
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      <name>Research Site</name>
      <address>
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    </facility>
  </location>
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    <facility>
      <name>Research Site</name>
      <address>
        <city>Chiang Rai</city>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Khon Kaen</city>
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    </facility>
  </location>
  <location>
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      <name>Research Site</name>
      <address>
        <city>Lampang</city>
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  <location>
    <facility>
      <name>Research Site</name>
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  <location>
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      <name>Research Site</name>
      <address>
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    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
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      </address>
    </facility>
  </location>
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    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Bulgaria</country>
    <country>Canada</country>
    <country>Chile</country>
    <country>China</country>
    <country>Costa Rica</country>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>India</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Mexico</country>
    <country>Netherlands</country>
    <country>Peru</country>
    <country>Philippines</country>
    <country>Poland</country>
    <country>Romania</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Thailand</country>
    <country>United States</country>
    <country>Vietnam</country>
  </location_countries>
  <removed_countries>
    <country>Puerto Rico</country>
    <country>Ukraine</country>
  </removed_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Resectable Non-small Cell Lung Cancer, NSCLC, Carcinoma, 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>Paclitaxel</mesh_term>
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Durvalumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:&#xD;
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
    <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
    <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
  </patient_data>
  <!-- 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/NCT03800134
org study id: D9106C00001
secondary id: 2018-002997-29
nct id: NCT03800134
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a Phase III, randomized, double-blind, placebo-controlled, multi-center international
      study assessing the activity of durvalumab and chemotherapy administered prior to surgery
      compared with placebo and chemotherapy administered prior to surgery in terms of pathological
      complete response.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Pathological Complete Response (pCR) in modified intent-to-treat (mITT)
time frame: From screening pathology to an average of 15 weeks after first dose.
description: Defined as the lack of any viable tumour cells after complete evaluation in the resected lung cancer specimen and all sampled regional lymph nodes.
measure: Event-Free Survival (EFS)
time frame: Up to 5.5 years after first patient randomized.
description: An event defined as documented RECIST 1.1 local or distant recurrence of lung cancer; death due to any cause; disease progression that precludes surgery or discovered upon attempting surgery that prevents completion of surgery.
measure: Disease-free survival (DFS) in modified resected population
time frame: From date of randomization to 5.5 years after date of resection
measure: Major Pathological Response (mPR)
time frame: From screening pathology to an average of 15 weeks after first dose.
measure: Overall Survival (OS)
time frame: From date of randomization to 5.5 years after randomization
measure: Event-free survival (EFS) in PD-L1-TC ≥1% positive patients
time frame: From date of randomization to 5.5 years after randomization
measure: pCR in PD-L1-TC ≥1% positive patients
time frame: From screening pathology to an average of 15 weeks after first dose
measure: Disease-Free Survival (DFS) in PD-L1-TC ≥1% positive patients
time frame: From date of randomization to 5.5 years after date of resection
measure: Major Pathological Response (mPR) in PD-L1-TC ≥1% positive patients
time frame: From screening pathology to an average of 15 weeks after first dose.
measure: Overall Survival (OS) in PD-L1-TC ≥1% positive patients
time frame: From date of randomization to 5.5 years after randomization.
measure: To assess disease-related symptoms and HRQoL (EORTC QLQ-C30) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
time frame: From date of screening to 6 months after last dose of IP
description: To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
measure: To assess disease-related symptoms and HRQoL (EORTC QLQ-LC13) in patients treated with durva + chemo prior to surgery followed by durva post-surgery compared with placebo + chemo prior to surgery followed by placebo post-surgery
time frame: From date of screening to 6 months after last dose of IP
description: To assess disease-related symptoms, functioning, and global health status/quality of life in patients.
measure: To assess the PK of durvalumab in blood (through concentration)
time frame: From date of randomization to 2 months after resection
description: To assess concentration of durvalumab in bloodstream.
measure: Presence of ADA for durvalumab
time frame: From date of randomization to 3 months after last dose of IP
description: To evaluate the presence of antibodies following treatment with study medications.
measure: Number of participants with all adverse events as assessed by CTCAE v5.0
time frame: 64 months
arm group label: Arm 1: Durvalumab + platinum-based chemotherapy
arm group type: Experimental
description: Durvalumab (MEDI4736) in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:
carboplatin/paclitaxel
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin
arm group label: Arm 2: Placebo + platinum-based chemotherapy
arm group type: Placebo Comparator
description: Placebo in concurrence with platinum-based chemotherapy.
All patients will receive 1 of the following platinum-based standard of care chemotherapy options, based on tumour histology and Investigator discretion:
carboplatin/paclitaxel
cisplatin/gemcitabine
pemetrexed/cisplatin
pemetrexed/carboplatin
intervention type: Drug
intervention name: Durvalumab
description: Durvalumab IV (intravenous infusion)
arm group label: Arm 1: Durvalumab + platinum-based chemotherapy
other name: MEDI4736
intervention type: Other
intervention name: Placebo
description: Placebo IV (intravenous infusion)
arm group label: Arm 2: Placebo + platinum-based chemotherapy
intervention type: Drug
intervention name: Carboplatin/Paclitaxel
description: Carboplatin/Paclitaxel, as per standard of care
arm group label: Arm 1: Durvalumab + platinum-based chemotherapy
arm group label: Arm 2: Placebo + platinum-based chemotherapy
intervention type: Drug
intervention name: Cisplatin/Gemcitabine
description: Cisplatin/Gemcitabine, as per standard of care
arm group label: Arm 1: Durvalumab + platinum-based chemotherapy
arm group label: Arm 2: Placebo + platinum-based chemotherapy
intervention type: Drug
intervention name: Pemetrexed/Cisplatin
description: Pemetrexed/Cisplatin, as per standard of care
arm group label: Arm 1: Durvalumab + platinum-based chemotherapy
arm group label: Arm 2: Placebo + platinum-based chemotherapy
intervention type: Drug
intervention name: Pemetrexed/Carboplatin
description: Pemetrexed/Carboplatin, as per standard of care
arm group label: Arm 1: Durvalumab + platinum-based chemotherapy
arm group label: Arm 2: Placebo + platinum-based chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 120 Years
healthy volunteers: No
last name: John Heymach, MD
role: Principal Investigator
affiliation: UT MD Anderson Cancer Institute
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country: Argentina
country: Austria
country: Belgium
country: Brazil
country: Bulgaria
country: Canada
country: Chile
country: China
country: Costa Rica
country: France
country: Germany
country: Hungary
country: India
country: Italy
country: Japan
country: Korea, Republic of
country: Mexico
country: Netherlands
country: Peru
country: Philippines
country: Poland
country: Romania
country: Russian Federation
country: Spain
country: Taiwan
country: Thailand
country: United States
country: Vietnam
country: Puerto Rico
country: Ukraine
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Cisplatin
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Pemetrexed
mesh term: Durvalumab
sharing ipd: Yes
ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd access criteria: When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home