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/NCT05990738</url>
    </required_header>
    <id_info>
      <org_study_id>1438-0009</org_study_id>
      <secondary_id>2023-506007-26-00</secondary_id>
      <secondary_id>U1111-1293-4098</secondary_id>
      <nct_id>NCT05990738</nct_id>
    </id_info>
    <brief_title>DAREON™-9: A Study to Test How Well Different Doses of BI 764532 Are Tolerated by People With Small Cell Lung Cancer When Taken Together With Topotecan</brief_title>
    <official_title>DAREON™-9: A Phase Ib Open-label Dose Escalation and Dose Confirmation Safety Study of Intravenous BI 764532 in Combination With Topotecan for the Treatment of Patients With Small Cell Lung Cancer</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>Yes</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 extensive stage small cell lung cancer. The study is in&#xD;
        people with advanced cancer that had previously received platinum-based chemotherapy and are&#xD;
        eligible to receive topotecan treatment.&#xD;
  &#xD;
        The purpose of this study is to find out the highest dose of BI 764532 that people can&#xD;
        tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may&#xD;
        help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions&#xD;
        into a vein. As an alternative, topotecan may also be taken orally (tablets).&#xD;
  &#xD;
        Participants may continue to take BI 764532 as long as they benefit from treatment and can&#xD;
        tolerate it. During this time, participants visit the study site regularly. The visits also&#xD;
        depend on the response to the treatment. At the study visits, the doctors check the health of&#xD;
        the participants, take necessary laboratory tests, and note any health problems that could&#xD;
        have been caused by the study treatment.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 15, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">October 27, 2025</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period</measure>
      <time_frame>up to 9 weeks</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part B: Occurrence of DLTs during the on-treatment period</measure>
      <time_frame>up to 36 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Part B: Occurrence of AEs during the on-treatment period</measure>
      <time_frame>up to 36 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Part A: Occurrence of DLTs during the on-treatment period</measure>
      <time_frame>up to 36 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part A: Occurrence of AEs during the on-treatment period</measure>
      <time_frame>up to 36 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part B: Objective response</measure>
      <time_frame>up to 36 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Part B: Duration of response</measure>
      <time_frame>up to 36 months</time_frame>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">44</enrollment>
    <condition>Small Cell Lung Carcinoma (SCLC)</condition>
    <arm_group>
      <arm_group_label>Part A: BI 764532 low dose + topotecan</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A: BI 764532 medium dose + topotecan</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part A: BI 764532 high dose + topotecan</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Part B: BI 764532 + topotecan</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>Part A: BI 764532 high dose + topotecan</arm_group_label>
      <arm_group_label>Part A: BI 764532 low dose + topotecan</arm_group_label>
      <arm_group_label>Part A: BI 764532 medium dose + topotecan</arm_group_label>
      <arm_group_label>Part B: BI 764532 + topotecan</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Topotecan</intervention_name>
      <description>Topotecan</description>
      <arm_group_label>Part A: BI 764532 high dose + topotecan</arm_group_label>
      <arm_group_label>Part A: BI 764532 low dose + topotecan</arm_group_label>
      <arm_group_label>Part A: BI 764532 medium dose + topotecan</arm_group_label>
      <arm_group_label>Part B: BI 764532 + topotecan</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Male or female participants ≥18 years old and at least at the legal age of consent in&#xD;
               countries where it is greater than 18 years at the time of signature of the informed&#xD;
               consent form (ICF).&#xD;
  &#xD;
            2. Signed and dated written informed consent in accordance with International Conference&#xD;
               of Harmonization-Good Clinical Practice (ICH-GCP) and local legislation prior to&#xD;
               admission to the trial&#xD;
  &#xD;
            3. Histologically or cytologically confirmed small cell lung cancer (SCLC)&#xD;
  &#xD;
            4. Extensive stage - small cell lung cancer (ES-SCLC) that progressed or recurred&#xD;
               following platinum-based treatment, and anti- programmed cell death protein 1 (PD-1)&#xD;
               or programmed cell death ligand 1 (PD-L1) as applicable&#xD;
  &#xD;
            5. Patients must be eligible for topotecan treatment according to label&#xD;
  &#xD;
            6. Availability of archival tumour tissue sample&#xD;
  &#xD;
            7. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 Further inclusion&#xD;
               criteria apply&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Previous treatment in this trial&#xD;
  &#xD;
            2. Current enrolment in another investigational device or drug trial, or &lt;30 days since&#xD;
               ending another investigational device or drug trial(s)&#xD;
  &#xD;
            3. Untreated or symptomatic brain metastases. Participants with treated, stable brain&#xD;
               metastases are eligible provided they meet the following criteria:&#xD;
  &#xD;
                 -  Radiotherapy or major surgery for brain metastases was completed at least 2 weeks&#xD;
                    (for radiotherapy) or 4 weeks (for major brain metastases surgery) prior to the&#xD;
                    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 central nervous system (CNS)&#xD;
                    disease.&#xD;
  &#xD;
            4. Presence of leptomeningeal carcinomatosis&#xD;
  &#xD;
            5. Previous treatment with T cell engager (TcE) or cell therapies targeting delta-like&#xD;
               ligand 3 (DLL3).&#xD;
  &#xD;
            6. Persistent toxicity from previous treatments that has not resolved to ≤ Common&#xD;
               Terminology Criteria for Adverse Events (CTCAE) Grade 1 (except for alopecia,&#xD;
               asthenia/fatigue, CTCAE Grade 2 neuropathy, or Grade 2 endocrinopathies controlled by&#xD;
               replacement therapy).&#xD;
  &#xD;
            7. Major surgery (major according to the investigator's assessment) within 28 days prior&#xD;
               to first administration of BI 764532 or planned during treatment period, e.g. hip&#xD;
               replacement.&#xD;
  &#xD;
            8. Previous or concomitant malignancies other than the one treated in this trial within&#xD;
               the last 2 years except&#xD;
  &#xD;
                 1. effectively treated non-melanoma skin cancers&#xD;
  &#xD;
                 2. effectively treated carcinoma in situ of the cervix&#xD;
  &#xD;
                 3. effectively treated ductal carcinoma in situ&#xD;
  &#xD;
                 4. other effectively treated malignancy that is considered cured by local treatment&#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>
    <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>http://www.mystudywindow.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 7, 2023</study_first_submitted>
    <study_first_submitted_qc>August 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 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>Small Cell Lung Carcinoma</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Topotecan</mesh_term>
    </intervention_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/NCT05990738
  org study id: 1438-0009
  secondary id: 2023-506007-26-00
  secondary id: U1111-1293-4098
  nct id: NCT05990738
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This study is open to adults with extensive stage small cell lung cancer. The study is in
        people with advanced cancer that had previously received platinum-based chemotherapy and are
        eligible to receive topotecan treatment.
  
        The purpose of this study is to find out the highest dose of BI 764532 that people can
        tolerate when taken together with topotecan. BI 764532 is an antibody-like molecule that may
        help the immune system fight cancer. Participants get BI 764532 and topotecan as infusions
        into a vein. As an alternative, topotecan may also be taken orally (tablets).
  
        Participants may continue to take BI 764532 as long as they benefit from treatment and can
        tolerate it. During this time, participants visit the study site regularly. The visits also
        depend on the response to the treatment. At the study visits, the doctors check the health of
        the participants, take necessary laboratory tests, and note any health problems that could
        have been caused by the study treatment.
  allocation: Non-Randomized
  intervention model: Sequential Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Part A: Occurrence of dose limiting toxicities (DLTs) in the maximum tolerated dose (MTD) evaluation period
  time frame: up to 9 weeks
  measure: Part B: Occurrence of DLTs during the on-treatment period
  time frame: up to 36 months
  measure: Part B: Occurrence of AEs during the on-treatment period
  time frame: up to 36 months
  measure: Part A: Occurrence of DLTs during the on-treatment period
  time frame: up to 36 months
  measure: Part A: Occurrence of AEs during the on-treatment period
  time frame: up to 36 months
  measure: Part B: Objective response
  time frame: up to 36 months
  measure: Part B: Duration of response
  time frame: up to 36 months
  arm group label: Part A: BI 764532 low dose + topotecan
  arm group type: Experimental
  arm group label: Part A: BI 764532 medium dose + topotecan
  arm group type: Experimental
  arm group label: Part A: BI 764532 high dose + topotecan
  arm group type: Experimental
  arm group label: Part B: BI 764532 + topotecan
  arm group type: Experimental
  intervention type: Drug
  intervention name: BI 764532
  description: BI 764532
  arm group label: Part A: BI 764532 high dose + topotecan
  arm group label: Part A: BI 764532 low dose + topotecan
  arm group label: Part A: BI 764532 medium dose + topotecan
  arm group label: Part B: BI 764532 + topotecan
  intervention type: Drug
  intervention name: Topotecan
  description: Topotecan
  arm group label: Part A: BI 764532 high dose + topotecan
  arm group label: Part A: BI 764532 low dose + topotecan
  arm group label: Part A: BI 764532 medium dose + topotecan
  arm group label: Part B: BI 764532 + topotecan
  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: http://www.mystudywindow.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Small Cell Lung Carcinoma
  mesh term: Topotecan
  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