xml: <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/NCT05963867</url>
    </required_header>
    <id_info>
      <org_study_id>1438-0004</org_study_id>
      <nct_id>NCT05963867</nct_id>
    </id_info>
    <brief_title>A Study to Test How BI 764532 is Taken up by Tumours in People With Small-cell Lung Cancer or Neuroendocrine Cancer</brief_title>
    <official_title>An Open-label Phase 1 PET Imaging Trial to Investigate [89Zr]Zr-BI 764532 Biodistribution and Tumour Uptake in Patients With Small-cell Lung Carcinoma or Neuroendocrine Carcinoma</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Boehringer Ingelheim</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Boehringer Ingelheim</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 open to adults with small cell lung cancer and other neuroendocrine cancers.&#xD;
        The study is in people with advanced cancer for whom previous treatment was not successful or&#xD;
        no standard treatment exists. The purpose of this study is to find out how a medicine called&#xD;
        BI 764532 gets distributed in the body and in tumours.&#xD;
  &#xD;
        Participants get BI 764532 when starting treatment. In the first weeks, doctors check how BI&#xD;
        764532 is taken up in tumours by means of an imaging method. If there is benefit for the&#xD;
        participants and if they can tolerate it, the treatment is given up to the maximum duration&#xD;
        of the study. During this time, participants visit the study site regularly. The total number&#xD;
        of visits depends on how they respond to and tolerate the treatment. Doctors record any&#xD;
        unwanted effects and regularly check the general health of the participants.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 19, 2023</start_date>
    <completion_date type="Anticipated">June 27, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 21, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses</measure>
      <time_frame>at baseline and up to 35 days</time_frame>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">12</enrollment>
    <condition>Small Cell Lung Carcinoma (SCLC)</condition>
    <condition>Neuroendocrine Neoplasms</condition>
    <arm_group>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort 2</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>BI 764532</intervention_name>
      <description>BI 764532</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>[89Zr]Zr-BI 764532</intervention_name>
      <description>[89Zr]Zr-BI 764532</description>
      <arm_group_label>Cohort 1</arm_group_label>
      <arm_group_label>Cohort 2</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥18 years&#xD;
  &#xD;
            -  Weight ≥ 60kg&#xD;
  &#xD;
            -  Signed and dated, written informed consent form (ICF) in accordance with International&#xD;
               Council for Harmonisation-Good Clinical Practice (ICH-GCP) and local legislation prior&#xD;
               to any trial-specific procedures, sampling, or analyses.&#xD;
  &#xD;
            -  Patient who failed conventional treatment or for whom no therapy of proven efficacy&#xD;
               exists or who is not eligible for established treatment options. Patient must have&#xD;
               exhausted available treatment options known to prolong survival for their disease.&#xD;
               Previous therapies should include at least one line of platinum-based chemotherapy.&#xD;
               Previous therapy with anti Programmed Cell Death Protein 1 (PD-1) or Programmed Cell&#xD;
               Death Ligand 1 (PD-L1) are allowed.&#xD;
  &#xD;
            -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.&#xD;
  &#xD;
            -  At least one evaluable lesion outside of Central Nervous System (CNS) as defined per&#xD;
               Response Evaluation Criteria in Solid Tumours (RECIST) 1.1&#xD;
  &#xD;
            -  Subjects with brain metastases are eligible provided they meet the following criteria:&#xD;
  &#xD;
                 -  radiotherapy or surgery for brain metastases was completed at least 2 weeks prior&#xD;
                    to the first administration of BI 764532,&#xD;
  &#xD;
                 -  patient is off steroids for at least 7 days (physiologic doses of steroids are&#xD;
                    permitted), and the patient is off anti-epileptic drugs for at least 7 days or on&#xD;
                    stable doses of anti-epileptic drugs for malignant CNS disease.&#xD;
  &#xD;
          Further inclusion criteria apply.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Previous or concomitant malignancies other than the one treated in this trial within&#xD;
               the last 2 years except:&#xD;
  &#xD;
                 -  effectively treated non-melanoma skin cancers&#xD;
  &#xD;
                 -  effectively treated carcinoma in situ of the cervix&#xD;
  &#xD;
                 -  effectively treated ductal carcinoma in situ&#xD;
  &#xD;
                 -  other effectively treated malignancy that is considered cured by local treatment&#xD;
  &#xD;
            -  Major injuries and/or surgery or bone fracture within 28 days of first dose BI 764532,&#xD;
               or planned surgical procedures&#xD;
  &#xD;
            -  Known leptomeningeal disease or spinal cord compression due to metastatic disease&#xD;
  &#xD;
            -  Anticoagulant treatment that cannot be safely interrupted based on opinion of the&#xD;
               investigator if medically needed&#xD;
  &#xD;
            -  Active infection that requires medical therapy or other clinically significant&#xD;
               intervention&#xD;
  &#xD;
            -  Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 2 weeks&#xD;
               prior to study entry (confirmed via polymerase chain reaction (PCR) test or other&#xD;
               applicable test as per local requirements) or suspected SARS-CoV-2 infection as per&#xD;
               physician assessment, or close contact (within 1 week) with an individual with&#xD;
               confirmed SARS-CoV-2 infection&#xD;
  &#xD;
            -  Any of the following known laboratory evidence of hepatitis virus infection:&#xD;
  &#xD;
                 -  Positive results of hepatitis B surface (HBs) antigen&#xD;
  &#xD;
                 -  Presence of hepatitis B core (HBc) antibody together with hepatitis B virus DNA&#xD;
                    (HBV-DNA)&#xD;
  &#xD;
                 -  Presence of hepatitis C ribonucleic acid (RNA)&#xD;
  &#xD;
            -  Known human immunodeficiency virus (HIV) infection. 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>
    <overall_contact>
      <last_name>Boehringer Ingelheim</last_name>
      <phone>1-800-243-0127</phone>
      <email>clintriage.rdg@boehringer-ingelheim.com</email>
    </overall_contact>
    <link>
      <url>https://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 18, 2023</study_first_submitted>
    <study_first_submitted_qc>July 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</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>Carcinoma</mesh_term>
      <mesh_term>Lung Neoplasms</mesh_term>
      <mesh_term>Small Cell Lung Carcinoma</mesh_term>
      <mesh_term>Neuroendocrine Tumors</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).&#xD;
  For more details refer to:&#xD;
  https://www.mystudywindow.com/msw/datatransparency</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05963867
  org study id: 1438-0004
  nct id: NCT05963867
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study is open to adults with small cell lung cancer and other neuroendocrine cancers.
        The study is in people with advanced cancer for whom previous treatment was not successful or
        no standard treatment exists. The purpose of this study is to find out how a medicine called
        BI 764532 gets distributed in the body and in tumours.
  
        Participants get BI 764532 when starting treatment. In the first weeks, doctors check how BI
        764532 is taken up in tumours by means of an imaging method. If there is benefit for the
        participants and if they can tolerate it, the treatment is given up to the maximum duration
        of the study. During this time, participants visit the study site regularly. The total number
        of visits depends on how they respond to and tolerate the treatment. Doctors record any
        unwanted effects and regularly check the general health of the participants.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Mean relative change from baseline of [89Zr]Zr-BI 764532 tumour-to-plasma ratios in all detectable lesions post BI 764532 doses
  time frame: at baseline and up to 35 days
  arm group label: Cohort 1
  arm group type: Experimental
  arm group label: Cohort 2
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 764532
  description: BI 764532
  arm group label: Cohort 1
  arm group label: Cohort 2
  intervention type: Drug
  intervention name: [89Zr]Zr-BI 764532
  description: [89Zr]Zr-BI 764532
  arm group label: Cohort 1
  arm group label: Cohort 2
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Boehringer Ingelheim
  phone: 1-800-243-0127
  email: clintriage.rdg@boehringer-ingelheim.com
  url: https://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Carcinoma
  mesh term: Lung Neoplasms
  mesh term: Small Cell Lung Carcinoma
  mesh term: Neuroendocrine Tumors
  sharing ipd: No
  ipd description: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).
  For more details refer to:
  https://www.mystudywindow.com/msw/datatransparency