<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/NCT02985203</url>
  </required_header>
  <id_info>
    <org_study_id>CTONG 1512</org_study_id>
    <nct_id>NCT02985203</nct_id>
  </id_info>
  <brief_title>Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Clinical Study to Investigate the Efficacy and Safety of Combination of Oral Navelbine and Cisplatin Followed by Metronomic Oral Navelbine in Patients With Advanced Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guangdong Association of Clinical Trials</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guangdong Association of Clinical Trials</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety&#xD;
      of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in&#xD;
      Patients with advanced Non-Small Cell Lung Cancer.&#xD;
&#xD;
      The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive&#xD;
      combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the&#xD;
      combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will&#xD;
      be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy&#xD;
      with metronomic oral Navelbine (Arm A) or other regimen (Arm B).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the 1st stage (Week 1-12), all patients will receive combination chemotherapy, i.e.&#xD;
      Platinum and Navelbine, for 4 cycles. The regimen is:&#xD;
&#xD;
      Navelbine oral 60mg/m2 d1,8 the first cycle; oral 80mg/m2 day1,8 in sequential cycles q3w&#xD;
      plus cisplatin: 75mg/m2 d1 q3w.&#xD;
&#xD;
      In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with&#xD;
      acceptable tolerance and have no PD will be allocated into 2 arms, to evaluate the efficacy&#xD;
      and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other&#xD;
      regimen (Arm B). The allocation will be done in sequence at each site, i.e., the first&#xD;
      subject who complete the combination chemotherapy with acceptable tolerance and have no PD&#xD;
      will be allocated to Arm A, and the second will be allocated to Arm B, and so on. Arm A will&#xD;
      continue with oral Navelbine 3 times weekly as maintenance therapy, up to 12 weeks, or till&#xD;
      progression, unacceptable toxicity or death occurred. As contrast, Arm B will receive other&#xD;
      therapy as per the physician's choice.&#xD;
&#xD;
      Arm A: Navelbine oral 50mg three times per week (Day 1, 3, 5 of each week ) Arm B:&#xD;
      Physician's choice (other than Navelbine oral) computed tomography (CT) or magnetic resonance&#xD;
      imaging (MRI) will be done at the screening visit, Week 7, Week 13 (before the initiation of&#xD;
      maintenance therapy), Week 19 (after 6 weeks of maintenance therapy), and Week 25 (after 12&#xD;
      weeks of maintenance therapy), to evaluate the tumor response. The Disease Control Rate&#xD;
      (proportion of patients in complete response (CR), partial response (PR) or stable disease&#xD;
      (SD)) after 6 weeks and 12 weeks of maintenance therapy will be evaluated separately for the&#xD;
      2 arms. And Arm B is for observational study only, and will provide rationale for control&#xD;
      group selecting in future study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    No participants were enrolled as schedule.&#xD;
  </why_stopped>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">April 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Disease control rate during maintenance</measure>
    <time_frame>12 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rate during maintenance</measure>
    <time_frame>12 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>progression-free survival</measure>
    <time_frame>8 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Adverse events</measure>
    <time_frame>8 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Lung Neoplasm Malignant</condition>
  <arm_group>
    <arm_group_label>Vinorelbine oral</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Physician's choice</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Observation or maintenance therapy other than orla navelbine.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Vinorelbine Oral</intervention_name>
    <description>Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine</description>
    <arm_group_label>Vinorelbine oral</arm_group_label>
    <other_name>Navelbine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women aged ≥ 18 years with life expectancy ≥ 6 months&#xD;
&#xD;
          -  Histologically or cytologically confirmed advanced (Stage III B - IV) NSCLC which has&#xD;
             not received antineoplastic treatment and not suitable for radical treatment,&#xD;
             including those have been resected more than 1 year before signing informed consent&#xD;
             form (ICF) then metastasized or relapsed and currently requiring chemotherapy&#xD;
&#xD;
          -  With no history of cancer other than in situ uterine cervix cancer or skin basal cell&#xD;
             carcinoma with no active disease within 5 years prior to signing the ICF&#xD;
&#xD;
          -  With at least one measurable target lesion(s) according to RECIST 1.1&#xD;
&#xD;
          -  Adequate hematopoietic function&#xD;
&#xD;
          -  Adequate hepatic and renal function&#xD;
&#xD;
          -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1&#xD;
&#xD;
          -  Women of child-bearing potential must have a negative pregnancy test (urine or serum)&#xD;
             within 7 days of drug administration and agree to take an adequate contraceptive&#xD;
             measure&#xD;
&#xD;
          -  Men who have sexual life and have a wife of child-bearing age must agree to take an&#xD;
             adequate contraceptive measure during and for 12 weeks after the last treatment with&#xD;
             Navelbine&#xD;
&#xD;
          -  Signed written informed consent&#xD;
&#xD;
          -  Able to comply with the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-small Cell Lung Cancer with positive sensitizing epidermal growth factor receptor&#xD;
             (EGFR) mutation positive or anaplastic lymphoma kinase (ALK) fusion oncogene, or with&#xD;
             unknown EGFR/ALK status&#xD;
&#xD;
          -  Resectable Non-Small Cell Lung Cancer or suitable for radical radiotherapy/&#xD;
             chemotherapy&#xD;
&#xD;
          -  Patients with medical conditions that the only manifestation is hydrothorax, ascites,&#xD;
             bone lesions or other unmeasurable diseases&#xD;
&#xD;
          -  Symptomatic CNS metastasis (CNS metastasis which has received radiotherapy or surgery&#xD;
             and symptom has been stable for more than 4 weeks could be enrolled)&#xD;
&#xD;
          -  With invasive malignancies except lung cancer&#xD;
&#xD;
          -  Inadequate hematopoietic function:&#xD;
&#xD;
               -  Neutrophil &lt;1.5*109/L;&#xD;
&#xD;
               -  Hb &lt; 100g/L;&#xD;
&#xD;
               -  platelet count (PLT) &lt;100*109/L&#xD;
&#xD;
          -  Inadequate hepatic or renal function:&#xD;
&#xD;
               -  aspartate aminotransferase (AST)/alanine aminotransferase (ALT)/alkaline&#xD;
                  phosphatase (AKP)&gt;2.5 upper limit of normal (ULN) in patients without liver or&#xD;
                  bone metastasis&#xD;
&#xD;
               -  AST and/or ALT &gt;1.5 ULN with AKP&gt;2.5 ULN&#xD;
&#xD;
               -  AKP&gt;5 ULN in patients with bone metastasis&#xD;
&#xD;
               -  ALT/AST&gt;5 ULN in patients with liver metastasis&#xD;
&#xD;
               -  Total bilirubin &gt; 1.5 ULN&#xD;
&#xD;
               -  Serum creatinine &gt;1.5 ULN&#xD;
&#xD;
               -  Calculated creatinine clearance below 60ml/min (Cockcroft and Gault formula)&#xD;
&#xD;
               -  Blood calcium&gt;ULN&#xD;
&#xD;
          -  Patient is pregnant or nursing&#xD;
&#xD;
          -  Patients with psychiatric disorder or other disease leading to incompliance to the&#xD;
             therapy&#xD;
&#xD;
          -  Known hypersensitivity to any ingredient of the regimen&#xD;
&#xD;
          -  Treatment with any investigational drug within 30 days before the beginning of&#xD;
             treatment with study drug&#xD;
&#xD;
          -  Malabsorption syndrome or any other disorder affecting gastrointestinal absorption&#xD;
&#xD;
          -  Any other severe, acute, or chronic medical condition or laboratory abnormality that&#xD;
             may increase the risk associated with study participation or study drug administration&#xD;
             or may interfere with the interpretation of study results and, in the judgment of the&#xD;
             Investigator, would make the patient inappropriate for the study.&#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>Zhen Wang, PhD,MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong General Hospital&amp;Guangdong Academy of Medical Sciences</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Guangdong General Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510080</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>March 10, 2020</last_update_submitted>
  <last_update_submitted_qc>March 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>lung cancer</keyword>
  <keyword>vinorelbine</keyword>
  <keyword>metronomic chemotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vinorelbine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02985203
org study id: CTONG 1512
nct id: NCT02985203
lead sponsor: 
has dmc: Yes
This is an open-label, multi-center clinical trial, aims to evaluate the efficacy and safety
      of combination of oral Navelbine and Cisplatin followed by metronomic oral Navelbine in
      Patients with advanced Non-Small Cell Lung Cancer.

      The study comprises two stages. In the 1st stage (Week 1-12), all patients will receive
      combination chemotherapy. In the 2nd stage (Week 13-25), patients who complete the
      combination chemotherapy with acceptable tolerance and have no progressive disease (PD) will
      be allocated into 2 arms, to evaluate the efficacy and safety of maintenance chemotherapy
      with metronomic oral Navelbine (Arm A) or other regimen (Arm B).
In the 1st stage (Week 1-12), all patients will receive combination chemotherapy, i.e.
      Platinum and Navelbine, for 4 cycles. The regimen is:

      Navelbine oral 60mg/m2 d1,8 the first cycle; oral 80mg/m2 day1,8 in sequential cycles q3w
      plus cisplatin: 75mg/m2 d1 q3w.

      In the 2nd stage (Week 13-25), patients who complete the combination chemotherapy with
      acceptable tolerance and have no PD will be allocated into 2 arms, to evaluate the efficacy
      and safety of maintenance chemotherapy with metronomic oral Navelbine (Arm A) or other
      regimen (Arm B). The allocation will be done in sequence at each site, i.e., the first
      subject who complete the combination chemotherapy with acceptable tolerance and have no PD
      will be allocated to Arm A, and the second will be allocated to Arm B, and so on. Arm A will
      continue with oral Navelbine 3 times weekly as maintenance therapy, up to 12 weeks, or till
      progression, unacceptable toxicity or death occurred. As contrast, Arm B will receive other
      therapy as per the physician's choice.

      Arm A: Navelbine oral 50mg three times per week (Day 1, 3, 5 of each week ) Arm B:
      Physician's choice (other than Navelbine oral) computed tomography (CT) or magnetic resonance
      imaging (MRI) will be done at the screening visit, Week 7, Week 13 (before the initiation of
      maintenance therapy), Week 19 (after 6 weeks of maintenance therapy), and Week 25 (after 12
      weeks of maintenance therapy), to evaluate the tumor response. The Disease Control Rate
      (proportion of patients in complete response (CR), partial response (PR) or stable disease
      (SD)) after 6 weeks and 12 weeks of maintenance therapy will be evaluated separately for the
      2 arms. And Arm B is for observational study only, and will provide rationale for control
      group selecting in future study.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Disease control rate during maintenance
time frame: 12 weeks
measure: Response rate during maintenance
time frame: 12 weeks
measure: Duration of response
time frame: 8 months
measure: progression-free survival
time frame: 8 months
measure: Adverse events
time frame: 8 months
arm group label: Vinorelbine oral
arm group type: Experimental
description: Oral Navelbine plus Cisplatin followed by metronomic oral vinorelbine.
arm group label: Physician's choice
arm group type: No Intervention
description: Observation or maintenance therapy other than orla navelbine.
intervention type: Drug
intervention name: Vinorelbine Oral
description: Oral vinorelbine plus cisplatin Followed by Metronomic oral Vinorelbine
arm group label: Vinorelbine oral
other name: Navelbine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhen Wang, PhD,MD
role: Principal Investigator
affiliation: Guangdong General Hospital&Guangdong Academy of Medical Sciences
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Neoplasms
mesh term: Vinorelbine
sharing ipd: No