<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/NCT03271554</url>
  </required_header>
  <id_info>
    <org_study_id>ML30132</org_study_id>
    <nct_id>NCT03271554</nct_id>
  </id_info>
  <brief_title>Treatment Registry of Alectinib in Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer in Korea</brief_title>
  <official_title>Treatment Registry of Alecensa in Korean Patients With Anaplastic Lymphoma Kinase (ALK)-Positive, Locally Advanced or Metastatic Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016.&#xD;
      The purpose of this registry is to investigate and confirm the type and incidence of newly&#xD;
      identified adverse events and any other factors affecting safety and effectiveness of the new&#xD;
      drug so that the regulatory authority can manage the marketing approval properly.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 9, 2017</start_date>
  <completion_date type="Actual">May 28, 2021</completion_date>
  <primary_completion_date type="Actual">May 28, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants with Adverse Events (AEs)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall Response Rate (ORR)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>ORR will be determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as assessed by physicians under routine clinical practice. Overall response rate was defined as the percentage of participants who had any evidence of Complete Response (CR) or Partial Response (PR): CR is defined as the disappearance of all target lesions and all nodes with short axis &lt;10 millimeter (mm); PR is defined as &gt;/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter &gt;/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures &gt;/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. Overall Response (OR) = CR + PR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Response (CR)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>CR will be determined according to RECIST v1,1 as assessed by physicians under routine clinical practice and is defined as disappearance of all target lesions and all nodes with short axis &lt;10 mm. Target lesions are those lesions with longest diameter &gt;/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures &gt;/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Partial Response (PR)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>PR will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as &gt;/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter &gt;/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures &gt;/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Stable Disease (SD)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>SD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as neither response nor progression. Response is defined as at least &gt;/=30% decrease in the sum of the longest diameter of target lesions. Progression is defined as &gt;/= 20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and &gt;/= 5 mm in absolute value. Target lesions are those lesions with longest diameter &gt;/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures &gt;/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Progressive Disease (PD)</measure>
    <time_frame>Up to approximately 3 years</time_frame>
    <description>PD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as &gt;/=20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and &gt;/= 5 mm in absolute value. Target lesions are those lesions with longest diameter &gt;/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures &gt;/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">355</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Alectinib</arm_group_label>
    <description>Participants with ALK-positive, locally advanced or metastatic non-small cell lung cancer, who are treated with alectinib in accordance with local clinical practice and local labeling, are observed in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Alectinib</intervention_name>
    <description>According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).</description>
    <arm_group_label>Alectinib</arm_group_label>
    <other_name>Alecensa</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with ALK-positive, locally advance or metastatic non-small cell lung cancer,&#xD;
        who are administered alectinib at physician's discretion in Korea.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Subjects who are administered alectinib at physician's discretion and fall into the&#xD;
        approved indication in Korea.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to alectinib or any ingredient of alectinib;&#xD;
&#xD;
          -  Pregnant or lactating women;&#xD;
&#xD;
          -  Pediatric subjects (age &lt;/=18 years);&#xD;
&#xD;
          -  Due to the presence of lactose, subjects with rare hereditary problems of galactose&#xD;
             intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not&#xD;
             take alectinib.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Inje University Busan Paik Hospital</name>
      <address>
        <city>Busan</city>
        <zip>47392</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dong-A University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49201</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49241</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kosin University Gospel Hospital</name>
      <address>
        <city>Busan</city>
        <zip>49267</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dongnam Institute of Radiological &amp; Medical Sciences</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chungbuk National University Hospital</name>
      <address>
        <city>Cheongju-si</city>
        <zip>28644</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyungpook National University Chilgok Hospital</name>
      <address>
        <city>Daegu</city>
        <zip>41404</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Keimyung University Dongsan Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>41931</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Daegu Catholic University Medical Center</name>
      <address>
        <city>Daegu</city>
        <zip>42472</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Konyang University Hospital</name>
      <address>
        <city>Daejeon</city>
        <zip>35365</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Wonju Severance Christian Hospital</name>
      <address>
        <city>Gangwon-do</city>
        <zip>26426</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University Ilsan Paik Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>10380</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uijeongbu St. Mary's Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>11765</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHA Bundang Medical Center</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>13496</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hallym University Sacred Heart Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>14068</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bucheon St Mary's hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>14647</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Hospital</name>
      <address>
        <city>Gyeonggi-do</city>
        <zip>16247</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pusan National University Yangsan Hospital</name>
      <address>
        <city>Gyeongsangnam-do</city>
        <zip>50612</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Catholic Univ. of Incheon St.Mary's Hospital</name>
      <address>
        <city>Incheon</city>
        <zip>21431</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gachon University Gil Medical Center</name>
      <address>
        <city>Incheon</city>
        <zip>21565</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inha University Hospital</name>
      <address>
        <city>Incheon</city>
        <zip>22332</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonbuk National University Hospital</name>
      <address>
        <city>Jeollabuk-do</city>
        <zip>54907</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chonnam National University Hwasun Hospital</name>
      <address>
        <city>Jeollanam-do</city>
        <zip>58128</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inje University, Sanggye-Paik Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>01757</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02447</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Anam Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>02841</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kangbuk Samsung Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03181</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital, Yonsei University</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gangdong Kyung Hee University Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>05278</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>Gangnam Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>06273</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>06351</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ewha Womans University Mokdong Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>07985</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Korea University Guro Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>08308</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soon Chun Hyang University Hospital; Department of Pulmonology and Allergy</name>
      <address>
        <city>Seoul</city>
        <zip>140-743</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yonsei University Wonju Severance Christian Hospital</name>
      <address>
        <city>Wonju-Si</city>
        <zip>220-701</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>September 1, 2017</study_first_submitted>
  <study_first_submitted_qc>September 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>November 17, 2022</last_update_submitted>
  <last_update_submitted_qc>November 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 18, 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>
  <!-- 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/NCT03271554
org study id: ML30132
nct id: NCT03271554
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Alectinib was approved by the Ministry of Food and Drug Safety (MFDS) in Korea in Oct 2016.
      The purpose of this registry is to investigate and confirm the type and incidence of newly
      identified adverse events and any other factors affecting safety and effectiveness of the new
      drug so that the regulatory authority can manage the marketing approval properly.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants with Adverse Events (AEs)
time frame: Up to approximately 3 years
description: An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as AEs. All AE events will be graded according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0.
measure: Overall Response Rate (ORR)
time frame: Up to approximately 3 years
description: ORR will be determined according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria version 1.1 as assessed by physicians under routine clinical practice. Overall response rate was defined as the percentage of participants who had any evidence of Complete Response (CR) or Partial Response (PR): CR is defined as the disappearance of all target lesions and all nodes with short axis <10 millimeter (mm); PR is defined as >/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ. Overall Response (OR) = CR + PR.
measure: Complete Response (CR)
time frame: Up to approximately 3 years
description: CR will be determined according to RECIST v1,1 as assessed by physicians under routine clinical practice and is defined as disappearance of all target lesions and all nodes with short axis <10 mm. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
measure: Percentage of Participants with Partial Response (PR)
time frame: Up to approximately 3 years
description: PR will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as >/=30% decrease in the sum of the longest diameter of target lesions. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
measure: Percentage of Participants with Stable Disease (SD)
time frame: Up to approximately 3 years
description: SD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as neither response nor progression. Response is defined as at least >/=30% decrease in the sum of the longest diameter of target lesions. Progression is defined as >/= 20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and >/= 5 mm in absolute value. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
measure: Percentage of Participants with Progressive Disease (PD)
time frame: Up to approximately 3 years
description: PD will be determined according to RECIST v1.1 as assessed by physicians under routine clinical practice and is defined as >/=20% increase in the sum of target lesions taking as reference the smallest sum measured during follow-up and >/= 5 mm in absolute value. Target lesions are those lesions with longest diameter >/=10 mm and limits that are sufficiently well defined for their measurement to be considered reliable. Lymph nodes are target lesions if short-axis measures >/=15 mm. Maximum number of selected target lesions is 5 per participant and 2 per organ.
arm group label: Alectinib
description: Participants with ALK-positive, locally advanced or metastatic non-small cell lung cancer, who are treated with alectinib in accordance with local clinical practice and local labeling, are observed in this study.
intervention type: Drug
intervention name: Alectinib
description: According to local labeling the recommended dose of alectinib is 600 mg given orally, twice daily with food (total daily dose of 1200 mg).
arm group label: Alectinib
other name: Alecensa
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
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country: Korea, Republic of
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung