<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/NCT03300115</url>
  </required_header>
  <id_info>
    <org_study_id>AC201602AVTN03</org_study_id>
    <nct_id>NCT03300115</nct_id>
  </id_info>
  <brief_title>Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Patients With Advanded NSCLC</brief_title>
  <official_title>Single-arm,Multi-center,Phase II Clinical Trial of the Efficacy and Safety of AC0010 in the Treatment of EGFR T790M Mutation-positive Patients With Advanded NSCLC</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hangzhou ACEA Pharmaceutical Research Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Guangdong Provincial People's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hangzhou ACEA Pharmaceutical Research Co., 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 study is a single-arm, multi-center, open-label clinical trial. The study aims to expand&#xD;
      the sample size based on the fixed dose recommended by the results of previous dose&#xD;
      exploration studies in order to further evaluate the study drug's efficacy and safety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand&#xD;
      the sample size based on the fixed dose recommended by the results of previous dose&#xD;
      exploration studies in order to further evaluate the study drug's efficacy and safety with&#xD;
      overall objective tumor response rate (ORR) as the primary efficacy evaluation indicator, and&#xD;
      further evaluate subjects' duration of response (DOR), progression-free survival (PFS),&#xD;
      disease control rate (DCR), overall survival (OS) and quality of life (QoL). Safety&#xD;
      indicators of subjects are further evaluated through adverse events, vital signs and clinical&#xD;
      laboratory parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 18, 2017</start_date>
  <completion_date type="Anticipated">December 17, 2020</completion_date>
  <primary_completion_date type="Anticipated">June 17, 2019</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ORR(Objective Response Rate)</measure>
    <time_frame>Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.</time_frame>
    <description>To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>DoR (Duration of Response)</measure>
    <time_frame>Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.</time_frame>
    <description>To assess the duration of response (DOR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PFS (Progression-free survival)</measure>
    <time_frame>Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.</time_frame>
    <description>To assess the progression-free survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR (Disease control rate)</measure>
    <time_frame>Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.</time_frame>
    <description>To assess the disease control rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS (Overall survival)</measure>
    <time_frame>Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.</time_frame>
    <description>To assess the overall survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The lung cancer symptoms and health-related quality of life (HRQoL)</measure>
    <time_frame>Every 3 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.</time_frame>
    <description>To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">222</enrollment>
  <condition>Metastatic Non-small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>AC0010</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Each participant will be given AC0010 300mg bid.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AC0010</intervention_name>
    <description>After subjects prove eligible after screening and are enrolled, they are given AC0010 300 mg Bid (the two doses are advised to be administered at an interval of 12 hours), receive evaluation of safety indicators every 3 weeks, efficacy evaluation every 6 weeks until disease progression or intolerable toxicities or withdrawal from the trial. (If the investigator suspects disease progression, CT or MRI may be performed in advance; if the patient does not have disease progression, subsequent efficacy evaluation will proceed still according to the protocol).</description>
    <arm_group_label>AC0010</arm_group_label>
    <other_name>AC0010MA</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 18-75 years (including 18 and 75 years old).&#xD;
&#xD;
          2. Histologically or cytologically confirmed metastatic or unresectable locally advanced,&#xD;
             recurrent non-small cell lung cancer which cannot receive radical surgery and&#xD;
             radiotherapy.&#xD;
&#xD;
          3. The patient has at least one radio graphically (CT, MRI)measurable lesion according to&#xD;
             the RECIST criteria for solid tumor response; long-diameter of tumor scanned by CT&amp;MRI&#xD;
             ≥10mm, or short-diameter of metastatic cervical lymph nodes≥15mm. With no radiotherapy&#xD;
             and biopsy.&#xD;
&#xD;
          4. Patients without CNS metastases or asymptomatic patients with brain metastases. The&#xD;
             number of CNS metastases focus≤2, maximum diameter &lt;10mm.&#xD;
&#xD;
          5. Document prove EGFR mutation before treatment of EGFR TKI, or show clinical benefit&#xD;
             after treatment of EGFR TKI (PR, CR evaluation according to RECIST or more than&#xD;
             half-year SD duration); tumor tissue proved to be EGFR T790M positive mutation by&#xD;
             center lab after last treatment.&#xD;
&#xD;
          6. Patients need to undergo biopsy of primary or metastatic tumor tissue and provide&#xD;
             pathological sections to site's central lab; otherwise, the patients need to undergo&#xD;
             biopsy of primary or metastatic tumor tissue in the screening period and provide&#xD;
             pathological sections to the site's central laboratory.&#xD;
&#xD;
          7. Patients who have previously received first-generation EGFR-TKI (erlotinib, gefitinib,&#xD;
             ectectin) treatment and developed resistance and are only allowed to have received one&#xD;
             chemotherapy regimen (maintenance treatment with the same drug is allowed; but&#xD;
             maintenance treatment with a different drug is not allowed), or are positive for&#xD;
             primary T790M mutation but have not received treatment or have only received&#xD;
             first-line treatment.&#xD;
&#xD;
          8. The patient must have good organ function, including meeting the laboratory test&#xD;
             requirements at screening.&#xD;
&#xD;
          9. Patients must recover to ≤Grade 1 (CTCAE v4.03)toxicity from the previous treatment&#xD;
             (patients with any grade of hair loss are allowed to enter the study).&#xD;
&#xD;
         10. ECOG score: 0-1 points. No deterioration in the last 2 weeks.&#xD;
&#xD;
         11. Expected survival time:&gt; 12 weeks.&#xD;
&#xD;
         12. Patients who can cooperate with the observation of adverse events and efficacy.&#xD;
&#xD;
         13. Patients or their legal representatives have signed a written informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute hepatitis C, chronic hepatitis C and active hepatitis B (positive HBsAg; HBcAb&#xD;
             or HBeAb positive and HBV DNA positive).&#xD;
&#xD;
          2. HIV antibody positive, or other acquired, congenital immunodeficiency disease, or a&#xD;
             history of organ transplantation.&#xD;
&#xD;
          3. A past history of interstitial lung disease and radiation pneumonia.&#xD;
&#xD;
          4. Clinically significant abnormalities of resting ECG in rhythm, conduction and&#xD;
             morphology, such as complete left bundle branch block, Grade II and above heart block,&#xD;
             PR interval&gt; 250 ms, or myocardial infarction within the past 6 months; there are risk&#xD;
             factors leading to prolongation of QTc interval or increasing arrhythmias, such as&#xD;
             heart failure, hypokalemia, congenital long QT syndrome, family history of long QT&#xD;
             syndrome or medical history of sudden death at an age of &lt; 40 years among the&#xD;
             patient's first-degree relatives, and 12-lead ECG QT interval correction Fridericia&#xD;
             method (QTcF interval)&gt; 450 ms for male, &gt;470ms for female.&#xD;
&#xD;
          5. The investigator judges based on safety concerns or clinical study process that the&#xD;
             patient had any other condition that is prohibited for participation in the clinical&#xD;
             study, such as severe infection/inflammation, intestinal obstruction, inability to&#xD;
             swallow medication, social/psychological problems, etc.&#xD;
&#xD;
             With clinically significant electrolyte abnormalities in laboratory tests;&#xD;
&#xD;
          6. In addition to NSCLC, patients who have been diagnosed with another and/or&#xD;
             treatment-requiring malignant disease in recent 5 years (this exclusion criterion does&#xD;
             not include the following circumstances: completely resected basal cell and squamous&#xD;
             cell skin cancer, inert malignant tumor currently requiring no treatment, and any type&#xD;
             of completely resected carcinoma in situ).&#xD;
&#xD;
             Patients who have used high-dose glucocorticoids or other immunosuppressive agents&#xD;
             within 1 month prior to screening.&#xD;
&#xD;
          7. Interval time between previous EGFR TKI treatment and AC0010 &lt;8 days or 5 half-time,&#xD;
             subject to the long time; Interval time between major surgery /radiotherapy and AC0010&#xD;
             &lt;4 weeks; Patients who are using any drug known to prolong QT interval or known potent&#xD;
             CYP3A4 enzyme inducer or inhibitor within 4 weeks before the first dose.&#xD;
&#xD;
             Patients who have used high-dose glucocorticoids or other immunosuppressive agents&#xD;
             within 1 month prior to screening.&#xD;
&#xD;
          8. Patients who have previously administered third-generation EGFR-TKI drugs&#xD;
             (e.g.,AZD9291, Avitinib, CO-1686, HM61713, etc.).&#xD;
&#xD;
          9. Patients who have been registered and received the study treatment or withdrawn from&#xD;
             the study cannot be enrolled.&#xD;
&#xD;
         10. Pregnant or lactating women.&#xD;
&#xD;
         11. Women with childbearing potential are defined as all women who are physiologically&#xD;
             able to have a pregnancy, unless they are using an efficient contraceptive method&#xD;
             during treatment and within 7 days after discontinuation of treatment.&#xD;
&#xD;
         12. Patients who are considered by the investigator as inappropriate to participate in the&#xD;
             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>Yilong Wu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Guangdong Provincial People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Wanhong Xu, PhD</last_name>
    <phone>+8657128908600</phone>
    <email>kayla.liu@aceapharma.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Beijing Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian Fang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Cancer Hospital Chinese Academy of Medical Sciences</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Junling Li</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhefeng Liu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Daping Hospital,Research Institute of Surgery Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yong He</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fujian Cancer Hospital</name>
      <address>
        <city>Fuzhou</city>
        <state>Fujian</state>
        <zip>350000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Cheng Huang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Guangdong Provincial People's Hospital</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yilong Wu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The People's Hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Nanning</city>
        <state>Guangxi</state>
        <zip>530000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Guosheng Feng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Henan Cancer Hospital</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yanqiu Zhao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tongji Medical College of HUST</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yuan Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhongnan Hospital of Wuhan University</name>
      <address>
        <city>Wuhan</city>
        <state>Hubei</state>
        <zip>430000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Conghua Xie</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Third Xiangya Hospital of Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Peiguo Cao</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Xiangya Hospital Central South University</name>
      <address>
        <city>Changsha</city>
        <state>Hunan</state>
        <zip>410000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chengping Hu</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jian'an Huang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Northern Jiangsu People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <zip>225000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Buhai Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Jilin Cancer Hospital</name>
      <address>
        <city>Chang chun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ying Cheng</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The First Hospital of Jilin University</name>
      <address>
        <city>Changchun</city>
        <state>Jilin</state>
        <zip>130000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiuwei Cui</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shandong Cancer Hospital</name>
      <address>
        <city>Jinan</city>
        <state>Shandong</state>
        <zip>250000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zhehai Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <zip>710000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Helong Zhang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>West China Hospital, Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zongan Liang</last_name>
    </contact>
    <investigator>
      <last_name>Zongan Liang</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jiang Zhu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tianjin Cancer Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Changli Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Tianjin Medical University General Hospital</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jun Chen</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hangzhou First People's Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Limin Wang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital,Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongming Pan</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jianjin Huang</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Zhejiang Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <zip>310000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yiping Zhang</last_name>
    </contact>
    <investigator>
      <last_name>Yun Fan</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Yiping Zhang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>February 18, 2019</last_update_submitted>
  <last_update_submitted_qc>February 18, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 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>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abivertinib</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/NCT03300115
org study id: AC201602AVTN03
nct id: NCT03300115
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand
      the sample size based on the fixed dose recommended by the results of previous dose
      exploration studies in order to further evaluate the study drug's efficacy and safety.
The study is a single-arm, multi-center, open-label clinical trial. The study aims to expand
      the sample size based on the fixed dose recommended by the results of previous dose
      exploration studies in order to further evaluate the study drug's efficacy and safety with
      overall objective tumor response rate (ORR) as the primary efficacy evaluation indicator, and
      further evaluate subjects' duration of response (DOR), progression-free survival (PFS),
      disease control rate (DCR), overall survival (OS) and quality of life (QoL). Safety
      indicators of subjects are further evaluated through adverse events, vital signs and clinical
      laboratory parameters.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: ORR(Objective Response Rate)
time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
description: To assess the overall objective response rate (ORR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
measure: DoR (Duration of Response)
time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
description: To assess the duration of response (DOR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
measure: PFS (Progression-free survival)
time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
description: To assess the progression-free survival (PFS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
measure: DCR (Disease control rate)
time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
description: To assess the disease control rate (DCR) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
measure: OS (Overall survival)
time frame: Every 6 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months.
description: To assess the overall survival (OS) of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
measure: The lung cancer symptoms and health-related quality of life (HRQoL)
time frame: Every 3 weeks from time of first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
description: To assess the safety of AC0010 in EGFR T790M mutation-positive patients with advanced non-small cell lung cancer (NSCLC).
arm group label: AC0010
arm group type: Experimental
description: Each participant will be given AC0010 300mg bid.
intervention type: Drug
intervention name: AC0010
description: After subjects prove eligible after screening and are enrolled, they are given AC0010 300 mg Bid (the two doses are advised to be administered at an interval of 12 hours), receive evaluation of safety indicators every 3 weeks, efficacy evaluation every 6 weeks until disease progression or intolerable toxicities or withdrawal from the trial. (If the investigator suspects disease progression, CT or MRI may be performed in advance; if the patient does not have disease progression, subsequent efficacy evaluation will proceed still according to the protocol).
arm group label: AC0010
other name: AC0010MA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Yilong Wu, MD
role: Principal Investigator
affiliation: Guangdong Provincial People's Hospital
last name: Wanhong Xu, PhD
phone: +8657128908600
email: kayla.liu@aceapharma.com
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country: China
responsible party type: Sponsor
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Abivertinib