xml: <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/NCT05987956</url>
    </required_header>
    <id_info>
      <org_study_id>IND 168453 to be IND EXEMPT</org_study_id>
      <secondary_id>FWA00015357</secondary_id>
      <secondary_id>NPI - 1831468511</secondary_id>
      <secondary_id>NPI - 1023387701</secondary_id>
      <secondary_id>IRB00009424</secondary_id>
      <secondary_id>IORG0007849</secondary_id>
      <secondary_id>IND 168453</secondary_id>
      <nct_id>NCT05987956</nct_id>
    </id_info>
    <brief_title>Pharmacogenomics IND EXEMPT SNP Clinical Study - Alectinib and Single Nucleotide Polymorphisms</brief_title>
    <acronym>Drugs-SNPs</acronym>
    <official_title>Explore the Relationship Between Single Nucleotide Polymorphisms and Alectinib Response and Toxicity in Patients With Non-Small Cell Lung Cancer.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medicine Invention Design, Inc</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Explore the relationship between drug target ALK gene single nucleotide polymorphisms and&#xD;
        ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based&#xD;
        on Oxford precisely sequencing drug targets' genes.&#xD;
  &#xD;
        Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms&#xD;
        and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on&#xD;
        Oxford precisely sequencing drug targets' genes.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The usual approach group, after lung tissue biopsy, 300 double blind random group separated&#xD;
        NSCLC patients currently used the Combined Chemotherapy on ALECENSA - alectinib hydrochloride&#xD;
        capsule plus GILOTRIF - afatinib tablet, film coated, it will try to look for the&#xD;
        relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the&#xD;
        relationship between the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based&#xD;
        on Oxford precisely sequencing drug targets' genes.&#xD;
  &#xD;
        The study approach group, after lung tissue biopsy, 300 double blind random group separated&#xD;
        NSCLC patients currently used the Combined Chemotherapy on ALECENSA - alectinib hydrochloride&#xD;
        capsule plus GILOTRIF - afatinib tablet, film coated, it will try to look for the&#xD;
        relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the&#xD;
        relationship between the Alectinib therapeutic safety and the CYP4503A4 SNP Genotyping, based&#xD;
        on Oxford precisely sequencing drug targets' genes.&#xD;
  &#xD;
          1. Detect drug target whole gene precision sequence of everyone patient for all 600&#xD;
             recruited double blind NSCLC patients.&#xD;
  &#xD;
          2. Mutually compare everyone patient drug target whole gene precision sequence for a total&#xD;
             of 600 recruited double blind NSCLC patients.&#xD;
  &#xD;
          3. Calculate drug target gene SNPs in all 600 recruited double blind NSCLC patients.&#xD;
  &#xD;
          4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.&#xD;
  &#xD;
          5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.&#xD;
  &#xD;
          6. Mutually compare the usual approach group SNPs (300 double blind random group separated&#xD;
             NSCLC patients) with the study approach group SNPs (300 double blind random group&#xD;
             separated NSCLC patients).&#xD;
  &#xD;
          7. Confirm the relationship between drug target gene SNPs and drug efficacy.&#xD;
  &#xD;
          8. Confirm the relationship between drug target gene SNPs and drug safety.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 8, 2023</start_date>
    <completion_date type="Anticipated">May 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 18, 2024</primary_completion_date>
    <phase>Phase 2/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>
      <intervention_model_description>The usual approach group (high dose)&#xD;
  The study approach group (low dose)</intervention_model_description>
      <primary_purpose>Health Services Research</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
      <masking_description>No-placebo and random and double blind</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.</measure>
      <time_frame>Up to 12 weeks</time_frame>
      <description>Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy High Dose on ALECENSA - alectinib plus GILOTRIF - afatinib, after lung tissue biopsy, to be the usual approach group.&#xD;
  Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy Low Dose on ALECENSA - alectinib plus GILOTRIF - afatinib, after lung tissue biopsy, to be the study approach group.&#xD;
  Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her NSCLC cell whole genome DNA with Oxford precisely sequencing.&#xD;
  Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.&#xD;
  Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.&#xD;
  Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">600</enrollment>
    <condition>Non-small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Alectinib - Usual</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Usual ALECENSA - Alectinib&#xD;
  Combined Chemotherapy (high dose)&#xD;
  Usual ALECENSA - alectinib hydrochloride capsule + GILOTRIF - afatinib tablet, film coated&#xD;
  Usual Approach Group (high dose)&#xD;
  ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily&#xD;
  GILOTRIF - afatinib tablet, film coated -- 40 mg orally once daily</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Alectinib - Study</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Study ALECENSA - Alectinib&#xD;
  Combined Chemotherapy (low dose)&#xD;
  Study ALECENSA - alectinib hydrochloride capsule + GILOTRIF - afatinib tablet, film coated&#xD;
  Study Approach Group (low dose)&#xD;
  ALECENSA - alectinib hydrochloride capsule -- 450 mg orally twice daily&#xD;
  GILOTRIF - afatinib tablet, film coated -- 30 mg orally once daily</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Alectinib - Usual</intervention_name>
      <description>Usual Alectinib Combined Chemotherapy (high dose)&#xD;
  ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily&#xD;
  GILOTRIF - afatinib tablet, film coated -- 40 mg orally once daily</description>
      <arm_group_label>Alectinib - Usual</arm_group_label>
      <other_name>Usual ALECENSA - alectinib hydrochloride capsule plus GILOTRIF - afatinib tablet, film coated</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Alectinib - Study</intervention_name>
      <description>Study Alectinib Combined Chemotherapy (low dose)&#xD;
  ALECENSA - alectinib hydrochloride capsule -- 450 mg orally twice daily&#xD;
  GILOTRIF - afatinib tablet, film coated -- 30 mg orally once daily</description>
      <arm_group_label>Alectinib - Study</arm_group_label>
      <other_name>Study ALECENSA - alectinib hydrochloride capsule plus GILOTRIF - afatinib tablet, film coated</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          -  Select 600 Non-Small Cell Lung Cancer Patients who are suitable for lung tissue biopsy&#xD;
  &#xD;
            -  Dosage Duration at least 90 days&#xD;
  &#xD;
            -  The usual approach group - Recruit 300 double blind random group separated NSCLC&#xD;
               patients currently used the Combined Chemotherapy High Dose on ALECENSA - alectinib&#xD;
               hydrochloride capsule plus GILOTRIF - afatinib tablet, film coated after lung tissue&#xD;
               biopsy, like as the usual approach group.&#xD;
  &#xD;
            -  The study approach group - Recruit 300 double blind random group separated NSCLC&#xD;
               patients currently used the Combined Chemotherapy Low Dose on ALECENSA - alectinib&#xD;
               hydrochloride capsule plus GILOTRIF - afatinib tablet, film coated after lung tissue&#xD;
               biopsy, like as the study approach group.&#xD;
  &#xD;
          Inclusion Criteria:&#xD;
  &#xD;
            -  1. Clinical diagnosis of Non-Small Cell Lung Cancer (NSCLC)&#xD;
  &#xD;
            -  2. Clinical lung tissue biopsy diagnosis of NSCLC&#xD;
  &#xD;
            -  3. Suitable for enough lung tissue biopsy of NSCLC&#xD;
  &#xD;
            -  4. Random and double blind&#xD;
  &#xD;
            -  5. Measurable disease&#xD;
  &#xD;
            -  6. Adequate organ functions&#xD;
  &#xD;
            -  7. Adequate performance status&#xD;
  &#xD;
            -  8. Age 22 years old and over&#xD;
  &#xD;
            -  9. Sign an informed consent form&#xD;
  &#xD;
            -  10. Receive blood-drawing&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  1. Pneumonectomy&#xD;
  &#xD;
            -  2. Treatment with other anti-cancer therapies and cannot be stopped currently&#xD;
  &#xD;
            -  3. Pregnancy&#xD;
  &#xD;
            -  4. Breast-feeding&#xD;
  &#xD;
            -  5. The patients with other serious intercurrent illness or infectious diseases&#xD;
  &#xD;
            -  6. Have more than one different kind of cancer at the same time&#xD;
  &#xD;
            -  7. Serious Allergy to Drugs&#xD;
  &#xD;
            -  8. Serious Bleed Tendency&#xD;
  &#xD;
            -  9. Serious Risks or Serious Adverse Events of the drug product&#xD;
  &#xD;
            -  10. The prohibition of drug products&#xD;
  &#xD;
            -  11. Have no therapeutic effects&#xD;
  &#xD;
            -  12. Follow up to the most current label&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>22 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Han Xu, MD/PhD/FAPCR</last_name>
      <role>Principal Investigator</role>
      <affiliation>Medicine Invention Design, Inc. - IORG0007849</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Han Xu, MD/PhD/FAPCR</last_name>
      <role>Study Director</role>
      <affiliation>Medicine Invention Design, Inc. - IORG0007849</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Han Xu, MD/PhD/FAPCR</last_name>
      <role>Study Chair</role>
      <affiliation>Medicine Invention Design, Inc. - IORG0007849</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Han Xu, MD/PhD/FAPCR</last_name>
      <phone>301-222-7143</phone>
      <email>hanxumd@gmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Han Xu, MD/PhD/FAPCR</last_name>
      <phone>301-326-8978</phone>
      <email>hanxumd@hotmail.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Medicine Invention Design, Inc. - IORG0007849</name>
        <address>
          <city>Rockville</city>
          <state>Maryland</state>
          <zip>20853</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Han Xu, MD/PhD/FAPCR</last_name>
        <phone>301-222-7143</phone>
        <email>hanxumd@gmail.com</email>
      </contact>
      <contact_backup>
        <last_name>HAN XU, MD/PhD/FAPCR</last_name>
        <phone>301-326-8978</phone>
        <email>midinc@hotmail.com</email>
      </contact_backup>
      <investigator>
        <last_name>Han Xu, MD/PhD/FAPCR</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://ohrp.cit.nih.gov/search</url>
      <description>FWA &lt; 00015357 &gt; &lt; Medicine Invention Design Incorporation (MIDI) &gt;</description>
    </link>
    <link>
      <url>http://ohrp.cit.nih.gov/search</url>
      <description>IRB &lt; 00009424 &gt; &lt; Medicine Invention Design Incorporation (MIDI) &gt;</description>
    </link>
    <link>
      <url>http://ohrp.cit.nih.gov/search</url>
      <description>IORG &lt; 0007849 &gt; &lt; Medicine Invention Design Incorporation (MIDI) &gt;</description>
    </link>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 29, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 8, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Medicine Invention Design, Inc</investigator_affiliation>
      <investigator_full_name>Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair</investigator_full_name>
      <investigator_title>M.D., Ph.D., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair</investigator_title>
    </responsible_party>
    <keyword>ALK</keyword>
    <keyword>EGFR</keyword>
    <keyword>NSCLC</keyword>
    <keyword>SNP</keyword>
    <keyword>Pharmacogenomics</keyword>
    <keyword>Gene</keyword>
    <keyword>Genetics</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>Afatinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 15, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT05987956/Prot_003.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Statistical Analysis Plan</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>No</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>August 15, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT05987956/SAP_004.pdf</document_url>
      </provided_document>
      <provided_document>
        <document_type>Informed Consent Form</document_type>
        <document_has_protocol>No</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>No</document_has_sap>
        <document_date>August 15, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/56/NCT05987956/ICF_005.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05987956
  org study id: IND 168453 to be IND EXEMPT
  secondary id: FWA00015357
  secondary id: NPI - 1831468511
  secondary id: NPI - 1023387701
  secondary id: IRB00009424
  secondary id: IORG0007849
  secondary id: IND 168453
  nct id: NCT05987956
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Explore the relationship between drug target ALK gene single nucleotide polymorphisms and
        ALECENSA - Alectinib therapeutic-effects in patients with non-small cell lung cancer, based
        on Oxford precisely sequencing drug targets' genes.
  
        Explore the relationship between drug target CYP4503A4 gene single nucleotide polymorphisms
        and ALECENSA - Alectinib side-effects in patients with non-small cell lung cancer, based on
        Oxford precisely sequencing drug targets' genes.
  The usual approach group, after lung tissue biopsy, 300 double blind random group separated
        NSCLC patients currently used the Combined Chemotherapy on ALECENSA - alectinib hydrochloride
        capsule plus GILOTRIF - afatinib tablet, film coated, it will try to look for the
        relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the
        relationship between the Alectinib therapeutic safety and the CYP4503A SNP Genotyping, based
        on Oxford precisely sequencing drug targets' genes.
  
        The study approach group, after lung tissue biopsy, 300 double blind random group separated
        NSCLC patients currently used the Combined Chemotherapy on ALECENSA - alectinib hydrochloride
        capsule plus GILOTRIF - afatinib tablet, film coated, it will try to look for the
        relationship between the Alectinib therapeutic efficacy and the ALK SNP Genotyping, and the
        relationship between the Alectinib therapeutic safety and the CYP4503A4 SNP Genotyping, based
        on Oxford precisely sequencing drug targets' genes.
  
          1. Detect drug target whole gene precision sequence of everyone patient for all 600
             recruited double blind NSCLC patients.
  
          2. Mutually compare everyone patient drug target whole gene precision sequence for a total
             of 600 recruited double blind NSCLC patients.
  
          3. Calculate drug target gene SNPs in all 600 recruited double blind NSCLC patients.
  
          4. Correlate everyone patient drug target gene SNP to everyone patient drug efficacy.
  
          5. Correlate everyone patient drug target gene SNP to everyone patient drug safety.
  
          6. Mutually compare the usual approach group SNPs (300 double blind random group separated
             NSCLC patients) with the study approach group SNPs (300 double blind random group
             separated NSCLC patients).
  
          7. Confirm the relationship between drug target gene SNPs and drug efficacy.
  
          8. Confirm the relationship between drug target gene SNPs and drug safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The usual approach group (high dose)
  The study approach group (low dose)
  primary purpose: Health Services Research
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: No-placebo and random and double blind
  measure: Measure and Report Alectinib Drug Targets' SNP Genotypes which are effectiveness-associated, and which are risk-associated.
  time frame: Up to 12 weeks
  description: Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy High Dose on ALECENSA - alectinib plus GILOTRIF - afatinib, after lung tissue biopsy, to be the usual approach group.
  Recruit 300 double blind random group separated NSCLC patients currently using the Combined Chemotherapy Low Dose on ALECENSA - alectinib plus GILOTRIF - afatinib, after lung tissue biopsy, to be the study approach group.
  Measure above every NSCLC patient-specific Alectinib drug target (ALK) SNP genotype in his or her NSCLC cell whole genome DNA with Oxford precisely sequencing.
  Report every NSCLC patient-specific ALK SNP genotype in whole genome DNA sequence.
  Measure above every NSCLC patient-specific Alectinib drug target (CYP4503A4) SNP genotype in his or her WBC cell whole genome DNA with Oxford precisely sequencing.
  Report every NSCLC patient-specific CYP4503A4 SNP genotype in whole genome DNA sequence.
  arm group label: Alectinib - Usual
  arm group type: Experimental
  description: Usual ALECENSA - Alectinib
  Combined Chemotherapy (high dose)
  Usual ALECENSA - alectinib hydrochloride capsule + GILOTRIF - afatinib tablet, film coated
  Usual Approach Group (high dose)
  ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
  GILOTRIF - afatinib tablet, film coated -- 40 mg orally once daily
  arm group label: Alectinib - Study
  arm group type: Experimental
  description: Study ALECENSA - Alectinib
  Combined Chemotherapy (low dose)
  Study ALECENSA - alectinib hydrochloride capsule + GILOTRIF - afatinib tablet, film coated
  Study Approach Group (low dose)
  ALECENSA - alectinib hydrochloride capsule -- 450 mg orally twice daily
  GILOTRIF - afatinib tablet, film coated -- 30 mg orally once daily
  intervention type: Drug
  intervention name: Alectinib - Usual
  description: Usual Alectinib Combined Chemotherapy (high dose)
  ALECENSA - alectinib hydrochloride capsule -- 600 mg orally twice daily
  GILOTRIF - afatinib tablet, film coated -- 40 mg orally once daily
  arm group label: Alectinib - Usual
  other name: Usual ALECENSA - alectinib hydrochloride capsule plus GILOTRIF - afatinib tablet, film coated
  intervention type: Drug
  intervention name: Alectinib - Study
  description: Study Alectinib Combined Chemotherapy (low dose)
  ALECENSA - alectinib hydrochloride capsule -- 450 mg orally twice daily
  GILOTRIF - afatinib tablet, film coated -- 30 mg orally once daily
  arm group label: Alectinib - Study
  other name: Study ALECENSA - alectinib hydrochloride capsule plus GILOTRIF - afatinib tablet, film coated
  criteria: 
  gender: All
  minimum age: 22 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Han Xu, MD/PhD/FAPCR
  role: Principal Investigator
  affiliation: Medicine Invention Design, Inc. - IORG0007849
  last name: Han Xu, MD/PhD/FAPCR
  role: Study Director
  affiliation: Medicine Invention Design, Inc. - IORG0007849
  last name: Han Xu, MD/PhD/FAPCR
  role: Study Chair
  affiliation: Medicine Invention Design, Inc. - IORG0007849
  last name: Han Xu, MD/PhD/FAPCR
  phone: 301-222-7143
  email: hanxumd@gmail.com
  last name: Han Xu, MD/PhD/FAPCR
  phone: 301-326-8978
  email: hanxumd@hotmail.com
  facility: 
  contact: 
  contact backup: 
  investigator: 
  country: United States
  url: http://ohrp.cit.nih.gov/search
  description: FWA < 00015357 > < Medicine Invention Design Incorporation (MIDI) >
  url: http://ohrp.cit.nih.gov/search
  description: IRB < 00009424 > < Medicine Invention Design Incorporation (MIDI) >
  url: http://ohrp.cit.nih.gov/search
  description: IORG < 0007849 > < Medicine Invention Design Incorporation (MIDI) >
  responsible party type: Sponsor-Investigator
  investigator affiliation: Medicine Invention Design, Inc
  investigator full name: Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair
  investigator title: M.D., Ph.D., Sponsor-Investigator, Medical Director, Medical Monitor, Safety Officer, IRB Chair
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Afatinib
  sharing ipd: No
  provided document: 
  provided document: 
  provided document: 