<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/NCT03237377</url>
  </required_header>
  <id_info>
    <org_study_id>J1772</org_study_id>
    <secondary_id>IRB00127418</secondary_id>
    <secondary_id>ESR-16-12244</secondary_id>
    <nct_id>NCT03237377</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Immunoradiation for Resectable Non-Small Cell Lung Cancer</brief_title>
  <official_title>Neoadjuvant Immunoradiation for Stage III Resectable Non-Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>AstraZeneca</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</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 is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus&#xD;
      tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic&#xD;
      radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the&#xD;
      pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is&#xD;
      deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the&#xD;
      durvalumab/thoracic RT combination is established, a second cohort investigating the&#xD;
      combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be&#xD;
      opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as&#xD;
      deemed appropriate by the treating investigator.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 12, 2017</start_date>
  <completion_date type="Anticipated">May 28, 2024</completion_date>
  <primary_completion_date type="Actual">November 4, 2021</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>Sequential Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Toxicities as measured by number of participants experiencing adverse events</measure>
    <time_frame>Up to 100 days</time_frame>
    <description>Number of participants experiencing adverse events as defined by CTCAE v4.0.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Feasibility of Preoperative Immunoradiation</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Number of participants with stage III resectable NSCLC who received durvalumab or durvalumab plus tremelimumab concurrently with thoracic radiation (RT) in the pre-surgical window prior to surgical resection, for whom planned surgical resection was not delayed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surgical Morbidity and Mortality</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Number of participants who experience post-operative death. Calculated through log-rank test and Cox proportional hazards (PH) model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Pathologic Response</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Percentage of participants with major pathologic response (MPR), partial response (PR) or no response (NR), where MPR is &gt;90% reduction in tumor cells, PR = 10-90% or NR = 0-10%. The percentage of patients whose tumor samples achieve MPR, PR and NR will be tabulated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Radiologic Response</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Percentage of participants with complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD) as defined by RECIST 1.1 and immune-related RECIST criteria when treated with preoperative immunoradiation followed by surgery. CR = disappearance of all target lesions, PR is =&gt;30% decrease in sum of diameters of target lesions, PD is &gt;20% increase in sum of diameters of target lesions, SD is &lt;30% decrease or &lt;20% increase in sum of diameters of target lesions.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response as measured by recurrence-free survival</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Time from first evidence of response until recurrence when treated with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall Survival</measure>
    <time_frame>Up to 3 years</time_frame>
    <description>Number of months alive after treatment with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">9</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Durvalumab with Radiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drug: Durvalumab Other Names: MEDI4736&#xD;
MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction&#xD;
Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy&#xD;
Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Durvalumab and Trememlimumab with Radiation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy&#xD;
Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Durvalumab</intervention_name>
    <description>1500mg via IV infusion every 4 weeks for up to 3 doses/cycles</description>
    <arm_group_label>Durvalumab and Trememlimumab with Radiation</arm_group_label>
    <arm_group_label>Durvalumab with Radiation</arm_group_label>
    <other_name>[MEDI4736]</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tremelimumab</intervention_name>
    <description>75mg via IV infusion every 4 weeks</description>
    <arm_group_label>Durvalumab and Trememlimumab with Radiation</arm_group_label>
    <other_name>[CP-675 206]</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Thoracic Radiation</intervention_name>
    <description>5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction</description>
    <arm_group_label>Durvalumab and Trememlimumab with Radiation</arm_group_label>
    <arm_group_label>Durvalumab with Radiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lobectomy</intervention_name>
    <description>patients may proceed to surgery post drug and radiation intervention for lung lobectomy</description>
    <arm_group_label>Durvalumab and Trememlimumab with Radiation</arm_group_label>
    <arm_group_label>Durvalumab with Radiation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of care adjuvant chemotherapy</intervention_name>
    <description>patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery</description>
    <arm_group_label>Durvalumab and Trememlimumab with Radiation</arm_group_label>
    <arm_group_label>Durvalumab with Radiation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Written informed consent and any locally-required authorization obtained.&#xD;
&#xD;
          -  Histologically-confirmed diagnosis of stage III non-small cell lung cancer (NSCLC)&#xD;
&#xD;
          -  Age≥18 years&#xD;
&#xD;
          -  Life expectancy &gt;6 months&#xD;
&#xD;
          -  Body weight &gt;30kg&#xD;
&#xD;
          -  Subjects with non-small cell lung cancer deemed surgically resectable by an attending&#xD;
             thoracic surgeon with lobectomy&#xD;
&#xD;
          -  ECOG Performance Status 0-1&#xD;
&#xD;
          -  Normal bone marrow and organ function on routine laboratory tests, as defined in&#xD;
             section 4.1&#xD;
&#xD;
          -  Evidence of post-menopausal status or negative urinary/serum pregnancy test for female&#xD;
             pre-menopausal subjects. Women will be considered post-menopausal if they have been&#xD;
             amenorrheic for 12 months without an alternative medical cause.&#xD;
&#xD;
          -  Ability to understand and willingness of sign consent form&#xD;
&#xD;
          -  Willingness to comply with the protocol for the duration of the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Involvement in the planning and/or conduct of the study (includes AstraZeneca staff&#xD;
             and staff at the study site)&#xD;
&#xD;
          -  Prior investigational therapy within 28 days/at least 5 half-lives before study drug&#xD;
             administration&#xD;
&#xD;
          -  Prior chest radiation&#xD;
&#xD;
          -  Prior history of interstitial lung disease or pneumonitis requiring corticosteroids,&#xD;
             or active non-infectious pneumonitis&#xD;
&#xD;
          -  Patients only suitable for surgical management with pneumonectomy, deemed by an&#xD;
             attending thoracic surgeon&#xD;
&#xD;
          -  Prior therapy with PD-1, PD-L1, CTLA-4 or anti-cancer vaccines, including durvalumab&#xD;
             and tremelimumab&#xD;
&#xD;
          -  Participation in another clinical study with an investigational product in the last 4&#xD;
             weeks or equivalent of 5 half-lives of the first dose of study treatment, whichever is&#xD;
             shorter&#xD;
&#xD;
          -  History of another primary malignancy that requires active ongoing treatment or, in&#xD;
             the opinion of the investigator, is likely to require treatment within 6 months of&#xD;
             trial enrollment&#xD;
&#xD;
          -  Current or prior use of immunosuppressive medication within 14 days before the first&#xD;
             dose of durvalumab or tremelimumab. The following are exceptions to this criterion:&#xD;
&#xD;
               -  Intranasal, inhaled, topical steroids, or local steroid injections (e.g., intra&#xD;
                  articular injection)&#xD;
&#xD;
               -  Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of&#xD;
                  prednisone or its equivalent&#xD;
&#xD;
               -  Steroids as premedication for hypersensitivity reactions (e.g., CT scan&#xD;
                  premedication)&#xD;
&#xD;
          -  Any unresolved toxicity (&gt;CTCAE grade 2) from previous anti-cancer therapy&#xD;
&#xD;
          -  Subjects with irreversible toxicity that is not reasonably expected to be exacerbated&#xD;
             by the investigational product may be included (e.g., hearing loss, peripherally&#xD;
             neuropathy)&#xD;
&#xD;
          -  Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment.&#xD;
             Concurrent use of hormonal therapy for non-cancer-related conditions (e.g., hormone&#xD;
             replacement therapy) is acceptable&#xD;
&#xD;
          -  Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of&#xD;
             radiation within 4 weeks of the first dose of study drug.&#xD;
&#xD;
          -  Major surgical procedure (as defined by the Investigator) within 28 days prior to the&#xD;
             first dose of IP. Note: Local surgery of isolated lesions for palliative intent is&#xD;
             acceptable&#xD;
&#xD;
          -  History of allogenic organ transplantation.&#xD;
&#xD;
          -  Active or prior documented autoimmune or inflammatory disorders (including&#xD;
             inflammatory bowel disease [e.g., colitis or Crohn's disease], diverticulitis [with&#xD;
             the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome,&#xD;
             or Wegener syndrome [granulomatosis with polyangiitis, Graves' disease, rheumatoid&#xD;
             arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this&#xD;
             criterion (vitiligo or alopecia; hypothyroidism (eg, following Hashimoto syndrome)&#xD;
             stable on hormone replacement; any chronic skin condition that does not require&#xD;
             systemic therapy; active disease in the last 5 years may be included but only after&#xD;
             consultation with the study physician; celiac disease controlled by diet alone.)&#xD;
&#xD;
          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active&#xD;
             infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable&#xD;
             angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active&#xD;
             bleeding diatheses including any subject known to have evidence of acute or chronic&#xD;
             hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric&#xD;
             illness/social situations that would limit compliance with study requirements or&#xD;
             compromise the ability of the subject to give written informed consent&#xD;
&#xD;
          -  Active infection including tuberculosis (clinical evaluation that includes clinical&#xD;
             history, physical examination and radiographic findings, and TB testing in line with&#xD;
             local practice), hepatitis B (known positive HBV surface antigen (HBsAg) result),&#xD;
             hepatitis C, or human immunodeficiency virus (positive HIV 1/2 antibodies). Subjects&#xD;
             with a past or resolved HBV infection (defined as the presence of hepatitis B core&#xD;
             antibody [anti-HBc] and absence of HBsAg) are eligible. Subjects positive for&#xD;
             hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative&#xD;
             for HCV RNA.&#xD;
&#xD;
          -  Receipt of live attenuated vaccination within 30 days prior to study entry or within&#xD;
             30 days of receiving durvalumab or tremelimumab&#xD;
&#xD;
          -  Female subjects who are pregnant, breast-feeding or male or female patients of&#xD;
             reproductive potential who are not employing an effective method of birth control.&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator, would interfere with&#xD;
             evaluation of study treatment or interpretation of patient safety or study result.&#xD;
&#xD;
          -  Known allergy or hypersensitivity to IP or any excipient&#xD;
&#xD;
          -  Uncontrolled psychiatric illness/social situations that would limit compliance with&#xD;
             study requirements or compromise the ability of the subject to give written consent&#xD;
&#xD;
          -  Any condition that, in the opinion of the investigator would interfere with evaluation&#xD;
             of study treatment or interpretation of patient safety or study results.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Patrick Forde, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Margaret Cancer Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 19, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <disposition_first_submitted>November 3, 2022</disposition_first_submitted>
  <last_update_submitted>November 8, 2022</last_update_submitted>
  <last_update_submitted_qc>November 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>Durvalumab</mesh_term>
    <mesh_term>Tremelimumab</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>May 30, 2023</submitted>
    <returned>June 23, 2023</returned>
    <submitted>July 14, 2023</submitted>
    <returned>August 3, 2023</returned>
    <submitted>August 25, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT03237377
org study id: J1772
secondary id: IRB00127418
secondary id: ESR-16-12244
nct id: NCT03237377
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
This is a pilot study of neoadjuvant 'immunoradiation' (durvalumab or durvalumab plus
      tremelimumab) administered every 4 weeks for 2 doses, concurrently with standard thoracic
      radiation (RT) (45Gy in 25 fractions), with one dose of immunotherapy alone delivered in the
      pre-surgical window, prior to surgical resection, for patients with stage IIIA NSCLC that is
      deemed resectable with a lobectomy by a thoracic surgeon. If preliminary safety of the
      durvalumab/thoracic RT combination is established, a second cohort investigating the
      combination of durvalumab/tremelimumab/thoracic RT prior to surgical resection will be
      opened. After surgical resection, patients may receive standard adjuvant chemotherapy, as
      deemed appropriate by the treating investigator.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Toxicities as measured by number of participants experiencing adverse events
time frame: Up to 100 days
description: Number of participants experiencing adverse events as defined by CTCAE v4.0.
measure: Feasibility of Preoperative Immunoradiation
time frame: Up to 3 years
description: Number of participants with stage III resectable NSCLC who received durvalumab or durvalumab plus tremelimumab concurrently with thoracic radiation (RT) in the pre-surgical window prior to surgical resection, for whom planned surgical resection was not delayed.
measure: Surgical Morbidity and Mortality
time frame: Up to 3 years
description: Number of participants who experience post-operative death. Calculated through log-rank test and Cox proportional hazards (PH) model.
measure: Percentage of Participants with Pathologic Response
time frame: Up to 3 years
description: Percentage of participants with major pathologic response (MPR), partial response (PR) or no response (NR), where MPR is >90% reduction in tumor cells, PR = 10-90% or NR = 0-10%. The percentage of patients whose tumor samples achieve MPR, PR and NR will be tabulated.
measure: Percentage of Participants with Radiologic Response
time frame: Up to 3 years
description: Percentage of participants with complete response (CR), partial response (PR), progressive disease (PD), and stable disease (SD) as defined by RECIST 1.1 and immune-related RECIST criteria when treated with preoperative immunoradiation followed by surgery. CR = disappearance of all target lesions, PR is =>30% decrease in sum of diameters of target lesions, PD is >20% increase in sum of diameters of target lesions, SD is <30% decrease or <20% increase in sum of diameters of target lesions.
measure: Duration of Response as measured by recurrence-free survival
time frame: Up to 3 years
description: Time from first evidence of response until recurrence when treated with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model.
measure: Overall Survival
time frame: Up to 3 years
description: Number of months alive after treatment with preoperative immunoradiation followed by surgery. Calculated through log-rank test and Cox proportional hazards (PH) model.
arm group label: Durvalumab with Radiation
arm group type: Experimental
description: Drug: Durvalumab Other Names: MEDI4736
MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction
Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy
Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
arm group label: Durvalumab and Trememlimumab with Radiation
arm group type: Experimental
description: Drugs: Durvalumab + Tremelimumab Other Names: MEDI4736 and CP-675 MEDI4736 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles + CP-675 206 75mg via IV infusion every 4 weeks up 3 doses/cycles Intervention: Radiation: Thoracic Radiation 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction Intervention: Procedure/Surgery: lobectomy patients may proceed to surgery post drug and radiation intervention for lung lobectomy
Intervention: Drug: Standard of care adjuvant chemotherapy patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
intervention type: Drug
intervention name: Durvalumab
description: 1500mg via IV infusion every 4 weeks for up to 3 doses/cycles
arm group label: Durvalumab and Trememlimumab with Radiation
arm group label: Durvalumab with Radiation
other name: [MEDI4736]
intervention type: Drug
intervention name: Tremelimumab
description: 75mg via IV infusion every 4 weeks
arm group label: Durvalumab and Trememlimumab with Radiation
other name: [CP-675 206]
intervention type: Radiation
intervention name: Thoracic Radiation
description: 5 days per week in once daily fractionation, 1.8-2.0 Gy per fraction
arm group label: Durvalumab and Trememlimumab with Radiation
arm group label: Durvalumab with Radiation
intervention type: Procedure
intervention name: lobectomy
description: patients may proceed to surgery post drug and radiation intervention for lung lobectomy
arm group label: Durvalumab and Trememlimumab with Radiation
arm group label: Durvalumab with Radiation
intervention type: Drug
intervention name: Standard of care adjuvant chemotherapy
description: patients may or may not proceed to adjuvant chemotherapy post trial drug and radiation intervention and surgery
arm group label: Durvalumab and Trememlimumab with Radiation
arm group label: Durvalumab with Radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Patrick Forde, MD
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
facility: 
country: Canada
country: United States
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Durvalumab
mesh term: Tremelimumab
submitted: May 30, 2023
returned: June 23, 2023
submitted: July 14, 2023
returned: August 3, 2023
submitted: August 25, 2023