<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/NCT02226757</url>
  </required_header>
  <id_info>
    <org_study_id>HER2-targeting in EGFR-mutated</org_study_id>
    <nct_id>NCT02226757</nct_id>
  </id_info>
  <brief_title>Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients</brief_title>
  <official_title>Paclitaxel-trastuzumab in EGFR-mutated NSCLC Patients After Progression on TKI-treatment; a Pilot-study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Amsterdam UMC, location VUmc</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on&#xD;
      standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2&#xD;
      expression, patients can participate in the trial after obtaining informed consent.&#xD;
&#xD;
      Patients will be treated with weekly paclitaxel-trastuzumab.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2014</start_date>
  <primary_completion_date type="Anticipated">August 2016</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>6 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Toxicity</measure>
    <time_frame>2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">16</enrollment>
  <condition>NSCLC</condition>
  <condition>HER2-expression</condition>
  <condition>EGFR-mutation</condition>
  <arm_group>
    <arm_group_label>Paclitaxel-trastuzumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Paclitaxel-trastuzumab weekly</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel-trastzumab</intervention_name>
    <description>Trastuzumab&#xD;
Dose:&#xD;
First dose: 4 mg/kg IV&#xD;
Subsequent doses: 2 mg/kg every week IV.&#xD;
The patient must be monitored for at least 6 hours after the start of the first infusion and for at least 2 hours after the start of subsequent infusions.&#xD;
Paclitaxel&#xD;
- Dose: 60 mg/m2 IV in 30 minutes, every week, after trastuzumab</description>
    <arm_group_label>Paclitaxel-trastuzumab</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed stage IV non-squamous NSCLC patients.&#xD;
&#xD;
          -  Patients must have been detected with an activating EGFR mutation at baseline and must&#xD;
             have yet progressed on erlotinib, gefitinib or afatinib monotherapy in daily dose of&#xD;
             150 mg, 250 mg or 40 mg respectively. (Patients with unknown mutation status that have&#xD;
             exhibited a response to these agents or stable disease for at least 6 months while on&#xD;
             treatment with gefitinib or erlotinib are also eligible).&#xD;
&#xD;
          -  Rebiopsy after having acquired resistance to TKI-treatment must have been performed&#xD;
             and HER2-overexpression (positive immunohistochemistry staining) must have been&#xD;
             detected.&#xD;
&#xD;
          -  There must be at least one measurable disease site, according to RECIST 1.1 criteria.&#xD;
&#xD;
          -  WHO performance status 0-2.&#xD;
&#xD;
          -  Willing and able to comply with the study prescriptions.&#xD;
&#xD;
          -  18 years or older.&#xD;
&#xD;
          -  Not pregnant or breast feeding and willing to take adequate contraceptive measures&#xD;
             during the study.&#xD;
&#xD;
          -  Ability to give written informed consent before patient registration.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No uncontrolled infectious disease.&#xD;
&#xD;
          -  No other active malignancy.&#xD;
&#xD;
          -  No major surgery (excluding diagnostic procedures like e.g. mediastinoscopy or VATS&#xD;
             biopsy) in the previous 4 weeks.&#xD;
&#xD;
          -  No treatment with investigational drugs.&#xD;
&#xD;
          -  No known hypersensitivity to trastuzumab-paclitaxel&#xD;
&#xD;
          -  No symptomatic brain metastases.&#xD;
&#xD;
          -  History of coronary artery disease, NYHA class III or IV and Left Ventricular Ejection&#xD;
             Fraction (LVEF) of &lt;45%.&#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>Justine Kuiper, MD</last_name>
    <phone>0031204442214</phone>
    <email>jl.kuiper@vumc.nl</email>
  </overall_contact>
  <location>
    <facility>
      <name>VU University medical Center</name>
      <address>
        <city>Amsterdam</city>
        <zip>1007MB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <contact>
      <last_name>Justine Kuiper, MD</last_name>
      <phone>+31204442214</phone>
      <email>jl.kuiper@vumc.nl</email>
    </contact>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>June 2, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>August 25, 2014</last_update_submitted>
  <last_update_submitted_qc>August 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 27, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Amsterdam UMC, location VUmc</investigator_affiliation>
    <investigator_full_name>Prof. dr. E.F. Smit</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <keyword>NSCLC</keyword>
  <keyword>HER2-expression</keyword>
  <keyword>EGFR-mutation</keyword>
  <keyword>Trastuzumab</keyword>
  <keyword>Paclitaxel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
  </intervention_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/NCT02226757
org study id: HER2-targeting in EGFR-mutated
nct id: NCT02226757
lead sponsor: 
has dmc: No
This study is a pilot study in EGFR-mutated NSCLC patients who have progressed on
      standard-dose TKIs. Tumor biopsies will be evaluated for HER2-expression. In case of HER2
      expression, patients can participate in the trial after obtaining informed consent.

      Patients will be treated with weekly paclitaxel-trastuzumab.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate
time frame: 6 weeks
measure: Disease control rate
time frame: 6 weeks
measure: progression-free survival
time frame: 2 years
measure: Toxicity
time frame: 2 years
arm group label: Paclitaxel-trastuzumab
arm group type: Experimental
description: Paclitaxel-trastuzumab weekly
intervention type: Drug
intervention name: Paclitaxel-trastzumab
description: Trastuzumab
Dose:
First dose: 4 mg/kg IV
Subsequent doses: 2 mg/kg every week IV.
The patient must be monitored for at least 6 hours after the start of the first infusion and for at least 2 hours after the start of subsequent infusions.
Paclitaxel
- Dose: 60 mg/m2 IV in 30 minutes, every week, after trastuzumab
arm group label: Paclitaxel-trastuzumab
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Justine Kuiper, MD
phone: 0031204442214
email: jl.kuiper@vumc.nl
facility: 
contact: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Amsterdam UMC, location VUmc
investigator full name: Prof. dr. E.F. Smit
investigator title: MD PhD
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel