<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/NCT02987998</url>
  </required_header>
  <id_info>
    <org_study_id>CASE4516</org_study_id>
    <nct_id>NCT02987998</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Chemoradiation Plus Pembrolizumab Followed By Consolidation Pembrolizumab in NSCLC</brief_title>
  <official_title>A Phase I Safety and Feasibility Study of Neoadjuvant Chemoradiation Plus Pembrolizumab Followed By Consolidation Pembrolizumab in Resectable Stage 3A Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nathan Pennell, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Case Comprehensive Cancer Center</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>
      The purpose of this study is to determine the feasibility and evaluate the safety of&#xD;
      delivering chemoradiotherapy, the usual approach to non-small cell lung cancer, in&#xD;
      combination with pembrolizumab (MK-3745), followed by consolidation pembrolizumab after&#xD;
      surgical resection. Consolidation therapy is treatment given following the initial treatment.&#xD;
&#xD;
      Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by&#xD;
      the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of&#xD;
      head and neck cancer. However, it has not been approved for use in other cancers such as&#xD;
      non-small cell lung cancer (NSCLC). Pembrolizumab is a monoclonal antibody that binds to the&#xD;
      surface of some cells of the immune system and activates them against cancer cells. It is not&#xD;
      chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary hypothesis is that the addition of pembrolizumab to neoadjuvant concurrent&#xD;
      chemoradiation, followed by consolidation pembrolizumab, will be safe and feasible to deliver&#xD;
      to patients with resectable stage 3A Non-small cell lung cancer (NSCLC).&#xD;
&#xD;
      This study also plans to observe the efficacy of this combination in the overall and&#xD;
      biomarker-positive population.&#xD;
&#xD;
      Primary Objective Primary objective of this phase 1 study is to determine safety and&#xD;
      feasibility of MK3475 with standard of care therapy of chemotherapy with radiation for newly&#xD;
      diagnosed stage 3 lung carcinoma.&#xD;
&#xD;
      • To define the Safety, tolerability and feasibility of MK3475 in combination with&#xD;
      chemotherapy with cisplatin and etoposide along with 45 Gy of radiation in newly diagnosed&#xD;
      stage 3 non-small cell lung carcinoma.&#xD;
&#xD;
      Secondary Objective(s)&#xD;
&#xD;
        -  Progression Free Survival&#xD;
&#xD;
        -  Objective response rate,&#xD;
&#xD;
        -  Complete pathologic response rate,&#xD;
&#xD;
        -  Nodal downstaging at surgery,&#xD;
&#xD;
        -  Overall survival,&#xD;
&#xD;
        -  Safety and tolerability&#xD;
&#xD;
      Correlative Objective(s) Exploratory objectives: Overall response rate, progression free&#xD;
      survival, overall survival in Programmed death-ligand (PDL-1) positive versus negative&#xD;
      subgroups&#xD;
&#xD;
      Study Design This is an open-label, single arm phase I trial of neoadjuvant chemotherapy +&#xD;
      pembrolizumab with concurrent radiation followed by surgical resection and consolidation&#xD;
      pembrolizumab in resectable stage 3A (N2+) NSCLC.&#xD;
&#xD;
      Eligible patients will have biopsy-confirmed T1-3N2M0 (stage IIIA) non-small cell lung cancer&#xD;
      (adenocarcinoma, squamous cell carcinoma, or large cell/NSCLC not otherwise specified),&#xD;
      performance status 0-1, adequate lung function and deemed medically resectable by a thoracic&#xD;
      surgeon, adequate organ function for chemotherapy, and no contraindications to pembrolizumab&#xD;
      (i.e. autoimmune disorders or underlying pulmonary fibrosis).&#xD;
&#xD;
      Because pembrolizumab has been safely added to multiple platinum doublet chemotherapy&#xD;
      regimens in lung cancer but not yet tested in the setting of concurrent radiation, we plan to&#xD;
      evaluate safety and feasibility of the combination therapy. 10 patients will be enrolled at&#xD;
      the full starting dose of all 3 agents. If 3 or more (&gt;30%) have grade 3 or higher pulmonary&#xD;
      toxicity or any grade 4 nonhematologic toxicity, the study will be stopped. If 2 or fewer&#xD;
      have &gt; grade 3 pulmonary toxicity or &gt; grade 4 other nonhematologic toxicity, then an&#xD;
      additional 10 will be enrolled. If 5 or fewer (&lt;25%) of the 20 patients have &gt; grade 3&#xD;
      pulmonary toxicity or &gt; grade 4 other nonhematologic toxicity, then this regimen will be&#xD;
      deemed safe and feasible for further study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    higher than expected rate of toxicity &amp; unrealistic timeline to complete trial under company's&#xD;
    proposed plan to reopen&#xD;
  </why_stopped>
  <start_date type="Actual">May 19, 2017</start_date>
  <completion_date type="Actual">November 28, 2022</completion_date>
  <primary_completion_date type="Actual">November 28, 2022</primary_completion_date>
  <phase>Phase 1</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>Number of patients with grade 3 pulmonary toxicity or grade 4 other non hematologic toxicity</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>If 5 or fewer (&lt;25%) of the 20 patients have &gt; grade 3 pulmonary toxicity or &gt; grade 4 other nonhematologic toxicity, then this regimen will be deemed safe and feasible for further study</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Progression Free Survival</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Time from beginning of treatment to progression, death, or five years, whichever came first. Progression is defined as Progressive Disease (PD): At least a 20% increase in the sum of 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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Number of patients with objective response (CR + PR) where complete response is defined as 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. And Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complete Pathologic Response Rate</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Pathological complete response is defined as absence of foci of tumor cells at the local site (pCR)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nodal Downstaging at Surgery</measure>
    <time_frame>Up to 4 weeks after induction treatment</time_frame>
    <description>Number of patients with reduced stages in nodes at surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 5 years</time_frame>
    <description>Time from beginning of treatment to death or 5 year, whichever comes first</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Stage IIIA Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Resectable Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Chemoradiation (Cisplatin + Etoposide + Pembrolizumab with concurrent radiation). Patients will be assessed for surgery followed by consolidation therapy</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Cisplatin (50mg/m2 IV D1, 8, 29, 36)</description>
    <arm_group_label>Resectable Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Etoposide</intervention_name>
    <description>Etoposide (50mg/m2 IV D1-5, 29-33)</description>
    <arm_group_label>Resectable Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pembrolizumab</intervention_name>
    <description>Pembrolizumab (200mg IV D1, 21, 42)</description>
    <arm_group_label>Resectable Patients</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Radiation</intervention_name>
    <description>Radiation (1.8Gy/D to 45Gy in 25 fractions)</description>
    <arm_group_label>Resectable Patients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically confirmed stage 3A Non-Small Cell Lung Cancer&#xD;
&#xD;
          -  Be willing and able to provide written informed consent/assent for the trial&#xD;
&#xD;
          -  Have measurable or unmeasurable disease based on RECIST 1.1.&#xD;
&#xD;
          -  Be willing to provide archival tissue from a tumor lesion or obtain a new biopsy if&#xD;
             tissue unavailable.&#xD;
&#xD;
          -  Have a performance status of 0 or 1 on the Eastern Cooperative Oncology group (ECOG)&#xD;
             Performance Scale.&#xD;
&#xD;
          -  Demonstrate adequate organ function&#xD;
&#xD;
               -  Absolute neutrophil count (ANC) ≥1,500/mcL&#xD;
&#xD;
               -  Platelets ≥100,000 / mcL&#xD;
&#xD;
               -  Hemoglobin ≥9 g/dL or ≥5.6 mmol/L without transfusion or erythropoiesis&#xD;
                  dependency&#xD;
&#xD;
               -  Serum creatinine or Measured or calculated creatinine clearance ≤1.5 X upper&#xD;
                  limit of normal (ULN) or ≥60 mL/min for subject with creatinine levels &gt; 1.5 X&#xD;
                  institutional ULN&#xD;
&#xD;
               -  Serum total bilirubin ≤ 1.5 X ULN, or Direct bilirubin ≤ ULN for subjects with&#xD;
                  total bilirubin levels &gt; 1.5 ULN&#xD;
&#xD;
               -  Aspartate transaminase (AST) (SGOT) and Alanine transaminase (ALT) (SGPT) ≤ 2.5 X&#xD;
                  ULN or ≤ 5 X ULN for subjects with liver metastases&#xD;
&#xD;
               -  Albumin ≥2.5 mg/dL&#xD;
&#xD;
               -  International Normalized Ratio (INR) or Prothrombin Time (PT) ≤1.5 X ULN unless&#xD;
                  subject is receiving anticoagulant therapy as long as PT or partial&#xD;
                  thromboplastin time (PTT) is within therapeutic range of intended use of&#xD;
                  anticoagulants ≤1.5 X ULN unless subject is receiving anticoagulant therapy as&#xD;
                  long as PT or PTT is within therapeutic range of intended use of anticoagulants&#xD;
&#xD;
          -  Female subject of childbearing potential should have a negative urine or serum&#xD;
             pregnancy within 72 hours prior to receiving the first dose of study medication. If&#xD;
             the urine test is positive or cannot be confirmed as negative, a serum pregnancy test&#xD;
             will be required&#xD;
&#xD;
          -  Female subjects of childbearing potential should be willing to use 2 methods of birth&#xD;
             control or be surgically sterile, or abstain from heterosexual activity for the course&#xD;
             of the study through 120 days after the last dose of study medication. Subjects of&#xD;
             childbearing potential are those who have not been surgically sterilized or have not&#xD;
             been free from menses for &gt; 1 year&#xD;
&#xD;
          -  Male subjects should agree to use an adequate method of contraception starting with&#xD;
             the first dose of study therapy through 120 days after the last dose of study therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Is currently participating and receiving study therapy or has participated in a study&#xD;
             of an investigational agent and received study therapy or used an investigational&#xD;
             device within 4 weeks of the first dose of treatment&#xD;
&#xD;
          -  Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any&#xD;
             other form of immunosuppressive therapy within 7 days prior to the first dose of trial&#xD;
             treatment&#xD;
&#xD;
          -  Has a known history of active Bacillus Tuberculosis (TB)&#xD;
&#xD;
          -  Hypersensitivity to pembrolizumab or any of its excipients.&#xD;
&#xD;
          -  Has had any prior chemotherapy, targeted small molecule therapy, or radiation therapy&#xD;
             for the currently diagnosed cancer.&#xD;
&#xD;
          -  Has a known additional malignancy that is progressing or requires active treatment.&#xD;
             Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the&#xD;
             skin that has undergone potentially curative therapy or in situ cervical cancer.&#xD;
&#xD;
          -  Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
             (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
             drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid&#xD;
             replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
             form of systemic treatment.&#xD;
&#xD;
          -  Has known history of, or any evidence of active, non-infectious pneumonitis.&#xD;
&#xD;
          -  Has an active infection requiring systemic therapy.&#xD;
&#xD;
          -  Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
             that might confound the results of the trial, interfere with the subject's&#xD;
             participation for the full duration of the trial, or is not in the best interest of&#xD;
             the subject to participate, in the opinion of the treating investigator.&#xD;
&#xD;
          -  Has known psychiatric or substance abuse disorders that would interfere with&#xD;
             cooperation with the requirements of the trial.&#xD;
&#xD;
          -  Is pregnant or breastfeeding, or expecting to conceive or father children within the&#xD;
             projected duration of the trial, starting with the pre-screening or screening visit&#xD;
             through 120 days after the last dose of trial treatment.&#xD;
&#xD;
          -  Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.&#xD;
&#xD;
          -  Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).&#xD;
&#xD;
          -  Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C&#xD;
&#xD;
          -  Has received a live vaccine within 30 days of planned start of study therapy.&#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>Nathan Pennell, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>December 15, 2022</last_update_submitted>
  <last_update_submitted_qc>December 15, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Case Comprehensive Cancer Center</investigator_affiliation>
    <investigator_full_name>Nathan Pennell, MD, PhD</investigator_full_name>
    <investigator_title>Study principal investigator</investigator_title>
  </responsible_party>
  <keyword>Pembrolizumab</keyword>
  <keyword>Chemoradiation</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>Pembrolizumab</mesh_term>
    <mesh_term>Etoposide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02987998
org study id: CASE4516
nct id: NCT02987998
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The purpose of this study is to determine the feasibility and evaluate the safety of
      delivering chemoradiotherapy, the usual approach to non-small cell lung cancer, in
      combination with pembrolizumab (MK-3745), followed by consolidation pembrolizumab after
      surgical resection. Consolidation therapy is treatment given following the initial treatment.

      Pembrolizumab is an investigational drug (also known as Keytruda), which has been approved by
      the FDA for use in certain types of skin cancer (melanoma), and for use in certain types of
      head and neck cancer. However, it has not been approved for use in other cancers such as
      non-small cell lung cancer (NSCLC). Pembrolizumab is a monoclonal antibody that binds to the
      surface of some cells of the immune system and activates them against cancer cells. It is not
      chemotherapy.
The primary hypothesis is that the addition of pembrolizumab to neoadjuvant concurrent
      chemoradiation, followed by consolidation pembrolizumab, will be safe and feasible to deliver
      to patients with resectable stage 3A Non-small cell lung cancer (NSCLC).

      This study also plans to observe the efficacy of this combination in the overall and
      biomarker-positive population.

      Primary Objective Primary objective of this phase 1 study is to determine safety and
      feasibility of MK3475 with standard of care therapy of chemotherapy with radiation for newly
      diagnosed stage 3 lung carcinoma.

      • To define the Safety, tolerability and feasibility of MK3475 in combination with
      chemotherapy with cisplatin and etoposide along with 45 Gy of radiation in newly diagnosed
      stage 3 non-small cell lung carcinoma.

      Secondary Objective(s)

        -  Progression Free Survival

        -  Objective response rate,

        -  Complete pathologic response rate,

        -  Nodal downstaging at surgery,

        -  Overall survival,

        -  Safety and tolerability

      Correlative Objective(s) Exploratory objectives: Overall response rate, progression free
      survival, overall survival in Programmed death-ligand (PDL-1) positive versus negative
      subgroups

      Study Design This is an open-label, single arm phase I trial of neoadjuvant chemotherapy +
      pembrolizumab with concurrent radiation followed by surgical resection and consolidation
      pembrolizumab in resectable stage 3A (N2+) NSCLC.

      Eligible patients will have biopsy-confirmed T1-3N2M0 (stage IIIA) non-small cell lung cancer
      (adenocarcinoma, squamous cell carcinoma, or large cell/NSCLC not otherwise specified),
      performance status 0-1, adequate lung function and deemed medically resectable by a thoracic
      surgeon, adequate organ function for chemotherapy, and no contraindications to pembrolizumab
      (i.e. autoimmune disorders or underlying pulmonary fibrosis).

      Because pembrolizumab has been safely added to multiple platinum doublet chemotherapy
      regimens in lung cancer but not yet tested in the setting of concurrent radiation, we plan to
      evaluate safety and feasibility of the combination therapy. 10 patients will be enrolled at
      the full starting dose of all 3 agents. If 3 or more (>30%) have grade 3 or higher pulmonary
      toxicity or any grade 4 nonhematologic toxicity, the study will be stopped. If 2 or fewer
      have > grade 3 pulmonary toxicity or > grade 4 other nonhematologic toxicity, then an
      additional 10 will be enrolled. If 5 or fewer (<25%) of the 20 patients have > grade 3
      pulmonary toxicity or > grade 4 other nonhematologic toxicity, then this regimen will be
      deemed safe and feasible for further study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of patients with grade 3 pulmonary toxicity or grade 4 other non hematologic toxicity
time frame: Up to 5 years
description: If 5 or fewer (<25%) of the 20 patients have > grade 3 pulmonary toxicity or > grade 4 other nonhematologic toxicity, then this regimen will be deemed safe and feasible for further study
measure: Progression Free Survival
time frame: Up to 5 years
description: Time from beginning of treatment to progression, death, or five years, whichever came first. Progression is defined as Progressive Disease (PD): At least a 20% increase in the sum of 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
measure: Objective Response Rate
time frame: Up to 5 years
description: Number of patients with objective response (CR + PR) where complete response is defined as 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. And Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
measure: Complete Pathologic Response Rate
time frame: Up to 5 years
description: Pathological complete response is defined as absence of foci of tumor cells at the local site (pCR)
measure: Nodal Downstaging at Surgery
time frame: Up to 4 weeks after induction treatment
description: Number of patients with reduced stages in nodes at surgery
measure: Overall Survival
time frame: Up to 5 years
description: Time from beginning of treatment to death or 5 year, whichever comes first
arm group label: Resectable Patients
arm group type: Experimental
description: Chemoradiation (Cisplatin + Etoposide + Pembrolizumab with concurrent radiation). Patients will be assessed for surgery followed by consolidation therapy
intervention type: Drug
intervention name: Cisplatin
description: Cisplatin (50mg/m2 IV D1, 8, 29, 36)
arm group label: Resectable Patients
intervention type: Drug
intervention name: Etoposide
description: Etoposide (50mg/m2 IV D1-5, 29-33)
arm group label: Resectable Patients
intervention type: Drug
intervention name: Pembrolizumab
description: Pembrolizumab (200mg IV D1, 21, 42)
arm group label: Resectable Patients
intervention type: Drug
intervention name: Radiation
description: Radiation (1.8Gy/D to 45Gy in 25 fractions)
arm group label: Resectable Patients
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nathan Pennell, MD, PhD
role: Principal Investigator
affiliation: Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: Case Comprehensive Cancer Center
investigator full name: Nathan Pennell, MD, PhD
investigator title: Study principal investigator
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Pembrolizumab
mesh term: Etoposide