<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/NCT03808701</url>
  </required_header>
  <id_info>
    <org_study_id>SCT200-D101</org_study_id>
    <nct_id>NCT03808701</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of SCT200 in Patients With Advanced Squamous Non-small Cell Lung Cancer</brief_title>
  <acronym>sNSCLC</acronym>
  <official_title>Recombinant Anti-EGFR Monoclonal Antibody（SCT200） in Patients With Advanced Squamous Non-small Cell Lung Cancer : a Phase Ib, Open-label, Multicenter Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinocelltech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinocelltech Ltd.</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR&#xD;
      monoclonal antibody（SCT200）in patients with advanced squamous non-small cell lung cancer&#xD;
      treated after failure of Two chemotherapy regimens (including Platinum-based drugs).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This open label multicenter phase Ib study is designed to evaluate Objective Response Rate&#xD;
      (ORR) in Squamous non-small cell Lung cancer treated with anti-EGFR monoclonal antibody&#xD;
      SCT200.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 1</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>Objective response rate (ORR)</measure>
    <time_frame>1 year</time_frame>
    <description>ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progress Free Survival ( PFS)</measure>
    <time_frame>1 year</time_frame>
    <description>PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate (DCR)</measure>
    <time_frame>1 year</time_frame>
    <description>The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of response (DOR)</measure>
    <time_frame>1 year</time_frame>
    <description>DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival (OS)</measure>
    <time_frame>1 year</time_frame>
    <description>OS is defined as time from first dose of SCT200 until the date of death from any cause.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AE</measure>
    <time_frame>1 year</time_frame>
    <description>AE are assessed according to NCI CTCAE v4.03.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of immunogenicity</measure>
    <time_frame>1 year</time_frame>
    <description>Serum SCT200 antibody levels were measured before and after administration.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>exploratory analysis</measure>
    <time_frame>1 year</time_frame>
    <description>To explore the possible correlation between EGFR and/or related gene expression and disease prognosis and therapeutic efficacy</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Advanced Squamous Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>low dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially, 9.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 12.0mg/kg of SCT200 will be administered every two weeks until disease progression.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HIGH dose group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Initially,12.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 15.0mg/kg of SCT200 will be administered every two weeks until disease progression.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCT200</intervention_name>
    <description>Recombinant Anti-EGFR Monoclonal Antibody</description>
    <arm_group_label>HIGH dose group</arm_group_label>
    <arm_group_label>low dose group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Able to provide written informed consent and can understand and comply with the&#xD;
        requirements of the study;&#xD;
&#xD;
        Men/Women from 18 to 75 years old;&#xD;
&#xD;
        Life expectancy of longer than 3 months ( clinical assessment);&#xD;
&#xD;
        With an Eastern Cooperative Oncology Group (ECOG) performance status 0-1;&#xD;
&#xD;
        Histological or cytological diagnosis of Squamous non-small cell Lung cancer;&#xD;
&#xD;
        Locally advanced or metastatic NSCLC(stage IIIB/IV or recurrent NSCLC that do not meet the&#xD;
        criteria for radical radiotherapy and chemotherapy，Tumor stage will be classified according&#xD;
        to UICC/AJCC staging system version 8).Participants has received at least two previous&#xD;
        chemotherapy regimens for treatment failure (including disease progression and unacceptable&#xD;
        toxic and side effects).&#xD;
&#xD;
        Note: a. first-line chemotherapy must be a platinum-containing two-drug regimen;b. Prior&#xD;
        adjuvant/neoadjuvant chemotherapy is permitted.If recurrence or metastasis occurs during or&#xD;
        within 6 months after the completion of adjuvant/neoadjuvant chemotherapy, it is considered&#xD;
        that adjuvant/neoadjuvant chemotherapy is a first-line systemic chemotherapy failure for&#xD;
        advanced disease.&quot; According to RECIST 1.1 , patients must have at least one measurable&#xD;
        lesion that can be accurately assessed at baseline.&#xD;
&#xD;
        Adequate organ and marrow function as defined below:&#xD;
&#xD;
        Absolute neutrophil count (ANC) greater than/equal to 1.5×l09/L; Platelets greater&#xD;
        than/equal to 75×109/L; Hemoglobin greater than/equal to 80g/L; Aspartate aminotransferase&#xD;
        (AST)/alanine aminotransferase (ALT) less than/equal to 3 times ULN, or less than/equal to&#xD;
        5 times ULN if known liver metastases; Total bilirubin less than/equal to 1.5 within&#xD;
        institutional limit of normal (ULN); Serum creatinine less than/equal to 1.5 times ULN;&#xD;
        Electrolyte: magnesium greater than/equal to normal.&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients are allergic to antibodies or other components contained in the test drugs;&#xD;
&#xD;
        Symptomatic metastatic central nervous system and/or cancerous meningitis.(After treatment&#xD;
        for brain metastasis, disease should be stable and last for at least 4 weeks prior to the&#xD;
        first study administration, not requiring for steroid or anticonvulsant therapy,Subjects&#xD;
        with stable neurological symptoms may be enrolled ).For stable asymptomatic brain&#xD;
        metastases that have been treated with radiotherapy, at least one other site besides the&#xD;
        brain metastasis can be measured ,The subject can be enrolled, but the interval between the&#xD;
        last radiotherapy should be more than 4 weeks..&#xD;
&#xD;
        Subject receiving bisphosphonate or denosumab treatment for bone metastases was initiated&#xD;
        within 28 days prior to study. (If the subject has received bisphosphonate or denosumab&#xD;
        treatment prior to study and showing stable time less than 28 days,the subject is allowed&#xD;
        to use it.) If the ongoing bisphosphonate therapy dose is considered to be increased or&#xD;
        bisphosphonate therapy is initiated due to the aggravation of bone pain, researchers should&#xD;
        confirm whether the subject has PD according to the RECIST1.1 version.&#xD;
&#xD;
        Patients with other primary malignancies, except for before 5 years or more, malignant&#xD;
        lesions had been treated with therapeutic measures and no known active lesions existed, and&#xD;
        the researchers judged that the risk of recurrence was low;Non-melanoma skin cancer treated&#xD;
        adequately without evidence of disease progression; cervical carcinoma in situ after&#xD;
        adequate treatment;Prostate intraepithelial neoplasm, no evidence of recurrence of prostate&#xD;
        cancer;&#xD;
&#xD;
        Patients administrated EGFR target treatment including EGFR TKI agent or anti- EGFR&#xD;
        monoclonal antibody;&#xD;
&#xD;
        Within 4 weeks, patients received anti-tumor drugs (such as chemotherapy, hormone therapy,&#xD;
        immune therapy, the antibody therapy, radiotherapy) or research drugs(42 days for&#xD;
        nitrosourea or mitomycin C), or patients with grade 2 or more adverse reaction caused by&#xD;
        previous anti-tumor therapy(except alopecia or neurotoxicity grade 2 or less);&#xD;
&#xD;
        Patients are currently enrolled in other research devices or in research drugs, or less&#xD;
        than 4 weeks from other research drugs or devices.&#xD;
&#xD;
        &quot;Patients received major surgery(such as general anesthesia ) within 4 weeks ,or subjects&#xD;
        did not recovered from the injury associated with the surgery.&#xD;
&#xD;
        Note: surgery requiring local/epidural anesthesia must have been completed for at least 72&#xD;
        hours and subjects must have recovered before starting the study medication.Skin biopsy&#xD;
        under local anesthesia has been completed for at least 1 hour.&quot;&#xD;
&#xD;
        Patients treated with EPO, G-CSF or GM-CSF before enrollment 2 weeks.&#xD;
&#xD;
        Patients who have clinically significant cardiovascular disease (defined as unstable angina&#xD;
        pectoris, symptomatic congestive heart failure (NYHA, greater than II), uncontrollable&#xD;
        severe arrhythmia); Patients occurred myocardial infarction within 6 months.&#xD;
&#xD;
        Patients who have interstitial lung disease, such as interstitial pneumonia, pulmonary&#xD;
        fibrosis, or on baseline chest CT or MRI reminder ILD .&#xD;
&#xD;
        Patients with clinical symptoms, required clinical intervention or stable time less than 4&#xD;
        weeks of serous cavity effusion (such as pleural effusion and ascites);&#xD;
&#xD;
        Patients with active hepatitis B or active hepatitis C, etc. (for patients with a history&#xD;
        of hepatitis B, whether treated or not, HBV DNA ≥104 or ≥ 2000IU/ml, HCV RNA≥15IU/ml); HIV&#xD;
        antibody positive (if there is no clinical evidence suggesting that there may be HIV&#xD;
        infection, there is no need to detect);&#xD;
&#xD;
        Patients with uncontrolled active infections before enrollment 2 weeks (except simple&#xD;
        urinary tract infection or upper respiratory tract infection);&#xD;
&#xD;
        Pregnant or lactating women(Serum test must be negative within 7 days prior to study&#xD;
        enrollment)&#xD;
&#xD;
        Patients((including male or female subjects) who were not willing to accept effective&#xD;
        contraceptive measures( intrauterine device, prophylactic or condom)during treatment and&#xD;
        within 6 months after treatment;&#xD;
&#xD;
        Subjects who are considered unsuitable for participating in this study for various reasons&#xD;
        at the discretion of the investigator，such as inability to comply with study and/or&#xD;
        follow-up procedures;&#xD;
&#xD;
        -&#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>CHENG YING, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Jilin provincial cancer hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>CHENG YING, MD</last_name>
    <phone>0431-85872688</phone>
    <email>chengying@csco.org.cn</email>
  </overall_contact>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 16, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 17, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>SCT200</keyword>
  <keyword>Squamous non-small cell Lung cancer</keyword>
  <keyword>NSCLC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</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/NCT03808701
org study id: SCT200-D101
nct id: NCT03808701
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the efficacy and safety of recombinant anti-EGFR
      monoclonal antibody（SCT200）in patients with advanced squamous non-small cell lung cancer
      treated after failure of Two chemotherapy regimens (including Platinum-based drugs).
This open label multicenter phase Ib study is designed to evaluate Objective Response Rate
      (ORR) in Squamous non-small cell Lung cancer treated with anti-EGFR monoclonal antibody
      SCT200.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Objective response rate (ORR)
time frame: 1 year
description: ORR is defined as proportion of patients achieving complete response (CR) or partial response (PR) according to RECIST v1.1 during trial treatment.
measure: Progress Free Survival ( PFS)
time frame: 1 year
description: PFS is defined as the time from first dose of SCT200 until the date of first documentation of progression or date of death, whichever occurs first,according to RECIST v1.1 criteria.
measure: Disease control rate (DCR)
time frame: 1 year
description: The achievement of any a stable response（SD）, partial response (PR) or complete response (CR), according to RECIST v1.1 criteria.
measure: Duration of response (DOR)
time frame: 1 year
description: DOR is defined as time from the date when a patient first meets the criteria for CR or PR according to RECIST v1.1, until the date that progressive disease (PD) is objectively documented or death, whichever occurs first.
measure: Overall survival (OS)
time frame: 1 year
description: OS is defined as time from first dose of SCT200 until the date of death from any cause.
measure: AE
time frame: 1 year
description: AE are assessed according to NCI CTCAE v4.03.
measure: Evaluation of immunogenicity
time frame: 1 year
description: Serum SCT200 antibody levels were measured before and after administration.
measure: exploratory analysis
time frame: 1 year
description: To explore the possible correlation between EGFR and/or related gene expression and disease prognosis and therapeutic efficacy
arm group label: low dose group
arm group type: Experimental
description: Initially, 9.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 12.0mg/kg of SCT200 will be administered every two weeks until disease progression.
arm group label: HIGH dose group
arm group type: Experimental
description: Initially,12.0mg/kg of SCT200 will be administered once a week for a maximum of 6 cycles. After 6 cycles, 15.0mg/kg of SCT200 will be administered every two weeks until disease progression.
intervention type: Drug
intervention name: SCT200
description: Recombinant Anti-EGFR Monoclonal Antibody
arm group label: HIGH dose group
arm group label: low dose group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: CHENG YING, MD
role: Principal Investigator
affiliation: Jilin provincial cancer hospital
last name: CHENG YING, MD
phone: 0431-85872688
email: chengying@csco.org.cn
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung