<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/NCT03017885</url>
  </required_header>
  <id_info>
    <org_study_id>1199-0272</org_study_id>
    <nct_id>NCT03017885</nct_id>
  </id_info>
  <brief_title>Post Marketing Surveillance of Nintedanib in Indian Patients With Non-small Cell Lung Cancer (NSCLC) After First-line Therapy</brief_title>
  <official_title>An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Locally Advanced, Metastatic or Locally Recurrent Non Small Cell Lung Cancer (NSCLC) of Adenocarcinoma Tumor Histology After First Line Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boehringer Ingelheim</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boehringer Ingelheim</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This active surveillance aims to collect the safety data of 100 NSCLC patients treated with&#xD;
      nintedanib per the approved Indian label within 2 years from the date of commercial&#xD;
      availability of the drug in India (23rd January 2017). The objective is to look at the safety&#xD;
      of nintedanib in the real world setting.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 28, 2017</start_date>
  <completion_date type="Actual">September 24, 2022</completion_date>
  <primary_completion_date type="Actual">September 24, 2022</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of all Adverse Drug Reactions (ADRs) in nintedanib &amp; docetaxel treated patients</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of all Serious Adverse Events (SAEs) in nintedanib &amp; docetaxel treated patients</measure>
    <time_frame>2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events.</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">28</enrollment>
  <condition>Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Group A</arm_group_label>
    <description>Patients who started treatment with nintedanib &amp; docetaxel after 23rd January, 2017 and have discontinued the drug at the time of participation in the active surveillance.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group B</arm_group_label>
    <description>Patients who started treatment with nintedanib &amp; docetaxel after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group C</arm_group_label>
    <description>Patients who have been newly prescribed nintedanib &amp; docetaxel at the time of participation in the active surveillance.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        This active surveillance aims to collect the safety data of 100 NSCLC patients treated with&#xD;
        nintedanib per the approved Indian label within 2 years from the date of commercial&#xD;
        availability of the drug in India (23rd January 2017).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥18 years of age with locally advanced and/or metastatic NSCLC of stage IIIB&#xD;
             or IV, or recurrent NSCLC and adenocarcinoma histology after first line chemotherapy&#xD;
             who have initiated or will initiate nintedanib &amp; docetaxel according to the package&#xD;
             insert after the commercial availability of drug in India (23rd January 2017).&#xD;
&#xD;
          -  Patients in whom it is possible to obtain voluntary informed consent from either the&#xD;
             patient or patient's legally authorised representative (applicable for Group B and C&#xD;
             patients).&#xD;
&#xD;
          -  Patients in whom data collection is possible from the medical records (applicable for&#xD;
             Group A and B patients).&#xD;
&#xD;
          -  Further inclusion criteria apply.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were previously treated with nintedanib.&#xD;
&#xD;
          -  Patients who are positive for endothelial growth factor receptor (EGFR) mutations or&#xD;
             anaplastic lymphoma kinase (ALK) rearrangements&#xD;
&#xD;
          -  Patients who are participating in a clinical trial.&#xD;
&#xD;
          -  Further exclusion criteria apply.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Zydus Hospitals and Healthcare Research Pvt. Ltd</name>
      <address>
        <city>Anand</city>
        <zip>388001</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Narayana Hrudyalaya</name>
      <address>
        <city>Bangalore</city>
        <zip>560099</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Manipal Hospitals</name>
      <address>
        <city>Bengaluru</city>
        <zip>560017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HCG Hospital</name>
      <address>
        <city>Bengaluru</city>
        <zip>560027</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sparsh Hospitals and Critical Care</name>
      <address>
        <city>Bhubaneshwar</city>
        <zip>751007</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Action Cancer Hospital, Delhi</name>
      <address>
        <city>Delhi</city>
        <zip>110063</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Apollo Health City Hospital</name>
      <address>
        <city>Hyderabad</city>
        <zip>500033</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yashoda Hospitals</name>
      <address>
        <city>Hyderabad</city>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chittaranjan National Cancer Institute</name>
      <address>
        <city>Kolkata</city>
        <zip>700026</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rajiv Gandhi Cancer Institute and Research Centre</name>
      <address>
        <city>New Delhi</city>
        <zip>110085</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SRM Institute of Medical Science</name>
      <address>
        <city>Vadapalani</city>
        <zip>600026</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <link>
    <url>http://www.mystudywindow.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 11, 2017</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 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>After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed &quot;Document Sharing Agreement&quot;.&#xD;
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.&#xD;
The data shared are the raw clinical study data sets.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.</ipd_time_frame>
    <ipd_access_criteria>For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.</ipd_access_criteria>
    <ipd_url>https://www.mystudywindow.com/msw/datasharing</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/NCT03017885
org study id: 1199-0272
nct id: NCT03017885
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This active surveillance aims to collect the safety data of 100 NSCLC patients treated with
      nintedanib per the approved Indian label within 2 years from the date of commercial
      availability of the drug in India (23rd January 2017). The objective is to look at the safety
      of nintedanib in the real world setting.
observational model: Cohort
time perspective: Other
measure: Incidence of all Adverse Drug Reactions (ADRs) in nintedanib & docetaxel treated patients
time frame: 2 years
measure: Incidence of all Serious Adverse Events (SAEs) in nintedanib & docetaxel treated patients
time frame: 2 years
measure: Percentage of patients who require nintedanib dose reductions and discontinuations due to adverse events.
time frame: 2 years
arm group label: Group A
description: Patients who started treatment with nintedanib & docetaxel after 23rd January, 2017 and have discontinued the drug at the time of participation in the active surveillance.
arm group label: Group B
description: Patients who started treatment with nintedanib & docetaxel after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance .
arm group label: Group C
description: Patients who have been newly prescribed nintedanib & docetaxel at the time of participation in the active surveillance.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
url: http://www.mystudywindow.com
description: Related Info
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
sharing ipd: Yes
ipd description: After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
ipd access criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
ipd url: https://www.mystudywindow.com/msw/datasharing