<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/NCT02998528</url>
  </required_header>
  <id_info>
    <org_study_id>CA209-816</org_study_id>
    <secondary_id>2016-003536-21</secondary_id>
    <nct_id>NCT02998528</nct_id>
  </id_info>
  <brief_title>A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)</brief_title>
  <acronym>CheckMate 816</acronym>
  <official_title>Randomized, OpenLabel, Phase 3 Trial of Nivolumab Plus Ipilimumab or Nivolumab Plus Platinum Doublet Chemotherapy Versus Platinum Doublet Chemotherapy in Early Stage NSCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ono Pharmaceutical Co. Ltd</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Bristol-Myers Squibb</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>
      The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and&#xD;
      chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus&#xD;
      ipilimumab's safety and effectiveness in treating resectable NSCLC.&#xD;
&#xD;
      This study has multiple primary endpoints.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 4, 2017</start_date>
  <completion_date type="Anticipated">November 8, 2028</completion_date>
  <primary_completion_date type="Actual">September 8, 2021</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>Yes</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Event-Free Survival (EFS)</measure>
    <time_frame>From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)</time_frame>
    <description>Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pathologic Complete Response (pCR) Rate</measure>
    <time_frame>From randomization up to a median of 30 months after randomization.</time_frame>
    <description>Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major Pathologic Response (MPR) Rate</measure>
    <time_frame>From randomization up to a median of 30 months after randomization.</time_frame>
    <description>Major pathologic response (MPR) rate is defined as number of randomized participants with &lt;/= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>From randomization to the date of death</time_frame>
    <description>Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Death or Distant Metastases (TTDM)</measure>
    <time_frame>From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)</time_frame>
    <description>TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">505</enrollment>
  <condition>Non Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Specified dose on specified days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nivolumab plus platinum doublet chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Specified dose on specified days</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nivolumab plus Ipilimumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Specified dose on specified days</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Nivolumab plus Ipilimumab</arm_group_label>
    <arm_group_label>Nivolumab plus platinum doublet chemotherapy</arm_group_label>
    <other_name>BMS-936558</other_name>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Nivolumab plus platinum doublet chemotherapy</arm_group_label>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gemcitabine</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Nivolumab plus platinum doublet chemotherapy</arm_group_label>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Nivolumab plus platinum doublet chemotherapy</arm_group_label>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Nivolumab plus platinum doublet chemotherapy</arm_group_label>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Specified dose on specified days</description>
    <arm_group_label>Nivolumab plus platinum doublet chemotherapy</arm_group_label>
    <arm_group_label>Platinum doublet chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ipilimumab</intervention_name>
    <description>This arm is closed and no longer enrolling patients.</description>
    <arm_group_label>Nivolumab plus Ipilimumab</arm_group_label>
    <other_name>BMS-734016</other_name>
    <other_name>Yervoy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Early stage IB-IIIA, operable non-small cell lung cancer, confirmed in tissue&#xD;
&#xD;
          -  Lung function capacity capable of tolerating the proposed lung surgery&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1&#xD;
&#xD;
          -  Available tissue of primary lung tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of locally advanced, inoperable or metastatic disease&#xD;
&#xD;
          -  Participants with active, known or suspected autoimmune disease&#xD;
&#xD;
          -  Prior treatment with any drug that targets T cell co-stimulations pathways (such as&#xD;
             checkpoint inhibitors)&#xD;
&#xD;
        Other protocol defined inclusion/exclusion criteria apply&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bristol-Myers Squibb</last_name>
    <role>Study Director</role>
    <affiliation>Bristol-Myers Squibb</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Local Institution - 0121</name>
      <address>
        <city>Glendale</city>
        <state>Arizona</state>
        <zip>85308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0081</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0025</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0007</name>
      <address>
        <city>Plainville</city>
        <state>Connecticut</state>
        <zip>06062</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Regional Hospital</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0136</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Of Florida</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Orlando Health, Inc.</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32806</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indian River Medical Center</name>
      <address>
        <city>Vero Beach</city>
        <state>Florida</state>
        <zip>32960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Georgia Oncology Center, P.C.</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0015</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60611</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0002</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois Cancer Specialists</name>
      <address>
        <city>Niles</city>
        <state>Illinois</state>
        <zip>60714</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0171</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0170</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0186</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center New Orleans</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0151</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0001</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0006</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0008</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southcoast Center For Cancer</name>
      <address>
        <city>Fairhaven</city>
        <state>Massachusetts</state>
        <zip>02719</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0012</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202-2608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0090</name>
      <address>
        <city>Hattiesburg</city>
        <state>Mississippi</state>
        <zip>39401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent Frontier Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0009</name>
      <address>
        <city>Hackensack</city>
        <state>New Jersey</state>
        <zip>07601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Hospital Luckow Pavili</name>
      <address>
        <city>Westwood</city>
        <state>New Jersey</state>
        <zip>07675</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0027</name>
      <address>
        <city>Albany</city>
        <state>New York</state>
        <zip>12208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0011</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0140</name>
      <address>
        <city>High Point</city>
        <state>North Carolina</state>
        <zip>27262</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christ Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MetroHealth Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Health Care System</name>
      <address>
        <city>Zanesville</city>
        <state>Ohio</state>
        <zip>43701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Permanente</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97227</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0139</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97239</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0010</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0018</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15212</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0013</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0021</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0146</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0092</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0005</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0035</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78745</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Oncology</name>
      <address>
        <city>Bedford</city>
        <state>Texas</state>
        <zip>76022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0153</name>
      <address>
        <city>Fort Bliss</city>
        <state>Texas</state>
        <zip>79918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0106</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77090</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Cancer Center</name>
      <address>
        <city>Lubbock</city>
        <state>Texas</state>
        <zip>79415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Texas Cancer Center - Sherman</name>
      <address>
        <city>Sherman</city>
        <state>Texas</state>
        <zip>75090-0504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0143</name>
      <address>
        <city>Tyler</city>
        <state>Texas</state>
        <zip>75701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0026</name>
      <address>
        <city>Waco</city>
        <state>Texas</state>
        <zip>76712</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Intermountain Medical Center</name>
      <address>
        <city>Murray</city>
        <state>Utah</state>
        <zip>84107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Regional Cancer Clinic</name>
      <address>
        <city>Saint George</city>
        <state>Utah</state>
        <zip>84770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0003</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0135</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0125</name>
      <address>
        <city>Fairfax</city>
        <state>Virginia</state>
        <zip>22031</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0198</name>
      <address>
        <city>Fredericksburg</city>
        <state>Virginia</state>
        <zip>22408</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0022</name>
      <address>
        <city>Capital Federal</city>
        <state>Buenos Aires</state>
        <zip>1426</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0023</name>
      <address>
        <city>Ciudad Autonoma De Buenos Aire</city>
        <state>Buenos Aires</state>
        <zip>1181</zip>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0079</name>
      <address>
        <city>Brasilia</city>
        <state>Distrito Federal</state>
        <zip>70200-730</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0077</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <zip>30130-090</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0076</name>
      <address>
        <city>Ijui</city>
        <state>RIO Grande DO SUL</state>
        <zip>98700-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0073</name>
      <address>
        <city>Porto Alegre</city>
        <state>RIO Grande DO SUL</state>
        <zip>90610-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fundacao Pio Xii Hosp Cancer De Barretos</name>
      <address>
        <city>Barretos</city>
        <state>Sao Paulo</state>
        <zip>14784-400</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0075</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>22793-080</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0095</name>
      <address>
        <city>Gatineau</city>
        <state>Quebec</state>
        <zip>J8P 7H2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0138</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H2X 0A9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0017</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0052</name>
      <address>
        <city>Trois-Rivieres</city>
        <state>Quebec</state>
        <zip>G8Z 3R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0016</name>
      <address>
        <city>Saskatoon</city>
        <state>Saskatchewan</state>
        <zip>S7N 4H4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0161</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100142</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0156</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0190</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510095</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0192</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410008</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0175</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0193</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410013</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0166</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0179</name>
      <address>
        <city>Nanchang</city>
        <state>Jiangxi</state>
        <zip>330006</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130012</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0159</name>
      <address>
        <city>XiAn</city>
        <state>Shan1xi</state>
        <zip>710061</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0180</name>
      <address>
        <city>Xian</city>
        <state>Shan3xi</state>
        <zip>710038</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0160</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200032</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0178</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0163</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300060</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0189</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310003</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0183</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0182</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310022</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0165</name>
      <address>
        <city>Shanghai</city>
        <zip>200030</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0059</name>
      <address>
        <city>Marseille Cedex 20</city>
        <zip>13915</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0112</name>
      <address>
        <city>Paris Cedex 5</city>
        <zip>75248</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0060</name>
      <address>
        <city>Paris</city>
        <zip>75018</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0064</name>
      <address>
        <city>Pierre Benite</city>
        <zip>69495</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0061</name>
      <address>
        <city>Rennes Cedex 9</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0113</name>
      <address>
        <city>Strasbourg</city>
        <zip>67100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0058</name>
      <address>
        <city>Toulouse</city>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0062</name>
      <address>
        <city>Tours Cedex 09</city>
        <zip>37044</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0019</name>
      <address>
        <city>Athens</city>
        <zip>11527</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0122</name>
      <address>
        <city>Thessaloniki</city>
        <zip>57001</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Budapest</city>
        <zip>1125</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution</name>
      <address>
        <city>Szekesfehervar</city>
        <zip>8000</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0068</name>
      <address>
        <city>Bari</city>
        <zip>70124</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0080</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0070</name>
      <address>
        <city>Perugia</city>
        <zip>06129</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0066</name>
      <address>
        <city>Ravenna</city>
        <zip>48121</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0067</name>
      <address>
        <city>Roma</city>
        <zip>00149</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0131</name>
      <address>
        <city>Nagoya-shi</city>
        <state>Aichi</state>
        <zip>4640021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0118</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>2778577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0111</name>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka</state>
        <zip>8078555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0110</name>
      <address>
        <city>Fukushima-shi</city>
        <state>Fukushima</state>
        <zip>9601295</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0109</name>
      <address>
        <city>Hiroshima-Shi</city>
        <state>Hiroshima</state>
        <zip>7348551</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0147</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>0030804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0133</name>
      <address>
        <city>Kobe-shi</city>
        <state>Hyogo</state>
        <zip>6500047</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0123</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa</state>
        <zip>2418515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0148</name>
      <address>
        <city>Sendai-shi</city>
        <state>Miyagi</state>
        <zip>9800873</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0108</name>
      <address>
        <city>Osaka-sayama-shi</city>
        <state>Osaka</state>
        <zip>5898511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0127</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>5418567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0119</name>
      <address>
        <city>Sakai-shi</city>
        <state>Osaka</state>
        <zip>5918555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0132</name>
      <address>
        <city>Sunto-gun</city>
        <state>Shizuoka</state>
        <zip>4118777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0126</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <zip>1138431</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0120</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>1600023</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0124</name>
      <address>
        <city>Tokyo</city>
        <zip>1138603</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0097</name>
      <address>
        <city>Busan</city>
        <zip>49267</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0098</name>
      <address>
        <city>Hwasun</city>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0105</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0050</name>
      <address>
        <city>Craiova</city>
        <zip>200347</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0051</name>
      <address>
        <city>Romania</city>
        <zip>400015</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0069</name>
      <address>
        <city>Sector 2</city>
        <zip>022328</zip>
        <country>Romania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0028</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0029</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0031</name>
      <address>
        <city>Majadahonda - Madrid</city>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0102</name>
      <address>
        <city>New Taipei City</city>
        <zip>235</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0107</name>
      <address>
        <city>Taichung</city>
        <zip>407219</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0099</name>
      <address>
        <city>Taipei</city>
        <zip>11031</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0100</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0093</name>
      <address>
        <city>Adana</city>
        <zip>01060</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0084</name>
      <address>
        <city>Ankara</city>
        <zip>06100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Local Institution - 0115</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Brazil</country>
    <country>Canada</country>
    <country>China</country>
    <country>France</country>
    <country>Greece</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Romania</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>Turkey</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>South Africa</country>
  </removed_countries>
  <link>
    <url>https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html</url>
    <description>BMS Clinical Trial Information</description>
  </link>
  <link>
    <url>https://www.bmsstudyconnect.com/s/US/English/USenHome</url>
    <description>BMS Clinical Trial Patient Recruiting</description>
  </link>
  <link>
    <url>https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm</url>
    <description>FDA Safety Alerts and Recalls</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 16, 2016</study_first_submitted>
  <study_first_submitted_qc>December 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <results_first_submitted>August 31, 2022</results_first_submitted>
  <results_first_submitted_qc>August 31, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 28, 2022</results_first_posted>
  <last_update_submitted>September 5, 2023</last_update_submitted>
  <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Vinorelbine</mesh_term>
    <mesh_term>Docetaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Gemcitabine</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Ipilimumab</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>August 18, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02998528/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 11, 2021</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/28/NCT02998528/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>One participant randomized to Arm A (nivo+ipi) received the wrong treatment of chemo. This participant is counted in Arm A for baseline and efficacy analyses (analyses based on the randomized population) and is counted in Arm B (chemo) for exposure and safety analyses (based on the treated population). This participant was randomized prior to Revised Protocol 02 and is not included in the All Treated Participants from the Concurrently Randomized Arms B and C population.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg</title>
          <description>Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
        <group group_id="P2">
          <title>Arm B: Platinum Doublet Chemo</title>
          <description>Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
        <group group_id="P3">
          <title>Arm C: Nivo 360 mg + Platinum Doublet Chemo</title>
          <description>Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Randomization Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="113"/>
                <participants group_id="P2" count="213"/>
                <participants group_id="P3" count="179"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>All Concurrently Randomized Participants in Arms B and C</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="179"/>
                <participants group_id="P3" count="179"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="112"/>
                <participants group_id="P2" count="207"/>
                <participants group_id="P3" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets study criteria</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Neoadjuvant Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="111"/>
                <participants group_id="P2" count="208"/>
                <participants group_id="P3" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>All Treated Participants From Concurrently Randomized Arms B and C</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="176"/>
                <participants group_id="P3" count="176"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="177"/>
                <participants group_id="P3" count="165"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
                <participants group_id="P2" count="31"/>
                <participants group_id="P3" count="11"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Participant request to discontinue study treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="7"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant withdrew consent</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="4"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant no longer meets study criteria</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study drug toxicity</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
                <participants group_id="P2" count="14"/>
                <participants group_id="P3" count="10"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study treatment</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
        <period>
          <title>Systemic Adjuvant Treatment Period</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="37"/>
                <participants group_id="P2" count="47"/>
                <participants group_id="P3" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="41"/>
                <participants group_id="P3" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Disease progression</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Study drug toxicity</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="5"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse event unrelated to study drug</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Participant request to discontinue treatment</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Other reasons</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants</population>
      <group_list>
        <group group_id="B1">
          <title>Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg</title>
          <description>Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
        <group group_id="B2">
          <title>Arm B: Platinum Doublet Chemo</title>
          <description>Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
        <group group_id="B3">
          <title>Arm C: Nivo 360 mg + Platinum Doublet Chemo</title>
          <description>Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="113"/>
            <count group_id="B2" value="213"/>
            <count group_id="B3" value="179"/>
            <count group_id="B4" value="505"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>&lt; 65</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62"/>
                    <measurement group_id="B2" value="99"/>
                    <measurement group_id="B3" value="93"/>
                    <measurement group_id="B4" value="254"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 65 AND &lt; 75</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="75"/>
                    <measurement group_id="B4" value="211"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 75 AND &lt; 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="11"/>
                    <measurement group_id="B4" value="39"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>&gt;= 85</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                    <measurement group_id="B2" value="65"/>
                    <measurement group_id="B3" value="51"/>
                    <measurement group_id="B4" value="156"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="73"/>
                    <measurement group_id="B2" value="148"/>
                    <measurement group_id="B3" value="128"/>
                    <measurement group_id="B4" value="349"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="53"/>
                    <measurement group_id="B2" value="105"/>
                    <measurement group_id="B3" value="100"/>
                    <measurement group_id="B4" value="258"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="103"/>
                    <measurement group_id="B3" value="79"/>
                    <measurement group_id="B4" value="240"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="96"/>
                    <measurement group_id="B3" value="86"/>
                    <measurement group_id="B4" value="223"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="64"/>
                    <measurement group_id="B2" value="108"/>
                    <measurement group_id="B3" value="89"/>
                    <measurement group_id="B4" value="261"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Event-Free Survival (EFS)</title>
        <description>Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).</description>
        <time_frame>From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)</time_frame>
        <population>All concurrently randomized participants in Arm C and Arm B</population>
        <group_list>
          <group group_id="O1">
            <title>Arm B: Platinum Doublet Chemo</title>
            <description>Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm C: Nivo 360 mg + Platinum Doublet Chemo</title>
            <description>Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Event-Free Survival (EFS)</title>
          <description>Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).</description>
          <population>All concurrently randomized participants in Arm C and Arm B</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20.80" lower_limit="14.03" upper_limit="26.71"/>
                    <measurement group_id="O2" value="31.57" lower_limit="30.16" upper_limit="NA">Insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.0052</p_value>
            <method>Log Rank</method>
            <method_desc>Stratified by PD-L1 (≥ 1% vs &lt;1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)</method_desc>
            <param_type>Cox Proportional Hazard</param_type>
            <param_value>0.63</param_value>
            <ci_percent>97.38</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.43</ci_lower_limit>
            <ci_upper_limit>0.91</ci_upper_limit>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pathologic Complete Response (pCR) Rate</title>
        <description>Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).</description>
        <time_frame>From randomization up to a median of 30 months after randomization.</time_frame>
        <population>All concurrently randomized participants in Arm C and Arm B</population>
        <group_list>
          <group group_id="O1">
            <title>Arm B: Platinum Doublet Chemo</title>
            <description>Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm C: Nivo 360 mg + Platinum Doublet Chemo</title>
            <description>Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Pathologic Complete Response (pCR) Rate</title>
          <description>Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).</description>
          <population>All concurrently randomized participants in Arm C and Arm B</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% Difference</param_type>
            <param_value>21.6</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>13.0</ci_lower_limit>
            <ci_upper_limit>30.3</ci_upper_limit>
            <estimate_desc>Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs &lt;1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.0001</p_value>
            <method>Cochran-Mantel-Haenszel</method>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>13.94</param_value>
            <ci_percent>99</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.49</ci_lower_limit>
            <ci_upper_limit>55.75</ci_upper_limit>
            <estimate_desc>Strata adjusted odds ratio (Arm C over Concurrent Arm B) the Mantel-Haenszel method. Stratified by PD-L1 (≥ 1% vs &lt;1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Major Pathologic Response (MPR) Rate</title>
        <description>Major pathologic response (MPR) rate is defined as number of randomized participants with &lt;/= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.</description>
        <time_frame>From randomization up to a median of 30 months after randomization.</time_frame>
        <population>All concurrently randomized participants in Arm C and Arm B</population>
        <group_list>
          <group group_id="O1">
            <title>Arm B: Platinum Doublet Chemo</title>
            <description>Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm C: Nivo 360 mg + Platinum Doublet Chemo</title>
            <description>Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Major Pathologic Response (MPR) Rate</title>
          <description>Major pathologic response (MPR) rate is defined as number of randomized participants with &lt;/= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.</description>
          <population>All concurrently randomized participants in Arm C and Arm B</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                    <measurement group_id="O2" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>% Difference</param_type>
            <param_value>27.9</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>19.6</ci_lower_limit>
            <ci_upper_limit>36.1</ci_upper_limit>
            <estimate_desc>Strata adjusted difference (Arm C - Concurrent Arm B) based on the CMH method of weighting. Stratified by PD-L1 (≥ 1% vs &lt;1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)</estimate_desc>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Odds Ratio (OR)</param_type>
            <param_value>5.70</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>3.16</ci_lower_limit>
            <ci_upper_limit>10.26</ci_upper_limit>
            <estimate_desc>Stratified by PD-L1 (≥ 1% vs &lt;1%/unevaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.</description>
        <time_frame>From randomization to the date of death</time_frame>
        <posting_date>11/2028</posting_date>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Death or Distant Metastases (TTDM)</title>
        <description>TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.</description>
        <time_frame>From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)</time_frame>
        <population>All concurrently randomized participants in Arm C and Arm B</population>
        <group_list>
          <group group_id="O1">
            <title>Arm B: Platinum Doublet Chemo</title>
            <description>Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
          <group group_id="O2">
            <title>Arm C: Nivo 360 mg + Platinum Doublet Chemo</title>
            <description>Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Death or Distant Metastases (TTDM)</title>
          <description>TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.</description>
          <population>All concurrently randomized participants in Arm C and Arm B</population>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="179"/>
                <count group_id="O2" value="179"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.71" lower_limit="22.41" upper_limit="NA">Insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="NA" lower_limit="36.60" upper_limit="NA">Insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <param_type>Hazard Ratio (HR)</param_type>
            <param_value>0.53</param_value>
            <ci_percent>95</ci_percent>
            <ci_n_sides>2-Sided</ci_n_sides>
            <ci_lower_limit>0.36</ci_lower_limit>
            <ci_upper_limit>0.77</ci_upper_limit>
            <estimate_desc>Stratified by: PD-L1 status (≥ 1% vs &lt;1%/not evaluable/indeterminate), disease stage (IB/II vs IIIA), and sex (male vs female)</estimate_desc>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All-cause mortality was assessed from first dose to primary completion (up to approximately 54 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose of neoadjuvant therapy (up to approximately 5.5 months).</time_frame>
      <desc>The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.</desc>
      <group_list>
        <group group_id="E1">
          <title>Arm A: Nivo 3 mg/kg + Ipi 1 mg/kg</title>
          <description>Participants received nivolumab 3 mg/kg IV over 30 minutes every 2 weeks for up to 3 doses (ie, 6 weeks of treatment; each cycle is 14 days). In Cycle 1 Day 1 only, nivolumab will be followed by a single dose of ipilimumab 1 mg/kg IV over 30 minutes.&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
        <group group_id="E2">
          <title>Arm B: Platinum Doublet Chemo</title>
          <description>Participants receive investigator-choice of platinum doublet chemotherapy regimens in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
        <group group_id="E3">
          <title>Arm C: Nivo 360 mg + Platinum Doublet Chemo</title>
          <description>Participants receive nivolumab 360 mg IV + platinum doublet chemotherapy in 3-week cycles up to a maximum of 3 cycles of IV chemotherapy (ie, 9 weeks of treatment; each cycle is 21 days).&#xD;
Following definitive surgery, participants could receive up to 4 cycles of adjuvant chemotherapy and/or radiation at the discretion of the investigator.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="113"/>
                <counts group_id="E2" subjects_affected="76" subjects_at_risk="213"/>
                <counts group_id="E3" subjects_affected="35" subjects_at_risk="179"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="58" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="52" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Coagulopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Myelosuppression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pancytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Sickle cell anaemia with crisis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cardiac ventricular thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Myocardial ischaemia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Myocarditis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Stress cardiomyopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Adrenal insufficiency</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypophysitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Inappropriate antidiuretic hormone secretion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Ocular myasthenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Colitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gastric ulcer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Haematochezia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Oesophageal perforation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Small intestinal obstruction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hepatitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaphylactic reaction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cellulitis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Empyema</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Enterocolitis infectious</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Gastroenteritis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Infectious pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Influenza</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Klebsiella bacteraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pleural infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pneumonia bacterial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pneumonia influenzal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Post procedural infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pyelonephritis acute</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Subcutaneous abscess</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Tuberculosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Wound infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Cardiac function disturbance postoperative</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Overdose</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Post procedural complication</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Post procedural haematoma</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Post procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Postoperative delirium</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Postoperative respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Postoperative wound complication</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Procedural haemorrhage</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Glycosylated haemoglobin increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hepatic enzyme abnormal</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Transaminases increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypokalaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Myositis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Cancer pain</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Endometrial cancer</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Malignant neoplasm progression</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="5" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Renal cancer</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Tumour pseudoprogression</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Carotid artery stenosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Encephalopathy</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Ischaemic stroke</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Myasthenia gravis</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Posterior reversible encephalopathy syndrome</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Prostatitis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Atelectasis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Bronchopleural fistula</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Bronchospasm</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Chylothorax</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Lung opacity</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pneumonia aspiration</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pulmonary embolism</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pulmonary fistula</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pulmonary mass</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic rupture</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Arterial thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Deep vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Embolism</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Iliac artery occlusion</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Subclavian vein thrombosis</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Thrombophlebitis superficial</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>24.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="102" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="200" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="157" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="75" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="62" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Thrombocytopenia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Tinnitus</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="17" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Hyperthyroidism</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypothyroidism</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="2" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="72" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="63" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="34" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="21" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="104" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="73" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Asthenia</sub_title>
                <counts group_id="E1" subjects_affected="13" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="19" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" subjects_affected="24" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="38" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="30" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="27" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="26" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="7" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="6" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pain</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="17" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Incision site pain</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Procedural pain</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="11" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Wound complication</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Blood creatinine increased</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="44" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="28" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="16" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="9" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="24" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="15" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="53" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="46" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hyperglycaemia</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="5" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hypomagnesaemia</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hyponatraemia</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" subjects_affected="12" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" subjects_affected="10" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="10" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" subjects_affected="9" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="16" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="8" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Neuropathy peripheral</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="10" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Anxiety</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="4" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="22" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="18" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="14" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="29" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="18" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="28" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="20" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="13" subjects_at_risk="176"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" subjects_affected="17" subjects_at_risk="111"/>
                <counts group_id="E2" subjects_affected="7" subjects_at_risk="208"/>
                <counts group_id="E3" subjects_affected="25" subjects_at_risk="176"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Bristol-Myers Squibb Study Director</name_or_title>
      <organization>Bristol-Myers Squibb</organization>
      <phone>Please email</phone>
      <email>Clinical.Trials@bms.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02998528
org study id: CA209-816
secondary id: 2016-003536-21
nct id: NCT02998528
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this neoadjuvant study is to compare nivolumab plus chemotherapy and
      chemotherapy alone in terms of safety and effectiveness, and to describe nivolumab plus
      ipilimumab's safety and effectiveness in treating resectable NSCLC.

      This study has multiple primary endpoints.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Event-Free Survival (EFS)
time frame: From randomization to disease progression, reoccurrence, or death due to any cause. (Up to a median of 30 months)
description: Event-free survival (EFS) is defined as the length of time from randomization to any of the following events: any progression of disease precluding surgery, progression or recurrence disease based on blinded independent central review (BICR) assessment per response evaluation criteria in solid tumors (RECIST) 1.1 after surgery, or death due to any cause. Participants who don't undergo surgery for reason other than progression will be considered to have an event at progression or death. Progression is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression).
measure: Pathologic Complete Response (pCR) Rate
time frame: From randomization up to a median of 30 months after randomization.
description: Pathologic complete response (pCR) rate is defined as the number of randomized participants with absence of residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR).
measure: Major Pathologic Response (MPR) Rate
time frame: From randomization up to a median of 30 months after randomization.
description: Major pathologic response (MPR) rate is defined as number of randomized participants with </= 10% residual tumor in lung and lymph nodes as evaluated by blinded independent pathological review (BIPR). Viable tumors in situ carcinoma should not be included in MPR calculation.
measure: Overall Survival (OS)
time frame: From randomization to the date of death
description: Overall survival (OS) is defined as the time between the date of randomization and the date of death. OS will be censored on the last date a participant was known to be alive.
measure: Time to Death or Distant Metastases (TTDM)
time frame: From randomization to the first date of distant metastasis or the date of death in the absence of distant metastasis (Up to a median of 30 months)
description: TTDM is defined as the time between the date of randomization and the first date of distant metastasis or the date of death in the absence of distant metastasis. Distant metastasis is defined as any new lesion that is outside of the thorax using blinded independent central review (BICR) according to response evaluation criteria in solid tumors (RECIST) 1.1. Patients who have not developed distant metastasis or died at the time of analysis will be censored on the date of their last evaluable tumor assessment.
arm group label: Platinum doublet chemotherapy
arm group type: Active Comparator
description: Specified dose on specified days
arm group label: Nivolumab plus platinum doublet chemotherapy
arm group type: Experimental
description: Specified dose on specified days
arm group label: Nivolumab plus Ipilimumab
arm group type: Experimental
description: Specified dose on specified days
intervention type: Biological
intervention name: Nivolumab
description: Specified dose on specified days
arm group label: Nivolumab plus Ipilimumab
arm group label: Nivolumab plus platinum doublet chemotherapy
other name: BMS-936558
other name: Opdivo
intervention type: Drug
intervention name: Cisplatin
description: Specified dose on specified days
arm group label: Nivolumab plus platinum doublet chemotherapy
arm group label: Platinum doublet chemotherapy
intervention type: Drug
intervention name: Vinorelbine
description: Specified dose on specified days
arm group label: Platinum doublet chemotherapy
intervention type: Drug
intervention name: Gemcitabine
description: Specified dose on specified days
arm group label: Nivolumab plus platinum doublet chemotherapy
arm group label: Platinum doublet chemotherapy
intervention type: Drug
intervention name: Docetaxel
description: Specified dose on specified days
arm group label: Platinum doublet chemotherapy
intervention type: Drug
intervention name: Pemetrexed
description: Specified dose on specified days
arm group label: Nivolumab plus platinum doublet chemotherapy
arm group label: Platinum doublet chemotherapy
intervention type: Drug
intervention name: Carboplatin
description: Specified dose on specified days
arm group label: Nivolumab plus platinum doublet chemotherapy
arm group label: Platinum doublet chemotherapy
intervention type: Drug
intervention name: Paclitaxel
description: Specified dose on specified days
arm group label: Nivolumab plus platinum doublet chemotherapy
arm group label: Platinum doublet chemotherapy
intervention type: Biological
intervention name: Ipilimumab
description: This arm is closed and no longer enrolling patients.
arm group label: Nivolumab plus Ipilimumab
other name: BMS-734016
other name: Yervoy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Bristol-Myers Squibb
role: Study Director
affiliation: Bristol-Myers Squibb
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country: Argentina
country: Brazil
country: Canada
country: China
country: France
country: Greece
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Romania
country: Spain
country: Taiwan
country: Turkey
country: United States
country: South Africa
url: https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html
description: BMS Clinical Trial Information
url: https://www.bmsstudyconnect.com/s/US/English/USenHome
description: BMS Clinical Trial Patient Recruiting
url: https://www.fda.gov/Safety/MedWatch/SafetyInformation/default.htm
description: FDA Safety Alerts and Recalls
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Vinorelbine
mesh term: Docetaxel
mesh term: Carboplatin
mesh term: Gemcitabine
mesh term: Nivolumab
mesh term: Pemetrexed
mesh term: Ipilimumab
provided document: 
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certain agreements: 
point of contact: 