<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/NCT03781869</url>
  </required_header>
  <id_info>
    <org_study_id>ALT-SCLC-01</org_study_id>
    <nct_id>NCT03781869</nct_id>
  </id_info>
  <brief_title>Study of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer</brief_title>
  <official_title>A Randomized Controlled Multicenter Clinical Trial to Compare the Efficacy and Safety of Anlotinib as the Maintenance Therapy for Extensive-stage Small Cell Lung Cancer After Combined With Etoposide and Cisplatin Chemotherapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Military Medical University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung&#xD;
      cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that,&#xD;
      compared with placebo, Anlotinib could improve the patients survival and had less toxic side&#xD;
      effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective&#xD;
      study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for&#xD;
      Extensive-stage small cell lung cancer after combined with etoposide and cisplatin&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2018</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Progression-free survival</measure>
    <time_frame>From randomization，each 42 days up to PD or death(up to 24 months</time_frame>
    <description>The first day of treatment to the date that disease progression is reported</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From randomization until death (up to 5 years)</time_frame>
    <description>The first day of treatment to death or last survival confirm date</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment-related adverse events</measure>
    <time_frame>the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months</time_frame>
    <description>Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Performance Status</measure>
    <time_frame>the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months</time_frame>
    <description>Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>each 42 days up to intolerance the toxicity or PD (up to 24 months)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Extensive-stage Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Anlotinib + Chemotherapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemotherapy</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Anlotinib Hydrochloride; etoposide and cisplatin</intervention_name>
    <description>etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days</description>
    <arm_group_label>Anlotinib + Chemotherapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>etoposide and cisplatin</intervention_name>
    <description>etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days</description>
    <arm_group_label>Chemotherapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologic or cytologic diagnosis of small cell lung caner&#xD;
&#xD;
          -  Advanced small cell lung cancer who had no prior cisplatin-based chemotherapy or&#xD;
             radiotherapy,at least one measurable lesion (by RECIST1.1)&#xD;
&#xD;
          -  Males or females between 18 Years to 75 Years.&#xD;
&#xD;
          -  Performance status of 0～2 on the ECOG criteria.&#xD;
&#xD;
          -  Main organs function is normal&#xD;
&#xD;
          -  Expected survival is above three months.&#xD;
&#xD;
          -  with asymptomatic brain metastases.&#xD;
&#xD;
          -  At least one measurable lung tumor lesion (according to RECIST criteria, the&#xD;
             application of conventional technology, diameter length of the lesion &gt;= 20mm or&#xD;
             spiral CT &gt;=10mm).&#xD;
&#xD;
          -  Adequate hematologic (Leukocyte count &gt;= 4.0×109/L, neutrophil count&gt;=2.0×109/L,&#xD;
             hemoglobin&gt;=95g/L, platelets&gt;=100×109/L), hepatic function (aspartate transaminase&#xD;
             (AST) &amp; alanine transaminase(ALT)&#xD;
&#xD;
             =&lt;upper normal limit(UNL) x1.5, bilirubin level =&lt; UNL x 1.5).&#xD;
&#xD;
          -  Patient can take oral medicine.&#xD;
&#xD;
          -  Patients have the ability to understand and voluntarily sign the informed consent, and&#xD;
             allow adequate follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of cardiovascular disease: congestive heart failure (CHF) &gt; New York Heart&#xD;
             Association (NYHA) II, active coronary artery disease(patients with myocardial&#xD;
             infarction six months ago can be recruited), arrhythmias need to be treated (allow&#xD;
             taking beta blockers or digoxin).&#xD;
&#xD;
          -  Serious clinical infection (&gt; NCI-CTCAE version 4.0 ,infection standard II).&#xD;
&#xD;
          -  Patients with epilepsy who need to take medicine (such as steroids or anti epilepsy&#xD;
             agents).&#xD;
&#xD;
          -  The patients had accepted allogeneic organ transplantation.&#xD;
&#xD;
          -  Bleeding tendency or coagulation disorders.&#xD;
&#xD;
          -  patients who need renal dialysis.&#xD;
&#xD;
          -  suffered from other tumor within 5 years( Except: cervical carcinoma in situ, cured&#xD;
             basal cell carcinoma, cured bladder epithelial tumor).&#xD;
&#xD;
          -  uncontrolled hypertension (systolic pressure&gt;150 mmHg , or diastolic pressure&gt; 90&#xD;
             mmHg).&#xD;
&#xD;
          -  thrombosis or embolism(cerebrovascular accidents including transient ischemic attack&#xD;
             within the last 6 months).&#xD;
&#xD;
          -  pulmonary hemorrhage &gt;CTCAE grade 2 within 4 weeks before first use of drugs.&#xD;
&#xD;
          -  Other organ hemorrhage &gt;CTCAE grade 3 within 4 weeks before first use of drugs.&#xD;
&#xD;
          -  severe uncured wounds, ulcers or fracture.&#xD;
&#xD;
          -  uncured dehydration.&#xD;
&#xD;
          -  Drugs abuse and medical, psychological or social conditions may interfere with the&#xD;
             patient's participation in research or the results of the evaluation effect.&#xD;
&#xD;
          -  Patients are allergic to drugs used in research.&#xD;
&#xD;
          -  Factors influencing the safety and compliance of patients.&#xD;
&#xD;
          -  Inability to comply with protocol or study procedures.&#xD;
&#xD;
          -  Pregnant or breast-feeding.&#xD;
&#xD;
          -  The researcher believe that the Patient is not suitable to participate in the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dong Wang, PH.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Daping Hospital, Third Military Medical University, Chongqing,China</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dong Wang, PH.D.</last_name>
    <phone>86-23-68757151</phone>
    <email>dongwang64@hotmail.com</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 20, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Dong Wang</investigator_full_name>
    <investigator_title>chief physician</investigator_title>
  </responsible_party>
  <keyword>Small Cell Lung Cancer; Anlotinib; Maintenance 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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Etoposide</mesh_term>
    <mesh_term>Etoposide phosphate</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/NCT03781869
org study id: ALT-SCLC-01
nct id: NCT03781869
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Anlotinib has been approved as a third-line treatment for advanced non-small-cell lung
      cancer. A phase II clinical studies of small cell lung cancer (ALTER-1210) also showed that,
      compared with placebo, Anlotinib could improve the patients survival and had less toxic side
      effects after 2-3 line therapy. The purpose of this multicenter, randomized, prospective
      study is to investigate the efficacy and safety of Anlotinib as the maintenance therapy for
      Extensive-stage small cell lung cancer after combined with etoposide and cisplatin
      chemotherapy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Progression-free survival
time frame: From randomization，each 42 days up to PD or death(up to 24 months
description: The first day of treatment to the date that disease progression is reported
measure: Overall survival
time frame: From randomization until death (up to 5 years)
description: The first day of treatment to death or last survival confirm date
measure: Objective Response Rate
time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
measure: Treatment-related adverse events
time frame: the first date of treatment to 30 days after the last dose of study drug,assessed up to 24 months
description: Treatment-related adverse events are assessed by common terminology criteria for adverse events(CTCAE) V4.0.
measure: Performance Status
time frame: the first date of treatment to 30 days after the last dose of study drug, assessed up to 24 months
description: Performance Status of patients will be assessed by Zubrod-Eastern cooperative oncology group(ECOG)-world health organization(WHO).
measure: Disease Control Rate
time frame: each 42 days up to intolerance the toxicity or PD (up to 24 months)
arm group label: Anlotinib + Chemotherapy
arm group type: Experimental
description: Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, and Anlotinib 12mg/d on day 1 to day 14 , repeated every 21 days, a total of 4-6 cycles, and then continue to take Anlotinib 12mg/d on day 1 to day 14, repeated every 21 days until progressive Disease(PD).
arm group label: Chemotherapy
arm group type: Placebo Comparator
description: Patients receive etoposide 100mg/m2 from day 1 to day 3, cisplatin 75mg/m2 on day 1, repeated every 21 days, a total of 4-6 cycles, and then follow up observation until PD.
intervention type: Drug
intervention name: Anlotinib Hydrochloride; etoposide and cisplatin
description: etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1 and Anlotinib Day 1 to day 14 followed by 7 days off treatment in a 21-day cycle, repeated every 21 days
arm group label: Anlotinib + Chemotherapy
intervention type: Drug
intervention name: etoposide and cisplatin
description: etoposide 100mg/m2 from day 1 to day 3, cisplatin 80mg/m2 on day 1, repeated every 21 days
arm group label: Chemotherapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Dong Wang, PH.D
role: Principal Investigator
affiliation: Daping Hospital, Third Military Medical University, Chongqing,China
last name: Dong Wang, PH.D.
phone: 86-23-68757151
email: dongwang64@hotmail.com
responsible party type: Principal Investigator
investigator affiliation: Third Military Medical University
investigator full name: Dong Wang
investigator title: chief physician
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Cisplatin
mesh term: Etoposide
mesh term: Etoposide phosphate