<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/NCT04484142</url>
  </required_header>
  <id_info>
    <org_study_id>DS1062-A-U202</org_study_id>
    <secondary_id>2020-002774-27</secondary_id>
    <nct_id>NCT04484142</nct_id>
  </id_info>
  <brief_title>Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations (TROPION-Lung05)</brief_title>
  <official_title>Phase 2, Single-arm, Open-label Study of DS-1062a in Advanced or Metastatic Non-small Cell Lung Cancer With Actionable Genomic Alterations and Progressed On or After Applicable Targeted Therapy and Platinum Based Chemotherapy (TROPION-Lung05)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Daiichi Sankyo, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants&#xD;
      with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic&#xD;
      alterations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will evaluate DS-1062a 6.0 mg/kg in participants with advanced or metastatic NSCLC&#xD;
      with actionable genomic alterations and who have been previously been treated with 1&#xD;
      platinum-containing therapy and 1 or more lines of targeted therapy. The study will be&#xD;
      divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period. The primary&#xD;
      analysis of Objective Response Rate (ORR) by blinded Independent Central Review (BICR) will&#xD;
      be conducted after all participants either have been followed for at least 9 months after the&#xD;
      start of study treatment or have discontinued from the study, whichever occurs first.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 30, 2021</start_date>
  <completion_date type="Anticipated">May 9, 2024</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2023</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective Response Rate (ORR) As Assessed by Blind Independent Central Review Per RECIST v1.1 Following DS-1062a Intravenous Infusion</measure>
    <time_frame>From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months</time_frame>
    <description>ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of Response (DOR) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous Infusion</measure>
    <time_frame>From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months</time_frame>
    <description>DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous (IV) Infusion</measure>
    <time_frame>From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months</time_frame>
    <description>PFS is defined as the time from the start of study treatment to the earlier of the dates of the first documentation of progressive disease or death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) Following DS-1062a Intravenous Infusion</measure>
    <time_frame>From baseline until death due to any cause, up to approximately 23 months</time_frame>
    <description>OS is defined as the time from the start of study treatment to the date of death due to any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Intravenous Infusion in Participants with Advanced or Metastatic NSCLC with Actionable Genomic Alterations</measure>
    <time_frame>From baseline up to approximately 23 months post treatment</time_frame>
    <description>Reported treatment-emergent adverse events, serious adverse events, adverse events of interest, and those considered related to the study drug or study procedures, or that associated DS-1062a reduction, interruption, or discontinuation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter Maximum Concentration (Cmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a</measure>
    <time_frame>Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a</measure>
    <time_frame>Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a</measure>
    <time_frame>Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days)</time_frame>
    <description>AUC up to the last quantifiable time (AUClast) and AUC during dosing interval (AUCtau) will be assessed for DS-1062, total Anti-TROP2 antibody, and MAAA-1181a.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">137</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>DS-1062a 6.0 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 6.0 mg/kg of DS-1062a</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DS-1062a</intervention_name>
    <description>DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks</description>
    <arm_group_label>DS-1062a 6.0 mg/kg</arm_group_label>
    <other_name>Datopotamab Deruxtecan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Participants eligible for inclusion in the study must meet all inclusion criteria for this&#xD;
        study.&#xD;
&#xD;
          -  Sign and date the inform consent form (ICF) prior to the start of any study- specific&#xD;
             qualification procedures.&#xD;
&#xD;
          -  Adults ≥18 years (if the legal age of consent is &gt;18 years old, then follow local&#xD;
             regulatory requirements)&#xD;
&#xD;
          -  Has pathologically documented NSCLC that:&#xD;
&#xD;
               1. Has stage IIIB, IIIC, or stage IV NSCLC disease at the time of enrollment (based&#xD;
                  on the American Joint Committee on Cancer, Eighth Edition).&#xD;
&#xD;
               2. Has one or more of the following documented activating genomic alterations: EGFR,&#xD;
                  ALK, ROS1, NTRK, BRAF, MET exon 14 skipping, or RET.&#xD;
&#xD;
        KRAS mutations in the absence of any of the genomic alterations specified above will be&#xD;
        excluded.&#xD;
&#xD;
        Overexpression of EGFR, in the absence of activating mutations, is NOT sufficient for&#xD;
        enrollment.&#xD;
&#xD;
        Participants who have not received osimertinib should be evaluated for the presence of EGFR&#xD;
        T790M mutation after relapse/progression on/after the most recent EGFR tyrosine kinase&#xD;
        inhibitor (TKI), unless the participant is already known to be positive with document&#xD;
        results for this mutation or unless osimertinib is not locally approved.&#xD;
&#xD;
          -  Has documentation of radiographic disease progression while on or after receiving the&#xD;
             most recent treatment regimen for advanced or metastatic NSCLC.&#xD;
&#xD;
          -  Participant must meet the following for advanced or metastatic NSCLC:&#xD;
&#xD;
               1. Has been treated with at least one but no more than two cytotoxic&#xD;
                  agent-containing therapy in the metastatic setting:&#xD;
&#xD;
                    -  One platinum-containing regimen (either as monotherapy or combination&#xD;
                       therapy).&#xD;
&#xD;
                    -  May have received up to one additional line of cytotoxic agent-containing&#xD;
                       therapy.&#xD;
&#xD;
                    -  Those who received a platinum-containing regimen as adjuvant therapy for&#xD;
                       early stage disease must have relapsed or progressed while on the treatment&#xD;
                       or within 6 months of the last dose OR received at least one additional&#xD;
                       course of platinum-containing therapy (which may or may not be same as in&#xD;
                       the adjuvant setting) for relapsed/progressive disease.&#xD;
&#xD;
               2. May have received up to one checkpoint inhibitor (CPI)-containing regimen (may be&#xD;
                  in combination with a cytotoxic agent as part of a regimen described above or as&#xD;
                  an additional CPI regimen without a cytotoxic agent).&#xD;
&#xD;
               3. Has been treated with 1 or more lines of non-CPI targeted therapy that is locally&#xD;
                  approved for the participant's applicable genomic alteration at the time of&#xD;
                  screening:&#xD;
&#xD;
                    -  Those who received a targeted agent for the applicable genomic alterations&#xD;
                       in the study as adjuvant therapy for early stage disease must have relapsed&#xD;
                       or progressed while on the treatment or within 6 months of the last dose OR&#xD;
                       received at least one additional course of targeted therapy for the same&#xD;
                       genomic alterations (which may or may not be same agent used in the adjuvant&#xD;
                       setting) for relapsed/progressive disease.&#xD;
&#xD;
                    -  Participants who have been treated with a prior TKI must receive additional&#xD;
                       targeted therapy, if clinically appropriate, for the genomic alterations&#xD;
                       that are considered amenable or the participant will not be allowed in the&#xD;
                       study.&#xD;
&#xD;
          -  Must undergo a mandatory pre-treatment tumor biopsy procedure or if available, a tumor&#xD;
             biopsy that was recently collected (within 3 months of screening) after completion of&#xD;
             the most recent anticancer treatment regimen and that has a minimum of 10 × 4 micron&#xD;
             sections or a tissue block equivalent of 10 × 4 micron sections may be substituted for&#xD;
             the mandatory biopsy collected during screening.&#xD;
&#xD;
          -  Measurable disease based on local imaging assessment using RECIST v1.1.&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 - 1 at screening.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Participants meeting any exclusion criteria for this study will be excluded from this&#xD;
        study.&#xD;
&#xD;
          -  Has spinal cord compression or clinically active central nervous system metastases,&#xD;
             defined as untreated and symptomatic, or requiring therapy with corticosteroids or&#xD;
             anticonvulsants to control associated symptoms. Participants with clinically inactive&#xD;
             brain metastases may be included in the study.&#xD;
&#xD;
          -  Has leptomeningeal carcinomatosis.&#xD;
&#xD;
          -  Has prior treatment with:&#xD;
&#xD;
               1. Any chemotherapeutic agent targeting topoisomerase I, including antibody drug&#xD;
                  conjugate (ADC) containing such agent.&#xD;
&#xD;
               2. TROP2-targeted therapy.&#xD;
&#xD;
          -  Uncontrolled or significant cardiovascular disease:&#xD;
&#xD;
               1. History of myocardial infarction within 6 months prior to Cycle 1 Day 1.&#xD;
&#xD;
               2. History of uncontrolled angina pectoris within 6 months prior to Cycle 1 Day 1.&#xD;
&#xD;
               3. Symptomatic congestive heart failure (CHF) (New York Heart Association Class II&#xD;
                  to IV) at screening. Participants with a history of Class II to IV CHF prior to&#xD;
                  screening must have returned to Class I CHF and have LVEF ≥50% (by either an ECHO&#xD;
                  or MUGA scan within 28 days of Cycle 1 Day 1) in order to be eligible.&#xD;
&#xD;
               4. History of serious cardiac arrhythmia requiring treatment.&#xD;
&#xD;
               5. LVEF &lt;50% or institutional lower limit of normal by ECHO or MUGA scan.&#xD;
&#xD;
               6. Uncontrolled hypertension (resting systolic blood pressure &gt;180 mmHg or diastolic&#xD;
                  blood pressure &gt;110 mmHg).&#xD;
&#xD;
          -  Has a history of (non-infectious) interstitial lung disease (ILD)/pneumonitis that&#xD;
             required steroids, has current ILD/pneumonitis, or where suspected ILD/pneumonitis&#xD;
             cannot be ruled out by imaging at screening.&#xD;
&#xD;
          -  Clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses&#xD;
&#xD;
          -  Clinically significant corneal disease.&#xD;
&#xD;
          -  Has other primary malignancies, except adequately resected non-melanoma skin cancer,&#xD;
             curatively treated in situ disease, or other solid tumors curatively treated, with no&#xD;
             evidence of disease for ≥3 years.&#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>Global Clinical Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California San Diego</name>
      <address>
        <city>La Jolla</city>
        <state>California</state>
        <zip>92093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA</name>
      <address>
        <city>Santa Monica</city>
        <state>California</state>
        <zip>90404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boca Raton Regional Hospital</name>
      <address>
        <city>Boca Raton</city>
        <state>Florida</state>
        <zip>33486</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute at Florida Cancer Center, North</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AdventHealth Orlando</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute at Florida Cancer Center, South</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33980</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moffitt Cancer Center</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Office of Dr. Frederick P. Smith MD</name>
      <address>
        <city>Chevy Chase</city>
        <state>Maryland</state>
        <zip>20815</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital Cancer Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dana Farber Cancer Institute</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Michigan</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>XCancer / Regional Cancer Care Associate (Astera)</name>
      <address>
        <city>East Brunswick</city>
        <state>New Jersey</state>
        <zip>08816</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NYU Langone Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10016</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Cancer and Blood Specialists</name>
      <address>
        <city>Port Jefferson</city>
        <state>New York</state>
        <zip>11776</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Avera Cancer Institute Sioux Falls</name>
      <address>
        <city>Sioux Falls</city>
        <state>South Dakota</state>
        <zip>57105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute at Tennessee Oncology - Chattanooga</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Crowley Cancer Research</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Cancer Specialists</name>
      <address>
        <city>Athens</city>
        <state>Virginia</state>
        <zip>30607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kadlec Clinic Hematology and Oncology</name>
      <address>
        <city>Kennewick</city>
        <state>Washington</state>
        <zip>99336</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>33612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>APHM - Hopital Nord</name>
      <address>
        <city>Marseille Cedex 20</city>
        <state>Bouches-Du-RhÃ´ne</state>
        <zip>13015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gustav Roussy Cancer Campus Grand Paris</name>
      <address>
        <city>Villejuif</city>
        <state>ile-de-France</state>
        <zip>94805</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of Nantes</name>
      <address>
        <city>Nantes</city>
        <state>Loire-Atlantique</state>
        <zip>44000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Toulouse Hopital Larrey</name>
      <address>
        <city>Toulouse</city>
        <state>Occitanie</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Leon Berard</name>
      <address>
        <city>Lyon</city>
        <state>Rhone</state>
        <zip>69008</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Curie</name>
      <address>
        <city>Paris</city>
        <zip>75005</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hopitaux Universitaire de Strasbourg- Nouvel Hopital Civil</name>
      <address>
        <city>Strasbourg</city>
        <zip>67091</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Intercommunal Toulon La Seyne sur mer Hopital Sainte-Musse</name>
      <address>
        <city>Toulon</city>
        <zip>83000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asklepios Fachklinik Muenchen-Gauting</name>
      <address>
        <city>Gauting</city>
        <state>Bayern</state>
        <zip>82131</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IKF Krankenhaus Nordwest</name>
      <address>
        <city>Frankfurt Am Main</city>
        <state>Hessen</state>
        <zip>60488</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitaet zu Koeln - Uniklinik Koeln</name>
      <address>
        <city>Koeln</city>
        <state>North Rhine-Westphal</state>
        <zip>50937</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medizinische Hochschule Hannover</name>
      <address>
        <city>Hannover</city>
        <zip>30625</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik Heidelberg gGmbH</name>
      <address>
        <city>Heidelberg</city>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Koranyi Institute for TB and Pulmonology</name>
      <address>
        <city>Budapest</city>
        <zip>H-1121</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonology Hospital Törökbálint</name>
      <address>
        <city>Torokbalint</city>
        <zip>H-2045</zip>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria Policlinico-OVE</name>
      <address>
        <city>Catania</city>
        <state>CT</state>
        <zip>95030</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione Policlinico Universitario Agostino Gemelli IRCCS</name>
      <address>
        <city>Rome</city>
        <state>RM</state>
        <zip>00168</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Turin San Luigi Hospital</name>
      <address>
        <city>Orbassano</city>
        <state>Torino</state>
        <zip>10043</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero-Universitaria S. Orsola Malpighi</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Europeo di Oncologia</name>
      <address>
        <city>Milano</city>
        <zip>20141</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliero Universitaria di Parma</name>
      <address>
        <city>Parma</city>
        <zip>43126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Arcispedale Santa Maria</name>
      <address>
        <city>Reggio Emilia</city>
        <zip>42123</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Toyoake-shi</city>
        <state>Aichi</state>
        <zip>470-1192</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa-shi</city>
        <state>Chiba</state>
        <zip>277-8577</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo-shi</city>
        <state>Hokkaido</state>
        <zip>003-0804</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto</state>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata-shi</city>
        <state>Niigata</state>
        <zip>961-8566</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata-shi</city>
        <state>Osaka</state>
        <zip>573-1191</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka City General Hospital</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>534-0021</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka-shi</city>
        <state>Osaka</state>
        <zip>541-8567</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Ōsaka-sayama</city>
        <state>Osaka</state>
        <zip>589-8511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Nagaizumi-chō</city>
        <state>Shizuoka</state>
        <zip>411-8777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima-shi</city>
        <state>Tokushima</state>
        <zip>770-8503</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo Ku</city>
        <state>Tokyo</state>
        <zip>104-0045</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of JFCR</name>
      <address>
        <city>Koto-Ku</city>
        <state>Tokyo</state>
        <zip>135-8550</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Aichi</city>
        <zip>464-8681</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>110744</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seoul National University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03080</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>6273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Netherlands Cancer Institute</name>
      <address>
        <city>Amsterdam</city>
        <state>North Holland</state>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Erasmus MC</name>
      <address>
        <city>Rotterdam</city>
        <state>Zuid Holland</state>
        <zip>3015 CD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Puerta de Hierro de Majadahonda</name>
      <address>
        <city>Majadahonda</city>
        <state>Madrid</state>
        <zip>28222</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Regional Universitario Malaga</name>
      <address>
        <city>Málaga</city>
        <state>Malaga</state>
        <zip>29010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital General Universitario de Alicante</name>
      <address>
        <city>Alicante</city>
        <zip>03010</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall dHebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic i Provincial de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>08036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>70403</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Taipei Veterans General Hospital</name>
      <address>
        <city>Taipei City</city>
        <zip>11217</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital NTUH</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Koo Foundation Sun Yat-Sen Cancer Center</name>
      <address>
        <city>Taipei</city>
        <zip>112</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>Germany</country>
    <country>Hungary</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 30, 2023</last_update_submitted>
  <last_update_submitted_qc>August 30, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Metastatic Non-small Cell Lung Cancer</keyword>
  <keyword>Advanced Metastatic Non-small Cell Lung Cancer</keyword>
  <keyword>Non-small Cell Lung Cancer</keyword>
  <keyword>DS-1062a</keyword>
  <keyword>Datopotamab Deruxtecan</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>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication</ipd_time_frame>
    <ipd_access_criteria>Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.</ipd_access_criteria>
    <ipd_url>http://vivli.org/ourmember/daiichi-sankyo/</ipd_url>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04484142
org study id: DS1062-A-U202
secondary id: 2020-002774-27
nct id: NCT04484142
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This is a study of the efficacy, pharmacokinetics, and safety of DS-1062a in participants
      with advanced or metastatic non-small cell lung cancer (NSCLC) with known actionable genomic
      alterations.
This study will evaluate DS-1062a 6.0 mg/kg in participants with advanced or metastatic NSCLC
      with actionable genomic alterations and who have been previously been treated with 1
      platinum-containing therapy and 1 or more lines of targeted therapy. The study will be
      divided into 3 periods: Screening Period, Treatment Period, and Follow-up Period. The primary
      analysis of Objective Response Rate (ORR) by blinded Independent Central Review (BICR) will
      be conducted after all participants either have been followed for at least 9 months after the
      start of study treatment or have discontinued from the study, whichever occurs first.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective Response Rate (ORR) As Assessed by Blind Independent Central Review Per RECIST v1.1 Following DS-1062a Intravenous Infusion
time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months
description: ORR is defined as the proportion of participants with a best overall response of confirmed complete response (CR) or confirmed partial response (PR). CR is defined as a disappearance of all target lesions and PR is defined as at least a 30% decrease in the sum of diameters of target lesions.
measure: Duration of Response (DOR) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous Infusion
time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months
description: DOR is defined as the time from the date of the first documentation of response (confirmed CR or confirmed PR) to the date of the first documentation of PD or death due to any cause, whichever occurs first.
measure: Progression-free Survival (PFS) As Assessed by Blinded Independent Central Review and by Investigator Per RECIST v1.1 Following DS-1062a Intravenous (IV) Infusion
time frame: From baseline until disease progression, death, or other protocol defined reason, up to approximately 23 months
description: PFS is defined as the time from the start of study treatment to the earlier of the dates of the first documentation of progressive disease or death due to any cause.
measure: Overall Survival (OS) Following DS-1062a Intravenous Infusion
time frame: From baseline until death due to any cause, up to approximately 23 months
description: OS is defined as the time from the start of study treatment to the date of death due to any cause.
measure: Percentage of Participants Who Reported Treatment-emergent Adverse Events Following DS-1062a Intravenous Infusion in Participants with Advanced or Metastatic NSCLC with Actionable Genomic Alterations
time frame: From baseline up to approximately 23 months post treatment
description: Reported treatment-emergent adverse events, serious adverse events, adverse events of interest, and those considered related to the study drug or study procedures, or that associated DS-1062a reduction, interruption, or discontinuation.
measure: Pharmacokinetic Parameter Maximum Concentration (Cmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a
time frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days)
measure: Pharmacokinetic Parameter Time to Maximum Concentration (Tmax) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a
time frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days)
measure: Pharmacokinetic Parameter Area Under the Concentration-Time Curve (AUC) of DS-1062a, Total Anti-TROP2 Antibody, and MAAA-1181a
time frame: Cycle 1, Day 1: predose (within 8 hours [h] of infusion), 30 minutes (min), 3 h, 5 h, 7 h postdose; Cycle 1, Day 2, Day 4, Day 8, and Day 15 postdose; Cycle 2 and Cycle 3, Day 1 predose (within 8 h) and postdose (within 1 h) (each cycle is 21 days)
description: AUC up to the last quantifiable time (AUClast) and AUC during dosing interval (AUCtau) will be assessed for DS-1062, total Anti-TROP2 antibody, and MAAA-1181a.
arm group label: DS-1062a 6.0 mg/kg
arm group type: Experimental
description: Participants will receive 6.0 mg/kg of DS-1062a
intervention type: Drug
intervention name: DS-1062a
description: DS-1062a will be administered as an intravenous (IV) infusion once every 3 weeks
arm group label: DS-1062a 6.0 mg/kg
other name: Datopotamab Deruxtecan
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Global Clinical Leader
role: Study Director
affiliation: Daiichi Sankyo, Inc.
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country: France
country: Germany
country: Hungary
country: Italy
country: Japan
country: Korea, Republic of
country: Netherlands
country: Spain
country: Taiwan
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Yes
ipd description: De-identified individual participant data (IPD) and applicable supporting clinical trial documents may be available upon request at https://vivli.org/. In cases where clinical trial data and supporting documents are provided pursuant to our company policies and procedures, Daiichi Sankyo will continue to protect the privacy of our clinical trial participants. Details on data sharing criteria and the procedure for requesting access can be found at this web address: https://vivli.org/ourmember/daiichi-sankyo/
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd time frame: Studies for which the medicine and indication have received European Union (EU) and United States (US), and/or Japan (JP) marketing approval on or after 01 January 2014 or by the US or EU or JP Health Authorities when regulatory submissions in all regions are not planned and after the primary study results have been accepted for publication
ipd access criteria: Formal request from qualified scientific and medical researchers on IPD and clinical study documents from clinical trials supporting products submitted and licensed in the United States, the European Union and/or Japan from 01 January 2014 and beyond for the purpose of conducting legitimate research. This must be consistent with the principle of safeguarding study participants' privacy and consistent with provision of informed consent.
ipd url: http://vivli.org/ourmember/daiichi-sankyo/