<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/NCT04401059</url>
  </required_header>
  <id_info>
    <org_study_id>HangzhouNU-2</org_study_id>
    <nct_id>NCT04401059</nct_id>
  </id_info>
  <brief_title>Synergistic Effect of Elemene Plus TKIs Compared With TKIs in EGFR-mutated Advanced NSCLC：Prospective Study</brief_title>
  <acronym>SELECT-2</acronym>
  <official_title>Synergistic Real-World Study and Evidence-based Medicine Evaluation of Elemene Combined With Tyrosine Kinase Inhibitors（TKIs）in the Treatment of Advanced Non-small Cell Lung Cancer (NSCLC): Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tian Xie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>LinkDoc Technology (Beijing) Co. Ltd.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hangzhou Normal University</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>
      This is a nationwide, multicenter and prospective cohort study. The purpose of this study is&#xD;
      to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced&#xD;
      non-small cell lung cancer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      About 9.2%-45.8% of Chinese patients with Non-small cell lung cancer were positive for EGFR&#xD;
      gene mutation. Gefitinib, Erlotinib, Icotinib, Afatinib showed efficacy superior to that of&#xD;
      chemotherapy in the treatment of EGFR mutation positive advanced NSCLC, and lower rates of&#xD;
      serious adverse events. However, after a median of 8 to 13 months of disease control,&#xD;
      patients ultimately progress due to acquired resistance of EGFR-TKIs. Elemene, a&#xD;
      chemotherapeutic isolated from the Chinese medicinal herb Rhizoma Zedoariae, has been shown&#xD;
      to have a comprehensive anti-tumor effect and the potential effect on reversing drug&#xD;
      resistance.&#xD;
&#xD;
      In this study, about 22 research centers will participate in. We planned to enroll 744&#xD;
      patients with advanced non-small cell lung adenocarcinoma who were positive for EGFR&#xD;
      mutations. The dynamic random method will be adopted in this study. Patients will be randomly&#xD;
      divided into the experimental group（Elemene plus first or third generation EGFR-TKIs), and&#xD;
      control group (First or third generation EGFR-TKIs, only). The purpose of this study is&#xD;
      evaluating the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced&#xD;
      non-small cell lung cancer. We also try to analyze the correlation between molecular&#xD;
      biomarkers and patient prognosis, including but not limited to drug-resistant genes and&#xD;
      circulating tumor cells.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 9, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2025</primary_completion_date>
  <phase>Phase 4</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>PFS</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>PFS was defined as the interval from the date of randomization to the date of the first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ORR</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>ORR was defined as the percentage of participants with the best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>DCR</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>OS</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>Overall survival (OS) was defined as the interval from the date of randomization to date of death from any cause, or the date of last known follow-up alive.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of AE or SAE</measure>
    <time_frame>Start of treatment until 30 days after the last treatment</time_frame>
    <description>Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.&#xD;
A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and severity of ADR or SADR</measure>
    <time_frame>Start of treatment until 30 days after the last treatment</time_frame>
    <description>All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.&#xD;
A SADR is a serious ADR according to the above criteria of SAE.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Quality of life (QOL)</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>Quality of Life (QOL) was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13).</description>
  </other_outcome>
  <other_outcome>
    <measure>Karnofsky Performance Scale (KPS)</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>KPS: Performance status were measured using Karnofsky Performance Scale (KPS)</description>
  </other_outcome>
  <other_outcome>
    <measure>Traditional Chinese Medical(TCM) symptoms score</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>TCM symptom score: Traditional Chinese Medical symptoms were measured from these eight aspects: chest pain, oppression in the chest, blood stasis, shortness of breath, weakness, palpitations, dry mouth, vexation. Particular attention should be paid to chest pain and weakness.</description>
  </other_outcome>
  <other_outcome>
    <measure>Molecular biomarkers</measure>
    <time_frame>Start of treatment until 1-year follow-up</time_frame>
    <description>Including but not limited to drug-resistant genes and circulating tumor cells. Such as PD-L1、MSI-H/dMMR、TMB、HLA、POLE、POLD1、DDR、TP53、KRAS、BRCA2、PBRM1、MDM2/4、EGFR、ALK、PTEN、JAK1/2、DNMT3A、STK11.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">744</enrollment>
  <condition>Carcinoma</condition>
  <condition>Non-Small-Cell Lung Cancer</condition>
  <condition>Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Elemene plus First or Third generation EGFR-TKIs</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Elemene Injectable Emulsion sequentially with Elemene Oral Emulsion plus First -generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or Third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>First or third generation EGFR-TKIs only</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Elemene plus first or third generation EGFR-TKIs</intervention_name>
    <description>Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day, continuous intravenous drip for 5 days. Continue to use Elemene Oral Emulsion. For specific usage, refer to the drug label.&#xD;
Elemene Oral Emulsion: 20ml: 176mg, 1 dose each time, 3 times a day. Use the Elemene Oral Emulsions until the disease progresses, the intolerable toxicity, the patient withdraws from the study, or dies for any reason.&#xD;
First or third generation EGFR-TKIs: refer to the drug label.</description>
    <arm_group_label>Elemene plus First or Third generation EGFR-TKIs</arm_group_label>
    <other_name>H10960114, H20010338</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>First or third generation EGFR-TKIs</intervention_name>
    <description>refer to the drug label.</description>
    <arm_group_label>First or third generation EGFR-TKIs only</arm_group_label>
    <other_name>Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age ≥ 18.&#xD;
&#xD;
          2. Histologically or cytologically confirmed advanced non-small cell lung&#xD;
             adenocarcinoma(stage IIIB~IV).&#xD;
&#xD;
          3. Patients with EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR&#xD;
             gene), plan to receive First-generation EGFR-TKIs (Gefitinib, Erlotinib, Icotinib) or&#xD;
             third generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib,&#xD;
             Furmonertinib) monotherapy for the first time (patients who have been using first- or&#xD;
             third-generation EGFR-TKIs for less than 28 days can be enrolled).&#xD;
&#xD;
          4. Patients positive for EGFR gene mutation (deletions in exon 19 and L858R in exon 21 of&#xD;
             the EGFR gene), with disease progression after receiving chemotherapy can be enrolled.&#xD;
&#xD;
          5. Confirmed by investigators, tumor tissue can't be surgically excised.&#xD;
&#xD;
          6. No prior exposure to elemene injectable and/or oral emulsion within one month.&#xD;
&#xD;
          7. Prior exposure to other Chinese patent medicine with similar efficacy within one&#xD;
             month. If more than one month, patients can be enrolled after a 30-day washout period&#xD;
             (without continuing to use the above medications).&#xD;
&#xD;
          8. The participant must be capable of understanding and complying with the protocol and&#xD;
             willing to sign a written informed consent document.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with any EGFR mutations other than 19DEL or 21L858R.&#xD;
&#xD;
          2. Accompanied by other active tumors. (Except for stable basal cell carcinoma after&#xD;
             treatment， If metachronous tumors have been controlled, participating was allowed )&#xD;
&#xD;
          3. Exposure to First- or third-generation EGFR-TKIs combined treatment, for example,&#xD;
             chemotherapy, anti-angiogenesis therapy.&#xD;
&#xD;
          4. Receiving radiotherapy or chemotherapy.&#xD;
&#xD;
          5. Pregnant or lactating women.&#xD;
&#xD;
          6. Allergic to Elemene.&#xD;
&#xD;
          7. Participating in other drug clinical trials.&#xD;
&#xD;
          8. Refuse to comply with the follow-up.&#xD;
&#xD;
          9. The researchers did not consider it appropriate to participate in this study for other&#xD;
             reasons.&#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>Ziping Wang, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University Cancer Hospital &amp; Institute</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tian Xie, PhD</last_name>
    <phone>+86-13606707928</phone>
    <email>xbs@dljg.sina.net</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kaifeng Wang, PhD</last_name>
    <phone>+86-13588088469</phone>
    <email>kaifengw@aliyun.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Affiliated Hospital of Nantong University</name>
      <address>
        <city>Nantong</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hongyu Zhao</last_name>
    </contact>
    <contact_backup>
      <phone>+86-18255179769</phone>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Panjin Central Hospital</name>
      <address>
        <city>Panjin</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qinghua Gao</last_name>
      <phone>+86-18102487506</phone>
      <email>gaoqinghuawl@sohu.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qi Li</last_name>
      <phone>18521301790</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>The Second People's Hospital of Yangcheng County</name>
      <address>
        <city>Jincheng</city>
        <state>Shanxi</state>
        <zip>048100</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Bing Wei</last_name>
      <phone>13835633832</phone>
      <email>564943978@qq.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Sichuan Academy of Medical Sciences· Sichuan Province People's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ke Xie</last_name>
      <phone>13008154897</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hangzhou Cancer Hospital</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jiyuan Ding</last_name>
      <phone>+86-13575467709</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Peking University Cancer Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ziping Wang</last_name>
    </contact>
    <contact_backup>
      <phone>+86-18322012056</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>May 18, 2020</study_first_submitted>
  <study_first_submitted_qc>May 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>May 15, 2023</last_update_submitted>
  <last_update_submitted_qc>May 15, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Hangzhou Normal University</investigator_affiliation>
    <investigator_full_name>Tian Xie</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Elemene</keyword>
  <keyword>TKI</keyword>
  <keyword>EGFR</keyword>
  <keyword>Real-world study</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gefitinib</mesh_term>
    <mesh_term>Osimertinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04401059
org study id: HangzhouNU-2
nct id: NCT04401059
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a nationwide, multicenter and prospective cohort study. The purpose of this study is
      to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced
      non-small cell lung cancer.
About 9.2%-45.8% of Chinese patients with Non-small cell lung cancer were positive for EGFR
      gene mutation. Gefitinib, Erlotinib, Icotinib, Afatinib showed efficacy superior to that of
      chemotherapy in the treatment of EGFR mutation positive advanced NSCLC, and lower rates of
      serious adverse events. However, after a median of 8 to 13 months of disease control,
      patients ultimately progress due to acquired resistance of EGFR-TKIs. Elemene, a
      chemotherapeutic isolated from the Chinese medicinal herb Rhizoma Zedoariae, has been shown
      to have a comprehensive anti-tumor effect and the potential effect on reversing drug
      resistance.

      In this study, about 22 research centers will participate in. We planned to enroll 744
      patients with advanced non-small cell lung adenocarcinoma who were positive for EGFR
      mutations. The dynamic random method will be adopted in this study. Patients will be randomly
      divided into the experimental group（Elemene plus first or third generation EGFR-TKIs), and
      control group (First or third generation EGFR-TKIs, only). The purpose of this study is
      evaluating the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced
      non-small cell lung cancer. We also try to analyze the correlation between molecular
      biomarkers and patient prognosis, including but not limited to drug-resistant genes and
      circulating tumor cells.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PFS
time frame: Start of treatment until 1-year follow-up
description: PFS was defined as the interval from the date of randomization to the date of the first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1.
measure: ORR
time frame: Start of treatment until 1-year follow-up
description: ORR was defined as the percentage of participants with the best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1.
measure: DCR
time frame: Start of treatment until 1-year follow-up
description: Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.
measure: OS
time frame: Start of treatment until 1-year follow-up
description: Overall survival (OS) was defined as the interval from the date of randomization to date of death from any cause, or the date of last known follow-up alive.
measure: Incidence and severity of AE or SAE
time frame: Start of treatment until 30 days after the last treatment
description: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
measure: Incidence and severity of ADR or SADR
time frame: Start of treatment until 30 days after the last treatment
description: All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions.
A SADR is a serious ADR according to the above criteria of SAE.
measure: Quality of life (QOL)
time frame: Start of treatment until 1-year follow-up
description: Quality of Life (QOL) was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13).
measure: Karnofsky Performance Scale (KPS)
time frame: Start of treatment until 1-year follow-up
description: KPS: Performance status were measured using Karnofsky Performance Scale (KPS)
measure: Traditional Chinese Medical(TCM) symptoms score
time frame: Start of treatment until 1-year follow-up
description: TCM symptom score: Traditional Chinese Medical symptoms were measured from these eight aspects: chest pain, oppression in the chest, blood stasis, shortness of breath, weakness, palpitations, dry mouth, vexation. Particular attention should be paid to chest pain and weakness.
measure: Molecular biomarkers
time frame: Start of treatment until 1-year follow-up
description: Including but not limited to drug-resistant genes and circulating tumor cells. Such as PD-L1、MSI-H/dMMR、TMB、HLA、POLE、POLD1、DDR、TP53、KRAS、BRCA2、PBRM1、MDM2/4、EGFR、ALK、PTEN、JAK1/2、DNMT3A、STK11.
arm group label: Elemene plus First or Third generation EGFR-TKIs
arm group type: Experimental
description: Elemene Injectable Emulsion sequentially with Elemene Oral Emulsion plus First -generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or Third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).
arm group label: First or third generation EGFR-TKIs only
arm group type: Active Comparator
description: First-generation EGFR-TKIs (Gefitinib,Erlotinib, Icotinib) or third-generation EGFR-TKIs (including but not limited to Osimertinib, Almonertinib, Furmonertinib).
intervention type: Drug
intervention name: Elemene plus first or third generation EGFR-TKIs
description: Elemene Injectable Emulsion: 20ml: 88mg, 6 injections each time, once a day, continuous intravenous drip for 5 days. Continue to use Elemene Oral Emulsion. For specific usage, refer to the drug label.
Elemene Oral Emulsion: 20ml: 176mg, 1 dose each time, 3 times a day. Use the Elemene Oral Emulsions until the disease progresses, the intolerable toxicity, the patient withdraws from the study, or dies for any reason.
First or third generation EGFR-TKIs: refer to the drug label.
arm group label: Elemene plus First or Third generation EGFR-TKIs
other name: H10960114, H20010338
intervention type: Drug
intervention name: First or third generation EGFR-TKIs
description: refer to the drug label.
arm group label: First or third generation EGFR-TKIs only
other name: Gefitinib(Iressa,YiRuiKe), Erlotinib(Tarceva), Icotinib(Kaimeina), Osimertinib(Tagrisso), Almonertinib, Furmonertinib, etc.
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ziping Wang, PhD
role: Principal Investigator
affiliation: Peking University Cancer Hospital & Institute
last name: Tian Xie, PhD
phone: +86-13606707928
email: xbs@dljg.sina.net
last name: Kaifeng Wang, PhD
phone: +86-13588088469
email: kaifengw@aliyun.com
facility: 
status: Recruiting
contact: 
contact backup: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Hangzhou Normal University
investigator full name: Tian Xie
investigator title: Professor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Gefitinib
mesh term: Osimertinib
sharing ipd: Undecided