xml: <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/NCT05984277</url>
    </required_header>
    <id_info>
      <org_study_id>D798AC00001</org_study_id>
      <secondary_id>2023-000056-38</secondary_id>
      <nct_id>NCT05984277</nct_id>
    </id_info>
    <brief_title>A Global Study of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for Participants With Metastatic Non-small Cell Lung Cancer.</brief_title>
    <acronym>eVOLVE-Lung02</acronym>
    <official_title>A Phase III, Two-Arm, Parallel, Randomized, Multi-Center, Open-Label, Global Study to Determine the Efficacy of Volrustomig (MEDI5752) Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy for First-Line Treatment of Patients With Metastatic Non-Small Cell Lung Cancer (mNSCLC).</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AstraZeneca</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>AstraZeneca</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety&#xD;
        of volrustomig in combination with chemotherapy compared with pembrolizumab in combination&#xD;
        with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 &lt; 50%.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Adult patients with a histologically or cytologically documented metastatic NSCLC, with&#xD;
        tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment.&#xD;
        Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig +&#xD;
        chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until&#xD;
        disease progression as efficacy assessment. All patients will be followed for survival until&#xD;
        the end of the study. An data monitoring committee (DMC) composed of independent experts will&#xD;
        be convened to confirm the safety and tolerability of the proposed dose and schedule.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 30, 2023</start_date>
    <completion_date type="Anticipated">May 16, 2029</completion_date>
    <primary_completion_date type="Anticipated">May 30, 2028</primary_completion_date>
    <phase>Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
      <masking_description>None (Open Label)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Overall Survival (OS), in PD-L1-negative participants.</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>PFS (using BICR assessments according to RECIST 1.1)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OS</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS (using Investigator assessments according to RECIST 1.1)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Overall Response Rate (ORR)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by BICR assessments using RECIST 1.1.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Response (DoR)</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>DoR is defined as the time from the date of first documented response until the date of documented progression per BICR assessments using RECIST 1.1 or death due to any cause (in the absence of progression). These analyses will include participants who have a confirmed response.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PFS2</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression) after the start of the first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Concentration of volrustomig in serum and PK parameters</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>To assess the PK of volrustomig</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Presence of ADAs against volrustomig in serum</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>To investigate the immunogenicity of volrustomig.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time-To-Deterioration (TTD) in physical functioning</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TTD of lung cancer symptoms</measure>
      <time_frame>Up to approximately 6 years</time_frame>
      <description>To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">900</enrollment>
    <condition>Metastatic Non-small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Arm 2</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Volrustomig</intervention_name>
      <description>Volrustomig</description>
      <arm_group_label>Arm 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pembrolizumab</intervention_name>
      <description>Pembrolizumab</description>
      <arm_group_label>Arm 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Carboplatin</intervention_name>
      <description>Carboplatin</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Paclitaxel</intervention_name>
      <description>Paclitaxel</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pemetrexed</intervention_name>
      <description>Pemetrexed</description>
      <arm_group_label>Arm 1</arm_group_label>
      <arm_group_label>Arm 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Key Inclusion Criteria:&#xD;
  &#xD;
            -  Histologically or cytologically documented squamous or non-squamous NSCLC.&#xD;
  &#xD;
            -  Stage IV NSCLC (according to Version 8 of the IASLC Staging Manual in Thoracic&#xD;
               Oncology 2016), not amenable to curative surgery or radiation.&#xD;
  &#xD;
            -  Absence of sensitizing EGFR mutations and ALK and ROS1 rearrangements.&#xD;
  &#xD;
            -  Absence of documented tumor genomic alteration results from tests conducted as part of&#xD;
               standard local practice in any other actionable driver oncogenes for which there are&#xD;
               locally approved targeted first-line therapies.&#xD;
  &#xD;
          Key Exclusion Criteria:&#xD;
  &#xD;
            -  Mixed small-cell lung cancer and NSCLC histology or sarcomatoid variant. Rare subtypes&#xD;
               are excluded.&#xD;
  &#xD;
            -  Spinal cord compression.&#xD;
  &#xD;
            -  Brain metastases unless asymptomatic, stable, and not requiring steroids for at least&#xD;
               14 days prior to start of study intervention. A minimum of 2 weeks must have elapsed&#xD;
               between the end of whole brain radiotherapy and study enrollment.&#xD;
  &#xD;
            -  History of another primary malignancy except for:&#xD;
  &#xD;
                 1. Malignancy treated with curative intent with no known active disease ≥ 2 years&#xD;
                    before the first dose of study intervention and of low potential risk for&#xD;
                    recurrence.&#xD;
  &#xD;
                 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence&#xD;
                    of disease.&#xD;
  &#xD;
                 3. Adequately treated carcinoma in situ without evidence of disease.&#xD;
  &#xD;
            -  As judged by the investigator, any condition that would interfere with evaluation of&#xD;
               the study intervention or interpretation of participant safety or study results.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>AstraZeneca Clinical Study Information Center</last_name>
      <phone>1-877-240-9479</phone>
      <email>information.center@astrazeneca.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Rosario</city>
          <zip>S2000DEJ</zip>
          <country>Argentina</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Linz</city>
          <zip>4021</zip>
          <country>Austria</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Calgary</city>
          <state>Alberta</state>
          <zip>T2N 4N2</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Halifax</city>
          <state>Nova Scotia</state>
          <zip>B3H 1V7</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Barrie</city>
          <state>Ontario</state>
          <zip>L4M 6M2</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Toronto</city>
          <state>Ontario</state>
          <zip>M4N 3M5</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Lévis</city>
          <state>Quebec</state>
          <zip>G6V 0B8</zip>
          <country>Canada</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Chengdu</city>
          <zip>611135</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Bergamo</city>
          <zip>24125</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Catanzaro</city>
          <zip>88100</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Milano</city>
          <zip>20162</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Padova</city>
          <zip>35128</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Parma</city>
          <zip>43126</zip>
          <country>Italy</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Fukuoka-shi</city>
          <zip>812-8582</zip>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Kashiwa</city>
          <zip>277-8577</zip>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Koto-ku</city>
          <zip>135-8550</zip>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Osakasayama-shi</city>
          <zip>589-8511</zip>
          <country>Japan</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Cheongju-si</city>
          <zip>28644</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Jinju-si</city>
          <zip>52727</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Seoul</city>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Seoul</city>
          <zip>06351</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Seoul</city>
          <zip>06591</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Suwon</city>
          <zip>16247</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Amsterdam</city>
          <zip>1081 HV</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Groningen</city>
          <zip>9728 NT</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Nieuwegein</city>
          <zip>3435 CM</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Tilburg</city>
          <zip>5042AD</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Lublin</city>
          <zip>20-954</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Przemysl</city>
          <zip>37-700</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Rzeszów</city>
          <zip>35-241</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Szklarska Poręba</city>
          <zip>58-580</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Tomaszów Mazowiecki</city>
          <zip>97-200</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Toruń</city>
          <zip>87-100</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Warszawa</city>
          <zip>01-138</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Warszawa</city>
          <zip>02-781</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Łódź</city>
          <zip>90-549</zip>
          <country>Poland</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Alicante</city>
          <zip>03010</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Barcelona</city>
          <zip>08003</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Barcelona</city>
          <zip>08025</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Bilbao (Vizcaya)</city>
          <zip>48013</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Madrid</city>
          <zip>28040</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Málaga</city>
          <zip>29011</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Palma</city>
          <zip>07198</zip>
          <country>Spain</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Taipei City</city>
          <zip>110</zip>
          <country>Taiwan</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Birmingham</city>
          <zip>B9 5SS</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Blackpool</city>
          <zip>FY3 8NR</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
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    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Bury St Edmunds</city>
          <zip>IP332QZ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
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    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Colchester</city>
          <zip>CO4 5JL</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>London</city>
          <zip>EC1A 7BE</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>London</city>
          <zip>NW3 2QG</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>London</city>
          <zip>SW10 9NH</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Research Site</name>
        <address>
          <city>Truro</city>
          <zip>TR1 3LJ</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Argentina</country>
      <country>Austria</country>
      <country>Canada</country>
      <country>China</country>
      <country>Italy</country>
      <country>Japan</country>
      <country>Korea, Republic of</country>
      <country>Netherlands</country>
      <country>Poland</country>
      <country>Spain</country>
      <country>Taiwan</country>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 2, 2023</last_update_submitted>
    <last_update_submitted_qc>August 2, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>metastatic non-small cell lung cancer</keyword>
    <keyword>non-squamous tumors</keyword>
    <keyword>squamous tumors</keyword>
    <keyword>PD-L1</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Paclitaxel</mesh_term>
      <mesh_term>Carboplatin</mesh_term>
      <mesh_term>Pembrolizumab</mesh_term>
      <mesh_term>Pemetrexed</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_time_frame>AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_time_frame>
      <ipd_access_criteria>When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. SignedData Sharing Agreement (non-negotiable contract for data accessors) must be inplace before accessing requested information. Additionally, all users will need toaccept the terms and conditions of the SAS MSE to gain access. For additionaldetails, please review the Disclosure Statements athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.</ipd_access_criteria>
      <ipd_url>https://astrazenecagroup-dt.pharmacm.com/DT/Home</ipd_url>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984277
  org study id: D798AC00001
  secondary id: 2023-000056-38
  nct id: NCT05984277
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  The purpose of eVOLVE-Lung02 is to test the effectiveness (efficacy) and measure the safety
        of volrustomig in combination with chemotherapy compared with pembrolizumab in combination
        with chemotherapy as 1L treatment in participants with mNSCLC in PD-L1 < 50%.
  Adult patients with a histologically or cytologically documented metastatic NSCLC, with
        tumors that lack activating EGFR, ALK, and ROS1 alterations are eligible for enrollment.
        Patients will be randomized in a 1:1 ratio to receive treatment with volrustomig +
        chemotherapy or pembrolizumab + chemotherapy. Tumor evaluation scans will be performed until
        disease progression as efficacy assessment. All patients will be followed for survival until
        the end of the study. An data monitoring committee (DMC) composed of independent experts will
        be convened to confirm the safety and tolerability of the proposed dose and schedule.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  masking description: None (Open Label)
  measure: Progression-Free Survival (PFS) (using BICR assessments according to RECIST 1.1)
  time frame: Up to approximately 6 years
  description: PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression), in PD-L1-negative participants.
  measure: Overall Survival (OS), in PD-L1-negative participants.
  time frame: Up to approximately 6 years
  description: OS is defined as the time from randomization until the date of death due to any cause, in PD-L1-negative participants.
  measure: PFS (using BICR assessments according to RECIST 1.1)
  time frame: Up to approximately 6 years
  description: PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by BICR, or death due to any cause (in the absence of progression). The analysis will include all randomized participants.
  measure: OS
  time frame: Up to approximately 6 years
  description: OS is defined as the time from randomization until the date of death due to any cause. The analysis will include all randomized participants.
  measure: PFS (using Investigator assessments according to RECIST 1.1)
  time frame: Up to approximately 6 years
  description: PFS is defined as the time from randomization until radiological progression per RECIST 1.1 as assessed by investigator, or death due to any cause (in the absence of progression).
  measure: Overall Response Rate (ORR)
  time frame: Up to approximately 6 years
  description: ORR is defined as the proportion of participants who have a confirmed CR or confirmed PR, as determined by BICR assessments using RECIST 1.1.
  measure: Duration of Response (DoR)
  time frame: Up to approximately 6 years
  description: DoR is defined as the time from the date of first documented response until the date of documented progression per BICR assessments using RECIST 1.1 or death due to any cause (in the absence of progression). These analyses will include participants who have a confirmed response.
  measure: PFS2
  time frame: Up to approximately 6 years
  description: PFS2 is defined as the time from randomization until the earliest of the progression event (following the initial investigator-assessed progression) after the start of the first subsequent therapy, or death. The date of second progression will be recorded by the investigator in the eCRF and defined according to local standard clinical practice.
  measure: Concentration of volrustomig in serum and PK parameters
  time frame: Up to approximately 6 years
  description: To assess the PK of volrustomig
  measure: Presence of ADAs against volrustomig in serum
  time frame: Up to approximately 6 years
  description: To investigate the immunogenicity of volrustomig.
  measure: Time-To-Deterioration (TTD) in physical functioning
  time frame: Up to approximately 6 years
  description: To assess participant-reported physical functioning in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
  measure: TTD of lung cancer symptoms
  time frame: Up to approximately 6 years
  description: To assess participant-reported pulmonary symptoms of mNSCLC in participants treated with volrustomig plus chemotherapy and pembrolizumab plus chemotherapy.
  arm group label: Arm 1
  arm group type: Experimental
  description: Volrustomig plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
  arm group label: Arm 2
  arm group type: Active Comparator
  description: Pembrolizumab plus histology-specific chemotherapy (carboplatin plus either pemetrexed or paclitaxel) via iv infusion
  intervention type: Drug
  intervention name: Volrustomig
  description: Volrustomig
  arm group label: Arm 1
  intervention type: Drug
  intervention name: Pembrolizumab
  description: Pembrolizumab
  arm group label: Arm 2
  intervention type: Drug
  intervention name: Carboplatin
  description: Carboplatin
  arm group label: Arm 1
  arm group label: Arm 2
  intervention type: Drug
  intervention name: Paclitaxel
  description: Paclitaxel
  arm group label: Arm 1
  arm group label: Arm 2
  intervention type: Drug
  intervention name: Pemetrexed
  description: Pemetrexed
  arm group label: Arm 1
  arm group label: Arm 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: AstraZeneca Clinical Study Information Center
  phone: 1-877-240-9479
  email: information.center@astrazeneca.com
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  country: Argentina
  country: Austria
  country: Canada
  country: China
  country: Italy
  country: Japan
  country: Korea, Republic of
  country: Netherlands
  country: Poland
  country: Spain
  country: Taiwan
  country: United Kingdom
  responsible party type: Sponsor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Paclitaxel
  mesh term: Carboplatin
  mesh term: Pembrolizumab
  mesh term: Pemetrexed
  sharing ipd: Yes
  ipd description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  ipd access criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. SignedData Sharing Agreement (non-negotiable contract for data accessors) must be inplace before accessing requested information. Additionally, all users will need toaccept the terms and conditions of the SAS MSE to gain access. For additionaldetails, please review the Disclosure Statements athttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
  ipd url: https://astrazenecagroup-dt.pharmacm.com/DT/Home