<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/NCT03792074</url>
  </required_header>
  <id_info>
    <org_study_id>SCT510-A301</org_study_id>
    <nct_id>NCT03792074</nct_id>
  </id_info>
  <brief_title>To Evaluate the Efficacy and Safety of SCT510 in the Treatment of Non-small Cell Lung Cancer</brief_title>
  <official_title>to Evaluate SCT510 Compared to Avasitin Respectively Combined Paclitaxel and Carboplatin First-line Treatment of Locally Advanced and Metastatic or Recurrent Squamous Cell Non-small Cell Lung Cancer Efficacy and Safety</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sinocelltech Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sinocelltech Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety, efficacy and immunogenicity of SCT510 combined with paclitaxel and&#xD;
      carboplatin compared with bevacizumab combined with paclitaxel and carboplatin in the&#xD;
      first-line treatment of locally advanced metastatic or recurrent squamous cell non-small cell&#xD;
      lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A randomized, double-blind, parallel-controlled, multicenter phase 3 clinical trial.&#xD;
&#xD;
      560 patients with non-resectable locally advanced, metastatic or recurrent non-squamous cell&#xD;
      non-small cell lung cancer (NSCLC) were randomly divided into two groups (SCT510 group and&#xD;
      bevacizumab group) at a 1:1 ratio, and the treatment included combination chemotherapy and&#xD;
      maintenance treatment, followed by follow-up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">January 2022</completion_date>
  <primary_completion_date type="Anticipated">May 2021</primary_completion_date>
  <phase>Phase 3</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>Objective response rate</measure>
    <time_frame>12 weeks</time_frame>
    <description>the proportion of subjects whose CR（complete response） and PR（partial response）combined , according to RECIST 1.1 criteria</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective response rate</measure>
    <time_frame>18 week</time_frame>
    <description>the proportion of subjects whose CR（complete response） and PR（partial response）combined , according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease control rate</measure>
    <time_frame>12 weeks and 18 weeks</time_frame>
    <description>the proportion of subjects with CR（complete response）, PR（partial response） and SD（Stable disease） combined，according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>3 years</time_frame>
    <description>The time from the first assessment of CR（complete response） or PR（partial response） to the first assessment of PD（progressive disease） or any cause of death，according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Progression free survival</measure>
    <time_frame>3 years</time_frame>
    <description>The time from randomization to PD（progressive disease） or any cause of death，according to RECIST 1.1 criteria</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>1-year overall survival rate</measure>
    <time_frame>1 year</time_frame>
    <description>The proportion of subjects who survived longer than 1 year after randomization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival</measure>
    <time_frame>3 years</time_frame>
    <description>Defined as the time from randomization of subjects to death from any cause</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">560</enrollment>
  <condition>Non-squamous Cell Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>SCT510 combined paclitaxel and carboplatin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SCT510 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bevacizumab combined paclitaxel and carboplatin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bevacizumab 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SCT510</intervention_name>
    <description>SCT510 Injection</description>
    <arm_group_label>SCT510 combined paclitaxel and carboplatin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bevacizumab</intervention_name>
    <description>Bevacizumab Injection</description>
    <arm_group_label>Bevacizumab combined paclitaxel and carboplatin</arm_group_label>
    <other_name>Avastin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Paclitaxel Injection</description>
    <arm_group_label>Bevacizumab combined paclitaxel and carboplatin</arm_group_label>
    <arm_group_label>SCT510 combined paclitaxel and carboplatin</arm_group_label>
    <other_name>PTX;TAX</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Carboplatin injection</description>
    <arm_group_label>Bevacizumab combined paclitaxel and carboplatin</arm_group_label>
    <arm_group_label>SCT510 combined paclitaxel and carboplatin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Volunteer to participate in this study and sign the informed consent;&#xD;
&#xD;
          2. age is ≤ 18 years old and ≥ 80 years old, regardless of gender;&#xD;
&#xD;
          3. Subjects with unresectable locally advanced metastatic（Not suitable for the&#xD;
             multidisciplinary treatment Ⅲ B - Ⅳ period of subjects, according to the international&#xD;
             association for the study of lung cancer (IASLC) lung cancer staging manual version 8&#xD;
             standard judgment） or recurrent non-squamous cell non-small cell lung cancer diagnosed&#xD;
             by histological and/or cytological examination.The diagnosis of non-squamous cell&#xD;
             non-small cell lung cancer based on sputum cytology requires immunohistochemical&#xD;
             confirmation.If multiple tumor components are mixed, the main cell types are&#xD;
             classified.&#xD;
&#xD;
          4. It is able to provide relevant documents about EGFR mutation and ALK fusion gene&#xD;
             status, and there is no EGFR sensitive mutation (including exon mutation no. 18&#xD;
             (G719X), exon deletion no. 19 and exon mutation no. 21 (L858R, L861Q)) and ALK&#xD;
             fusion.Subjects who have not previously undergone EGFR and ALK gene testing will need&#xD;
             to undergo genetic testing during the screening period.Among them, subjects whose EGFR&#xD;
             or ALK gene status cannot be determined for various reasons can be enrolled;Subjects&#xD;
             who are known to have EGFR sensitive mutations and/or ALK fusion may also be enrolled&#xD;
             if they are currently unable to obtain the corresponding targeted drugs (including the&#xD;
             rejection of the subjects) and chemotherapy is standard treatment at the research&#xD;
             center;&#xD;
&#xD;
          5. According to RECIST v1.1 criteria, at least one measurable lesion was ensured;The&#xD;
             lesions that had received radiotherapy before could only be selected as target lesions&#xD;
             if there was clear disease progression 3 months after the end of radiotherapy.&#xD;
&#xD;
          6. Systemic antitumor therapy for locally advanced metastatic or recurrent non-squamous&#xD;
             non-small cell lung cancer has not been accepted.If the subjects in the complete early&#xD;
             non-small cell lung cancer after radical treatment received adjuvant therapy, and&#xD;
             disease relapse, participants need to ensure that adjuvant therapy over time from this&#xD;
             study first dosing interval more than 6 months, and auxiliary treatment led to a&#xD;
             variety of toxic effects have been restored (according to the CTCAE v4.03 standard&#xD;
             judgment level 1 or less, except for hair loss).&#xD;
&#xD;
          7. Eastern Cooperative Oncology Group （ECOG） physical condition score 0 or 1&#xD;
&#xD;
          8. the expected survival time is more than 6 months;&#xD;
&#xD;
          9. Laboratory inspection meets the following requirements:&#xD;
&#xD;
               -  absolute neutrophil value (ANC) is greater than 1.5 x 109/L, platelet count (PLT)&#xD;
                  is greater than 100 x 109/L, hemoglobin (HGB) is greater than 90 g/L, and white&#xD;
                  blood cell (WBC) is greater than 3.0 x 109/L;&#xD;
&#xD;
               -  liver function: total bilirubin (TBil) &lt; 1.5 times the normal upper limit;&#xD;
                  Aspartate aminotransferase(AST/SGOT),Alanine aminotransferase&#xD;
                  (ALT/SGPT),andalkaline phosphatase(ALP) &lt; 2.5 times the normal upper limit;In the&#xD;
                  case of liver metastasis, AST and ALT were less than or equal to 5.0 times the&#xD;
                  upper limit of normal values.In the case of liver metastasis and/or bone&#xD;
                  metastasis, ALP is less than or equal to 5.0 times the normal upper limit.&#xD;
&#xD;
               -  renal function: upper limit of normal serum creatinine (Scr) less than 1.5 times;&#xD;
&#xD;
               -  urine protein &lt; 2 (+) detected by routine urine test;If the urine protein at&#xD;
                  baseline is greater than or equal to 2 (+), the 24-hour urine protein&#xD;
                  quantification must be less than or equal to 1.0 g.&#xD;
&#xD;
               -  coagulation function: the international standardized ratio (INR) is no more than&#xD;
                  1.5, and the activation time of partial thrombin (APTT) is no more than 1.5 times&#xD;
                  the upper limit of normal value;&#xD;
&#xD;
         10. Heart function: left ventricular ejection fraction (LVEF) 50% or higher;&#xD;
&#xD;
         11. able to communicate well with researchers and follow the visit, treatment, laboratory&#xD;
             examination and other relevant regulations stipulated in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. subjects with mixed non-small cell and small cell carcinoma, squamous cell carcinoma&#xD;
             or mixed adenosquamous carcinoma with squamous cell as the main component&#xD;
&#xD;
          2. patients with a history of tracheoesophageal fistula, gastrointestinal perforation or&#xD;
             gastrointestinal fistula and intraperitoneal abscess within 6 months before&#xD;
             randomization;&#xD;
&#xD;
          3. patients with malignant tumors other than lung cancer within the first 5 years were&#xD;
             randomized, excluding cured carcinoma in situ of the cervix, skin basal cells cancer&#xD;
             or squamous epithelial cells skin cancer, local prostate cancer after radical&#xD;
             resection and ductal carcinoma in situ of the breast after radical resection;&#xD;
&#xD;
          4. severe cardiovascular and cerebrovascular diseases, including cerebrovascular&#xD;
             accidents (CVA), transient ischemic attack (TIA), myocardial infarction and&#xD;
             significant vascular diseases (including but not limited to aortic aneurysms requiring&#xD;
             surgical repair or recent arterial thrombosis) within the first 6 months&#xD;
             randomly;Patients with unstable angina, New York heart association (NYHA)&#xD;
             classification ≥ Ⅱ heart failure and arrhythmia drugs can't control;&#xD;
&#xD;
          5. Subjects who received lung radiotherapy within the first 4 weeks or who had not&#xD;
             recovered from radiation-related toxicity were randomized.For all other anatomical&#xD;
             sites, subjects received radiotherapy within the first 2 weeks of randomization or did&#xD;
             not recover from radiation-related toxicity;&#xD;
&#xD;
          6. Major surgery was performed within the first 4 weeks of randomization or major&#xD;
             surgical treatment was planned during the trial period (the researchers determined&#xD;
             that there was a risk of bleeding or wound healing complications);&#xD;
&#xD;
          7. Have bleeding tendency, high bleeding risk or coagulation dysfunction, including&#xD;
             thrombotic disease within 6 months prior to randomization and/or hemoptysis history&#xD;
             within 3 months prior to randomization (single hemoptysis is more than 2.5mL);Or&#xD;
             recently (less than 10 days after the first study drug treatment) using a full dose&#xD;
             oral or extralimental anticoagulant or thrombolytic agent or aspirin (&gt; 325 mg/ day)&#xD;
             or other nsaids that inhibit platelet function;Or prior to surgery, the researchers&#xD;
             determined that there was a tendency to bleed;&#xD;
&#xD;
          8. subjects with high suspicion of idiopathic pulmonary fibrosis, organic pneumonia,&#xD;
             drug-related pneumonia, idiopathic pneumonia or active pneumonia in chest CT scan&#xD;
             during the screening period;&#xD;
&#xD;
          9. subjects with known central nervous system metastasis (except asymptomatic brain&#xD;
             metastasis and subjects with treated symptoms controlled and stable symptoms within 1&#xD;
             month prior to randomization).Patients with clinical suspected central nervous system&#xD;
             metastasis must undergo enhanced CT or MRI within the first 28 days randomly to&#xD;
             exclude central nervous system metastasis.&#xD;
&#xD;
         10. imaging examination showed signs of tumor invasion into the large blood vessel, and&#xD;
             the tumor had completely approached, wrapped or invaded the large blood vessel cavity&#xD;
             (such as pulmonary artery or superior vena cava);&#xD;
&#xD;
         11. patients with hypertension (systolic blood pressure &gt; 150 mmHg or diastolic blood&#xD;
             pressure &gt; 100 mmHg) who are still under poor control after combined treatment with&#xD;
             two or more antihypertensive drugs in the screening period, as well as those who have&#xD;
             a history of hypertension crisis or hypertensive encephalosis;&#xD;
&#xD;
         12. The presence of unhealed wounds, active peptic ulcers and fractures (excluding healed&#xD;
             old fractures);&#xD;
&#xD;
         13. There is a large amount of pericardial effusion, peritoneal or pleural effusion that&#xD;
             cannot be controlled by drainage or other symptomatic treatment (symptomatic treatment&#xD;
             is allowed before enrollment, but drugs with anti-tumor indications, such as&#xD;
             chemotherapy drugs, anti-angiogenic drugs and molecular targeted drugs, cannot be&#xD;
             given);&#xD;
&#xD;
         14. HBsAg is positive, and the titer detection of HBV-DNA in peripheral blood ≥ 1x103 copy&#xD;
             number /mL (or the quantitative determination of HBV-DNA ≥200 units /mL); HCV or HIV&#xD;
             or syphilis positive subjects;At present, there are other active infectious diseases,&#xD;
             which are not suitable for inclusion in this study.&#xD;
&#xD;
         15. known for SCT510, bevacizumab, paclitaxel and carboplatin injection and its material&#xD;
             composition allergies;&#xD;
&#xD;
         16. women who are pregnant or breast-feeding;&#xD;
&#xD;
         17. women of child-bearing age or male subjects who are unwilling to take effective&#xD;
             contraceptive measures during the study period or within 6 months after the last&#xD;
             administration of the study drugs;&#xD;
&#xD;
         18. subjects who have participated in other clinical studies in the first 4 weeks of&#xD;
             randomization or who are receiving treatment in other clinical trials (except those&#xD;
             who participated in the overall survival follow-up of one study);&#xD;
&#xD;
         19. previous history of alcoholism or drug abuse;&#xD;
&#xD;
         20. in addition to the above circumstances, the researcher believes that there are other&#xD;
             circumstances that are not suitable for inclusion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ming gao</last_name>
    <phone>8618610163675</phone>
    <email>ming_gao@sinocelltech.com</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 26, 2018</study_first_submitted>
  <study_first_submitted_qc>January 1, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>January 1, 2019</last_update_submitted>
  <last_update_submitted_qc>January 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Bevacizumab</mesh_term>
    <mesh_term>Carboplatin</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/NCT03792074
org study id: SCT510-A301
nct id: NCT03792074
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
To evaluate the safety, efficacy and immunogenicity of SCT510 combined with paclitaxel and
      carboplatin compared with bevacizumab combined with paclitaxel and carboplatin in the
      first-line treatment of locally advanced metastatic or recurrent squamous cell non-small cell
      lung cancer.
A randomized, double-blind, parallel-controlled, multicenter phase 3 clinical trial.

      560 patients with non-resectable locally advanced, metastatic or recurrent non-squamous cell
      non-small cell lung cancer (NSCLC) were randomly divided into two groups (SCT510 group and
      bevacizumab group) at a 1:1 ratio, and the treatment included combination chemotherapy and
      maintenance treatment, followed by follow-up.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Objective response rate
time frame: 12 weeks
description: the proportion of subjects whose CR（complete response） and PR（partial response）combined , according to RECIST 1.1 criteria
measure: Objective response rate
time frame: 18 week
description: the proportion of subjects whose CR（complete response） and PR（partial response）combined , according to RECIST 1.1 criteria
measure: Disease control rate
time frame: 12 weeks and 18 weeks
description: the proportion of subjects with CR（complete response）, PR（partial response） and SD（Stable disease） combined，according to RECIST 1.1 criteria
measure: Duration of Response
time frame: 3 years
description: The time from the first assessment of CR（complete response） or PR（partial response） to the first assessment of PD（progressive disease） or any cause of death，according to RECIST 1.1 criteria
measure: Progression free survival
time frame: 3 years
description: The time from randomization to PD（progressive disease） or any cause of death，according to RECIST 1.1 criteria
measure: 1-year overall survival rate
time frame: 1 year
description: The proportion of subjects who survived longer than 1 year after randomization
measure: Overall survival
time frame: 3 years
description: Defined as the time from randomization of subjects to death from any cause
arm group label: SCT510 combined paclitaxel and carboplatin
arm group type: Experimental
description: SCT510 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row
arm group label: Bevacizumab combined paclitaxel and carboplatin
arm group type: Active Comparator
description: Bevacizumab 15mg/kg+ paclitaxel 175mg+ carboplatin (AUC=5), intravenous infusion，on day 1，Once every 3 weeks;Four to six cycles in a row
intervention type: Drug
intervention name: SCT510
description: SCT510 Injection
arm group label: SCT510 combined paclitaxel and carboplatin
intervention type: Drug
intervention name: Bevacizumab
description: Bevacizumab Injection
arm group label: Bevacizumab combined paclitaxel and carboplatin
other name: Avastin
intervention type: Drug
intervention name: Paclitaxel
description: Paclitaxel Injection
arm group label: Bevacizumab combined paclitaxel and carboplatin
arm group label: SCT510 combined paclitaxel and carboplatin
other name: PTX;TAX
intervention type: Drug
intervention name: Carboplatin
description: Carboplatin injection
arm group label: Bevacizumab combined paclitaxel and carboplatin
arm group label: SCT510 combined paclitaxel and carboplatin
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: ming gao
phone: 8618610163675
email: ming_gao@sinocelltech.com
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Bevacizumab
mesh term: Carboplatin