<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/NCT03822351</url>
  </required_header>
  <id_info>
    <org_study_id>D9108C00001</org_study_id>
    <nct_id>NCT03822351</nct_id>
  </id_info>
  <brief_title>Durvalumab Alone or in Combination With Novel Agents in Subjects With NSCLC</brief_title>
  <acronym>COAST</acronym>
  <official_title>A Phase 2 Open-label, Multicenter, Randomized, Multidrug Platform Study of Durvalumab (MEDI4736) Alone or in Combination With Novel Agents in Subjects With Locally Advanced, Unresectable (Stage III) Non-small Cell Lung Cancer (COAST)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>MedImmune LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>MedImmune LLC</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to compare the clinical activity of durvalumab alone vs&#xD;
      durvalumab in combination with novel agents. The overall study goal is early identification&#xD;
      of novel durvalumab combinations that are more active than durvalumab alone in the treatment&#xD;
      of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug&#xD;
      platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in&#xD;
      combination with novel agents in subjects with locally advanced, unresectable, Stage III&#xD;
      non-small cell lung cancer (NSCLC).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 19, 2018</start_date>
  <completion_date type="Anticipated">June 21, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 21, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <intervention_model_description>At study onset subjects will be randomized equally to all study treatment arms open for enrollment and will remain on study treatment for up to 12 months.&#xD;
Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other reason. The treatment arms are Control Arm, Arm A and Arm B.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response (OR) rate as a measure of antitumor activity of durvalumab alone vs durvalumab in combination with novel agents</measure>
    <time_frame>ORR at 16weeks after randomization is the timing for radiologic assessment of the primary endpoint</time_frame>
    <description>Best overall response of confirmed CR or confirmed PR according to RECIST v1.1</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of Adverse Events as a measure of safety during the treatment period</measure>
    <time_frame>From time of informed consent through treatment period (12 months) or up to 3 months post last dose of study treatment</time_frame>
    <description>The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DoR) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents</measure>
    <time_frame>From time of first documented response until disease progression or up to a maximum of 5 years after randomization</time_frame>
    <description>The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only subjects who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control (DC) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents</measure>
    <time_frame>From time of randomization until disease progression or up to a maximum of 5 years</time_frame>
    <description>confirmed CR, confirmed PR, or SD based on RECIST v1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-Free Survival (PFS) and Progression-Free Survival 12 month landmark rate (PFS-12) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents</measure>
    <time_frame>From time of randomization until disease progression or up to a maximum of 5 years</time_frame>
    <description>From randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum durvalumab concentration levels</measure>
    <time_frame>From randomization up to 15 months after first treatment</time_frame>
    <description>Pharmacokinetics of durvalumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serum concentration levels of durvalumab or novel agents</measure>
    <time_frame>From randomization up to 15 months after first treatment</time_frame>
    <description>Pharmacokinetics of durvalumab alone and/or in combination with novel agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of detectable anti-drug antibody (ADA) to durvalumab</measure>
    <time_frame>From randomization up to 15 months after first treatment</time_frame>
    <description>Immunogenicity of durvalumab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Development of detectable anti-drug antibody (ADA) to durvalumab or novel biologic agents</measure>
    <time_frame>From randomization up to 15 months after first treatment</time_frame>
    <description>Immunogenicity of durvalumab alone and/or in combination with novel biologic agents</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinically significant laboratory values as a measure of safety</measure>
    <time_frame>From screening until disease progression or death, up to a maximum of 5 years after randomization</time_frame>
    <description>Assess the presence of clinically significant laboratory values taken at times indicated in the assessment schedule from baseline in terms of number of patients with abnormal values</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence of clinically significant vital sign values as a measure of safety</measure>
    <time_frame>From screening until disease progression or death, up to a maximum of 5 years after randomization</time_frame>
    <description>Assess the presence of clinically significant vital sign values from baseline</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">188</enrollment>
  <condition>Stage III Non-small Cell Lung Cancer</condition>
  <condition>Unresectable</condition>
  <arm_group>
    <arm_group_label>Control Arm (Durvalumab monotherapy)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>durvalumab IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm A (durvalumab + oleclumab):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>durvalumab IV and oleclumab IV</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B (durvalumab + monalizumab)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>durvalumab IV and monalizumab IV</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab + Oleclumab</intervention_name>
    <description>Durvalumab + Oleclumab</description>
    <arm_group_label>Arm A (durvalumab + oleclumab):</arm_group_label>
    <other_name>Durvalumab (MEDI-4736)</other_name>
    <other_name>Oleclumab (MEDI-9447)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>Durvalumab</description>
    <arm_group_label>Control Arm (Durvalumab monotherapy)</arm_group_label>
    <other_name>Durvalumab (MEDI-4736)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab + Monalizumab</intervention_name>
    <description>Durvalumab + Monalizumab</description>
    <arm_group_label>Arm B (durvalumab + monalizumab)</arm_group_label>
    <other_name>Durvalumab (MEDI-4736)</other_name>
    <other_name>Monalizumab (IPH2201)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Main Inclusion Criteria:&#xD;
&#xD;
          1. Written informed consent and any locally required authorization obtained from the&#xD;
             subject prior to performing any protocol-related procedures, including screening&#xD;
             evaluation&#xD;
&#xD;
          2. Age 18 years or older&#xD;
&#xD;
          3. Body weight ≥ 35 kg&#xD;
&#xD;
          4. Subjects must have histologically or cytologically documented NSCLC who present with&#xD;
             locally advanced, unresectable, Stage III disease&#xD;
&#xD;
          5. Subjects must have completed, without progressing, definitive cCRT within 42 days&#xD;
             prior to being randomized into the study:&#xD;
&#xD;
          6. Provision of tumor tissue sample, when available, from original diagnosis obtained&#xD;
             before initiation of chemoradiotherapy&#xD;
&#xD;
          7. Life expectancy ≥ 12 weeks&#xD;
&#xD;
          8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1&#xD;
&#xD;
          9. Subjects must have at least one previously irradiated tumor lesion that can be&#xD;
             measured by RECIST v1.1&#xD;
&#xD;
        Main Exclusion Criteria:&#xD;
&#xD;
          1. Mixed small cell and non-small cell lung cancer histology&#xD;
&#xD;
          2. Current or prior use of immunosuppressive medication within 14 days before the first&#xD;
             dose of study drug.&#xD;
&#xD;
          3. Prior exposure to any anti-PD1, anti-PD-L1, or anti-CTLA4 antibody for treatment of&#xD;
             NSCLC&#xD;
&#xD;
          4. Subjects with history of ≥ Grade 2 pneumonitis from prior chemoradiation therapy&#xD;
&#xD;
          5. Subjects with a history of venous thrombosis within the past 3 months&#xD;
&#xD;
          6. Subjects with history of myocardial infarction, transient ischemic attack, or stroke&#xD;
             in the past 6 months&#xD;
&#xD;
          7. Congestive heart failure&#xD;
&#xD;
          8. Active or prior documented autoimmune or inflammatory disorders&#xD;
&#xD;
          9. History of active primary immunodeficiency&#xD;
&#xD;
         10. Active infection including tuberculosis, hepatitis B, hepatitis C, or human&#xD;
             immunodeficiency virus (HIV)&#xD;
&#xD;
         11. History of allogenic organ transplantation&#xD;
&#xD;
         12. QTcF interval ≥ 470 ms&#xD;
&#xD;
         13. History of another primary malignancy&#xD;
&#xD;
         14. Concurrent enrollment in another therapeutic clinical study or during the follow-up&#xD;
             period of an interventional study. Enrollment in observational studies will be allowed&#xD;
&#xD;
         15. Females who are pregnant, lactating, or intend to become pregnant during their&#xD;
             participation in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Anaheim</city>
        <state>California</state>
        <zip>92801</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>Sacramento</city>
        <state>California</state>
        <zip>95825</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>West Haven</city>
        <state>Connecticut</state>
        <zip>06516</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Winter Haven</city>
        <state>Florida</state>
        <zip>33881</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>Lexington</city>
        <state>Kentucky</state>
        <zip>40503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Baton Rouge</city>
        <state>Louisiana</state>
        <zip>70809</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Covington</city>
        <state>Louisiana</state>
        <zip>70433</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rosedale</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</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>Portland</city>
        <state>Oregon</state>
        <zip>97227-1191</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gettysburg</city>
        <state>Pennsylvania</state>
        <zip>17325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lancaster</city>
        <state>Pennsylvania</state>
        <zip>17601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Germantown</city>
        <state>Tennessee</state>
        <zip>38138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Memphis</city>
        <state>Tennessee</state>
        <zip>38120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Edmonton</city>
        <state>Alberta</state>
        <zip>T6G 1Z2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5G 2M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bordeaux Cedex</city>
        <zip>33076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Bron</city>
        <zip>69677</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Creteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>La Rochelle Cedex</city>
        <zip>17019</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lille</city>
        <zip>59037</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Limoges Cedex</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lyon Cedex 04</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Marseille Cedex 20</city>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Nice</city>
        <zip>06189</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Rennes Cedex 9</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Strasbourg Cedex</city>
        <zip>67085</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Hong Kong</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Jordan</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Kowloon</city>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Catania</city>
        <zip>95125</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Cremona</city>
        <zip>26100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milano</city>
        <zip>20132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Milano</city>
        <zip>20133</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Palermo</city>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Siena</city>
        <zip>53100</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Gdynia</city>
        <zip>81-519</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-153</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lodz</city>
        <zip>90-242</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1400-038</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Lisboa</city>
        <zip>1500-650</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto</city>
        <zip>4099-001</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Porto</city>
        <zip>4200-072</zip>
        <country>Portugal</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>A Coruña</city>
        <zip>15006</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Badajoz</city>
        <zip>06008</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Barcelona</city>
        <zip>08916</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Castelló de la Plana</city>
        <zip>12002</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Madrid</city>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Málaga</city>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Valencia</city>
        <zip>46014</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Chiayi</city>
        <zip>61363</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>Taichung</city>
        <zip>402</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>France</country>
    <country>Hong Kong</country>
    <country>Italy</country>
    <country>Poland</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>December 10, 2018</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <last_update_submitted>February 17, 2023</last_update_submitted>
  <last_update_submitted_qc>February 17, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Locally Advanced NSCLC</keyword>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>Cancer</keyword>
  <keyword>Lung</keyword>
  <keyword>Unresectable</keyword>
  <keyword>Stage III</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>
    <mesh_term>Antibodies, Monoclonal</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: 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 rerefer 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 de-identified 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/NCT03822351
org study id: D9108C00001
nct id: NCT03822351
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to compare the clinical activity of durvalumab alone vs
      durvalumab in combination with novel agents. The overall study goal is early identification
      of novel durvalumab combinations that are more active than durvalumab alone in the treatment
      of patients with unresectable, Stage III NSCLC who have not progressed after cCRT.
Study D9108C00001 (COAST) is a Phase 2, open-label, multicenter, randomized multidrug
      platform study assessing the efficacy and safety of durvalumab alone vs durvalumab in
      combination with novel agents in subjects with locally advanced, unresectable, Stage III
      non-small cell lung cancer (NSCLC).
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: At study onset subjects will be randomized equally to all study treatment arms open for enrollment and will remain on study treatment for up to 12 months.
Study treatment will be discontinued upon disease progression, unacceptable toxicity, or other reason. The treatment arms are Control Arm, Arm A and Arm B.
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response (OR) rate as a measure of antitumor activity of durvalumab alone vs durvalumab in combination with novel agents
time frame: ORR at 16weeks after randomization is the timing for radiologic assessment of the primary endpoint
description: Best overall response of confirmed CR or confirmed PR according to RECIST v1.1
measure: Incidence of Adverse Events as a measure of safety during the treatment period
time frame: From time of informed consent through treatment period (12 months) or up to 3 months post last dose of study treatment
description: The secondary endpoint of safety as assessed by the presence of adverse events and serious adverse events
measure: Duration of Response (DoR) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
time frame: From time of first documented response until disease progression or up to a maximum of 5 years after randomization
description: The duration from the first documentation of a subsequently confirmed OR to the first documentation of a disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first. Only subjects who have achieved OR (confirmed CR or confirmed PR) will be evaluated for DoR
measure: Disease Control (DC) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
time frame: From time of randomization until disease progression or up to a maximum of 5 years
description: confirmed CR, confirmed PR, or SD based on RECIST v1.1
measure: Progression-Free Survival (PFS) and Progression-Free Survival 12 month landmark rate (PFS-12) as a measure of efficacy of durvalumab alone vs durvalumab in combination with novel agents
time frame: From time of randomization until disease progression or up to a maximum of 5 years
description: From randomization until the first documentation of disease progression according to RECIST v1.1 or death due to any cause, whichever occurs first
measure: Serum durvalumab concentration levels
time frame: From randomization up to 15 months after first treatment
description: Pharmacokinetics of durvalumab
measure: Serum concentration levels of durvalumab or novel agents
time frame: From randomization up to 15 months after first treatment
description: Pharmacokinetics of durvalumab alone and/or in combination with novel agents
measure: Development of detectable anti-drug antibody (ADA) to durvalumab
time frame: From randomization up to 15 months after first treatment
description: Immunogenicity of durvalumab
measure: Development of detectable anti-drug antibody (ADA) to durvalumab or novel biologic agents
time frame: From randomization up to 15 months after first treatment
description: Immunogenicity of durvalumab alone and/or in combination with novel biologic agents
measure: Number of patients with clinically significant laboratory values as a measure of safety
time frame: From screening until disease progression or death, up to a maximum of 5 years after randomization
description: Assess the presence of clinically significant laboratory values taken at times indicated in the assessment schedule from baseline in terms of number of patients with abnormal values
measure: Incidence of clinically significant vital sign values as a measure of safety
time frame: From screening until disease progression or death, up to a maximum of 5 years after randomization
description: Assess the presence of clinically significant vital sign values from baseline
arm group label: Control Arm (Durvalumab monotherapy)
arm group type: Experimental
description: durvalumab IV
arm group label: Arm A (durvalumab + oleclumab):
arm group type: Experimental
description: durvalumab IV and oleclumab IV
arm group label: Arm B (durvalumab + monalizumab)
arm group type: Experimental
description: durvalumab IV and monalizumab IV
intervention type: Drug
intervention name: Durvalumab + Oleclumab
description: Durvalumab + Oleclumab
arm group label: Arm A (durvalumab + oleclumab):
other name: Durvalumab (MEDI-4736)
other name: Oleclumab (MEDI-9447)
intervention type: Drug
intervention name: Durvalumab
description: Durvalumab
arm group label: Control Arm (Durvalumab monotherapy)
other name: Durvalumab (MEDI-4736)
intervention type: Drug
intervention name: Durvalumab + Monalizumab
description: Durvalumab + Monalizumab
arm group label: Arm B (durvalumab + monalizumab)
other name: Durvalumab (MEDI-4736)
other name: Monalizumab (IPH2201)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: France
country: Hong Kong
country: Italy
country: Poland
country: Portugal
country: Spain
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Durvalumab
mesh term: Antibodies, Monoclonal
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 rerefer 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 de-identified 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