<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/NCT03807778</url>
  </required_header>
  <id_info>
    <org_study_id>TAK-788-1003</org_study_id>
    <secondary_id>U1111-1223-2659</secondary_id>
    <secondary_id>JapicCTI-194584</secondary_id>
    <nct_id>NCT03807778</nct_id>
  </id_info>
  <brief_title>A Study of TAK-788 in Japanese Adults With Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Phase 1/2 Study of the Oral EGFR/HER2 Inhibitor TAK-788 in Japanese Non-Small Cell Lung Cancer Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Takeda</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Takeda</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of&#xD;
      the study.&#xD;
&#xD;
      The main aim of the 1st part of the study is to check how much TAK-788 adults with non-small&#xD;
      cell lung cancer (NSCLC) can receive without getting side effects from it.&#xD;
&#xD;
      The main aim of the 2nd part of the study is to learn if the condition of adults with&#xD;
      non-small cell lung cancer improves after treatment with TAK-788. Another aim is to continue&#xD;
      checking for side effects from TAK-788.&#xD;
&#xD;
      In the 1st part of the study, at the first visit, the study doctor will check who can take&#xD;
      part. For those that can take part, participants will take a capsule of TAK-788 once a day&#xD;
      for 28 days. This will count as 1 cycle. Different small groups of participants will receive&#xD;
      lower to higher doses of TAK-788. The study doctors will check for side effects after each&#xD;
      dose of TAK 788. In this way, researchers can work out the best dose of TAK-788 to give&#xD;
      participants in the 2nd part of the study.&#xD;
&#xD;
      Participants will visit the clinic 30 days after their treatment has finished for a final&#xD;
      check-up.&#xD;
&#xD;
      In the 2nd part of the study, at the first visit, the study doctor will check who can take&#xD;
      part. Participants will receive the best dose of TAK-788 worked out from the 1st part of the&#xD;
      study. Participants will receive TAK-788 in the same way as those from the 1st part of the&#xD;
      study. The study doctors will learn if the condition of these participants improves after&#xD;
      treatment with TAK-788. The study doctors will also check for side effects from TAK-788.&#xD;
&#xD;
      After treatment has finished, participants will visit the clinic every 12 weeks until the end&#xD;
      of the study.&#xD;
&#xD;
      In both parts of the study, participants can receive TAK-788 for up to just over 1 year, or&#xD;
      longer if their condition stays improved.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The drug being tested in this study is called TAK-788. TAK-788 is being tested to treat&#xD;
      Japanese participants with NSCLC. This study has two parts (Phase 1 part and Phase 2 part),&#xD;
      Phase 1 part of this study will look at the safety, efficacy, tolerability and PK of TAK-788&#xD;
      orally administered once daily, and will determine a RP2D. Phase 2 study will look at the&#xD;
      efficacy and safety of TAK-788 in treatment naive Japanese NSCLC patients with epidermal&#xD;
      growth factor receptor (EGFR) exon 20 insertion mutation. All participants will be assigned&#xD;
      to Phase 1 part or Phase 2 part and will be asked to take TAK-788 capsule as following dosage&#xD;
      and regimen;&#xD;
&#xD;
      Phase 1 part; TAK-788, 40 mg as starting dose, once daily, and escalating up to 160 mg until&#xD;
      a Maximum Tolerated Dose (MTD). An expansion phase may be followed at any dose to further&#xD;
      confirm safety observations following identification of MTD/RP2D.&#xD;
&#xD;
      Phase 2 part; TAK-788, 160 mg, once daily&#xD;
&#xD;
      The study will enroll approximately 58-63 participants (Phase 1 part; 28-33 and Phase 2 part;&#xD;
      30).&#xD;
&#xD;
      This multi-center trial will be conducted in Japan. The overall time to participate in this&#xD;
      study of Phase 1 part is approximately 3 years and Phase 2 part is approximately 4 years.&#xD;
      Participants will make multiple visits to the clinic in the treatment period, and the&#xD;
      post-treatment period including follow-up assessments after the last dose of the study drug.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">February 4, 2019</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Actual">November 8, 2021</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase 1 Part: Recommended Phase 2 Dose (RP2D) of Orally Administered TAK-788</measure>
    <time_frame>Up to approximately 28 days</time_frame>
    <description>The RP2D is the maximum tolerated dose (MTD) or less. An RP2D less than the MTD may be chosen if aspects of tolerability or efficacy not encompassed by the MTD determination suggest utilizing a lower dose.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase 2 Part: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)</measure>
    <time_frame>Up to approximately 1.5 years</time_frame>
    <description>IRC assessed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in participants with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2) mutations. ORR is defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST version 1.1. CR: Disappearance of all extranodal target lesions; PR: At least a 30% decrease in Sum of the Longest Diameters (SLD) of target lesions, taking as a reference the baseline SLD.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)</measure>
    <time_frame>Up to approximately 1.5 years</time_frame>
    <description>An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs)</measure>
    <time_frame>Up to approximately 1.5 years</time_frame>
    <description>Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: DLTs of Orally Administered TAK-788</measure>
    <time_frame>Up to approximately 28 days</time_frame>
    <description>Toxicity will be evaluated according to the NCI CTCAE, Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Maximum Tolerated Dose (MTD) of Orally Administered TAK-788</measure>
    <time_frame>Up to approximately 28 days</time_frame>
    <description>The MTD is the highest dose level at which the participant tolerates treatment without dose-limiting toxicities.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Cmax: Maximum Plasma Concentration for TAK-788 and its Active Metabolites after a Single Oral Dose</measure>
    <time_frame>Up to 24 hours; Pre-dose and multiple time points post-dose on Cycle 1 Day 1 (C1D1)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Tmax: Time to Cmax for TAK-788 and its Active Metabolites after a Single Oral Dose</measure>
    <time_frame>Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: AUC24: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 hours for TAK-788 and its Active Metabolites after a Single Oral Dose</measure>
    <time_frame>Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-788 and its Active Metabolites after a Single Oral Dose</measure>
    <time_frame>Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Cmax, ss: Maximum Plasma Concentration for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses</measure>
    <time_frame>Up to approximately 57 days; Pre-dose and multiple time points post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Tmax, ss: Time to Cmax for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses</measure>
    <time_frame>Up to approximately 57 days; Pre-dose and multiple time points post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: AUC24, ss: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 hours for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses</measure>
    <time_frame>Up to approximately 57 days; Pre-dose and multiple time points post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 1 Part: Rac: Extent of Accumulation Ratio on Multiple Dosing for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses</measure>
    <time_frame>Up to approximately 57 days; Pre-dose and multiple time points post-dose</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>IRC assessed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in participants with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2) mutations. ORR is defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Duration of Response (DOR)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Time to Response</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>Time to response is defined as the time interval from the date of randomization until the initial observation of CR or PR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Disease Control Rate (DCR)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 42 days) after the initiation of study drug.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Progression Free Survival (PFS)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST version 1.1 are met or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Overall Survival (OS)</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>OS is defined as the interval from the date of randomization until death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Phase 2 Part: Patient-reported Symptoms (particular core symptoms of lung cancer), Functioning, and HRQoL as Assessed by the EORTC lung cancer module QLQ-LC13</measure>
    <time_frame>Up to approximately 4 years</time_frame>
    <description>EORTC QLQ-LC13 contains 13 questions to assess for: dyspnea, and a series of single items including pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Score of each item will range from 0 to 100, where 0 indicates no symptoms and 100 indicates worst possible symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>TAK-788, Phase 1 Part</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-788 40 milligrams (mg) (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle for up to disease progression or intolerable toxicity, or another discontinuation criterion, and increasing until 160 mg, once daily (for up to approximately 10-12 cycles).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TAK-788, Phase 2 Part</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>TAK-788 160 mg, once daily, for up to approximately 10-12 cycles.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAK-788</intervention_name>
    <description>TAK-788 capsule</description>
    <arm_group_label>TAK-788, Phase 1 Part</arm_group_label>
    <arm_group_label>TAK-788, Phase 2 Part</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        General Inclusion Criteria (Both in Phase 1 and Phase 2 Part);&#xD;
&#xD;
          1. Male or female patients ≥20 years old.&#xD;
&#xD;
          2. Must have measurable disease by RECIST v1.1. Previously irradiated lesions may not be&#xD;
             used for target lesions, unless there is unambiguous radiological progression after&#xD;
             radiotherapy.&#xD;
&#xD;
          3. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1.&#xD;
&#xD;
          4. Minimum life expectancy of 3 months or more.&#xD;
&#xD;
          5. Adequate renal and hepatic function as defined by the following criteria:&#xD;
&#xD;
             •Total serum bilirubin ≤1.5 × upper limit of normal (ULN) (≤3.0 × ULN for patients&#xD;
             with Gilbert syndrome or if liver function abnormalities are due to underlying&#xD;
             malignancy);&#xD;
&#xD;
             •Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤2.5 × ULN (or ≤5&#xD;
             × ULN if liver function abnormalities are due to underlying malignancy);&#xD;
&#xD;
             •Estimated creatinine clearance ≥30 mL/min (calculated by using the Cockcroft-Gault&#xD;
             equation);&#xD;
&#xD;
             •Serum albumin ≥2 g/dL; and&#xD;
&#xD;
             •Serum lipase ≤1.5 × ULN; and&#xD;
&#xD;
             •Serum amylase ≤1.5 × ULN unless the increased serum amylase is due to salivary&#xD;
             isoenzymes.&#xD;
&#xD;
          6. Adequate bone marrow function as defined by the following criteria:&#xD;
&#xD;
               -  Absolute neutrophil count ≥1.5 × 109/L;&#xD;
&#xD;
               -  Platelet count ≥75 × 109/L in Phase 1 Part and ≥100 × 109/L in Phase 2 Part; and&#xD;
&#xD;
               -  Hemoglobin ≥9.0 g/dL.&#xD;
&#xD;
          7. Normal QT interval on screening ECG, defined as QTcF of ≤450 ms in males or ≤470 ms in&#xD;
             females.&#xD;
&#xD;
          8. Female patients who:&#xD;
&#xD;
               -  Are postmenopausal (natural amenorrhea and not due to other medical reasons) for&#xD;
                  at least 1 year before the screening visit, OR&#xD;
&#xD;
               -  Are surgically sterile, OR&#xD;
&#xD;
               -  If they are of childbearing potential, agree to practice 1 highly effective&#xD;
                  non-hormonal method of contraception and 1 additional effective (barrier) method&#xD;
                  (see Section 8.7.1) at the same time, from the time of signing the informed&#xD;
                  consent form (ICF) through 30 days after the last dose of study drug, OR&#xD;
&#xD;
               -  Agree to practice true abstinence, when this is in line with the preferred and&#xD;
                  usual lifestyle of the subject.&#xD;
&#xD;
        Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods),&#xD;
        withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of&#xD;
        contraception.&#xD;
&#xD;
        Male patients, even if surgically sterilized (ie, status postvasectomy), who:&#xD;
&#xD;
          -  Agree to practice effective barrier contraception during the entire study treatment&#xD;
             period and through 30 days after the last dose of study drug, OR&#xD;
&#xD;
          -  Agree to practice true abstinence, when this is in line with the preferred and usual&#xD;
             lifestyle of the subject.&#xD;
&#xD;
        Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, postovulation methods),&#xD;
        withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of&#xD;
        contraception.&#xD;
&#xD;
        9.Voluntary written consent must be given before performance of any study related procedure&#xD;
        not part of standard medical care, with the understanding that consent may be withdrawn by&#xD;
        the patient at any time without prejudice to future medical care.&#xD;
&#xD;
        10.Willingness and ability to comply with scheduled visits and study procedures.&#xD;
&#xD;
          -  Phase-Specific Inclusion Criteria (Phase 1 part);&#xD;
&#xD;
             1.Have histologically or cytologically confirmed locally advanced (and not a candidate&#xD;
             for definitive therapy) (Stage IIIB) or metastatic NSCLC (Stage IV).&#xD;
&#xD;
             2.Refractory to standard available therapies. 3.All toxicities from prior therapy have&#xD;
             resolved to ≤ grade 1 according to the National Cancer Institute Common Terminology&#xD;
             Criteria for Adverse Events (NCI CTCAE v5.0), or have resolved to baseline, at the&#xD;
             time of first dose of TAK-788. Note: treatment-related grade &gt;1 alopecia or&#xD;
             treatment-related grade 2 peripheral neuropathy are allowed if deemed irreversible.&#xD;
&#xD;
          -  Phase-Specific Inclusion Criteria (Phase 2 part);&#xD;
&#xD;
               1. Histologically or cytologically confirmed locally advanced not suitable for&#xD;
                  definitive therapy, recurrent, or metastatic (Stage IV) NSCLC.&#xD;
&#xD;
               2. Not received prior systemic treatment for locally advanced or metastatic disease&#xD;
                  (with the exception below): Neoadjuvant or adjuvant chemotherapy/immunotherapy&#xD;
                  for Stage I to III or combined modality chemotherapy/radiation for locally&#xD;
                  advanced disease is allowed if completed &gt;6 months before the development of&#xD;
                  metastatic disease.&#xD;
&#xD;
               3. A documented EGFR in-frame exon 20 insertion (including A763_Y764insFQEA,&#xD;
                  V769_D770insASV, D770_N771insNPG, D770_N771insSVD, H773_V774insNPH, or any other&#xD;
                  in-frame exon 20 insertion mutation) by a local test that has been analytically&#xD;
                  validated per local authority guidelines. The EGFR exon 20 insertion mutation can&#xD;
                  be either alone or in combination with other EGFR or HER2 mutations except EGFR&#xD;
                  common mutations (exon 19 del or L858R).&#xD;
&#xD;
               4. Adequate tumor tissue available, either from primary or metastatic sites, for&#xD;
                  central laboratory confirmation of EGFR in-frame exon 20 insertion mutation.&#xD;
                  Note: confirmation of central test positivity is not required before the first&#xD;
                  dose of TAK-788.&#xD;
&#xD;
                  Exclusion Criteria:&#xD;
&#xD;
                  General Exclusion Criteria (Both in Phase 1 and Phase 2 Part);&#xD;
&#xD;
               1. Have been diagnosed with another primary malignancy other than NSCLC except for&#xD;
                  adequately treated non-melanoma skin cancer or cervical cancer in situ;&#xD;
                  definitively treated non-metastatic prostate cancer; or patients with another&#xD;
                  primary malignancy who are definitively relapse-free with at least 3 years&#xD;
                  elapsed since the diagnosis of the other primary malignancy.&#xD;
&#xD;
               2. Have undergone major surgery within 28 days prior to first dose of TAK-788. Minor&#xD;
                  surgical procedures, such as catheter placement or minimally invasive biopsy, are&#xD;
                  allowed.&#xD;
&#xD;
               3. Have current spinal cord compression (symptomatic or asymptomatic and detected by&#xD;
                  radiographic imaging) or leptomeningeal disease (symptomatic or asymptomatic).&#xD;
&#xD;
               4. Have significant, uncontrolled, or active cardiovascular disease, including, but&#xD;
                  not restricted to:&#xD;
&#xD;
          -  Myocardial infarction within 6 months prior to the first dose of study drug;&#xD;
&#xD;
          -  Unstable angina within 6 months prior to first dose;&#xD;
&#xD;
          -  Congestive heart failure within 6 months prior to first dose;&#xD;
&#xD;
          -  History of clinically significant (as determined by the treating physician) atrial&#xD;
             arrhythmia;&#xD;
&#xD;
          -  Any history of ventricular arrhythmia; or&#xD;
&#xD;
          -  Cerebrovascular accident or transient ischemic attack within 6 months prior to first&#xD;
             dose.&#xD;
&#xD;
             5.Have uncontrolled hypertension. Patients with hypertension should be under treatment&#xD;
             on study entry to control blood pressure.&#xD;
&#xD;
             6.Currently being treated with medications known to be associated with the development&#xD;
             of Torsades de Pointes.&#xD;
&#xD;
             7.Have an ongoing or active infection, including, but not limited to, the requirement&#xD;
             for intravenous antibiotics. Have a known history of HIV infection. Testing of HIV is&#xD;
             not required in the absence of history.Hepatitis B surface antigen (HBsAg) positive&#xD;
             patients are allowed to enroll if hepatitis B virus (HBV)-DNA is below 1000 copies/mL&#xD;
             in the plasma.Patients who have positive hepatitis C virus (HCV) antibody can be&#xD;
             enrolled but must have HCV-RNA undetectable in the plasma.&#xD;
&#xD;
             8.Currently have or have a history of interstitial lung disease (ILD), radiation&#xD;
             pneumonitis that required steroid treatment, or drug-related pneumonitis.&#xD;
&#xD;
             9.Female patients who are lactating and breastfeeding or have a positive serum&#xD;
             pregnancy test during the screening period.&#xD;
&#xD;
          -  Note: Female patients who are lactating will be eligible if they discontinue&#xD;
             breastfeeding.&#xD;
&#xD;
             10.Have gastrointestinal illness or disorder that could affect oral absorption of&#xD;
             TAK-788.&#xD;
&#xD;
             11.Have any condition or illness that, in the opinion of the investigator, might&#xD;
             compromise patient safety or interfere with the evaluation of the safety of the drug.&#xD;
&#xD;
          -  Phase-Specific Exclusion Criteria (Phase 1 part);&#xD;
&#xD;
               1. Previously received TAK-788.&#xD;
&#xD;
               2. Received small-molecule anticancer therapy (including cytotoxic chemotherapy and&#xD;
                  investigational agents) within 14 days prior to the first dose of TAK-788 (except&#xD;
                  for reversible EGFR TKIs [ie, erlotinib or gefitinib] up to 7 days prior to the&#xD;
                  first dose of TAK-788).&#xD;
&#xD;
               3. Received antineoplastic monoclonal antibodies including immunotherapy within 28&#xD;
                  days prior to the first dose of TAK-788.&#xD;
&#xD;
               4. Received radiotherapy within 14 days prior to the first dose of TAK-788,&#xD;
                  Stereotactic radiosurgery (SRS) and stereotactic body radiosurgery are allowed up&#xD;
                  to 7 days prior to the first dose.&#xD;
&#xD;
               5. Have symptomatic CNS metastases (parenchymal or leptomeningeal) at screening or&#xD;
                  asymptomatic disease requiring corticosteroids to control symptoms within 7 days&#xD;
                  prior to the first dose of TAK-788.&#xD;
&#xD;
                  Note: If a patient has worsening neurological symptoms or signs due to CNS&#xD;
                  metastases, the patient needs to complete local therapy and be neurologically&#xD;
                  stable (with no requirement for corticosteroids or use of anticonvulsants) for 7&#xD;
                  days prior to the first dose of TAK-788. Patients with no prior history of signs&#xD;
                  or symptoms of CNS metastases but who receive prophylactic steroids or&#xD;
                  anticonvulsants are allowed.&#xD;
&#xD;
               6. Received a strong cytochrome P450 (CYP)3A inhibitor or strong CYP3A inducer&#xD;
                  within 2 weeks prior to first dose of TAK-788.&#xD;
&#xD;
          -  Phase-Specific Exclusion Criteria (Phase 2 part);&#xD;
&#xD;
               1. Received radiotherapy within 14 days before the first dose of TAK-788 or has not&#xD;
                  recovered from radiotherapy-related toxicities. Stereotactic radiosurgery,&#xD;
                  stereotactic body radiotherapy, or palliative radiation outside the chest and&#xD;
                  brain is allowed up to 7 days before the first dose of TAK-788.&#xD;
&#xD;
               2. Have known active brain metastases (have either previously untreated intracranial&#xD;
                  CNS metastases or previously treated intracranial CNS metastases with&#xD;
                  radiologically documented new or progressing CNS lesions). Brain metastases are&#xD;
                  allowed if they have been treated with surgery and/or radiation and have been&#xD;
                  stable without requiring corticosteroids to control symptoms within 7 days before&#xD;
                  the first dose of TAK-788, and have no evidence of new or enlarging brain&#xD;
                  metastases.&#xD;
&#xD;
               3. Received a moderate or strong CYP3A inhibitor or moderate or strong CYP3A inducer&#xD;
                  within 10 days prior to first dose of TAK-788.&#xD;
&#xD;
               4. Have cardiac ejection fraction &lt;50% by echocardiogram or multigated acquisition&#xD;
                  (MUGA) scan at screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Study Director</last_name>
    <role>Study Director</role>
    <affiliation>Takeda</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aichi Cancer Center Hospital</name>
      <address>
        <city>Nagoya</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fujita Health University Hospital</name>
      <address>
        <city>Toyoake</city>
        <state>Aichi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital East</name>
      <address>
        <city>Kashiwa</city>
        <state>Chiba</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume</city>
        <state>Fukuoka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hokkaido Cancer Center</name>
      <address>
        <city>Sapporo</city>
        <state>Hokkaido</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hyogo Cancer Cente</name>
      <address>
        <city>Akashi</city>
        <state>Hyogo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kanagawa Cancer Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sendai Kousei Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Okayama University Hospital</name>
      <address>
        <city>Kita-ku</city>
        <state>Okayama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kansai Medical University Hospital</name>
      <address>
        <city>Hirakata</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kindai University Hospital</name>
      <address>
        <city>Osakasayama</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital Organization Kinki-Chuo Chest Medical Center</name>
      <address>
        <city>Sakai</city>
        <state>Osaka</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saitama Cancer Center</name>
      <address>
        <city>Ina</city>
        <state>Saitama</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokyo Metropolitan Cancer and Infectious Diseases Center Komagome Hospital</name>
      <address>
        <city>Bunkyo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cancer Center Hospital</name>
      <address>
        <city>Chuo-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Institute Hospital</name>
      <address>
        <city>Koto-ku</city>
        <state>Tokyo</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yamaguchi Ube Medical Center</name>
      <address>
        <city>Ube</city>
        <state>Yamaguchi</state>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyushu University Hospital</name>
      <address>
        <city>Fukuoka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hiroshima University Hospital</name>
      <address>
        <city>Hiroshima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Niigata Cancer Center Hospital</name>
      <address>
        <city>Niigata</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Osaka International Cancer Institute</name>
      <address>
        <city>Osaka</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tokushima University Hospital</name>
      <address>
        <city>Tokushima</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wakayama Medical University Hospital</name>
      <address>
        <city>Wakayama</city>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <link>
    <url>https://clinicaltrials.takeda.com/study-detail/5f6b603a4db2bf003ab4a2bd</url>
    <description>To obtain more information on the study, click here/on this link</description>
  </link>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>January 15, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>July 12, 2022</last_update_submitted>
  <last_update_submitted_qc>July 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.</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_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_access_criteria>IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.</ipd_access_criteria>
    <ipd_url>https://vivli.org/ourmember/takeda/</ipd_url>
  </patient_data>
  <pending_results>
    <submitted>November 6, 2022</submitted>
    <submission_canceled>November 6, 2022</submission_canceled>
    <submitted>November 7, 2022</submitted>
    <returned>September 15, 2023</returned>
  </pending_results>
  <!-- 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/NCT03807778
org study id: TAK-788-1003
secondary id: U1111-1223-2659
secondary id: JapicCTI-194584
nct id: NCT03807778
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is in 2 parts. Different participants will take part in the 1st and 2nd parts of
      the study.

      The main aim of the 1st part of the study is to check how much TAK-788 adults with non-small
      cell lung cancer (NSCLC) can receive without getting side effects from it.

      The main aim of the 2nd part of the study is to learn if the condition of adults with
      non-small cell lung cancer improves after treatment with TAK-788. Another aim is to continue
      checking for side effects from TAK-788.

      In the 1st part of the study, at the first visit, the study doctor will check who can take
      part. For those that can take part, participants will take a capsule of TAK-788 once a day
      for 28 days. This will count as 1 cycle. Different small groups of participants will receive
      lower to higher doses of TAK-788. The study doctors will check for side effects after each
      dose of TAK 788. In this way, researchers can work out the best dose of TAK-788 to give
      participants in the 2nd part of the study.

      Participants will visit the clinic 30 days after their treatment has finished for a final
      check-up.

      In the 2nd part of the study, at the first visit, the study doctor will check who can take
      part. Participants will receive the best dose of TAK-788 worked out from the 1st part of the
      study. Participants will receive TAK-788 in the same way as those from the 1st part of the
      study. The study doctors will learn if the condition of these participants improves after
      treatment with TAK-788. The study doctors will also check for side effects from TAK-788.

      After treatment has finished, participants will visit the clinic every 12 weeks until the end
      of the study.

      In both parts of the study, participants can receive TAK-788 for up to just over 1 year, or
      longer if their condition stays improved.
The drug being tested in this study is called TAK-788. TAK-788 is being tested to treat
      Japanese participants with NSCLC. This study has two parts (Phase 1 part and Phase 2 part),
      Phase 1 part of this study will look at the safety, efficacy, tolerability and PK of TAK-788
      orally administered once daily, and will determine a RP2D. Phase 2 study will look at the
      efficacy and safety of TAK-788 in treatment naive Japanese NSCLC patients with epidermal
      growth factor receptor (EGFR) exon 20 insertion mutation. All participants will be assigned
      to Phase 1 part or Phase 2 part and will be asked to take TAK-788 capsule as following dosage
      and regimen;

      Phase 1 part; TAK-788, 40 mg as starting dose, once daily, and escalating up to 160 mg until
      a Maximum Tolerated Dose (MTD). An expansion phase may be followed at any dose to further
      confirm safety observations following identification of MTD/RP2D.

      Phase 2 part; TAK-788, 160 mg, once daily

      The study will enroll approximately 58-63 participants (Phase 1 part; 28-33 and Phase 2 part;
      30).

      This multi-center trial will be conducted in Japan. The overall time to participate in this
      study of Phase 1 part is approximately 3 years and Phase 2 part is approximately 4 years.
      Participants will make multiple visits to the clinic in the treatment period, and the
      post-treatment period including follow-up assessments after the last dose of the study drug.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Phase 1 Part: Recommended Phase 2 Dose (RP2D) of Orally Administered TAK-788
time frame: Up to approximately 28 days
description: The RP2D is the maximum tolerated dose (MTD) or less. An RP2D less than the MTD may be chosen if aspects of tolerability or efficacy not encompassed by the MTD determination suggest utilizing a lower dose.
measure: Phase 2 Part: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)
time frame: Up to approximately 1.5 years
description: IRC assessed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in participants with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2) mutations. ORR is defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST version 1.1. CR: Disappearance of all extranodal target lesions; PR: At least a 30% decrease in Sum of the Longest Diameters (SLD) of target lesions, taking as a reference the baseline SLD.
measure: Phase 1 Part: Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
time frame: Up to approximately 1.5 years
description: An Adverse Event (AE) is defined as any untoward medical occurrence in a clinical investigation participant who has signed informed consent to participate in a study; it does not necessarily have to have a causal relationship with this treatment. A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug.
measure: Phase 1 Part: Number of Participants with First Cycle Dose-Limiting Toxicities (DLTs)
time frame: Up to approximately 1.5 years
description: Toxicity will be evaluated according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.
measure: Phase 1 Part: DLTs of Orally Administered TAK-788
time frame: Up to approximately 28 days
description: Toxicity will be evaluated according to the NCI CTCAE, Version 5.00. DLT will be defined as any of the events specified in the protocol that are considered by the investigator to be at least possibly related to therapy with study medications.
measure: Phase 1 Part: Maximum Tolerated Dose (MTD) of Orally Administered TAK-788
time frame: Up to approximately 28 days
description: The MTD is the highest dose level at which the participant tolerates treatment without dose-limiting toxicities.
measure: Phase 1 Part: Cmax: Maximum Plasma Concentration for TAK-788 and its Active Metabolites after a Single Oral Dose
time frame: Up to 24 hours; Pre-dose and multiple time points post-dose on Cycle 1 Day 1 (C1D1)
measure: Phase 1 Part: Tmax: Time to Cmax for TAK-788 and its Active Metabolites after a Single Oral Dose
time frame: Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1
measure: Phase 1 Part: AUC24: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 hours for TAK-788 and its Active Metabolites after a Single Oral Dose
time frame: Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1
measure: Phase 1 Part: AUClast: Area Under the Plasma Concentration-Time Curve from Time 0 to the Time of the Last Quantifiable Concentration for TAK-788 and its Active Metabolites after a Single Oral Dose
time frame: Up to 24 hours; Pre-dose and multiple time points post-dose on C1D1
measure: Phase 1 Part: Cmax, ss: Maximum Plasma Concentration for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses
time frame: Up to approximately 57 days; Pre-dose and multiple time points post-dose
measure: Phase 1 Part: Tmax, ss: Time to Cmax for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses
time frame: Up to approximately 57 days; Pre-dose and multiple time points post-dose
measure: Phase 1 Part: AUC24, ss: Area Under the Plasma Concentration-Time Curve from Time 0 to 24 hours for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses
time frame: Up to approximately 57 days; Pre-dose and multiple time points post-dose
measure: Phase 1 Part: Rac: Extent of Accumulation Ratio on Multiple Dosing for TAK-788 and its Active Metabolites at Steady State after Multiple Oral Doses
time frame: Up to approximately 57 days; Pre-dose and multiple time points post-dose
measure: Phase 2 Part: Overall Response Rate (ORR) as Assessed by the Independent Review Committee (IRC)
time frame: Up to approximately 4 years
description: IRC assessed objective response rate (ORR) using Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 in participants with epidermal growth factor receptor (EGFR) or human epidermal growth factor 2 (HER2) mutations. ORR is defined as the percentage of participants achieving complete response (CR) and partial response (PR) per RECIST version 1.1. CR: Disappearance of all target lesions; PR: At least a 30% decrease in SLD of target lesions, taking as a reference the baseline SLD.
measure: Phase 2 Part: Duration of Response (DOR)
time frame: Up to approximately 4 years
description: Duration of response is defined as the time interval from the time that the measurement criteria are first met for CR/PR (whichever is first recorded) until the first date that PD is objectively documented.
measure: Phase 2 Part: Time to Response
time frame: Up to approximately 4 years
description: Time to response is defined as the time interval from the date of randomization until the initial observation of CR or PR.
measure: Phase 2 Part: Disease Control Rate (DCR)
time frame: Up to approximately 4 years
description: DCR is defined as the percentage of participants who have achieved CR, PR, or stable disease (SD) (in the case of SD, measurements must have met the SD criteria at least once after study entry at a minimum interval of 42 days) after the initiation of study drug.
measure: Phase 2 Part: Progression Free Survival (PFS)
time frame: Up to approximately 4 years
description: PFS is defined as the time interval from the date of randomization until the first date at which the criteria for progressive disease (PD) according to RECIST version 1.1 are met or death, whichever occurs first.
measure: Phase 2 Part: Overall Survival (OS)
time frame: Up to approximately 4 years
description: OS is defined as the interval from the date of randomization until death.
measure: Phase 2 Part: Patient-reported Symptoms, Functioning, and Health-related Quality of Life (HRQoL) as Assessed by the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-C30
time frame: Up to approximately 4 years
description: EORTC QLQ-C30 is a cancer-specific questionnaire which comprises of 5 functional scales (physical, role, cognitive, emotional, and social functioning); 3 symptom scales (fatigue, pain, and nausea/vomiting); and a global health status/quality-of-life (QoL) scale. Six single-item scales are also included (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Raw scores will be converted into scale scores ranging from 0 to 100. For the functional scales and the global health status/QoL scale, higher scores represent better HRQoL, whereas for the symptom scales lower scores represent better HRQoL (i.e., a low level of symptomatology/problems).
measure: Phase 2 Part: Patient-reported Symptoms (particular core symptoms of lung cancer), Functioning, and HRQoL as Assessed by the EORTC lung cancer module QLQ-LC13
time frame: Up to approximately 4 years
description: EORTC QLQ-LC13 contains 13 questions to assess for: dyspnea, and a series of single items including pain, coughing, sore mouth, dysphagia, peripheral neuropathy, alopecia, and hemoptysis. Score of each item will range from 0 to 100, where 0 indicates no symptoms and 100 indicates worst possible symptoms.
arm group label: TAK-788, Phase 1 Part
arm group type: Experimental
description: TAK-788 40 milligrams (mg) (as the starting dose), capsules, orally, once daily on Days 1-28 of each 28-day treatment cycle for up to disease progression or intolerable toxicity, or another discontinuation criterion, and increasing until 160 mg, once daily (for up to approximately 10-12 cycles).
arm group label: TAK-788, Phase 2 Part
arm group type: Experimental
description: TAK-788 160 mg, once daily, for up to approximately 10-12 cycles.
intervention type: Drug
intervention name: TAK-788
description: TAK-788 capsule
arm group label: TAK-788, Phase 1 Part
arm group label: TAK-788, Phase 2 Part
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Study Director
role: Study Director
affiliation: Takeda
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Japan
url: https://clinicaltrials.takeda.com/study-detail/5f6b603a4db2bf003ab4a2bd
description: To obtain more information on the study, click here/on this link
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Yes
ipd description: Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd access criteria: IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
ipd url: https://vivli.org/ourmember/takeda/
submitted: November 6, 2022
submission canceled: November 6, 2022
submitted: November 7, 2022
returned: September 15, 2023