<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/NCT01703091</url>
  </required_header>
  <id_info>
    <org_study_id>14658</org_study_id>
    <secondary_id>I4T-JE-JVCG</secondary_id>
    <nct_id>NCT01703091</nct_id>
  </id_info>
  <brief_title>A Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Randomized, Double-Blind, Phase 2 Study of Docetaxel and Ramucirumab Versus Docetaxel and Placebo in the Treatment of Stage IV Non-Small Cell Lung Cancer Following Disease Progression After One Prior Platinum-Based Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effects of ramucirumab in combination with&#xD;
      docetaxel in participants with Stage IV non-small cell lung cancer who have had disease&#xD;
      progression during or after one prior first-line platinum-based chemotherapy with or without&#xD;
      maintenance therapy for advanced/metastatic disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-Free Survival (PFS)</measure>
    <time_frame>Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)</time_frame>
    <description>PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS)</measure>
    <time_frame>Baseline to Death from Any Cause (Up to 28 Months)</time_frame>
    <description>OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]</measure>
    <time_frame>Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)</time_frame>
    <description>Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to &lt;10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]</measure>
    <time_frame>Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)</time_frame>
    <description>Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to &lt;10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score</measure>
    <time_frame>Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)</time_frame>
    <description>The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in Lung Cancer Symptom Scale (LCSS)</measure>
    <time_frame>Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)</time_frame>
    <description>The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">197</enrollment>
  <condition>Non-small Cell Lung Cancer Metastatic</condition>
  <arm_group>
    <arm_group_label>Ramucirumab plus Docetaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ramucirumab 10 milligram per kilogram (mg/kg) on Day 1 of every 21 day cycle, administered as an intravenous (IV) infusion over approximately 60 minutes. Docetaxel 60 milligram per square meter (mg/m2) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo plus Docetaxel</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo (administered at a volume equivalent to a dose of milligram per kilogram (mg/kg)) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. Docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ramucirumab</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Ramucirumab plus Docetaxel</arm_group_label>
    <other_name>LY 3009806</other_name>
    <other_name>IMC-1121B</other_name>
    <other_name>Cyramza®</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Placebo plus Docetaxel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Docetaxel</intervention_name>
    <description>Administered IV</description>
    <arm_group_label>Placebo plus Docetaxel</arm_group_label>
    <arm_group_label>Ramucirumab plus Docetaxel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-Small Cell Lung Cancer disease&#xD;
&#xD;
          -  Clinical stage IV or recurrent disease&#xD;
&#xD;
          -  One prior first-line platinum-based chemotherapy regimen with or without maintenance&#xD;
             therapy&#xD;
&#xD;
          -  For Non-Small Cell Lung Cancer (NSCLC) tumors other than squamous cell histology, the&#xD;
             epidermal growth factor receptor (EGFR) mutation status is known prior to&#xD;
             randomization&#xD;
&#xD;
          -  For participants with activating epidermal growth factor receptor (EGFR) mutation&#xD;
             only, prior epidermal growth factor receptor- tyrosine kinase inhibitor (EGFR-TKI)&#xD;
             monotherapy (only one regimen in the setting of single use) should be utilized&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1&#xD;
&#xD;
          -  Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
             version RECIST version 1.1&#xD;
&#xD;
          -  Adequate organ function&#xD;
&#xD;
          -  Estimated life expectancy of at least 3 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have undergone major surgery within 28 days prior to randomization or have planned&#xD;
             major surgery during study treatment&#xD;
&#xD;
          -  Receiving concurrent treatment with other anticancer therapy&#xD;
&#xD;
          -  Central nervous system disease other than stable and treated brain metastasis&#xD;
&#xD;
          -  Has major blood vessel invasion or encasement by cancer&#xD;
&#xD;
          -  Has intratumor cavitation&#xD;
&#xD;
          -  Has a history of uncontrolled thrombotic disorder&#xD;
&#xD;
          -  Is receiving therapeutic anticoagulation with drugs&#xD;
&#xD;
          -  Is receiving chronic therapy with nonsteroidal anti-inflammatory drugs&#xD;
&#xD;
          -  Has a history of hemoptysis within 2 months prior to randomization&#xD;
&#xD;
          -  Has clinically relevant congestive heart failure&#xD;
&#xD;
          -  Has experienced any arterial thromboembolic event&#xD;
&#xD;
          -  Has uncontrolled arterial hypertension&#xD;
&#xD;
          -  Has had a serious or nonhealing wound or, ulcer&#xD;
&#xD;
          -  Has significant existing conditions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Aichi</city>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Chiba</city>
        <zip>277 8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ehime</city>
        <zip>791-0280</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Fukuoka</city>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hokkaido</city>
        <zip>060-8648</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Hyogo</city>
        <zip>673-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Ishikawa</city>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Kanagawa</city>
        <zip>236-0051</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Miyagi</city>
        <zip>980-8574</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Okayama</city>
        <zip>700-8558</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Osaka</city>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Saitama</city>
        <zip>362-0806</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Shizuoka</city>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Tokyo</city>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.</name>
      <address>
        <city>Yamaguchi</city>
        <zip>755-0241</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>December 14, 2015</results_first_submitted>
  <results_first_submitted_qc>December 14, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 20, 2016</results_first_posted>
  <last_update_submitted>September 10, 2019</last_update_submitted>
  <last_update_submitted_qc>September 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2019</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>Docetaxel</mesh_term>
    <mesh_term>Ramucirumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/</ipd_url>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Study completion was defined as death due to any cause or disease progression.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Ramucirumab Plus Docetaxel</title>
          <description>Ramucirumab 10 milligrams/kilogram (mg/kg) administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 milligrams/square meter (mg/m2) administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
        </group>
        <group group_id="P2">
          <title>Placebo Plus Docetaxel</title>
          <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
                <participants group_id="P2" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Received at Least One Dose of Study Drug</title>
              <participants_list>
                <participants group_id="P1" count="94"/>
                <participants group_id="P2" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="89"/>
                <participants group_id="P2" count="95"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Physician Decision</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Sponsor Decision</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All randomized participants who had received at least one dose of study drug.</population>
      <group_list>
        <group group_id="B1">
          <title>Ramucirumab + Docetaxel</title>
          <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
        </group>
        <group group_id="B2">
          <title>Placebo + Docetaxel</title>
          <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
        </group>
        <group group_id="B3">
          <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="94"/>
            <count group_id="B2" value="98"/>
            <count group_id="B3" value="192"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.9" lower_limit="29" upper_limit="78"/>
                    <measurement group_id="B2" value="64.1" lower_limit="27" upper_limit="79"/>
                    <measurement group_id="B3" value="64" lower_limit="27" upper_limit="79"/>
                  </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="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="66"/>
                    <measurement group_id="B2" value="71"/>
                    <measurement group_id="B3" value="137"/>
                  </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_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="192"/>
                  </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_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </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_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="94"/>
                    <measurement group_id="B2" value="98"/>
                    <measurement group_id="B3" value="192"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival (PFS)</title>
        <description>PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.</description>
        <time_frame>Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)</time_frame>
        <population>Full Analysis Set (FAS) population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 13 and 9, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Ramucirumab + Docetaxel</title>
            <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival (PFS)</title>
          <description>PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.</description>
          <population>Full Analysis Set (FAS) population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 13 and 9, respectively.</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="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.22" lower_limit="3.52" upper_limit="6.97"/>
                    <measurement group_id="O2" value="4.21" lower_limit="2.83" upper_limit="5.62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Overall Survival (OS)</title>
        <description>OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.</description>
        <time_frame>Baseline to Death from Any Cause (Up to 28 Months)</time_frame>
        <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 36 and 35, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>Ramucirumab + Docetaxel</title>
            <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Overall Survival (OS)</title>
          <description>OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.</description>
          <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy. The number of censored participant data for ramucirumab and placebo is 36 and 35, respectively.</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="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.15" lower_limit="12.45" upper_limit="26.55"/>
                    <measurement group_id="O2" value="14.65" lower_limit="11.93" upper_limit="24.44"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]</title>
        <description>Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to &lt;10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.</description>
        <time_frame>Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)</time_frame>
        <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Ramucirumab + Docetaxel</title>
            <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]</title>
          <description>Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to &lt;10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.</description>
          <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="28.9" lower_limit="19.1" upper_limit="40.5"/>
                    <measurement group_id="O2" value="18.5" lower_limit="10.8" upper_limit="28.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]</title>
        <description>Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to &lt;10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.</description>
        <time_frame>Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)</time_frame>
        <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Ramucirumab + Docetaxel</title>
            <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]</title>
          <description>Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to &lt;10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.</description>
          <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
          <units>Percentage of Participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="78.9" lower_limit="68.1" upper_limit="87.5"/>
                    <measurement group_id="O2" value="70.4" lower_limit="59.2" upper_limit="80.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score</title>
        <description>The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).</description>
        <time_frame>Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)</time_frame>
        <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Ramucirumab + Docetaxel</title>
            <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score</title>
          <description>The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).</description>
          <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
          <units>Units on a Scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Cycle 1 (n = 69, 77)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.024" spread="0.1928"/>
                    <measurement group_id="O2" value="-0.007" spread="0.1918"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 2 (n = 62, 66)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.021" spread="0.2190"/>
                    <measurement group_id="O2" value="0.006" spread="0.1961"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 3 (n = 48, 53)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.010" spread="0.2324"/>
                    <measurement group_id="O2" value="-0.005" spread="0.1891"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 4 (n = 40, 48)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.015" spread="0.1683"/>
                    <measurement group_id="O2" value="-0.026" spread="0.1610"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 5 (n = 32, 40)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.000" spread="0.2280"/>
                    <measurement group_id="O2" value="-0.012" spread="0.1433"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 6 (n = 28, 36)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.035" spread="0.1741"/>
                    <measurement group_id="O2" value="-0.005" spread="0.1409"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 7 (n = 25 ,31)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.002" spread="0.1857"/>
                    <measurement group_id="O2" value="-0.039" spread="0.1282"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cycle 8 (n = 23, 30)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.053" spread="0.1750"/>
                    <measurement group_id="O2" value="-0.071" spread="0.1800"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>30-Day Follow Up (n= 56, 70)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-0.102" spread="0.2209"/>
                    <measurement group_id="O2" value="-0.132" spread="0.3344"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in Lung Cancer Symptom Scale (LCSS)</title>
        <description>The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.</description>
        <time_frame>Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)</time_frame>
        <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
        <group_list>
          <group group_id="O1">
            <title>Ramucirumab + Docetaxel</title>
            <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
          <group group_id="O2">
            <title>Placebo + Docetaxel</title>
            <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Lung Cancer Symptom Scale (LCSS)</title>
          <description>The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.</description>
          <population>FAS population: All randomized participants who received at least one dose of study drug and whose prior therapy did not include EGFR-TKI monotherapy.</population>
          <units>Millimeter</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="76"/>
                <count group_id="O2" value="81"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Loss of Appetite (n=73, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-12.5" spread="26.23"/>
                    <measurement group_id="O2" value="-16.2" spread="21.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fatigue (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.9" spread="25.38"/>
                    <measurement group_id="O2" value="-7.8" spread="23.59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Cough (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.4" spread="23.10"/>
                    <measurement group_id="O2" value="-18.3" spread="23.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Dyspnea (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-4.7" spread="23.09"/>
                    <measurement group_id="O2" value="-8.7" spread="20.16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hemoptysis (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-1.2" spread="12.83"/>
                    <measurement group_id="O2" value="-3.7" spread="17.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-9.6" spread="23.66"/>
                    <measurement group_id="O2" value="-9.0" spread="21.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Overall Symptoms (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-7.1" spread="26.10"/>
                    <measurement group_id="O2" value="-11.5" spread="19.83"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Interference with Activity Level (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-8.4" spread="25.84"/>
                    <measurement group_id="O2" value="-11.9" spread="21.98"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Quality of Life (n=73, 80)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-11.7" spread="28.06"/>
                    <measurement group_id="O2" value="-12.7" spread="21.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASBI (n=73, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-2.82" spread="14.93"/>
                    <measurement group_id="O2" value="-6.93" spread="12.06"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total LCSS (n=73, 79)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-3.20" spread="15.64"/>
                    <measurement group_id="O2" value="-7.13" spread="11.74"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <desc>All randomized participants who received at least one dose of study drug.</desc>
      <group_list>
        <group group_id="E1">
          <title>Ramucirumab + Docetaxel</title>
          <description>Ramucirumab 10 mg/kg administered as an intravenous (IV) infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
        </group>
        <group group_id="E2">
          <title>Placebo + Docetaxel</title>
          <description>Placebo administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle. Docetaxel 60 mg/m2 administered as an IV infusion over approximately 60 minutes on Day 1 of every 21-day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 18.0</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="30" subjects_at_risk="94"/>
                <counts group_id="E2" subjects_affected="31" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Splenomegaly</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Anorectal disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Gastric ulcer haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Ileus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Ileus paralytic</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Large intestine perforation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General physical health deterioration</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Drug-induced liver injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Hepatic cirrhosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Bronchopulmonary aspergillosis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Diverticulitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Herpes zoster</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Lung abscess</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Sepsis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Hypercalcaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Bone pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Chondrocalcinosis pyrophosphate</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lymphangiosis carcinomatosa</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Metastases to meninges</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Cognitive disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Bladder disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Interstitial lung disease</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Lung disorder</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Obstructive airways disorder</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pleurisy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pneumonitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pneumothorax</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="94"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pulmonary haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA 18.0</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="94" subjects_at_risk="94"/>
                <counts group_id="E2" subjects_affected="98" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="60" subjects_affected="37" subjects_at_risk="94"/>
                <counts group_id="E2" events="68" subjects_affected="41" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Febrile neutropenia</sub_title>
                <counts group_id="E1" events="29" subjects_affected="26" subjects_at_risk="94"/>
                <counts group_id="E2" events="17" subjects_affected="15" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Leukopenia</sub_title>
                <counts group_id="E1" events="33" subjects_affected="13" subjects_at_risk="94"/>
                <counts group_id="E2" events="63" subjects_affected="24" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Neutropenia</sub_title>
                <counts group_id="E1" events="46" subjects_affected="17" subjects_at_risk="94"/>
                <counts group_id="E2" events="70" subjects_affected="30" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye discharge</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Lacrimation increased</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="94"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Abdominal pain upper</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="94"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Constipation</sub_title>
                <counts group_id="E1" events="34" subjects_affected="15" subjects_at_risk="94"/>
                <counts group_id="E2" events="36" subjects_affected="28" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="50" subjects_affected="31" subjects_at_risk="94"/>
                <counts group_id="E2" events="50" subjects_affected="23" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="52" subjects_affected="34" subjects_at_risk="94"/>
                <counts group_id="E2" events="52" subjects_affected="39" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Periodontal disease</sub_title>
                <counts group_id="E1" events="7" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Stomatitis</sub_title>
                <counts group_id="E1" events="92" subjects_affected="50" subjects_at_risk="94"/>
                <counts group_id="E2" events="41" subjects_affected="31" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="15" subjects_affected="14" subjects_at_risk="94"/>
                <counts group_id="E2" events="31" subjects_affected="22" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Face oedema</sub_title>
                <counts group_id="E1" events="18" subjects_affected="15" subjects_at_risk="94"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="45" subjects_affected="29" subjects_at_risk="94"/>
                <counts group_id="E2" events="47" subjects_affected="25" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Malaise</sub_title>
                <counts group_id="E1" events="97" subjects_affected="43" subjects_at_risk="94"/>
                <counts group_id="E2" events="85" subjects_affected="47" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Oedema peripheral</sub_title>
                <counts group_id="E1" events="38" subjects_affected="34" subjects_at_risk="94"/>
                <counts group_id="E2" events="33" subjects_affected="28" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pyrexia</sub_title>
                <counts group_id="E1" events="54" subjects_affected="31" subjects_at_risk="94"/>
                <counts group_id="E2" events="45" subjects_affected="26" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Hypersensitivity</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="94"/>
                <counts group_id="E2" events="15" subjects_affected="5" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Conjunctivitis</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Lung infection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="94"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Paronychia</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pharyngitis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Skin infection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E2" events="4" subjects_affected="3" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Upper respiratory tract infection</sub_title>
                <counts group_id="E1" events="14" subjects_affected="9" subjects_at_risk="94"/>
                <counts group_id="E2" events="7" subjects_affected="5" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Alanine aminotransferase increased</sub_title>
                <counts group_id="E1" events="17" subjects_affected="15" subjects_at_risk="94"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Aspartate aminotransferase increased</sub_title>
                <counts group_id="E1" events="26" subjects_affected="19" subjects_at_risk="94"/>
                <counts group_id="E2" events="12" subjects_affected="6" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Blood bilirubin increased</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="94"/>
                <counts group_id="E2" events="11" subjects_affected="6" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Gamma-glutamyltransferase increased</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Lymphocyte count decreased</sub_title>
                <counts group_id="E1" events="16" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E2" events="43" subjects_affected="11" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Neutrophil count decreased</sub_title>
                <counts group_id="E1" events="281" subjects_affected="73" subjects_at_risk="94"/>
                <counts group_id="E2" events="219" subjects_affected="69" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Platelet count decreased</sub_title>
                <counts group_id="E1" events="42" subjects_affected="22" subjects_at_risk="94"/>
                <counts group_id="E2" events="22" subjects_affected="14" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Weight decreased</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E2" events="12" subjects_affected="9" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>White blood cell count decreased</sub_title>
                <counts group_id="E1" events="261" subjects_affected="73" subjects_at_risk="94"/>
                <counts group_id="E2" events="226" subjects_affected="68" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Decreased appetite</sub_title>
                <counts group_id="E1" events="90" subjects_affected="54" subjects_at_risk="94"/>
                <counts group_id="E2" events="92" subjects_affected="51" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Hypoalbuminaemia</sub_title>
                <counts group_id="E1" events="44" subjects_affected="29" subjects_at_risk="94"/>
                <counts group_id="E2" events="32" subjects_affected="21" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Hypophosphataemia</sub_title>
                <counts group_id="E1" events="4" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="24" subjects_affected="18" subjects_at_risk="94"/>
                <counts group_id="E2" events="27" subjects_affected="14" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Back pain</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E2" events="17" subjects_affected="13" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="32" subjects_affected="19" subjects_at_risk="94"/>
                <counts group_id="E2" events="26" subjects_affected="18" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="94"/>
                <counts group_id="E2" events="7" subjects_affected="6" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="36" subjects_affected="25" subjects_at_risk="94"/>
                <counts group_id="E2" events="34" subjects_affected="26" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="16" subjects_affected="12" subjects_at_risk="94"/>
                <counts group_id="E2" events="22" subjects_affected="16" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="94"/>
                <counts group_id="E2" events="27" subjects_affected="27" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Insomnia</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="94"/>
                <counts group_id="E2" events="21" subjects_affected="18" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Proteinuria</sub_title>
                <counts group_id="E1" events="36" subjects_affected="28" subjects_at_risk="94"/>
                <counts group_id="E2" events="11" subjects_affected="8" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E2" events="12" subjects_affected="11" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E2" events="9" subjects_affected="9" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="90" subjects_affected="46" subjects_at_risk="94"/>
                <counts group_id="E2" events="21" subjects_affected="18" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Haemoptysis</sub_title>
                <counts group_id="E1" events="9" subjects_affected="6" subjects_at_risk="94"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Hiccups</sub_title>
                <counts group_id="E1" events="24" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E2" events="24" subjects_affected="9" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Oropharyngeal pain</sub_title>
                <counts group_id="E1" events="6" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="94"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Alopecia</sub_title>
                <counts group_id="E1" events="63" subjects_affected="63" subjects_at_risk="94"/>
                <counts group_id="E2" events="62" subjects_affected="61" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dermatitis acneiform</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="94"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Dry skin</sub_title>
                <counts group_id="E1" events="18" subjects_affected="17" subjects_at_risk="94"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nail discolouration</sub_title>
                <counts group_id="E1" events="22" subjects_affected="22" subjects_at_risk="94"/>
                <counts group_id="E2" events="19" subjects_affected="19" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Nail ridging</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="94"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Onychomadesis</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="94"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Palmar-plantar erythrodysaesthesia syndrome</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="94"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Pruritus</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="94"/>
                <counts group_id="E2" events="8" subjects_affected="7" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Rash</sub_title>
                <counts group_id="E1" events="8" subjects_affected="7" subjects_at_risk="94"/>
                <counts group_id="E2" events="16" subjects_affected="12" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E2" events="8" subjects_affected="6" subjects_at_risk="98"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Flushing</sub_title>
                <counts group_id="E1" events="12" subjects_affected="4" subjects_at_risk="94"/>
                <counts group_id="E2" events="12" subjects_affected="7" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="94"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="98"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="94"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="98"/>
              </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>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Chief Medical Officer</name_or_title>
      <organization>Eli Lilly and Company</organization>
      <phone>800-545-5979</phone>
    </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/NCT01703091
org study id: 14658
secondary id: I4T-JE-JVCG
nct id: NCT01703091
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effects of ramucirumab in combination with
      docetaxel in participants with Stage IV non-small cell lung cancer who have had disease
      progression during or after one prior first-line platinum-based chemotherapy with or without
      maintenance therapy for advanced/metastatic disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression-Free Survival (PFS)
time frame: Baseline to Measured Progressive Disease or Death from Any Cause (Up to 21 Months)
description: PFS was defined as the time from baseline until measured progressive disease (PD) or death from any cause, whichever is first. According to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), PD was at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study. In addition to the 20% relative increase, the sum must have also demonstrated an absolute increase of at least 5 millimeters (mm). The appearance of 1 or more new lesions and/or unequivocal progression of existing nontarget lesions was also considered progression. Participants without objectively determined PD, who were alive at the end of the follow-up period (or lost to follow-up), were censored on the date of the participant's last complete radiographic tumor assessment; if no baseline or post-baseline radiologic assessment was available, the participant was censored at the date of randomization.
measure: Overall Survival (OS)
time frame: Baseline to Death from Any Cause (Up to 28 Months)
description: OS was defined as time from baseline to the date of death from any cause. Participants who were alive at the end of the follow-up period (or lost to follow-up) were censored on the last date the participant was known to be alive.
measure: Percentage of Participants Who Achieved Best Overall Tumor Response of Complete Response (CR) or Partial Response (PR) [Objective Tumor Response Rate (ORR)]
time frame: Baseline to Measured Progressive Disease or Participant Stops Study (Up to 97 Weeks)
description: Participants achieved an objective response if they had a best overall response of complete response (CR) or partial response (PR). According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. The percentage of participants who achieved an objective response equals (number of participants with CR or PR)/(number of participants assessed)*100.
measure: Percentage of Participants Who Achieved Best Overall Disease Response of CR, PR or Stable Disease (SD) [Disease Control Rate (DCR)]
time frame: Baseline to Measured Progressive Disease or Participant Stopped Study (Up to 97 Weeks)
description: Participants achieved disease control if they had a best overall response of PR, CR or SD. According to RECIST v1.1, CR was the disappearance of all non-nodal target lesions, with the short axes of any target lymph node reduced to <10 mm, the disappearance of all nontarget lesions, and the normalization of tumor marker levels (if tumor markers were initially above the upper limit of normal [ULN]); PR was defined as at least a 30% decrease in the sum of the diameters of target lesions (including the short axes of any target lymph node), taking as reference the baseline sum diameter. SD was neither sufficient shrinkage to qualify as PR nor sufficient increase to qualify as PD, taking as reference the smallest sum diameter since treatment started. The percentage of participants who achieved disease control equals (number of participants with CR, PR, or SD)/(number of participants assessed)*100.
measure: Change From Baseline in European Quality of Life Questionnaire - 5 Dimension (EQ-5D) Index Score
time frame: Baseline, Day 21 Each Cycle (Cycle = 21 Days) and 30-Day Follow Up (Up to 97 Weeks)
description: The EQ-5D is a quality-of-life instrument which allowed participants to rate their health state in 5 health domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression using a scale from 1 to 3 (no problem, some problems, and extreme problems, respectively). These combinations of attributes were converted into a weighted Health State Index score according to a United Kingdom population-based algorithm; the possible values for the Health State Index score ranged from -0.59 (severe problems in all 5 dimensions) to 1.0 (no problem in any dimension).
measure: Change From Baseline in Lung Cancer Symptom Scale (LCSS)
time frame: Baseline to Measured Progressive Disease or Participant Stopped Study (up to 97 weeks)
description: The participant-reported LCSS was a 9-item questionnaire. Six items were symptom-specific measures for lung cancer (loss of appetite, fatigue, cough, dyspnea, hemoptysis, and pain), and 3 summation items described total symptomatic distress, interference with activity level, and global quality of life. Participant responses to each item were measured using a visual analog scale (VAS) from 0 (best outcome) to 100 (worst outcome). The Average Symptom Burden Index (ASBI) was the mean of the 6 symptom-specific items in the LCSS. The Total LCSS was the mean of all 9 LCSS items. Maximum improvement in LCSS scores, ASBI, and Total LCSS score was the largest decrease from baseline for each variable, which was the smallest (most negative or smallest positive) non-missing value among all change from baseline values for each variable.
arm group label: Ramucirumab plus Docetaxel
arm group type: Experimental
description: Ramucirumab 10 milligram per kilogram (mg/kg) on Day 1 of every 21 day cycle, administered as an intravenous (IV) infusion over approximately 60 minutes. Docetaxel 60 milligram per square meter (mg/m2) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
arm group label: Placebo plus Docetaxel
arm group type: Placebo Comparator
description: Placebo (administered at a volume equivalent to a dose of milligram per kilogram (mg/kg)) on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes. Docetaxel 60 mg/m2 on Day 1 of every 21 day cycle, administered as an IV infusion over approximately 60 minutes.
intervention type: Drug
intervention name: Ramucirumab
description: Administered IV
arm group label: Ramucirumab plus Docetaxel
other name: LY 3009806
other name: IMC-1121B
other name: Cyramza®
intervention type: Drug
intervention name: Placebo
description: Administered IV
arm group label: Placebo plus Docetaxel
intervention type: Drug
intervention name: Docetaxel
description: Administered IV
arm group label: Placebo plus Docetaxel
arm group label: Ramucirumab plus Docetaxel
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Docetaxel
mesh term: Ramucirumab
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: https://vivli.org/
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 