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/NCT05990127</url>
    </required_header>
    <id_info>
      <org_study_id>AK104-307</org_study_id>
      <nct_id>NCT05990127</nct_id>
    </id_info>
    <brief_title>A Study of AK104/Tislelizumab With Chemotherapy as First-line Treatment in PD-L1 TPS &lt; 1% Non-small Cell Lung Cancer</brief_title>
    <official_title>A Randomized, Double-blind, Phase III Trial to Compare the Efficacy and Safety of AK104 Combined With Chemotherapy to Tislelizumab Combined With Chemotherapy as First-line Treatment in PD-L1 TPS &lt; 1% Non-small Cell Lung Cancer (NSCLC)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Akeso</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Akeso</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a randomized, double-blind, phase III clinical study to compare the efficacy and&#xD;
        safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line&#xD;
        treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS &lt; 1%.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">November 14, 2023</start_date>
    <completion_date type="Anticipated">November 28, 2026</completion_date>
    <primary_completion_date type="Anticipated">August 5, 2025</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Overall Survival(OS)</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>OS is defined as the time from randomization to death due to any cause.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Progression-Free Survival(PFS) by investigator(INV)</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Progression-Free Survival(PFS) by Blind independent center review(BIRC)</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR) was assessed by INV</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>ORR is the proportion of subjects with CR or PR based on RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR) was assessed by INV</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>Disease control rate (DCR) was assessed based on RECIST V1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR) was assessed by INV</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>The time from the first administration to the date of documented CR or PR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR) was assessed by INV</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Objective response rate (ORR) was assessed by BIRC</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>ORR is the proportion of subjects with CR or PR based on RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate (DCR) was assessed BIRC</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>Disease control rate (DCR) was assessed based on RECIST V1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to response (TTR) was assessed by BIRC</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>The time from the first administration to the date of documented CR or PR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response (DOR) was assessed by BIRC</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>The number of subjects experiencing adverse events (AEs)</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pharmacokinetic</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Antidrug antibodies (ADA) of AK104</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>Proportion of subjects who develop detectable anti-drug antibodies (ADAs)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, &quot;Not at all&quot;; 2, &quot;A little&quot;; 3, &quot;Quite a bit&quot;; to 4, &quot;Very much&quot;. Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29)</measure>
      <time_frame>Through Database Cutoff Date (Up to approximately 39 months)</time_frame>
      <description>EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, &quot;Not at all&quot;; 2, &quot;A little&quot;; 3, &quot;Quite a bit&quot;; to 4, &quot;Very much&quot;. For symptoms scales, higher scores indicated greater symptom burden.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">642</enrollment>
    <condition>Locally Advanced or Metastatic NSCLC</condition>
    <arm_group>
      <arm_group_label>AK104 arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Tislelizumab arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>AK104</intervention_name>
      <description>AK104 IV, q3w</description>
      <arm_group_label>AK104 arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Tislelizumab</intervention_name>
      <description>Tislelizumab IV, q3w</description>
      <arm_group_label>Tislelizumab arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>carboplatin</intervention_name>
      <description>carboplatin IV, q3w</description>
      <arm_group_label>AK104 arm</arm_group_label>
      <arm_group_label>Tislelizumab arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Pemetrexed</intervention_name>
      <description>Pemetrexed IV, q3w (for Nonsquamous NSCLC)</description>
      <arm_group_label>AK104 arm</arm_group_label>
      <arm_group_label>Tislelizumab arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Paclitaxel</intervention_name>
      <description>Paclitaxel IV, q3w (for squamous NSCLC)</description>
      <arm_group_label>AK104 arm</arm_group_label>
      <arm_group_label>Tislelizumab arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. The subjects voluntarily participated in the study with full informed consent and&#xD;
               signed written informed consent form.&#xD;
  &#xD;
            2. Aged ≥18 years when the subject signed the informed consent.&#xD;
  &#xD;
            3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.&#xD;
  &#xD;
            4. Life expectancy ≥ 3 months.&#xD;
  &#xD;
            5. Histologically or cytologically confirmed locally advanced (Stage IIIB/IIIC) that not&#xD;
               amenable to complete surgical resection and not amenable to radical&#xD;
               concurrent/sequential chemoradiation or metastatic (Stage IV) NSCLC (American Joint&#xD;
               Committee on Cancer [AJCC] 8th edition).&#xD;
  &#xD;
            6. No prior systemic therapy for advanced or metastatic NSCLC was received.&#xD;
  &#xD;
            7. PD-L1 TPS &lt; 1%.&#xD;
  &#xD;
            8. No EGFR sensitive mutations or ALK gene translocation alterations.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Histologically confirmed small cell lung cancer (SCLC).&#xD;
  &#xD;
            2. NSCLC with driver gene mutations for approved targeted drug indications.&#xD;
  &#xD;
            3. Active central nervous system (CNS) metastases were present.&#xD;
  &#xD;
            4. Pulmonary radiation therapy &gt; 30 Gy within 6 months prior to first dose.&#xD;
  &#xD;
            5. Active malignant tumors within the past 5 years, except for tumors in this study and&#xD;
               scured local tumors.&#xD;
  &#xD;
            6. Pregnant or lactating women.&#xD;
  &#xD;
            7. Clinically significant cardiovascular or cerebrovascular disease.&#xD;
  &#xD;
            8. Subjects with a known history of severe hypersensitivity to other monoclonal&#xD;
               antibodies. A known history of allergy or hypersensitivity to all investigational&#xD;
               drugs or any of their components.&#xD;
  &#xD;
            9. Active autoimmune disease requiring systemic treatment within 2 years prior to the&#xD;
               start of study treatment, or autoimmune diseases that may relapse or require scheduled&#xD;
               treatment as judged by the Investigator.&#xD;
  &#xD;
           10. Known active pulmonary tuberculosis.&#xD;
  &#xD;
           11. Patients with active hepatitis B or active hepatitis C.&#xD;
  &#xD;
           12. Known medical history of immunodeficiency or positive HIV test.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Jie Wang, M.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cancer hospital, Chinese academy of medical sciences and Peking union medical college</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Qingming Wang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Henan Cancer Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhifang Yao, M.D.</last_name>
      <phone>+86-0760-89873999</phone>
      <email>clinicaltrials@akesobio.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>The first affiliated hospital of bengbu medical college</name>
        <address>
          <city>Bengbu</city>
          <state>Anhui</state>
          <zip>233099</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Anhui provincial hospital</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230001</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Anhui provincial cancer hospital</name>
        <address>
          <city>Hefei</city>
          <state>Anhui</state>
          <zip>230088</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The first affiliated hospital of wannan medical college</name>
        <address>
          <city>Wuhu</city>
          <state>Anhui</state>
          <zip>241001</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Cancer hospital, Chinese academy of medical sciences and Peking union medical college</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100021</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Fifth Medical Center of the Chinese People's Liberation Army General Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100039</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Beijing Cancer Hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100142</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Beijing Chest hospital</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>101149</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Chongqing University Cancer Hospital</name>
        <address>
          <city>Chongqing</city>
          <state>Chongqing</state>
          <zip>400030</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Fujian cancer hospital</name>
        <address>
          <city>Fuzhou</city>
          <state>Fujian</state>
          <zip>350014</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Zhangzhou municipal hospital of fujian province</name>
        <address>
          <city>Zhangzhou</city>
          <state>Fujian</state>
          <zip>363099</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Gansu provincial cancer hospital</name>
        <address>
          <city>Lanzhou</city>
          <state>Gansu</state>
          <zip>730050</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Sun Yat-sen University</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510080</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Affiliated cancer hospital and institute of guangzhou medical university</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510095</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Nanfang hospital</name>
        <address>
          <city>Guangzhou</city>
          <state>Guangdong</state>
          <zip>510515</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Cancer hospital Chinses academy of medical sciences， shenzhen center</name>
        <address>
          <city>Shenzhen</city>
          <state>Guangdong</state>
          <zip>518172</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hainan cancer hospital</name>
        <address>
          <city>Haikou</city>
          <state>Hainan</state>
          <zip>570312</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Affiliated hospital of Hebei university</name>
        <address>
          <city>Baoding</city>
          <state>Hebei</state>
          <zip>050031</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The second people's hospital of Hengshui</name>
        <address>
          <city>Hengshui</city>
          <state>Hebei</state>
          <zip>053099</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Second Hospital of HeBei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050004</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Fourth Hospital of Hebei Medical University</name>
        <address>
          <city>Shijiazhuang</city>
          <state>Hebei</state>
          <zip>050011</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tangshang people's hospital</name>
        <address>
          <city>Tangshan</city>
          <state>Hebei</state>
          <zip>063001</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Harbin medical university cancer hospital</name>
        <address>
          <city>Harbin</city>
          <state>Heilongjiang</state>
          <zip>150081</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Jiamusi Tuberculosis Prevention and Control Hospital (Jiamusi Cancer Hospital)</name>
        <address>
          <city>Jiamusi</city>
          <state>Heilongjiang</state>
          <zip>154007</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The first hospital of Qiqihar</name>
        <address>
          <city>Qiqihar</city>
          <state>Heilongjiang</state>
          <zip>161005</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Henan University of Science and Technology</name>
        <address>
          <city>Luoyang</city>
          <state>Henan</state>
          <zip>450052</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Nanyang central hospital</name>
        <address>
          <city>Nanyang</city>
          <state>Henan</state>
          <zip>473005</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xinxiang Medical College</name>
        <address>
          <city>Xinxiang</city>
          <state>Henan</state>
          <zip>45310</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Henan Cancer Hospital</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450003</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Zhengzhou University</name>
        <address>
          <city>Zhengzhou</city>
          <state>Henan</state>
          <zip>450052</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Renmin Hospital of Wuhan University</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430060</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hubei Cancer Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430079</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Xiangya Hospital of Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410008</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Second Xiangya Hospital, Central South University</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410012</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hunan Cancer Hospital</name>
        <address>
          <city>Changsha</city>
          <state>Hunan</state>
          <zip>410013</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Soochow University</name>
        <address>
          <city>Suzhou</city>
          <state>Jiangsu</state>
          <zip>215006</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The affiliated hospital of xuzhou medical university</name>
        <address>
          <city>Xuzhou</city>
          <state>Jiangsu</state>
          <zip>221799</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>First Affiliated Hospital of Gannan medical college</name>
        <address>
          <city>Ganzhou</city>
          <state>Jiangxi</state>
          <zip>341000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>First Affiliated Hospital of Nanchang University</name>
        <address>
          <city>Nanchang</city>
          <state>Jiangxi</state>
          <zip>330006</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The first hospital of Jilin Universit</name>
        <address>
          <city>Changchun</city>
          <state>Jilin</state>
          <zip>130061</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tonghua Central Hospital</name>
        <address>
          <city>Tonghua</city>
          <state>Jilin</state>
          <zip>134099</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Hospital of China medical University</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110002</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Liaoning cancer hospital</name>
        <address>
          <city>Shenyang</city>
          <state>Liaoning</state>
          <zip>110801</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>General hospital of ningxia medical university</name>
        <address>
          <city>Yinchuan</city>
          <state>Ningxia</state>
          <zip>750003</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Qinghai university affiliated hospital</name>
        <address>
          <city>Xining</city>
          <state>Qinghai</state>
          <zip>810012</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Binzhou medical university hospital</name>
        <address>
          <city>Binzhou</city>
          <state>Shandong</state>
          <zip>256603</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shandong Cancer Hospital</name>
        <address>
          <city>Jinan</city>
          <state>Shandong</state>
          <zip>250117</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Affiliated Hospital of Qingdao University</name>
        <address>
          <city>Qingdao</city>
          <state>Shandong</state>
          <zip>266000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Weifang NO.2 people's Hospital</name>
        <address>
          <city>Weifang</city>
          <state>Shandong</state>
          <zip>261041</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Zhongshan Hospital, Fudan university</name>
        <address>
          <city>Shanghai</city>
          <state>Shanghai</state>
          <zip>200032</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Changzhi people's hospital</name>
        <address>
          <city>Changzhi</city>
          <state>Shanxi</state>
          <zip>046099</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Shanxi Cancer hospital</name>
        <address>
          <city>Taiyuan</city>
          <state>Shanxi</state>
          <zip>030013</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
        <address>
          <city>Xi'an</city>
          <state>Shanxi</state>
          <zip>710061</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Sichuan Cancer Hospital</name>
        <address>
          <city>Chengdu</city>
          <state>Sichuan</state>
          <zip>610042</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Mianyang central hospital</name>
        <address>
          <city>Mianyang</city>
          <state>Sichuan</state>
          <zip>621099</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Second People's Hospital of Yibin City</name>
        <address>
          <city>Yibin</city>
          <state>Sichuan</state>
          <zip>644000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tianjin Medical University Cancer Institute &amp; Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300060</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Tianjin Chest Hospital</name>
        <address>
          <city>Tianjin</city>
          <state>Tianjin</state>
          <zip>300222</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Xinjiang Medical University Cancer Hospital</name>
        <address>
          <city>Urumqi</city>
          <state>Xinjiang</state>
          <zip>830000</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Yunnan Cancer Hospital /the Third Affiliated Hospital of Kunming Medical University</name>
        <address>
          <city>Kunming</city>
          <state>Yunnan</state>
          <zip>650118</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The First Affiliated Hospital, Zhejiang University School of Medicine (FAHZU)</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310003</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Zhejiang Cancer Hospital</name>
        <address>
          <city>Hangzhou</city>
          <state>Zhejiang</state>
          <zip>310005</zip>
          <country>China</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 10, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 10, 2023</last_update_submitted>
    <last_update_submitted_qc>August 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>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>Pemetrexed</mesh_term>
      <mesh_term>Tislelizumab</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </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/NCT05990127
  org study id: AK104-307
  nct id: NCT05990127
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  This is a randomized, double-blind, phase III clinical study to compare the efficacy and
        safety of AK104 combined chemotherapy versus Tislelizumab combined chemotherapy in first-line
        treatment of Locally advanced or metastatic NSCLC with PD-L1 TPS < 1%.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Overall Survival(OS)
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: OS is defined as the time from randomization to death due to any cause.
  measure: Progression-Free Survival(PFS) by investigator(INV)
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
  measure: Progression-Free Survival(PFS) by Blind independent center review(BIRC)
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1
  measure: Objective response rate (ORR) was assessed by INV
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: ORR is the proportion of subjects with CR or PR based on RECIST v1.1
  measure: Disease control rate (DCR) was assessed by INV
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: Disease control rate (DCR) was assessed based on RECIST V1.1 criteria
  measure: Time to response (TTR) was assessed by INV
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: The time from the first administration to the date of documented CR or PR
  measure: Duration of response (DOR) was assessed by INV
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria
  measure: Objective response rate (ORR) was assessed by BIRC
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: ORR is the proportion of subjects with CR or PR based on RECIST v1.1
  measure: Disease control rate (DCR) was assessed BIRC
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: Disease control rate (DCR) was assessed based on RECIST V1.1 criteria
  measure: Time to response (TTR) was assessed by BIRC
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: The time from the first administration to the date of documented CR or PR
  measure: Duration of response (DOR) was assessed by BIRC
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: Measured from the date of partial or complete response to therapy until the disease progression per RECIST v1.1 criteria
  measure: The number of subjects experiencing adverse events (AEs)
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and clinically significant abnormal laboratory results.
  measure: Pharmacokinetic
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: The endpoints for assessment of PK of AK104 include serum concentrations of AK104 at different timepoints after AK104 administration
  measure: Antidrug antibodies (ADA) of AK104
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: Proportion of subjects who develop detectable anti-drug antibodies (ADAs)
  measure: Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30)
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: EORTC QLQ-C30 measures cancer patients' physical, psychological, and social functions. Scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". Higher score for the functioning scales and global health status denotes a better level of functioning, while higher scores on the symptom and single-item scales indicate a higher level of symptoms.
  measure: Health-related Quality of Life (HRQoL) assessment using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Lung Cancer 29 module (EORTC QLQ-LC29)
  time frame: Through Database Cutoff Date (Up to approximately 39 months)
  description: EORTC-QLQ-LC29 measures the quality of life in patients with lung cancer. Symptom scale ranges from: 1, "Not at all"; 2, "A little"; 3, "Quite a bit"; to 4, "Very much". For symptoms scales, higher scores indicated greater symptom burden.
  arm group label: AK104 arm
  arm group type: Experimental
  arm group label: Tislelizumab arm
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: AK104
  description: AK104 IV, q3w
  arm group label: AK104 arm
  intervention type: Drug
  intervention name: Tislelizumab
  description: Tislelizumab IV, q3w
  arm group label: Tislelizumab arm
  intervention type: Drug
  intervention name: carboplatin
  description: carboplatin IV, q3w
  arm group label: AK104 arm
  arm group label: Tislelizumab arm
  intervention type: Drug
  intervention name: Pemetrexed
  description: Pemetrexed IV, q3w (for Nonsquamous NSCLC)
  arm group label: AK104 arm
  arm group label: Tislelizumab arm
  intervention type: Drug
  intervention name: Paclitaxel
  description: Paclitaxel IV, q3w (for squamous NSCLC)
  arm group label: AK104 arm
  arm group label: Tislelizumab arm
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Jie Wang, M.D.
  role: Principal Investigator
  affiliation: Cancer hospital, Chinese academy of medical sciences and Peking union medical college
  last name: Qingming Wang
  role: Principal Investigator
  affiliation: Henan Cancer Hospital
  last name: Zhifang Yao, M.D.
  phone: +86-0760-89873999
  email: clinicaltrials@akesobio.com
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  country: China
  responsible party type: Sponsor
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Paclitaxel
  mesh term: Carboplatin
  mesh term: Pemetrexed
  mesh term: Tislelizumab
  sharing ipd: No