<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/NCT02200081</url>
  </required_header>
  <id_info>
    <org_study_id>MGN1703-C03</org_study_id>
    <nct_id>NCT02200081</nct_id>
  </id_info>
  <brief_title>Randomized Study of Maintenance Therapy With MGN1703 in Patients With SCLC</brief_title>
  <acronym>IMPULSE</acronym>
  <official_title>Randomized Clinical Study of Maintenance Therapy With Immunomodulator MGN1703 in Patients With Extensive Disease Small Cell Lung Cancer After Platinum-Based First-Line Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mologen AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mologen AG</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC) as&#xD;
      maintenance treatment in patients with extensive disease small cell lung cancer (SCLC) who&#xD;
      achieved at least a partial response (PR) following platinum-based first-line therapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2014</start_date>
  <completion_date type="Actual">October 5, 2017</completion_date>
  <primary_completion_date type="Actual">November 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>24 months</time_frame>
    <description>The primary efficacy endpoint is the OS which is defined as the time interval starting with the randomization and lasting until death (=event) or until the date of last information available from the patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>OS1</measure>
    <time_frame>24 months</time_frame>
    <description>The secondary efficacy endpoint OS1 is defined as the time interval starting at the first cycle of induction therapy and lasting until death (=event) or until the date of last information available from the patient.&#xD;
OS1 will be estimated by Kaplan-Meier estimates. The comparison between the treatment groups will be performed using the log-rank test with a significance level of α = 2.5% for the 1-sided test. The OS1 will be presented as Kaplan-Meier figures also.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass</measure>
    <time_frame>24 months</time_frame>
    <description>Progression-free survival is the time after randomization to either disease progression (PD), measured using RECIST 1.1 and irRC criteria and confirmed via centralized review or death</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">103</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>MGN1703</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MGN1703, solution in Dulbecco's Phosphate-Buffered Saline (DPBS), 2 mL of 60 mg/4 mL (15 mg/mL), administered SC at 2 application sites twice weekly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Continous first line therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>MGN1703</intervention_name>
    <arm_group_label>MGN1703</arm_group_label>
    <other_name>dSLIM</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard of care</intervention_name>
    <description>Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other</description>
    <arm_group_label>Standard of care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        1. Male and female patients with extensive disease SCLC ≥ 18 years of age receiving first&#xD;
             line treatment;&#xD;
&#xD;
          2. Histology of SCLC or mixed histology of SCLC if SCLC histology is at least 80%;&#xD;
&#xD;
          3. Completion of 4 cycles of first-line therapy with a platinum-based regimen and no&#xD;
             other prior chemotherapy;&#xD;
&#xD;
          4. Documented evidence of tumor response as assessed by investigators after the first 2&#xD;
             cycles of platinum-based chemotherapy followed by a confirmed PR or CR at the end of&#xD;
             fourth cycle by CT or MRI scan;&#xD;
&#xD;
          5. Brain metastases are allowed only after cranial irradiation, if not requiring&#xD;
             continuous treatment with steroids or anticonvulsants;&#xD;
&#xD;
          6. ECOG performance status 0 or 1;&#xD;
&#xD;
          7. Adequate organ function with total bilirubin, lactate dehydrogenase [LDH], alkaline&#xD;
             phosphatase [AP], gamma glutamyltransferase [GGT], albumin, creatinine, urea,&#xD;
             electrolytes, and coagulation parameters ≤ 1.5 × upper limit of normal (ULN), and with&#xD;
             aspartate aminotransferase [AST] and ALT ≤ 2.5 × ULN in the absence of liver&#xD;
             metastases or ≤ 5.0 × ULN in the presence of liver metastases;&#xD;
&#xD;
          8. Adequate hematological parameters: absolute neutrophil count ≥ 1.5 × 109/L; platelet&#xD;
             count ≥ 100 × 109/L; leukocyte count ≥ 3.0 × 109/L; lymphocytes ≥ 1.0 × 109/L;&#xD;
             hemoglobin ≥ 9.0 g/dL or 5.59 mmol/L;&#xD;
&#xD;
          9. Patients with reproductive potential agree to use effective contraceptive measures&#xD;
             throughout the study;&#xD;
&#xD;
         10. Negative pregnancy test in women of childbearing potential;&#xD;
&#xD;
         11. Signed informed consent form (ICF).&#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_official>
    <last_name>Veerle Surmont, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital Ghent, Belgium 9000</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Georg Pall, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medizinische Universitaet Innsbruck</name>
      <address>
        <city>Innsbruck</city>
        <zip>6020</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis Gent</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Thoraxklinik Heidelberg gGmbH</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden Württemberg</state>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Fundación Jiménez Díaz</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Germany</country>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Thomas M, Ponce-Aix S, Navarro A, Riera-Knorrenschild J, Schmidt M, Wiegert E, Kapp K, Wittig B, Mauri C, Domine Gomez M, Kollmeier J, Sadjadian P, Frohling KP, Huber RM, Wolf M; IMPULSE study team. Immunotherapeutic maintenance treatment with toll-like receptor 9 agonist lefitolimod in patients with extensive-stage small-cell lung cancer: results from the exploratory, controlled, randomized, international phase II IMPULSE study. Ann Oncol. 2018 Oct 1;29(10):2076-2084. doi: 10.1093/annonc/mdy326.</citation>
    <PMID>30137193</PMID>
  </results_reference>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>January 9, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 25, 2014</study_first_posted>
  <last_update_submitted>November 13, 2018</last_update_submitted>
  <last_update_submitted_qc>November 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 15, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Extensive disease</keyword>
  <keyword>After first line therapy</keyword>
  <keyword>Immuno therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</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/NCT02200081
org study id: MGN1703-C03
nct id: NCT02200081
lead sponsor: 
has dmc: Yes
Evaluation of efficacy and safety of MGN1703 administered twice weekly subcutaneously (SC) as
      maintenance treatment in patients with extensive disease small cell lung cancer (SCLC) who
      achieved at least a partial response (PR) following platinum-based first-line therapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Overall survival (OS)
time frame: 24 months
description: The primary efficacy endpoint is the OS which is defined as the time interval starting with the randomization and lasting until death (=event) or until the date of last information available from the patient.
measure: OS1
time frame: 24 months
description: The secondary efficacy endpoint OS1 is defined as the time interval starting at the first cycle of induction therapy and lasting until death (=event) or until the date of last information available from the patient.
OS1 will be estimated by Kaplan-Meier estimates. The comparison between the treatment groups will be performed using the log-rank test with a significance level of α = 2.5% for the 1-sided test. The OS1 will be presented as Kaplan-Meier figures also.
measure: Progression-free survival (PFS) PFS from the start of the first cycle of induction therapy (PFS1) ass
time frame: 24 months
description: Progression-free survival is the time after randomization to either disease progression (PD), measured using RECIST 1.1 and irRC criteria and confirmed via centralized review or death
arm group label: MGN1703
arm group type: Experimental
description: MGN1703, solution in Dulbecco's Phosphate-Buffered Saline (DPBS), 2 mL of 60 mg/4 mL (15 mg/mL), administered SC at 2 application sites twice weekly
arm group label: Standard of care
arm group type: Other
description: Continous first line therapy
intervention type: Drug
intervention name: MGN1703
arm group label: MGN1703
other name: dSLIM
intervention type: Other
intervention name: Standard of care
description: Usual Standard of Care according to local investigators practise, e.g. Treatment break continous treatment and other
arm group label: Standard of care
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Veerle Surmont, MD
role: Principal Investigator
affiliation: University Hospital Ghent, Belgium 9000
last name: Georg Pall, MD
role: Principal Investigator
affiliation: Medizinische Universität Innsbruck, Innere Medizin, Hämatologie und Onkologie
facility: 
facility: 
facility: 
facility: 
country: Austria
country: Belgium
country: Germany
country: Spain
citation: Thomas M, Ponce-Aix S, Navarro A, Riera-Knorrenschild J, Schmidt M, Wiegert E, Kapp K, Wittig B, Mauri C, Domine Gomez M, Kollmeier J, Sadjadian P, Frohling KP, Huber RM, Wolf M; IMPULSE study team. Immunotherapeutic maintenance treatment with toll-like receptor 9 agonist lefitolimod in patients with extensive-stage small-cell lung cancer: results from the exploratory, controlled, randomized, international phase II IMPULSE study. Ann Oncol. 2018 Oct 1;29(10):2076-2084. doi: 10.1093/annonc/mdy326.
PMID: 30137193
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma