<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/NCT03292133</url>
  </required_header>
  <id_info>
    <org_study_id>17-291</org_study_id>
    <nct_id>NCT03292133</nct_id>
  </id_info>
  <brief_title>A Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer</brief_title>
  <official_title>A Phase 2 Study of EGF816 and Gefitinib in TKI-naïve EGFR-mutant Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Massachusetts General Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Novartis</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Massachusetts General Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is studying a combination of drugs as a possible treatment for EGFR&#xD;
      mutation-positive lung cancer.&#xD;
&#xD;
      The drugs involved in this study are:&#xD;
&#xD;
        -  EGF816&#xD;
&#xD;
        -  Gefitinib&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research study is a Phase II clinical trial. Phase II clinical trials test the safety&#xD;
      and effectiveness of an investigational drug to learn whether the drug works in treating a&#xD;
      specific disease or patient population. &quot;Investigational&quot; means that the drug or drugs are&#xD;
      being studied and have not been approved together for patients.&#xD;
&#xD;
      The FDA (the U.S. Food and Drug Administration) has approved gefitinib as a treatment option&#xD;
      for EGFR mutation-positive lung cancer.&#xD;
&#xD;
      The FDA has not approved EGF816 as a treatment for any disease at this time.&#xD;
&#xD;
      In this research study, the investigators are studying the safety and efficacy of the&#xD;
      combination of the study drugs EGF816 and gefitinib.&#xD;
&#xD;
      Both EGF816 and gefitinib are inhibitors which target a specific mutation in cancer and may&#xD;
      stop tumors growing and multiplying.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 31, 2017</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2023</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>Progression Free Survival at 9 months</measure>
    <time_frame>9 months</time_frame>
    <description>The number of participants that are free from objective disease progression or death at 9 months. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.&#xD;
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response Rate</measure>
    <time_frame>2 years</time_frame>
    <description>The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.&#xD;
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to &lt;10 mm.&#xD;
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.&#xD;
All CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criteria for response are first met.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>2 years</time_frame>
    <description>Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety and Tolerability of the EGF816/gefitinib combination (Summary of the adverse events experienced by study participants as evaluated by CTCAE v4)</measure>
    <time_frame>2 years</time_frame>
    <description>Summary of the adverse events experienced by study participants as evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v4.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Lung Cancer</condition>
  <arm_group>
    <arm_group_label>EGF816 + Gefitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients will receive gefitinib orally once daily&#xD;
EGF816 will be administered orally once daily&#xD;
Participant will be requested to maintain a medication diary of each dose of medication</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EGF816</intervention_name>
    <description>EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying</description>
    <arm_group_label>EGF816 + Gefitinib</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Gefitinib</intervention_name>
    <description>Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying</description>
    <arm_group_label>EGF816 + Gefitinib</arm_group_label>
    <other_name>Iressa</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have a pathologically-confirmed diagnosis of non-small cell lung&#xD;
             cancer (NSCLC).&#xD;
&#xD;
          -  Participants must have advanced disease - either stage IV disease, stage IIIB disease&#xD;
             not amenable to definitive multi-modality therapy, or recurrent disease after a prior&#xD;
             diagnosis of stage I-III disease. All staging is via the American Joint Committee on&#xD;
             Cancer (AJCC)/IASLC 7th edition proposed staging criteria&#xD;
&#xD;
          -  An EGFR sensitizing mutation must be detected in tumor tissue. Specifically, patients&#xD;
             harboring the most common mutations, deletions in exon 19 or the L858R mutation in&#xD;
             exon 21 are eligible. Other EGFR sensitizing mutations may be eligible after&#xD;
             discussion with the principal investigator. Patients may be enrolled in the study&#xD;
             based on an activating EGFR mutation detected by a CLIA-certified tissue or&#xD;
             plasma-based assay, but will be required to undergo a mandatory tumor biopsy during&#xD;
             study screening.&#xD;
&#xD;
          -  Participants must have measurable disease, per RECIST 1.1. See Section 11 for the&#xD;
             evaluation of measurable disease.&#xD;
&#xD;
          -  Patients in the six patient safety run-in cohort may have had a prior EGFR TKI in the&#xD;
             metastatic setting (to allow for patients who started initial therapy at an outside&#xD;
             hospital), but treatment duration must have been less than three months. After the&#xD;
             initial six-patient safety run-in, no prior EGFR TKI therapy in the metastatic setting&#xD;
             is allowed. An EGFR TKI given in the adjuvant setting (i.e. with no measurable disease&#xD;
             at the time of administration) is allowable provided the subject has been off of EGFR&#xD;
             TKI therapy for at least six months at the time of enrollment.&#xD;
&#xD;
          -  Patients may have had no more than one prior line of chemotherapy or immunotherapy in&#xD;
             the metastatic setting. At least 14 days must have elapsed from the last&#xD;
             chemo/immunotherapy administration until the start of protocol treatment, and patients&#xD;
             must have recovered from the side effects of any of these agents.&#xD;
&#xD;
          -  Patients must be screened for HBV. Patients who are either HBsAg positive or HBV-DNA&#xD;
             positive must be willing and able to take antiviral therapy 1-2 weeks prior to 1st&#xD;
             dose of study treatment and continue on antiviral therapy for at least 4 weeks after&#xD;
             the last dose of EGF816. Additional management of the patients would be provided by a&#xD;
             physician with expertise in management of HBV, if needed. Patients must have negative&#xD;
             hepatitis C antibody (HCV-Ab) or positive HCV-Ab but undetectable level of HCV-RNA.&#xD;
             Note: patients with detectable HCV-RNA are not eligible for the study.&#xD;
&#xD;
          -  Patients must receive insurance approval for or be willing to pay for commercial&#xD;
             gefitinib.&#xD;
&#xD;
          -  Age &gt;/= 18 years.&#xD;
&#xD;
          -  ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)&#xD;
&#xD;
          -  Life expectancy of greater than 12 weeks.&#xD;
&#xD;
          -  Participants must have normal organ and marrow function as defined below:&#xD;
&#xD;
               -  Leukocytes ≥3,000/mcL&#xD;
&#xD;
               -  Absolute neutrophil count ≥1,500/mcL&#xD;
&#xD;
               -  Platelets ≥100,000/mcL&#xD;
&#xD;
               -  Total bilirubin &gt;1.5 x upper limit of normal (ULN)&#xD;
&#xD;
                  *For patients with Gilbert's syndrome total bilirubin &gt;3.0 x ULN&#xD;
&#xD;
               -  AST(SGOT)/ALT(SGPT) ≤3 × institutional upper limit of normal; for patients with&#xD;
                  known hepatic metastases AST and/or ALT &gt; 5x ULN&#xD;
&#xD;
               -  Creatinine ≤1.5 × institutional upper limit of normal&#xD;
&#xD;
          -  The effects of EGF816 and gefitinib on the developing human fetus are unknown. For&#xD;
             this reason, women of child-bearing potential and men must agree to use highly&#xD;
             effective contraception during the study and for 3 months after stopping the study&#xD;
             treatment. Highly effective contraception methods include:&#xD;
&#xD;
               -  Total abstinence (when this is in line with the preferred and usual lifestyle of&#xD;
                  the subject. Periodic abstinence (e.g., calendar, ovulation, symptom thermal,&#xD;
                  postovulation methods) and withdrawal are not acceptable methods of contraception&#xD;
&#xD;
               -  Female sterilization (have had surgical bilateral oophorectomy with or without&#xD;
                  hysterectomy) or tubal ligation at least six weeks before taking study treatment.&#xD;
                  In case of oophorectomy alone, only when the reproductive status of the woman has&#xD;
                  been confirmed by follow up hormone level assessment&#xD;
&#xD;
               -  Male Partner: male sterilization (at least 6 months prior to screening). For&#xD;
                  female subjects on the study the vasectomized male partner should be the sole&#xD;
                  partner for that subject.&#xD;
&#xD;
               -  Combination of any two of the following (a+b or a+c, or b+c):&#xD;
&#xD;
               -  A. Use of oral, injected or implanted hormonal methods of contraception or other&#xD;
                  forms of hormonal contraception that have comparable efficacy (failure rate &lt;1%),&#xD;
                  for example hormone vaginal ring or transdermal hormone contraception.&#xD;
&#xD;
               -  B. Placement of an intrauterine device (IUD) or intrauterine system (IUS)&#xD;
&#xD;
               -  C. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or&#xD;
                  cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal suppository.&#xD;
&#xD;
               -  D. In case of use of oral contraception women should have been stable on the same&#xD;
                  pill for a minimum of 30 days before taking study treatment.&#xD;
&#xD;
               -  Women are considered post-menopausal and not of childbearing potential if they&#xD;
                  have had 12 months of natural (spontaneous) amenorrhea with an appropriate&#xD;
                  clinical profile (e.g. age appropriate, history of vasomotor symptoms) or have&#xD;
                  had surgical bilateral oophorectomy (with or without hysterectomy) or tubal&#xD;
                  ligation at least six weeks ago. In the case of oophorectomy alone, only when the&#xD;
                  reproductive status of the woman has been confirmed by follow up hormone level&#xD;
                  assessment is she considered not of childbearing potential.&#xD;
&#xD;
               -  Sexually active males must agree to use a condom during intercourse while taking&#xD;
                  drug and for 3 months after stopping treatment; men should not father a child in&#xD;
                  this period. A condom is required to be used also by vasectomized men in order to&#xD;
                  prevent delivery of the drug via seminal fluid.&#xD;
&#xD;
          -  Ability to understand and the willingness to sign a written informed consent document.&#xD;
             Written informed consent must be obtained prior to any screening procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with clinically active or symptomatic interstitial lung disease or&#xD;
             interstitial pneumonitis (i.e., affecting activities of daily living or requiring&#xD;
             therapeutic intervention) and patients with history of clinically significant&#xD;
             interstitial lung disease or radiation pneumonitis.&#xD;
&#xD;
          -  Patients with clinically symptomatic brain metastases or leptomeningeal disease.&#xD;
             Patients may be on a stable dose of corticosteroids to control brain metastases if&#xD;
             they have been on a stable dose for two weeks prior to study treatment and are&#xD;
             clinically asymptomatic.&#xD;
&#xD;
          -  Patients who have had radiation to the lung fields within four weeks of starting&#xD;
             treatment. For patients receiving palliative radiation to thoracic vertebrae, ribs or&#xD;
             other sites where the radiation field includes the lungs, radiation must be completed&#xD;
             at least two weeks before starting treatment. For all palliative radiation to all&#xD;
             other sites, at least 7 days must have elapsed prior to starting to treatment. At&#xD;
             least six months must have elapsed from radiation given with curative intent.&#xD;
&#xD;
          -  Patients who have had major surgery (e.g., intra-thoracic, intra-abdominal or&#xD;
             intra-pelvic) within 2 weeks prior to starting study drug or who have not recovered&#xD;
             from side effects of such procedure. Video-assisted thoracic surgery (VATS) and&#xD;
             mediastinoscopy will not be counted as major surgery and patients can be enrolled in&#xD;
             the study ≥1 week after the procedure.&#xD;
&#xD;
          -  Patients unable or unwilling to undergo a biopsy for research during the screening&#xD;
             period, 2-3 weeks into the course of therapy and at the time of progression.&#xD;
&#xD;
          -  Patients with a second, clinically active, cancer. Patients with second cancers which&#xD;
             have been treated with curative intent and/or are currently inactive are allowed.&#xD;
&#xD;
          -  Patients who have undergone a bone marrow or solid organ transplant.&#xD;
&#xD;
          -  Known history of human immunodeficiency virus (HIV) seropositivity (HIV testing is not&#xD;
             mandatory).&#xD;
&#xD;
          -  Participants who are receiving any other investigational agents. Patients previously&#xD;
             treated with investigational agents must complete a washout period of at least one&#xD;
             week or five half-lives, whichever is longer, before starting treatment.&#xD;
&#xD;
          -  Patients receiving concomitant immunosuppressive agents or chronic corticosteroid use,&#xD;
             except those on steroid to control brain metastases, those on topical or inhaled&#xD;
             steroids, or steroids given via local injection.&#xD;
&#xD;
          -  Patients with clinically significant, uncontrolled cardiovascular disease, such as:&#xD;
&#xD;
               -  Unstable angina within 6 months prior to screening&#xD;
&#xD;
               -  Myocardial infarction within 6 months prior to screening&#xD;
&#xD;
               -  Patients with a history of documented congestive heart failure (New York Heart&#xD;
                  Association functional classification III-IV)&#xD;
&#xD;
               -  Peripheral vascular disease&#xD;
&#xD;
               -  Patients with uncontrolled hypertension defined as a Systolic Blood Pressure&#xD;
                  (SBP) ≥ 160 mm Hg and/or Diastolic Blood Pressure (DBP) ≥ 100 mm Hg, with or&#xD;
                  without anti-hypertensive medication. Initiation or adjustment of&#xD;
                  antihypertensive medication(s) is allowed prior to screening&#xD;
&#xD;
               -  Ventricular arrhythmias&#xD;
&#xD;
               -  Supraventricular and nodal arrhythmias not controlled with medication&#xD;
&#xD;
               -  Other cardiac arrhythmia not controlled with medication&#xD;
&#xD;
               -  Patients with corrected QT (QTc) ≥450 ms (male patients) or ≥460 ms (female&#xD;
                  patients) using Fridericia correction (QTcF) on the screening ECG (using&#xD;
                  triplicate ECGs)&#xD;
&#xD;
               -  Patients with history of congenital long QT syndrome or history of torsade de&#xD;
                  pointes&#xD;
&#xD;
          -  History of allergic reactions attributed to compounds of similar chemical or biologic&#xD;
             composition to EGF816 or gefitinib.&#xD;
&#xD;
          -  Participants receiving any medications or substances that are strong inhibitors or&#xD;
             inducers of CYP3A4 are ineligible. Because the lists of these agents are constantly&#xD;
             changing, it is important to regularly consult a frequently-updated list such as&#xD;
             http://medicine.iupui.edu/clinpharm/ddis/table.aspx; medical reference texts such as&#xD;
             the Physicians' Desk Reference may also provide this information. As part of the&#xD;
             enrollment/informed consent procedures, the patient will be counseled on the risk of&#xD;
             interactions with other agents, and what to do if new medications need to be&#xD;
             prescribed or if the patient is considering a new over-the-counter medicine or herbal&#xD;
             product.&#xD;
&#xD;
          -  Unable or unwilling to swallow tablets or capsules.&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac&#xD;
             arrhythmia, or psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements&#xD;
&#xD;
          -  Pregnant women are excluded from this study because the effects of EGF816 and&#xD;
             gefitinib on a developing fetus are unknown. Because there is an unknown but potential&#xD;
             risk for adverse events in nursing infants secondary to treatment of the mother with&#xD;
             EGF816 or gefitinib, breastfeeding should be discontinued if the mother is treated&#xD;
             with EGF816 and gefitinib&#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>Zofia Piotrowska, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Massachusetts General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Massachusetts General Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 26, 2023</last_update_submitted>
  <last_update_submitted_qc>May 26, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 31, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Massachusetts General Hospital</investigator_affiliation>
    <investigator_full_name>Zofia Piotrowska</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Lung Cancer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gefitinib</mesh_term>
    <mesh_term>Nazartinib</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03292133
org study id: 17-291
nct id: NCT03292133
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This research study is studying a combination of drugs as a possible treatment for EGFR
      mutation-positive lung cancer.

      The drugs involved in this study are:

        -  EGF816

        -  Gefitinib
This research study is a Phase II clinical trial. Phase II clinical trials test the safety
      and effectiveness of an investigational drug to learn whether the drug works in treating a
      specific disease or patient population. "Investigational" means that the drug or drugs are
      being studied and have not been approved together for patients.

      The FDA (the U.S. Food and Drug Administration) has approved gefitinib as a treatment option
      for EGFR mutation-positive lung cancer.

      The FDA has not approved EGF816 as a treatment for any disease at this time.

      In this research study, the investigators are studying the safety and efficacy of the
      combination of the study drugs EGF816 and gefitinib.

      Both EGF816 and gefitinib are inhibitors which target a specific mutation in cancer and may
      stop tumors growing and multiplying.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression Free Survival at 9 months
time frame: 9 months
description: The number of participants that are free from objective disease progression or death at 9 months. Progression is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions).
measure: Response Rate
time frame: 2 years
description: The number of participants that achieve either a complete response (CR) or a partial response (PR). Response is evaluated using Response Evaluation Criteria In Solid Tumors (RECIST) 1.1.
Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm.
Partial Response (PR): At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
All CRs and PRs must be confirmed by a second assessment not earlier than 4 weeks after the criteria for response are first met.
measure: Overall Survival
time frame: 2 years
description: Overall survival is defined as time from the start of treatment until death. Overall survival will be analyzed using the Kaplan-Meier method.
measure: Safety and Tolerability of the EGF816/gefitinib combination (Summary of the adverse events experienced by study participants as evaluated by CTCAE v4)
time frame: 2 years
description: Summary of the adverse events experienced by study participants as evaluated by Common Terminology Criteria for Adverse Events (CTCAE) v4.
arm group label: EGF816 + Gefitinib
arm group type: Experimental
description: All patients will receive gefitinib orally once daily
EGF816 will be administered orally once daily
Participant will be requested to maintain a medication diary of each dose of medication
intervention type: Drug
intervention name: EGF816
description: EGF816 is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
arm group label: EGF816 + Gefitinib
intervention type: Drug
intervention name: Gefitinib
description: Gefitinib is an inhibitor which target a specific mutation in cancer and may stop tumors growing and multiplying
arm group label: EGF816 + Gefitinib
other name: Iressa
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zofia Piotrowska, MD
role: Principal Investigator
affiliation: Massachusetts General Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Massachusetts General Hospital
investigator full name: Zofia Piotrowska
investigator title: Principal Investigator
mesh term: Lung Neoplasms
mesh term: Gefitinib
mesh term: Nazartinib
sharing ipd: No