<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/NCT03260491</url>
  </required_header>
  <id_info>
    <org_study_id>U31402-A-U102</org_study_id>
    <secondary_id>2017-000543-41</secondary_id>
    <secondary_id>194868</secondary_id>
    <nct_id>NCT03260491</nct_id>
  </id_info>
  <brief_title>U3-1402 in Metastatic or Unresectable Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Multicenter, Open-Label Phase 1 Study of U3-1402 in Subjects With Metastatic or Unresectable Non-small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daiichi Sankyo, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </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 study is designed to evaluate safety and antitumor activity of U3-1402 in two parts:&#xD;
      Dose Escalation and Dose Expansion.&#xD;
&#xD;
      In Dose Escalation, U3-1402 will be evaluated in participants with metastatic or unresectable&#xD;
      NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease&#xD;
      progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy.&#xD;
&#xD;
      In Dose Expansion, U3-1402 will be evaluated in participants with metastatic or unresectable&#xD;
      NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without&#xD;
      EGFR-activating mutations) with disease progression during/after systemic treatment for&#xD;
      locally advanced or metastatic disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objectives are:&#xD;
&#xD;
        -  For Dose Escalation, to assess the safety and tolerability of U3-1402 in the study&#xD;
           population and to determine the recommended dose for expansion (RDE) of U3-1402 in the&#xD;
           study population&#xD;
&#xD;
        -  For Dose Expansion, to investigate the antitumor activity of U3-1402&#xD;
&#xD;
      The number of treatment cycles is not fixed in this study. Participants will continue study&#xD;
      treatment (for approximately 36 months) until they decide not to (withdraw consent), their&#xD;
      disease gets worse [progressive disease (PD)], or side effects become unacceptable&#xD;
      (unacceptable toxicity) or other stopping reasons have been met.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 30, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Actual">January 28, 2022</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dose-limiting toxicities (DLTs) during dose escalation</measure>
    <time_frame>21 days of Cycle 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Summary of adverse events during dose escalation</measure>
    <time_frame>By the global end of trial date, approximately within 36 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) Committee during dose expansion</measure>
    <time_frame>Approximately within 36 months</time_frame>
    <description>ORR will be evaluated using RECIST v1.1.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)</measure>
    <time_frame>Cycle 1: Day 1, pre-dose and end of infusion (EOI), 2 hours, 4 hours, 8 hours; Day 8, Day 15; Cycle 2: Day 1, pre-dose (each cycle is 21 days)</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)</measure>
    <time_frame>Cycle 1: Day 1, pre-dose and end of infusion (EOI), 2 hours, 4 hours, 8 hours; Day 8, Day 15; Cycle 2: Day 1, pre-dose (each cycle is 21 days)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) during dose escalation</measure>
    <time_frame>Approximately within 36 months</time_frame>
    <description>Evaluated using RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) during dose escalation</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR) during dose escalation</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response (TTR) during dose escalation</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS) during dose escalation</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival (OS) during dose escalation</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Summary of adverse events during dose expansion</measure>
    <time_frame>By the global end of trial date, approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]), from time 0 to Day 21 (AUC-21d), and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion</measure>
    <time_frame>During approximately the first 84 days after dosing</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall response rate (ORR) during dose expansion</measure>
    <time_frame>Approximately within 36 months</time_frame>
    <description>Evaluated using RECIST 1.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR) during dose expansion</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR) during dose expansion</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to response (TTR) during dose expansion</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival (PFS) during dose expansion</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS) during dose expansion</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of participants who are anti-drug antibody (ADA)-positive (baseline and post-baseline) and Percentage of participants who have treatment-emergent ADA during dose expansion (Cohort 4)</measure>
    <time_frame>Approximately within 36 months</time_frame>
  </secondary_outcome>
  <number_of_arms>9</number_of_arms>
  <enrollment type="Actual">271</enrollment>
  <condition>Non-Small Cell Lung Cancer (NSCLC)</condition>
  <arm_group>
    <arm_group_label>Dose Escalation: Cohort 1, 3.2 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the Dose Escalation Cohort 1 will receive U3-1402 intravenously (IV) once every three weeks at 3.2 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation: Cohort 2, 4.8 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Dose Escalation Cohort 2 will receive U3-1402 intravenously (IV) once every three weeks at 4.8 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation: Cohort 3, 5.6 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 5.6 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Escalation: Cohort 4, 6.4 mg/kg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 6.4 mg/kg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 1, EGFR mutant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with adenocarcinoma NSCLC with EGFR mutations in the Dose Expansion Cohort 1 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 2, EGFR wild-type</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with squamous or non-squamous NSCLC without EGFR-activating mutations in the Dose Expansion Cohort 2 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 3a, EGFR mutant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3a will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE) or, if applicable, adjusted RDE (aRDE).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 3b, EGFR mutant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3b will receive U3-1402 IV once every three weeks following an up-titration regimen (Cycle 1, Day 1: 57% of RDE or aRDE; Cycle 2, Day 1: 86% of RDE or, if applicable aRDE; Cycle 3 and subsequent cycles, Day 1: 114% of RDE or aRDE).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion: Cohort 4, EGFR mutant</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants with NSCLC (including any histology other than small-cell or combined small-cell and non-small cell) with an EGFR-activating mutation will receive U3-1402 IV at 5.6 mg/kg every 3 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>U3-1402 (FL-DP)</intervention_name>
    <description>U3-1402 (frozen liquid drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a).</description>
    <arm_group_label>Dose Escalation: Cohort 1, 3.2 mg/kg</arm_group_label>
    <arm_group_label>Dose Escalation: Cohort 2, 4.8 mg/kg</arm_group_label>
    <arm_group_label>Dose Escalation: Cohort 3, 5.6 mg/kg</arm_group_label>
    <arm_group_label>Dose Escalation: Cohort 4, 6.4 mg/kg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>U3-1402 (CTM-1 Lyo-DP)</intervention_name>
    <description>U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the clinical manufacturing sites.</description>
    <arm_group_label>Dose Expansion: Cohort 1, EGFR mutant</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 2, EGFR wild-type</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 3a, EGFR mutant</arm_group_label>
    <arm_group_label>Dose Expansion: Cohort 3b, EGFR mutant</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>U3-1402 (CTM-3 Lyo-DP)</intervention_name>
    <description>U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the commercial manufacturing sites.</description>
    <arm_group_label>Dose Expansion: Cohort 4, EGFR mutant</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria for both Dose Escalation and Dose Expansion:&#xD;
&#xD;
          1. Has locally advanced or metastatic NSCLC, not amenable to curative surgery or&#xD;
             radiation&#xD;
&#xD;
          2. Has at least one measurable lesion per RECIST version 1.1&#xD;
&#xD;
          3. Has Eastern Cooperative Oncology Group performance status of 0 or 1 at Screening&#xD;
&#xD;
        Inclusion Criteria for Dose Escalation only:&#xD;
&#xD;
          1. Has histologically or cytologically documented adenocarcinoma NSCLC&#xD;
&#xD;
          2. Has acquired resistance to EGFR TKI according to the Jackman criteria (PMID: 19949011)&#xD;
&#xD;
               1. Historical confirmation that the tumor harbors an epidermal growth factor&#xD;
                  receptor (EGFR) mutation known to be associated with EGFR tyrosine kinase&#xD;
                  inhibitor (TKI) sensitivity (including G719X, exon 19 deletion, L858R, L861Q)&#xD;
&#xD;
               2. Has experienced clinical benefit from an EGFR TKI, followed by systemic&#xD;
                  progression of disease [Response Evaluation Criteria in Solid Tumors (RECIST)&#xD;
                  version 1.1] or World Health Organization (WHO)] while on continuous treatment&#xD;
                  with an EGFR TKI&#xD;
&#xD;
          3. Is currently receiving and able to discontinue erlotinib, gefinitib, afatinib, or&#xD;
             osimertinib&#xD;
&#xD;
          4. Has been receiving erlotinib, gefitinib, afatinib, or osimertinib for at least 6 weeks&#xD;
             with well-controlled related toxicities less than Grade 3 in severity at the time of&#xD;
             Screening&#xD;
&#xD;
          5. Has radiological documentation of disease progression while receiving continuous&#xD;
             treatment with erlotinib, gefitinib, afatinib, or osimertinib&#xD;
&#xD;
          6. Is willing to provide archival tumor tissue from a biopsy performed within 6 months of&#xD;
             progression during treatment with erlotinib, gefitinib, afatinib, or osimertinib OR&#xD;
             has at least one lesion, not previously irradiated, amenable to core biopsy and is&#xD;
             willing to undergo screening tumor biopsy&#xD;
&#xD;
          7. Demonstrates absence of EGFR T790M mutation if treated with erlotinib, gefitinib, or&#xD;
             afatinib. No EGFR mutation testing is required if treated with osimertinib.&#xD;
&#xD;
        Inclusion Criteria for all cohorts of Dose Expansion only:&#xD;
&#xD;
          1. Has received systemic therapy for locally advanced or metastatic disease including at&#xD;
             least 1 platinum-based chemotherapy regimen&#xD;
&#xD;
          2. Has documented radiological disease progression during/after most recent treatment&#xD;
             regimen for locally-advanced or metastatic disease&#xD;
&#xD;
          3. For Cohorts 1, 2, 3a, and 3b: Is willing to provide archival tumor tissue from a&#xD;
             biopsy performed within 6 months of consent and performed after progression&#xD;
             during/after treatment with most recent cancer therapy regimen OR has at least 1&#xD;
             lesion, not previously irradiated, amenable to core biopsy and is willing to undergo&#xD;
             tumor biopsy. Tumor tissue must be of sufficient quantity as defined in the laboratory&#xD;
             manual and contain adequate tumor tissue content as confirmed by haematoxylin and&#xD;
             eosin (H&amp;S) staining at central laboratory.&#xD;
&#xD;
               -  For Cohort 4: Neither archival tumor tissue nor core tumor biopsy will be&#xD;
                  collected&#xD;
&#xD;
        Inclusion Criteria specific to Cohorts 1, 3a, 3b, and 4 of Dose Expansion:&#xD;
&#xD;
          1. Has histologically or cytologically documented:&#xD;
&#xD;
               1. Cohort 1: Adenocarcinoma NSCLC&#xD;
&#xD;
               2. Cohorts 3a, 3b, and 4: NSCLC (including any histology other than small-cell or&#xD;
                  combined small cell and non-small cell)&#xD;
&#xD;
          2. Has documentation of radiological disease progression following one or more lines of&#xD;
             EGFR TKI treatment. Participants with EGFR T790M mutation following treatment with&#xD;
             erlotinib, gefitinib afatinib, or dacomitinib must have received and have&#xD;
             documentation of radiological disease progression following treatment with osimertinib&#xD;
             unless unable or unwilling.&#xD;
&#xD;
          3. Has documentation of EGFR-activating mutation(s) detected from tumor tissue: G719X,&#xD;
             exon deletion 19, L858R, or L861Q. Participants with other EGFR-activating mutations&#xD;
             may be eligible following discussion with the Sponsor.&#xD;
&#xD;
        Inclusion Criteria specific to Cohort 2 of Dose Expansion:&#xD;
&#xD;
          1. Has histologically or cytologically documented squamous or non-squamous NSCLC (ie,&#xD;
             without EGFR-activating mutations).&#xD;
&#xD;
          2. Has received prior treatment with anti-PD-1 or anti-PD-L1 antibody-based regimen in&#xD;
             the locally advanced or metastatic setting unless unable or unwilling. Participants&#xD;
             with NSCLC known to harbor a genomic alteration(s) other than EGFR mutation(s) (eg,&#xD;
             ALK or ROS1 fusion) for which treatment is available must have also received prior&#xD;
             treatment with at least 1 genotype-directed therapy.&#xD;
&#xD;
        Exclusion Criteria for Dose Escalation and Dose Expansion:&#xD;
&#xD;
          1. Has any evidence of small cell histology, or combined small cell and non-small cell&#xD;
             histology, in original tumor biopsy or in Screening biopsy performed after progression&#xD;
&#xD;
          2. Treatment with any of the following:&#xD;
&#xD;
               1. Any cytotoxic chemotherapy, investigational agent or other anticancer drug(s)&#xD;
                  from a previous cancer treatment regimen or clinical study (other than EGFR TKI&#xD;
                  in Cohorts 1, 3a, 3b, and 4 only), within 14 days of the first dose of study&#xD;
                  treatment&#xD;
&#xD;
               2. Immune checkpoint inhibitor therapy within 21 days of the first dose of study&#xD;
                  treatment&#xD;
&#xD;
               3. Prior treatment with an anti-HER3 antibody (dose escalation only)&#xD;
&#xD;
               4. Prior treatment with a topoisomerase I inhibitor (dose escalation only)&#xD;
&#xD;
               5. Prior treatment with an antibody-drug conjugate (ADC) that consists of an&#xD;
                  exatecan derivative that is a topoisomerase I inhibitor (eg, DS-8201a) (dose&#xD;
                  escalation only)&#xD;
&#xD;
               6. Major surgery (excluding placement of vascular access) within 4 weeks of the&#xD;
                  first dose of study drug treatment&#xD;
&#xD;
               7. Radiotherapy treatment to more than 30% of the bone marrow or with a wide field&#xD;
                  of radiation within 4 weeks of the first dose of study drug treatment, or&#xD;
                  palliative radiation therapy within 2 weeks of the first dose of study drug&#xD;
                  treatment, or stereotactic radiotherapy within 1 week prior to the first dose of&#xD;
                  U3-1402&#xD;
&#xD;
          3. Has history of other active malignancy within 3 years prior to enrollment, except:&#xD;
&#xD;
               1. Adequately treated non-melanoma skin cancer OR&#xD;
&#xD;
               2. Superficial bladder tumors (Ta, Tis, T1) OR&#xD;
&#xD;
               3. Curatively treated in situ disease&#xD;
&#xD;
          4. 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. Participants with treated brain&#xD;
             metastases that are no longer symptomatic and who require no treatment with&#xD;
             corticosteroids or anticonvulsants may be included in the study if they have recovered&#xD;
             from the acute toxic effect of radiotherapy. A minimum of 2 weeks must have elapsed&#xD;
             between the end of whole brain radiotherapy and study enrollment (1 week for&#xD;
             stereotactic radiotherapy)&#xD;
&#xD;
          5. Has history of myocardial infarction within the past 6 months&#xD;
&#xD;
          6. Has symptomatic congestive heart failure[New York Heart Association (NYHA) Classes&#xD;
             II-IV], unstable angina within the past 6 months, or cardiac arrhythmia requiring&#xD;
             antiarrhythmic treatment&#xD;
&#xD;
          7. Has left ventricular ejection fraction (LVEF) &lt; 50% by either echocardiogram (ECHO) or&#xD;
             multigated acquisition scan (MUGA)&#xD;
&#xD;
          8. Has any clinically important abnormalities in rhythm, conduction or morphology of&#xD;
             resting electrocardiogram (ECG), eg, complete left bundle branch block, third-degree&#xD;
             heart block, second-degree heart block, or PR interval &gt; 250 milliseconds (ms)&#xD;
&#xD;
          9. Has a mean corrected QT interval using Fridericia's Correction Formula (QTcF)&#xD;
             prolongation to &gt; 470 ms for females and &gt; 450 ms for males in three successive&#xD;
             Screening measurements&#xD;
&#xD;
         10. Unable or unwilling to discontinue concomitant drugs that are known to prolong the QT&#xD;
             interval&#xD;
&#xD;
         11. Has any factors that increase the risk of corrected QT (QTc) interval prolongation or&#xD;
             risk of arrhythmic events, such as congenital long QT syndrome, family history of long&#xD;
             QT syndrome, or unexplained sudden death under 40 years of age in first-degree&#xD;
             relatives.&#xD;
&#xD;
         12. Has any history of interstitial lung disease (ILD) (including pulmonary fibrosis or&#xD;
             severe radiation pneumonitis), has current ILD/pneumonitis, or is suspected to have&#xD;
             such disease by imaging during screening&#xD;
&#xD;
         13. Has clinically significant corneal disease&#xD;
&#xD;
        Additional Exclusion Criteria for Dose Expansion Cohort 2:&#xD;
&#xD;
        1. Has documentation of one or more of the following EGFR-activating mutations: G719X, exon&#xD;
        19 deletion, L858R, or L861Q&#xD;
&#xD;
        Additional Exclusion Criteria for Dose Expansion Cohort 4:&#xD;
&#xD;
          1. Evidence of any leptomeningeal disease&#xD;
&#xD;
          2. Clinically severe respiratory compromise (based on Investigator's assessment)&#xD;
             resulting from intercurrent pulmonary illnesses including, but not limited to:&#xD;
&#xD;
               1. Any underlying pulmonary disorder&#xD;
&#xD;
               2. Any autoimmune, connective tissue or inflammatory disorders with pulmonary&#xD;
                  involvement OR prior complete pneumonectomy&#xD;
&#xD;
          3. Is receiving chronic systemic corticosteroids dosed at &gt;10 mg/day prednisone or&#xD;
             equivalent anti-inflammatory activity or any form of immunosuppressive therapy prior&#xD;
             to enrollment&#xD;
&#xD;
          4. Resting systolic blood pressure &gt;180 mmHg or diastolic blood pressure &gt;110 mmHg&#xD;
&#xD;
          5. Prior or ongoing clinically relevant illness, medical condition, surgical history,&#xD;
             physical finding, or laboratory abnormality that could affect the safety of the&#xD;
             subject; alter the absorption, distribution, metabolism or excretion of the study&#xD;
             drug; or confound the assessment of 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_official>
    <last_name>Global Clinical Leader</last_name>
    <role>Study Director</role>
    <affiliation>Daiichi Sankyo, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>City of Hope</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</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>Winship Cancer Institute of Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Massachusetts General Hospital</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>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan-Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sarah Cannon Research Institute/Tennesse Oncology</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seattle Cancer Care Alliance</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osaka</city>
        <zip>5898511</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shizuoka Cancer Center</name>
      <address>
        <city>Shizuoka</city>
        <zip>4118777</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cancer Institute Hospital of Japanese Foundation for Cancer Research (JFCR)</name>
      <address>
        <city>Tokyo</city>
        <zip>1358550</zip>
        <country>Japan</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>Asan Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>05505</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Netherlands Cancer Institute</name>
      <address>
        <city>Amsterdam</city>
        <zip>1066 CX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</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>Chung Shan Medical University Hospital</name>
      <address>
        <city>Taichung</city>
        <zip>40705</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cheng Kung University Hospital</name>
      <address>
        <city>Tainan</city>
        <zip>00704</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>00100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
    <country>Korea, Republic of</country>
    <country>Netherlands</country>
    <country>Spain</country>
    <country>Taiwan</country>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Jackman D, Pao W, Riely GJ, Engelman JA, Kris MG, Janne PA, Lynch T, Johnson BE, Miller VA. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol. 2010 Jan 10;28(2):357-60. doi: 10.1200/JCO.2009.24.7049. Epub 2009 Nov 30.</citation>
    <PMID>19949011</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>February 15, 2023</last_update_submitted>
  <last_update_submitted_qc>February 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Oncology</keyword>
  <keyword>Advanced Non-small Cell Lung Cancer</keyword>
  <keyword>Inoperable Non-small Cell Lung Cancer</keyword>
  <keyword>Metastatic</keyword>
  <keyword>Unresectable</keyword>
  <keyword>Epidermal growth factor receptor</keyword>
  <keyword>EGFR</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>Patritumab deruxtecan</mesh_term>
  </intervention_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>https://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/NCT03260491
org study id: U31402-A-U102
secondary id: 2017-000543-41
secondary id: 194868
nct id: NCT03260491
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is designed to evaluate safety and antitumor activity of U3-1402 in two parts:
      Dose Escalation and Dose Expansion.

      In Dose Escalation, U3-1402 will be evaluated in participants with metastatic or unresectable
      NSCLC with epidermal growth factor receptor (EGFR) activating mutation after disease
      progression during/after EGFR tyrosine kinase inhibitor (TKI) therapy.

      In Dose Expansion, U3-1402 will be evaluated in participants with metastatic or unresectable
      NSCLC with EGFR activating mutation or squamous or non-squamous NSCLC (ie, without
      EGFR-activating mutations) with disease progression during/after systemic treatment for
      locally advanced or metastatic disease.
The primary objectives are:

        -  For Dose Escalation, to assess the safety and tolerability of U3-1402 in the study
           population and to determine the recommended dose for expansion (RDE) of U3-1402 in the
           study population

        -  For Dose Expansion, to investigate the antitumor activity of U3-1402

      The number of treatment cycles is not fixed in this study. Participants will continue study
      treatment (for approximately 36 months) until they decide not to (withdraw consent), their
      disease gets worse [progressive disease (PD)], or side effects become unacceptable
      (unacceptable toxicity) or other stopping reasons have been met.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Dose-limiting toxicities (DLTs) during dose escalation
time frame: 21 days of Cycle 1
measure: Summary of adverse events during dose escalation
time frame: By the global end of trial date, approximately within 36 months
measure: Overall response rate (ORR) assessed by Blinded Independent Central Review (BICR) Committee during dose expansion
time frame: Approximately within 36 months
description: ORR will be evaluated using RECIST v1.1.
measure: Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)
time frame: Cycle 1: Day 1, pre-dose and end of infusion (EOI), 2 hours, 4 hours, 8 hours; Day 8, Day 15; Cycle 2: Day 1, pre-dose (each cycle is 21 days)
measure: Area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion (Cohort 4)
time frame: Cycle 1: Day 1, pre-dose and end of infusion (EOI), 2 hours, 4 hours, 8 hours; Day 8, Day 15; Cycle 2: Day 1, pre-dose (each cycle is 21 days)
measure: Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
time frame: During approximately the first 84 days after dosing
measure: Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
time frame: During approximately the first 84 days after dosing
measure: Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]) and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
time frame: During approximately the first 84 days after dosing
measure: Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
time frame: During approximately the first 84 days after dosing
measure: Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
time frame: During approximately the first 84 days after dosing
measure: Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
time frame: During approximately the first 84 days after dosing
measure: Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose escalation
time frame: During approximately the first 84 days after dosing
measure: Overall response rate (ORR) during dose escalation
time frame: Approximately within 36 months
description: Evaluated using RECIST 1.1
measure: Disease control rate (DCR) during dose escalation
time frame: Approximately within 36 months
measure: Duration of response (DOR) during dose escalation
time frame: Approximately within 36 months
measure: Time to response (TTR) during dose escalation
time frame: Approximately within 36 months
measure: Progression free survival (PFS) during dose escalation
time frame: Approximately within 36 months
measure: Overall Survival (OS) during dose escalation
time frame: Approximately within 36 months
measure: Summary of adverse events during dose expansion
time frame: By the global end of trial date, approximately within 36 months
measure: Maximum serum concentration (Cmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
time frame: During approximately the first 84 days after dosing
measure: Time of maximum concentration (Tmax) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
time frame: During approximately the first 84 days after dosing
measure: Area under the serum concentration-time curve from time 0 to 8 hours (AUC[0-8]), from time 0 to Day 21 (AUC-21d), and up to last quantifiable time (AUC[last]) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
time frame: During approximately the first 84 days after dosing
measure: Terminal elimination rate constant (Kel) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
time frame: During approximately the first 84 days after dosing
measure: Elimination half-life (t1/2) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
time frame: During approximately the first 84 days after dosing
measure: Total body clearance (CL) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
time frame: During approximately the first 84 days after dosing
measure: Volume of distribution after a single-dose (Vz) and at steady-state after multiple doses (Vss) of U3-1402, total anti-HER3 antibody, and MAAA 1181a during dose expansion
time frame: During approximately the first 84 days after dosing
measure: Overall response rate (ORR) during dose expansion
time frame: Approximately within 36 months
description: Evaluated using RECIST 1.1
measure: Disease control rate (DCR) during dose expansion
time frame: Approximately within 36 months
measure: Duration of response (DOR) during dose expansion
time frame: Approximately within 36 months
measure: Time to response (TTR) during dose expansion
time frame: Approximately within 36 months
measure: Progression free survival (PFS) during dose expansion
time frame: Approximately within 36 months
measure: Overall survival (OS) during dose expansion
time frame: Approximately within 36 months
measure: Percentage of participants who are anti-drug antibody (ADA)-positive (baseline and post-baseline) and Percentage of participants who have treatment-emergent ADA during dose expansion (Cohort 4)
time frame: Approximately within 36 months
arm group label: Dose Escalation: Cohort 1, 3.2 mg/kg
arm group type: Experimental
description: Participants in the Dose Escalation Cohort 1 will receive U3-1402 intravenously (IV) once every three weeks at 3.2 mg/kg.
arm group label: Dose Escalation: Cohort 2, 4.8 mg/kg
arm group type: Experimental
description: Participants in Dose Escalation Cohort 2 will receive U3-1402 intravenously (IV) once every three weeks at 4.8 mg/kg.
arm group label: Dose Escalation: Cohort 3, 5.6 mg/kg
arm group type: Experimental
description: Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 5.6 mg/kg.
arm group label: Dose Escalation: Cohort 4, 6.4 mg/kg
arm group type: Experimental
description: Participants in Dose Escalation Cohort 3 will receive U3-1402 intravenously (IV) once every three weeks at 6.4 mg/kg.
arm group label: Dose Expansion: Cohort 1, EGFR mutant
arm group type: Experimental
description: Participants with adenocarcinoma NSCLC with EGFR mutations in the Dose Expansion Cohort 1 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).
arm group label: Dose Expansion: Cohort 2, EGFR wild-type
arm group type: Experimental
description: Participants with squamous or non-squamous NSCLC without EGFR-activating mutations in the Dose Expansion Cohort 2 will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE).
arm group label: Dose Expansion: Cohort 3a, EGFR mutant
arm group type: Experimental
description: Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3a will receive U3-1402 IV once every three weeks at the established recommended dose for expansion (RDE) or, if applicable, adjusted RDE (aRDE).
arm group label: Dose Expansion: Cohort 3b, EGFR mutant
arm group type: Experimental
description: Randomized participants with NSCLC and EGFR mutations in the Dose Expansion Cohort 3b will receive U3-1402 IV once every three weeks following an up-titration regimen (Cycle 1, Day 1: 57% of RDE or aRDE; Cycle 2, Day 1: 86% of RDE or, if applicable aRDE; Cycle 3 and subsequent cycles, Day 1: 114% of RDE or aRDE).
arm group label: Dose Expansion: Cohort 4, EGFR mutant
arm group type: Experimental
description: Participants with NSCLC (including any histology other than small-cell or combined small-cell and non-small cell) with an EGFR-activating mutation will receive U3-1402 IV at 5.6 mg/kg every 3 weeks.
intervention type: Drug
intervention name: U3-1402 (FL-DP)
description: U3-1402 (frozen liquid drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a).
arm group label: Dose Escalation: Cohort 1, 3.2 mg/kg
arm group label: Dose Escalation: Cohort 2, 4.8 mg/kg
arm group label: Dose Escalation: Cohort 3, 5.6 mg/kg
arm group label: Dose Escalation: Cohort 4, 6.4 mg/kg
intervention type: Drug
intervention name: U3-1402 (CTM-1 Lyo-DP)
description: U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the clinical manufacturing sites.
arm group label: Dose Expansion: Cohort 1, EGFR mutant
arm group label: Dose Expansion: Cohort 2, EGFR wild-type
arm group label: Dose Expansion: Cohort 3a, EGFR mutant
arm group label: Dose Expansion: Cohort 3b, EGFR mutant
intervention type: Drug
intervention name: U3-1402 (CTM-3 Lyo-DP)
description: U3-1402 (lyophilized drug product) consists of an antibody component (patritumab, U3-1287) covalently conjugated to a drug-linker (MAAA-1162a) containing a drug component (MAAA-1181a) that was manufactured by the commercial manufacturing sites.
arm group label: Dose Expansion: Cohort 4, EGFR mutant
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.
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
country: Korea, Republic of
country: Netherlands
country: Spain
country: Taiwan
country: United States
citation: Jackman D, Pao W, Riely GJ, Engelman JA, Kris MG, Janne PA, Lynch T, Johnson BE, Miller VA. Clinical definition of acquired resistance to epidermal growth factor receptor tyrosine kinase inhibitors in non-small-cell lung cancer. J Clin Oncol. 2010 Jan 10;28(2):357-60. doi: 10.1200/JCO.2009.24.7049. Epub 2009 Nov 30.
PMID: 19949011
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Patritumab deruxtecan
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: https://vivli.org/ourmember/daiichi-sankyo/