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/NCT05967689</url>
    </required_header>
    <id_info>
      <org_study_id>TAS6417-201</org_study_id>
      <secondary_id>2023-503865-48</secondary_id>
      <nct_id>NCT05967689</nct_id>
    </id_info>
    <brief_title>A Study of Zipalertinib in Patients With Advanced Non-Small Cell Lung Cancer With Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertions or Other Uncommon Mutation.</brief_title>
    <acronym>REZILIENT2</acronym>
    <official_title>An Open-Label, Phase 2b, Global Multicenter Cohort Trial to Assess the Safety and Efficacy of Zipalertinib in Patients With Locally Advanced or Metastatic Non-Small Cell Lung Cancer With Exon 20 Insertion and Uncommon/Single or Compound Epidermal Growth Factor Receptor Mutations.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Taiho Oncology, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Taiho Oncology, Inc.</source>
    <oversight_info>
      <has_dmc>No</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>
        The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients&#xD;
        with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other&#xD;
        mutations.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will evaluate the safety and efficacy of zipalertinib in patients with locally&#xD;
        advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other uncommon/single or&#xD;
        compound EGFRmt.&#xD;
  &#xD;
        Patients will be enrolled into 1 of the 4 following cohorts:&#xD;
  &#xD;
          -  Cohort A (&quot;prior ex20ins treatment&quot;) will include patients harboring EGFR ex20ins&#xD;
             mutations who have progressed on or after initial treatment with standard platinum-based&#xD;
             chemotherapy and prior treatment with an ex20 agent for their advanced disease&#xD;
             (administered together or separately).&#xD;
  &#xD;
          -  Cohort B (&quot;1st line&quot;) will include patients harboring EGFR ex20ins mutations who have&#xD;
             not received prior treatment for advanced disease.&#xD;
  &#xD;
          -  Cohort C (&quot;active brain mets&quot;) will include patients harboring EGFR ex20ins or other&#xD;
             uncommon single and compound mutations and active brain metastases. Patients may or may&#xD;
             not have had prior treatment for advanced disease.&#xD;
  &#xD;
          -  Cohort D (&quot;other uncommon EGFRmt&quot;) will include patients harboring other, non ex20ins&#xD;
             uncommon single or compound EGFRmt who have progressed on or after treatment with&#xD;
             standard systemic anticancer therapy.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 27, 2023</start_date>
    <completion_date type="Anticipated">October 20, 2025</completion_date>
    <primary_completion_date type="Anticipated">June 30, 2025</primary_completion_date>
    <phase>Phase 2</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>4 Cohorts based on eligibility criteria</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>All Cohorts: objective response rate (ORR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>All Cohorts: The rate and severity of treatment emergent AEs</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All Cohorts: Overall Survival (OS)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Antitumor activity is assessed by response evaluation criteria RECIST 1.1 by measuring</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All Cohorts: Disease control rate (DCR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All Cohorts: Duration of response (DoR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival (PFS)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort C: Intracranial (i) Overall Response Rate (iORR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort C: intracranial duration of complete response (iDCR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cohort C: intracranial duration of Response (iDoR)</measure>
      <time_frame>Up to approximately 2 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>All Cohorts: Pharmacokinetic (PK) parameter</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Minimum Plasma Concentration (Cmin)</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Pharmacokinetic (PK) parameter</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Minimum Plasma Concentration [Cmin]</description>
    </other_outcome>
    <other_outcome>
      <measure>Pharmacokinetic (PK) parameter</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Maximum Plasma Concentration [Cmax]</description>
    </other_outcome>
    <other_outcome>
      <measure>Pharmacokinetic (PK) parameter</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Area Under Curve [AUC]</description>
    </other_outcome>
    <other_outcome>
      <measure>EGFR mutation status</measure>
      <time_frame>Up to approximately 2 years</time_frame>
      <description>Local central tests results</description>
    </other_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Advanced or Metastatic NSCLC Harboring Epidermal Growth Factor Receptor (EGFR) Exon 20 Insertion (ex20ins) Mutations</condition>
    <arm_group>
      <arm_group_label>Cohort A (&quot;prior ex20ins treatment&quot;)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort A (&quot;prior ex20ins treatment&quot;) participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort B (&quot;1st line treatment&quot;)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort B participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort C (&quot;active brain mets&quot;)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort C participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Cohort D (&quot;other uncommon EGFRmt&quot;).</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Cohort D participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>TAS6417</intervention_name>
      <description>Oral tablets/capsules</description>
      <arm_group_label>Cohort A (&quot;prior ex20ins treatment&quot;)</arm_group_label>
      <arm_group_label>Cohort B (&quot;1st line treatment&quot;)</arm_group_label>
      <arm_group_label>Cohort C (&quot;active brain mets&quot;)</arm_group_label>
      <arm_group_label>Cohort D (&quot;other uncommon EGFRmt&quot;).</arm_group_label>
      <other_name>CLN-081</other_name>
      <other_name>zipalertinib</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Written informed consent&#xD;
  &#xD;
            2. ≥18 years of age (or meets the country's regulatory definition of legal adult age,&#xD;
               whichever is greater&#xD;
  &#xD;
            3. Pathologically confirmed, locally advanced or metastatic NSCLC meeting all the&#xD;
               following criteria:&#xD;
  &#xD;
               Cohort A patients:&#xD;
  &#xD;
                 -  Documented EGFR ex20ins mutation status, as determined by local testing performed&#xD;
                    at a CLIA certified (US) or locally certified laboratory (outside the US).&#xD;
  &#xD;
                 -  Progressed on or after systemic therapy with an agent targeting ex20ins, either&#xD;
                    alone or in combination with standard platinum-based chemotherapy for the&#xD;
                    treatment of advanced disease. Patients who discontinued previous treatment due&#xD;
                    to unacceptable toxicity are eligible.&#xD;
  &#xD;
                 -  Patients with brain metastasis must be neurologically stable. Patients must have&#xD;
                    received CNS-directed therapy and have no evidence of progression for at least 4&#xD;
                    weeks after CNS-directed treatment, as ascertained by clinical examination and&#xD;
                    brain imaging (MRI or CT scan) during the screening period, and they must be on a&#xD;
                    stable or decreasing dose of corticosteroids and/or anti-convulsant medications&#xD;
                    for at least 2 weeks prior to the first dose of study treatment. Patients with&#xD;
                    history of uncontrolled seizures or leptomeningeal disease are not eligible.&#xD;
  &#xD;
               Cohort B patients:&#xD;
  &#xD;
                 -  Documented EGFR ex20ins mutation status, as determined by local testing performed&#xD;
                    at a CLIA certified (US) or locally certified laboratory (outside the US).&#xD;
  &#xD;
                 -  Not received prior systemic therapy for locally advanced or metastatic disease.&#xD;
                    Prior adjuvant/neoadjuvant treatment for early-stage disease must have been&#xD;
                    completed &gt;6 months prior to the first dose of study treatment.&#xD;
  &#xD;
                 -  Patients with brain metastasis must be neurologically stable. Patients must have&#xD;
                    received CNS-directed therapy and have no evidence of progression for at least 4&#xD;
                    weeks after CNS-directed treatment, as ascertained by clinical examination and&#xD;
                    brain imaging (MRI or CT scan) during the screening period, and they must be on a&#xD;
                    stable or decreasing dose of corticosteroids and/or anti-convulsant medications&#xD;
                    for at least 2 weeks prior to the first dose of study treatment. Patients with&#xD;
                    history of uncontrolled seizures or leptomeningeal disease are not eligible.&#xD;
  &#xD;
               Cohort C patients:&#xD;
  &#xD;
                 -  Documented EGFR ex20ins mutation status, as determined by local testing performed&#xD;
                    at a CLIA certified (US) or locally certified laboratory (outside the US).&#xD;
  &#xD;
                 -  Presence of brain metastasis(es), which may be measurable or nonmeasurable by&#xD;
                    RANO-BM criteria, characterized as one of the following:&#xD;
  &#xD;
                      -  Newly diagnosed and/or progressive brain metastasis (es) not subjected to&#xD;
                         CNS-directed therapy, OR&#xD;
  &#xD;
                      -  Leptomeningeal disease (LMD) confirmed by a positive cerebrospinal fluid&#xD;
                         cytology, or unequivocal radiographic and/or clinical determination.&#xD;
  &#xD;
               Cohort D patients:&#xD;
  &#xD;
                 -  Documented other non-ex20ins uncommon single or compound EGFRmt status, as&#xD;
                    determined by local testing performed at a CLIA certified (US) or locally&#xD;
                    certified laboratory (outside the US). A list of eligible mutations will be&#xD;
                    provided in a separate manual.&#xD;
  &#xD;
                 -  Patients with brain metastasis must be neurologically stable. Patients must have&#xD;
                    received CNS-directed therapy and have no evidence of progression for at least 4&#xD;
                    weeks after CNS-directed treatment, as ascertained by clinical examination and&#xD;
                    brain imaging (MRI or CT scan) during the screening period, and they must be on a&#xD;
                    stable or decreasing dose of corticosteroids and/or anti-convulsant medications&#xD;
                    for at least 2 weeks prior to the first dose of study treatment. Patients with&#xD;
                    history of uncontrolled seizures or leptomeningeal disease are not eligible.&#xD;
  &#xD;
            4. Measurable disease per RECIST 1.1.&#xD;
  &#xD;
            5. Archival tumor tissue available for submission, with minimum quantity sufficient to&#xD;
               evaluate EGFRmt status and, where possible, other biomarkers (details provided in a&#xD;
               laboratory manual). Patients with insufficient tissue may be eligible following&#xD;
               discussion with the sponsor.&#xD;
  &#xD;
            6. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 17. Adequate&#xD;
               organ function, as defined by the hematologic, renal and hepatic laboratory values&#xD;
  &#xD;
          4. Women of childbearing potential (WOCBP) must have a negative serum pregnancy test prior&#xD;
          to administration of the first dose of study treatment. Female patients are not considered&#xD;
          to be of childbearing potential if they are post-menopausal (no menses for 12 months&#xD;
          without an alternative medical cause) or permanently sterile (hysterectomy, bilateral&#xD;
          salpingectomy, or bilateral oophorectomy).&#xD;
  &#xD;
          5. Both males and females of reproductive potential must agree to use effective birth&#xD;
          control during the study prior to the first dose of study drug and for 6 months after the&#xD;
          last dose of study treatment.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient is currently receiving an investigational drug in a clinical trial or&#xD;
               participating in any other type of medical research judged to be scientifically or&#xD;
               medically incompatible with this study.&#xD;
  &#xD;
            2. Has received any of the following within the specific time frame specified:&#xD;
  &#xD;
                 1. Patient has received Zipalertinib (TAS6417/CLN081) at any time&#xD;
  &#xD;
                 2. Thoracic radiotherapy ≤28 days or palliative radiation ≤14 days prior to the&#xD;
                    first dose of study treatment&#xD;
  &#xD;
                 3. Anticancer immunotherapy ≤28 days prior to the first dose of study treatment&#xD;
  &#xD;
                 4. Major surgery (excluding placement of vascular access) ≤28 days prior to the&#xD;
                    first dose of study treatment.&#xD;
  &#xD;
            3. Have any unresolved toxicity of Grade ≥2 from previous anticancer treatment, except&#xD;
               for Grade 2 alopecia or skin pigmentation. Patients with other chronic but stable&#xD;
               Grade 2 toxicities may be allowed to enroll after agreement between the investigator&#xD;
               and Sponsor.&#xD;
  &#xD;
            4. Past medical history of interstitial lung disease, treatment-related pneumonitis (any&#xD;
               grade), or evidence of clinically active interstitial lung disease.&#xD;
  &#xD;
            5. Impaired cardiac function or clinically significant cardiac disease including any of&#xD;
               the following:&#xD;
  &#xD;
                 1. History of congestive heart failure (CHF) Class III/IV according to the New York&#xD;
                    Heart Association (NYHA) Functional Classification (Appendix A)&#xD;
  &#xD;
                 2. Serious cardiac arrhythmias requiring treatment.&#xD;
  &#xD;
                 3. Resting corrected QT interval (QTc) &gt;470 msec using Fridericia's formula (QTcF).&#xD;
  &#xD;
            6. Is unable to swallow tablets/capsules or has any disease or condition that may&#xD;
               significantly affect gastrointestinal absorption of zipalertinib (eg, inflammatory&#xD;
               bowel disease, malabsorption syndrome, or prior gastric/bowel resection).&#xD;
  &#xD;
            7. History of another primary malignancy ≤2 years prior to the date of first dose of&#xD;
               study treatment unless at least one of the following criteria are met:&#xD;
  &#xD;
                 1. Adequately treated basal or squamous cell carcinoma of the skin&#xD;
  &#xD;
                 2. Cancer of the breast or cervix in situ&#xD;
  &#xD;
                 3. Patients with previously treated malignancy if all treatment for that malignancy&#xD;
                    was completed at least 2 years prior to first dose and no evidence of disease&#xD;
  &#xD;
                 4. Patients with concurrent malignancy clinically stable and not requiring&#xD;
                    tumor-directed treatment&#xD;
  &#xD;
            8. Known history of hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) that&#xD;
               is not controlled with treatment.&#xD;
  &#xD;
            9. History of COVID-19 infection within 4 weeks prior to enrolment and/or has persistent&#xD;
               clinically significant pulmonary symptoms related to prior COVID-19 infection.&#xD;
  &#xD;
           10. Active bleeding disorders.&#xD;
  &#xD;
           11. Known hypersensitivity to the ingredients in zipalertinib or any drugs similar in&#xD;
               structure or class.&#xD;
  &#xD;
           12. Is pregnant or lactating.&#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_contact>
      <last_name>Taiho Oncology, INC</last_name>
      <phone>609-250-7336</phone>
      <email>clinicaltrialinfo@taihooncology.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Gabrail Cancer and Research Center</name>
        <address>
          <city>Canton</city>
          <state>Ohio</state>
          <zip>44718</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 11, 2023</study_first_submitted>
    <study_first_submitted_qc>July 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>NSCLC</keyword>
    <keyword>Carcinoma</keyword>
    <keyword>Non-Small Cell Lung</keyword>
    <keyword>Lung disease</keyword>
    <keyword>locally advanced/ metastatic</keyword>
    <keyword>ex20ins mutation</keyword>
    <keyword>Insertion Mutations</keyword>
    <keyword>EGFR uncommon/ single mutation Phase 2, Phase 2b, Phase II Exon 20</keyword>
    <keyword>TAS6417/ CLN-081</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05967689
  org study id: TAS6417-201
  secondary id: 2023-503865-48
  nct id: NCT05967689
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  The purpose of this study is to evaluate the safety and efficacy of zipalertinib in patients
        with locally advanced or metastatic NSCLC harboring EGFR ex20ins mutations and other
        mutations.
  This study will evaluate the safety and efficacy of zipalertinib in patients with locally
        advanced or metastatic NSCLC harboring EGFR ex20ins mutations or other uncommon/single or
        compound EGFRmt.
  
        Patients will be enrolled into 1 of the 4 following cohorts:
  
          -  Cohort A ("prior ex20ins treatment") will include patients harboring EGFR ex20ins
             mutations who have progressed on or after initial treatment with standard platinum-based
             chemotherapy and prior treatment with an ex20 agent for their advanced disease
             (administered together or separately).
  
          -  Cohort B ("1st line") will include patients harboring EGFR ex20ins mutations who have
             not received prior treatment for advanced disease.
  
          -  Cohort C ("active brain mets") will include patients harboring EGFR ex20ins or other
             uncommon single and compound mutations and active brain metastases. Patients may or may
             not have had prior treatment for advanced disease.
  
          -  Cohort D ("other uncommon EGFRmt") will include patients harboring other, non ex20ins
             uncommon single or compound EGFRmt who have progressed on or after treatment with
             standard systemic anticancer therapy.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  intervention model description: 4 Cohorts based on eligibility criteria
  primary purpose: Treatment
  masking: None (Open Label)
  measure: All Cohorts: objective response rate (ORR)
  time frame: Up to approximately 2 years
  measure: All Cohorts: The rate and severity of treatment emergent AEs
  time frame: Up to approximately 2 years
  measure: All Cohorts: Overall Survival (OS)
  time frame: Up to approximately 2 years
  description: Antitumor activity is assessed by response evaluation criteria RECIST 1.1 by measuring
  measure: All Cohorts: Disease control rate (DCR)
  time frame: Up to approximately 2 years
  measure: All Cohorts: Duration of response (DoR)
  time frame: Up to approximately 2 years
  measure: Progression-free survival (PFS)
  time frame: Up to approximately 2 years
  measure: Cohort C: Intracranial (i) Overall Response Rate (iORR)
  time frame: Up to approximately 2 years
  measure: Cohort C: intracranial duration of complete response (iDCR)
  time frame: Up to approximately 2 years
  measure: Cohort C: intracranial duration of Response (iDoR)
  time frame: Up to approximately 2 years
  measure: All Cohorts: Pharmacokinetic (PK) parameter
  time frame: Up to approximately 2 years
  description: Minimum Plasma Concentration (Cmin)
  measure: Pharmacokinetic (PK) parameter
  time frame: Up to approximately 2 years
  description: Minimum Plasma Concentration [Cmin]
  measure: Pharmacokinetic (PK) parameter
  time frame: Up to approximately 2 years
  description: Maximum Plasma Concentration [Cmax]
  measure: Pharmacokinetic (PK) parameter
  time frame: Up to approximately 2 years
  description: Area Under Curve [AUC]
  measure: EGFR mutation status
  time frame: Up to approximately 2 years
  description: Local central tests results
  arm group label: Cohort A ("prior ex20ins treatment")
  arm group type: Experimental
  description: Cohort A ("prior ex20ins treatment") participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
  arm group label: Cohort B ("1st line treatment")
  arm group type: Experimental
  description: Cohort B participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
  arm group label: Cohort C ("active brain mets")
  arm group type: Experimental
  description: Cohort C participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
  arm group label: Cohort D ("other uncommon EGFRmt").
  arm group type: Experimental
  description: Cohort D participants will receive zipalertinib orally twice a day (BID) continuously until documentation of PD or until other withdrawal criteria are met, whichever comes first.
  intervention type: Drug
  intervention name: TAS6417
  description: Oral tablets/capsules
  arm group label: Cohort A ("prior ex20ins treatment")
  arm group label: Cohort B ("1st line treatment")
  arm group label: Cohort C ("active brain mets")
  arm group label: Cohort D ("other uncommon EGFRmt").
  other name: CLN-081
  other name: zipalertinib
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Taiho Oncology, INC
  phone: 609-250-7336
  email: clinicaltrialinfo@taihooncology.com
  facility: 
  status: Recruiting
  country: United States
  responsible party type: Sponsor
  mesh term: Carcinoma, Non-Small-Cell Lung
  sharing ipd: No