<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/NCT03228537</url>
  </required_header>
  <id_info>
    <org_study_id>NCI-2017-01230</org_study_id>
    <secondary_id>NCI-2017-01230</secondary_id>
    <secondary_id>S1619</secondary_id>
    <secondary_id>S1619</secondary_id>
    <secondary_id>U10CA180888</secondary_id>
    <nct_id>NCT03228537</nct_id>
  </id_info>
  <brief_title>Atezolizumab, Pemetrexed Disodium, Cisplatin, and Surgery With or Without Radiation Therapy in Treating Patients With Stage I-III Pleural Malignant Mesothelioma</brief_title>
  <official_title>A Feasibility Trial of Neoadjuvant Cisplatin-Pemetrexed With Atezolizumab in Combination and in Maintenance for Resectable Malignant Pleural Mesothelioma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Cancer Institute (NCI)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Cancer Institute (NCI)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and&#xD;
      surgery with or without radiation therapy works in treating patients with stage I-III pleural&#xD;
      malignant mesothelioma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may&#xD;
      help the body's immune system attack the cancer, and may interfere with the ability of tumor&#xD;
      cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking&#xD;
      some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin,&#xD;
      work in different ways to stop the growth of tumor cells, either by killing the cells, by&#xD;
      stopping them from dividing, or by stopping them from spreading. Giving atezolizumab,&#xD;
      pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the&#xD;
      amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill&#xD;
      any remaining tumor cells.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVE:&#xD;
&#xD;
      I. To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed disodium&#xD;
      (pemetrexed)-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible&#xD;
      and safe for patients with resectable malignant pleural mesothelioma.&#xD;
&#xD;
      SECONDARY OBJECTIVES:&#xD;
&#xD;
      I. To evaluate progression free survival (both by Response Evaluation Criteria in Solid&#xD;
      Tumors [RECIST] 1.1 and also using a modified RECIST for pleural tumors) in patients with&#xD;
      resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant&#xD;
      cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance&#xD;
      atezolizumab.&#xD;
&#xD;
      II. To evaluate overall survival in patients with resectable malignant pleural mesothelioma&#xD;
      treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/-&#xD;
      radiation, followed by one year of maintenance atezolizumab.&#xD;
&#xD;
      III. To evaluate response rate (confirmed and unconfirmed, complete and partial, both by&#xD;
      RECIST 1.1 and also using a modified RECIST for pleural tumors) in the subset of this patient&#xD;
      population with measurable disease.&#xD;
&#xD;
      TRANSLATIONAL MEDICINE OBJECTIVES:&#xD;
&#xD;
      I. To evaluate the association between immunohistochemical (IHC) expression of PD-L1 in&#xD;
      tumors and clinical outcomes in mesothelioma patients treated with trimodality/bimodality&#xD;
      therapy including atezolizumab (anti-PD-L1).&#xD;
&#xD;
      II. To evaluate the association between expression of immune-related genes identified by&#xD;
      Immune Nanostring (depending on ribonucleic acid [RNA] availability) and clinical outcomes in&#xD;
      mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab.&#xD;
&#xD;
      III. To evaluate the association between multiplex immunofluorescence (IF) of up to 10 immune&#xD;
      markers in two panels and clinical outcomes in mesothelioma patients treated with&#xD;
      trimodality/bimodality therapy including atezolizumab.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      NEOADJUVANT: Patients receive atezolizumab intravenously (IV) over 30-60 minutes, pemetrexed&#xD;
      disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21&#xD;
      days for 4 cycles in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo&#xD;
      extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP&#xD;
      will then undergo radiation therapy (RT).&#xD;
&#xD;
      MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients&#xD;
      receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1&#xD;
      year in the absence of disease progression or unexpected toxicity.&#xD;
&#xD;
      After completion of study treatment, patients are followed up for up to 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">November 3, 2017</start_date>
  <completion_date type="Anticipated">October 24, 2023</completion_date>
  <primary_completion_date type="Actual">October 1, 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>Progression free survival</measure>
    <time_frame>From date of registration to step 1 to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years</time_frame>
    <description>Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be evaluated using the method of Kaplan-Meier. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Overall survival</measure>
    <time_frame>From date of initial registration to date of death due to any cause, assessed up to 3 years</time_frame>
    <description>Will be evaluated using the method of Kaplan-Meier. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Modified Response Evaluation Criteria in Solid Tumors (RECIST) progression free survival</measure>
    <time_frame>From date of registration to step 1 to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years</time_frame>
    <description>Will be assessed by modified RECIST 1.1. Will be evaluated using the method of Kaplan-Meier. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Biphasic Mesothelioma</condition>
  <condition>Epithelioid Mesothelioma</condition>
  <condition>Stage I Pleural Malignant Mesothelioma AJCC v7</condition>
  <condition>Stage IA Pleural Malignant Mesothelioma AJCC v7</condition>
  <condition>Stage IB Pleural Malignant Mesothelioma AJCC v7</condition>
  <condition>Stage II Pleural Malignant Mesothelioma AJCC v7</condition>
  <condition>Stage III Pleural Malignant Mesothelioma AJCC v7</condition>
  <arm_group>
    <arm_group_label>Treatment (chemotherapy, surgery, RT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.&#xD;
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo EPP or PD. Patients who undergo EPP will then undergo RT.&#xD;
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Atezolizumab</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, surgery, RT)</arm_group_label>
    <other_name>MPDL 3280A</other_name>
    <other_name>MPDL 328OA</other_name>
    <other_name>MPDL-3280A</other_name>
    <other_name>MPDL3280A</other_name>
    <other_name>MPDL328OA</other_name>
    <other_name>RG7446</other_name>
    <other_name>RO5541267</other_name>
    <other_name>Tecentriq</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Cisplatin</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, surgery, RT)</arm_group_label>
    <other_name>Abiplatin</other_name>
    <other_name>Blastolem</other_name>
    <other_name>Briplatin</other_name>
    <other_name>CDDP</other_name>
    <other_name>Cis-diammine-dichloroplatinum</other_name>
    <other_name>Cis-diamminedichloridoplatinum</other_name>
    <other_name>Cis-diamminedichloro Platinum (II)</other_name>
    <other_name>Cis-diamminedichloroplatinum</other_name>
    <other_name>Cis-dichloroammine Platinum (II)</other_name>
    <other_name>Cis-platinous Diamine Dichloride</other_name>
    <other_name>Cis-platinum</other_name>
    <other_name>Cis-platinum II</other_name>
    <other_name>Cis-platinum II Diamine Dichloride</other_name>
    <other_name>Cismaplat</other_name>
    <other_name>Cisplatina</other_name>
    <other_name>Cisplatinum</other_name>
    <other_name>Cisplatyl</other_name>
    <other_name>Citoplatino</other_name>
    <other_name>Citosin</other_name>
    <other_name>Cysplatyna</other_name>
    <other_name>DDP</other_name>
    <other_name>Lederplatin</other_name>
    <other_name>Metaplatin</other_name>
    <other_name>Neoplatin</other_name>
    <other_name>Peyrone's Chloride</other_name>
    <other_name>Peyrone's Salt</other_name>
    <other_name>Placis</other_name>
    <other_name>Plastistil</other_name>
    <other_name>Platamine</other_name>
    <other_name>Platiblastin</other_name>
    <other_name>Platiblastin-S</other_name>
    <other_name>Platinex</other_name>
    <other_name>Platinol</other_name>
    <other_name>Platinol- AQ</other_name>
    <other_name>Platinol-AQ</other_name>
    <other_name>Platinol-AQ VHA Plus</other_name>
    <other_name>Platinoxan</other_name>
    <other_name>Platinum</other_name>
    <other_name>Platinum Diamminodichloride</other_name>
    <other_name>Platiran</other_name>
    <other_name>Platistin</other_name>
    <other_name>Platosin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Extrapleural Pneumonectomy</intervention_name>
    <description>Undergo EPP</description>
    <arm_group_label>Treatment (chemotherapy, surgery, RT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pemetrexed Disodium</intervention_name>
    <description>Given IV</description>
    <arm_group_label>Treatment (chemotherapy, surgery, RT)</arm_group_label>
    <other_name>Alimta</other_name>
    <other_name>Almita</other_name>
    <other_name>LY231514</other_name>
    <other_name>N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pleurectomy</intervention_name>
    <description>Undergo PD</description>
    <arm_group_label>Treatment (chemotherapy, surgery, RT)</arm_group_label>
    <other_name>Excision of Pleura</other_name>
  </intervention>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Radiation Therapy</intervention_name>
    <description>Undergo RT</description>
    <arm_group_label>Treatment (chemotherapy, surgery, RT)</arm_group_label>
    <other_name>Cancer Radiotherapy</other_name>
    <other_name>Energy Type</other_name>
    <other_name>ENERGY_TYPE</other_name>
    <other_name>Irradiate</other_name>
    <other_name>Irradiated</other_name>
    <other_name>Irradiation</other_name>
    <other_name>Radiation</other_name>
    <other_name>Radiation Therapy, NOS</other_name>
    <other_name>Radiotherapeutics</other_name>
    <other_name>Radiotherapy</other_name>
    <other_name>RT</other_name>
    <other_name>Therapy, Radiation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  STEP 1: NEOADJUVANT&#xD;
&#xD;
          -  Patient must have stage I-III malignant pleural mesothelioma that is deemed resectable&#xD;
             and must be planning to undergo pleurectomy decortication (P/D) or extrapleural&#xD;
             pneumonectomy (EPP)&#xD;
&#xD;
          -  Patient must have epithelioid or biphasic histology (sarcomatoid histology is&#xD;
             excluded); histologic diagnosis and typing of mesothelioma requires at least a core&#xD;
             needle biopsy or surgical biopsy of the pleura via thoracoscopy and small thoracotomy;&#xD;
             cytology only will not be regarded as sufficient for the diagnosis&#xD;
&#xD;
          -  Patient must have computed tomography (CT) chest/abdomen/pelvis with contrast or&#xD;
             fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/CT scan performed within&#xD;
             28 days prior to step 1 registration&#xD;
&#xD;
          -  Patients must have non-measurable or measurable disease documented by CT or magnetic&#xD;
             resonance imaging (MRI); the CT from a combined PET/CT may be used to document only&#xD;
             non-measurable disease unless it is of diagnostic quality; measurable disease must be&#xD;
             assessed within 28 days prior to step 1 registration; non-measurable disease must be&#xD;
             assessed within 42 days prior to step 1 registration; all disease must be assessed and&#xD;
             documented on the RECIST 1.1 and modified RECIST baseline tumor assessment form&#xD;
&#xD;
          -  Patient must have undergone extended surgical staging including mediastinoscopy or&#xD;
             endobronchial ultrasound; at minimum, samples must be obtained from the mediastinal&#xD;
             stations 4R, 7 (subcarinal), and 4L; this surgical staging must be performed within 42&#xD;
             days prior to step 1 registration; patient must be T1-3 and N0-N2 (single station)&#xD;
&#xD;
          -  Patient must undergo video-assisted thoracoscopic surgery and diagnostic laparoscopy&#xD;
             within 28 days prior to step 1 registration to rule out peritoneal disease spread&#xD;
&#xD;
          -  Patient must have consultation with a surgeon within 21 days prior to step 1&#xD;
             registration; the surgeon must confirm that the patient's disease is resectable by&#xD;
             pleurectomy decortication (P/D) or extrapleural pneumonectomy (EPP) and that the&#xD;
             patient is an appropriate candidate for the surgical procedures&#xD;
&#xD;
          -  Patient must not have had prior immunotherapy or chemotherapy for malignant pleural&#xD;
             mesothelioma&#xD;
&#xD;
          -  Patient must have Zubrod performance status 0 or 1 documented within 28 days prior to&#xD;
             step 1 registration&#xD;
&#xD;
          -  Patients requiring hearing aids or reporting hearing loss must have audiogram&#xD;
             performed within 28 days prior to step 1 registration&#xD;
&#xD;
          -  Patient must have not had any major surgery or radiation within 28 days prior to step&#xD;
             1 registration; diagnostic thoracotomies and laparoscopies are not considered major&#xD;
             surgeries&#xD;
&#xD;
          -  Patients must not have any anticancer therapy or investigational agent within 28 days&#xD;
             prior to step 1 registration&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) &gt;= 1,500/mcl (documented within 28 days prior to step&#xD;
             1 registration)&#xD;
&#xD;
          -  Hemoglobin &gt;= 9 g/dl (documented within 28 days prior to step 1 registration)&#xD;
&#xD;
          -  Platelets &gt;= 100,000/mcl (documented within 28 days prior to step 1 registration)&#xD;
&#xD;
          -  Creatinine =&lt; 1.5 x upper limit of normal (ULN) (documented within 28 days prior to&#xD;
             step 1 registration)&#xD;
&#xD;
          -  Creatinine clearance &gt;= 45 ml/min (documented within 28 days prior to step 1&#xD;
             registration)&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x upper limit of normal (ULN) (within 28 days prior to step 1&#xD;
             registration)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =&lt; 3 x ULN (within&#xD;
             28 days prior to step 1 registration)&#xD;
&#xD;
          -  No other prior malignancy is allowed except for the following: adequately treated&#xD;
             basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated&#xD;
             stage I or II cancer from which the patient is currently in complete remission, or any&#xD;
             other cancer from which the patient has been disease free for three years&#xD;
&#xD;
          -  Patients must not be pregnant or nursing due to the potential teratogenic side effects&#xD;
             of the protocol treatment; women of reproductive potential and men must have agreed to&#xD;
             use an effective contraceptive method for the duration of study treatment and for 5&#xD;
             months (150 days) after the last dose of atezolizumab; a woman is considered to be of&#xD;
             &quot;reproductive potential&quot; if she has had menses at any time in the preceding 12&#xD;
             consecutive months; in addition to routine contraceptive methods, &quot;effective&#xD;
             contraception&quot; also includes heterosexual celibacy and surgery intended to prevent&#xD;
             pregnancy (or with a side effect of pregnancy prevention) defined as a hysterectomy,&#xD;
             bilateral oophorectomy or bilateral tubal ligation; however, if at any point a&#xD;
             previously celibate patient chooses to become heterosexually active during the time&#xD;
             period for use of contraceptive measures outlined in the protocol, he/she is&#xD;
             responsible for beginning contraceptive measures&#xD;
&#xD;
          -  Patient must NOT have a history of severe allergic, anaphylactic, or other&#xD;
             hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins&#xD;
&#xD;
          -  Patient must NOT have a known hypersensitivity or allergy to biopharmaceuticals&#xD;
             produced in Chinese hamster ovary cells or any component of the atezolizumab&#xD;
             formulation&#xD;
&#xD;
          -  Patients must not have severe infections within 28 days prior to step 1 registration,&#xD;
             including but not limited to hospitalization for complications of infection,&#xD;
             bacteremia, or severe pneumonia&#xD;
&#xD;
          -  Patients must not have active autoimmune disease that has required systemic treatment&#xD;
             in past two years (i.e., with use of disease modifying agents, corticosteroids or&#xD;
             immunosuppressive drugs); replacement therapy (e.g., thyroxine, insulin, or&#xD;
             physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency,&#xD;
             etc.) is not considered a form of systemic treatment; autoimmune diseases include, but&#xD;
             are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory&#xD;
             bowel disease, vascular thrombosis associated with antiphospholipid syndrome,&#xD;
             Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome,&#xD;
             multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis;&#xD;
             this protocol includes an immunotherapy agent which can precipitate known autoimmune&#xD;
             diseases&#xD;
&#xD;
          -  Patients must not have undergone prior allogeneic bone marrow transplantation or prior&#xD;
             solid organ transplantation&#xD;
&#xD;
          -  Patient must not have active tuberculosis&#xD;
&#xD;
          -  Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including&#xD;
             drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic&#xD;
             organizing pneumonia, etc.), or evidence of active pneumonitis; this protocol includes&#xD;
             an immunotherapy agent which can precipitate known pneumonitis&#xD;
&#xD;
          -  Patient must not have active (chronic or acute) hepatitis B virus (HBV) infection as&#xD;
             evidenced by testing performed within 28 days prior to registration; patients with&#xD;
             past or resolved HBV infection are eligible; active HBV is defined as having a&#xD;
             positive hepatitis B surface antigen (HBsAg) test; past or resolved HBV is defined as&#xD;
             having a negative HBsAG test and a positive total hepatitis B core antibody (HBcAb)&#xD;
             test; patient must not have active hepatitis C virus (HCV) infection as evidenced by&#xD;
             testing performed within 28 days prior to registration; active HCV is defined as&#xD;
             having a positive HCV antibody test followed by a positive HCV RNA test&#xD;
&#xD;
          -  Patient must NOT have a known positive test for human immunodeficiency virus (HIV);&#xD;
             patients do not need to be screened for HIV; patients with HIV are excluded due to a&#xD;
             potential incompetent immune system and need for medications that could interfere with&#xD;
             the treatment and immunotherapy&#xD;
&#xD;
          -  Patient must not have significant cardiovascular disease, such as New York Heart&#xD;
             Association cardiac disease (class II or greater), myocardial infarction within 3&#xD;
             months prior to initiation of treatment, unstable arrhythmias, or unstable angina&#xD;
             given the higher risks associated with surgical resection&#xD;
&#xD;
          -  Patient must not receive live, attenuated influenza vaccine within 4 weeks prior to&#xD;
             registration or at any time during the study and until 5 months after the last dose of&#xD;
             atezolizumab&#xD;
&#xD;
          -  Patient must be willing to have tissue specimens submitted for translational medicine&#xD;
             studies&#xD;
&#xD;
          -  Patient must be offered the opportunity to participate in tissue and blood banking for&#xD;
             future studies&#xD;
&#xD;
          -  Patient must be informed of the investigational nature of this study and must sign and&#xD;
             give written informed consent in accordance with institutional and federal guidelines&#xD;
&#xD;
          -  As a part of the Oncology Patient Enrollment Network (OPEN) registration process, the&#xD;
             treating institution's identity is provided in order to ensure that the current&#xD;
             (within 365 days) date of institutional review board approval for this study has been&#xD;
             entered in the system&#xD;
&#xD;
          -  STEP 2: SURGERY&#xD;
&#xD;
          -  Patient must have a CT of chest/abdomen with contrast or FDG-PET/CT scan within 28&#xD;
             days prior to step 2 registration; patients must not have evidence of progression per&#xD;
             RECIST 1.1 or modified RECIST for pleural tumors&#xD;
&#xD;
          -  Patients planning to receive EPP must also be evaluated for appropriateness of&#xD;
             radiation therapy (RT) by a radiation oncologist within 14 days prior to step 2&#xD;
             registration&#xD;
&#xD;
          -  Patients must have a Zubrod performance status of 0-1 documented within 28 days prior&#xD;
             to step 2 registration&#xD;
&#xD;
          -  Patients must have postoperative predicted forced expiratory volume in 1 second (FEV1)&#xD;
             &gt; 35% prior to surgery obtained within 28 days prior to step 2 registration; pulmonary&#xD;
             function tests to ascertain these values must be obtained within 28 days prior to Step&#xD;
             2 registration&#xD;
&#xD;
          -  Patients must have postoperative predicted carbon monoxide diffusing capability (DLCO)&#xD;
             &gt; 35% prior to surgery obtained within 28 days prior to step 2 registration; pulmonary&#xD;
             function tests to ascertain these values must be obtained within 28 days prior to Step&#xD;
             2 registration&#xD;
&#xD;
          -  Patient must have received at least two cycles of triplet neoadjuvant therapy (all&#xD;
             three drugs) during step 1&#xD;
&#xD;
          -  Patient must be registered to step 2 no less than 21 days and no more than 90 days&#xD;
             after the end of their final cycle of neoadjuvant therapy&#xD;
&#xD;
          -  STEP 3: MAINTENANCE&#xD;
&#xD;
          -  Patient must have received either P/D or EPP and must have recovered from all effects&#xD;
             of surgery with adequate wound healing; patients who received radiation therapy (RT)&#xD;
             must be registered to step 3 within 90 days after discontinuing RT; patients who did&#xD;
             not receive RT must be registered to step 3 within 90 days after surgery&#xD;
&#xD;
          -  Patient must have a CT of chest/abdomen/pelvis with contrast or FDG-PET/CT scan within&#xD;
             28 days prior to step 3 registration; patient must not have evidence of progression&#xD;
             per RECIST 1.1 or modified RECIST for pleural tumors&#xD;
&#xD;
          -  Patient may have discontinued RT early due to toxicity or other reasons&#xD;
&#xD;
          -  Patients must have a Zubrod performance status of 0-1 documented within 28 days prior&#xD;
             to step 3 registration&#xD;
&#xD;
          -  ANC &gt; 1,500/mcl (documented within 28 days prior to step 3 registration)&#xD;
&#xD;
          -  Hemoglobin &gt; 9 g/dl (documented within 28 days prior to step 3 registration)&#xD;
&#xD;
          -  Platelets &gt; 100,000/mcl (documented within 28 days prior to step 3 registration)&#xD;
&#xD;
          -  Creatinine &lt; 1.5 x ULN (documented within 28 days prior to step 3 registration)&#xD;
&#xD;
          -  Total bilirubin =&lt; 1.5 x upper limit of normal (ULN) (within 28 days prior to step 3&#xD;
             registration)&#xD;
&#xD;
          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =&lt; 3 x ULN (within&#xD;
             28 days prior to step 3 registration)&#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>Anne S Tsao</last_name>
    <role>Principal Investigator</role>
    <affiliation>SWOG Cancer Research Network</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic Hospital in Arizona</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85054</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Saint Vincent Cancer Center Hot Springs</name>
      <address>
        <city>Hot Springs</city>
        <state>Arkansas</state>
        <zip>71913</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>PCR Oncology</name>
      <address>
        <city>Arroyo Grande</city>
        <state>California</state>
        <zip>93420</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>City of Hope Comprehensive Cancer Center</name>
      <address>
        <city>Duarte</city>
        <state>California</state>
        <zip>91010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Comprehensive Cancer Center</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95817</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Penrose-Saint Francis Healthcare</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Penrose</name>
      <address>
        <city>Colorado Springs</city>
        <state>Colorado</state>
        <zip>80907</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Porter Adventist Hospital</name>
      <address>
        <city>Denver</city>
        <state>Colorado</state>
        <zip>80210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Oncology PC</name>
      <address>
        <city>Durango</city>
        <state>Colorado</state>
        <zip>81301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mountain Blue Cancer Care Center</name>
      <address>
        <city>Golden</city>
        <state>Colorado</state>
        <zip>80401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Lakewood</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Anthony Hospital</name>
      <address>
        <city>Lakewood</city>
        <state>Colorado</state>
        <zip>80228</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Littleton Adventist Hospital</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Longmont United Hospital</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Longmont</name>
      <address>
        <city>Longmont</city>
        <state>Colorado</state>
        <zip>80501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parker Adventist Hospital</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Parker</name>
      <address>
        <city>Parker</city>
        <state>Colorado</state>
        <zip>80138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary Corwin Medical Center</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers - Pueblo</name>
      <address>
        <city>Pueblo</city>
        <state>Colorado</state>
        <zip>81008</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rocky Mountain Cancer Centers-Thornton</name>
      <address>
        <city>Thornton</city>
        <state>Colorado</state>
        <zip>80260</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baptist MD Anderson Cancer Center</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32207</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Boise</name>
      <address>
        <city>Boise</city>
        <state>Idaho</state>
        <zip>83706</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Caldwell</name>
      <address>
        <city>Caldwell</city>
        <state>Idaho</state>
        <zip>83605</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Health - Coeur d'Alene</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Idaho Urologic Institute-Meridian</name>
      <address>
        <city>Meridian</city>
        <state>Idaho</state>
        <zip>83642</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Alphonsus Cancer Care Center-Nampa</name>
      <address>
        <city>Nampa</city>
        <state>Idaho</state>
        <zip>83687</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Clinic Cancer Services - Post Falls</name>
      <address>
        <city>Post Falls</city>
        <state>Idaho</state>
        <zip>83854</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Cancer Clinic</name>
      <address>
        <city>Sandpoint</city>
        <state>Idaho</state>
        <zip>83864</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush - Copley Medical Center</name>
      <address>
        <city>Aurora</city>
        <state>Illinois</state>
        <zip>60504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Bloomington</name>
      <address>
        <city>Bloomington</city>
        <state>Illinois</state>
        <zip>61704</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Canton</name>
      <address>
        <city>Canton</city>
        <state>Illinois</state>
        <zip>61520</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital of Carbondale</name>
      <address>
        <city>Carbondale</city>
        <state>Illinois</state>
        <zip>62902</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SIH Cancer Institute</name>
      <address>
        <city>Carterville</city>
        <state>Illinois</state>
        <zip>62918</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Carthage</name>
      <address>
        <city>Carthage</city>
        <state>Illinois</state>
        <zip>62321</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centralia Oncology Clinic</name>
      <address>
        <city>Centralia</city>
        <state>Illinois</state>
        <zip>62801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle at The Riverfront</name>
      <address>
        <city>Danville</city>
        <state>Illinois</state>
        <zip>61832</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Specialists of Illinois - Decatur</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Decatur Memorial Hospital</name>
      <address>
        <city>Decatur</city>
        <state>Illinois</state>
        <zip>62526</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Effingham</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Crossroads Cancer Center</name>
      <address>
        <city>Effingham</city>
        <state>Illinois</state>
        <zip>62401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Eureka</name>
      <address>
        <city>Eureka</city>
        <state>Illinois</state>
        <zip>61530</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Galesburg</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Western Illinois Cancer Treatment Center</name>
      <address>
        <city>Galesburg</city>
        <state>Illinois</state>
        <zip>61401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Kewanee Clinic</name>
      <address>
        <city>Kewanee</city>
        <state>Illinois</state>
        <zip>61443</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Macomb</name>
      <address>
        <city>Macomb</city>
        <state>Illinois</state>
        <zip>61455</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Physician Group-Mattoon/Charleston</name>
      <address>
        <city>Mattoon</city>
        <state>Illinois</state>
        <zip>61938</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Care Center of O'Fallon</name>
      <address>
        <city>O'Fallon</city>
        <state>Illinois</state>
        <zip>62269</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Ottawa Clinic</name>
      <address>
        <city>Ottawa</city>
        <state>Illinois</state>
        <zip>61350</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Pekin</name>
      <address>
        <city>Pekin</city>
        <state>Illinois</state>
        <zip>61554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center</name>
      <address>
        <city>Pekin</city>
        <state>Illinois</state>
        <zip>61554</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peoria</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSF Saint Francis Radiation Oncology at Peoria Cancer Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61615</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Medical Center of Illinois</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61636</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OSF Saint Francis Medical Center</name>
      <address>
        <city>Peoria</city>
        <state>Illinois</state>
        <zip>61637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Peru</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Radiation Oncology</name>
      <address>
        <city>Peru</city>
        <state>Illinois</state>
        <zip>61354</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Illinois CancerCare-Princeton</name>
      <address>
        <city>Princeton</city>
        <state>Illinois</state>
        <zip>61356</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southern Illinois University School of Medicine</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Springfield Clinic</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62781</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southwest Illinois Health Services LLP</name>
      <address>
        <city>Swansea</city>
        <state>Illinois</state>
        <zip>62226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Carle Cancer Center</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Carle Foundation Hospital</name>
      <address>
        <city>Urbana</city>
        <state>Illinois</state>
        <zip>61801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rush-Copley Healthcare Center</name>
      <address>
        <city>Yorkville</city>
        <state>Illinois</state>
        <zip>60560</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mary Greeley Medical Center</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Ames</name>
      <address>
        <city>Ames</city>
        <state>Iowa</state>
        <zip>50010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Boone</name>
      <address>
        <city>Boone</city>
        <state>Iowa</state>
        <zip>50036</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Oncology and Hematology Associates-West Des Moines</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Cancer Center-West Lakes</name>
      <address>
        <city>Clive</city>
        <state>Iowa</state>
        <zip>50325</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Mercy Hospital</name>
      <address>
        <city>Council Bluffs</city>
        <state>Iowa</state>
        <zip>51503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Greater Regional Medical Center</name>
      <address>
        <city>Creston</city>
        <state>Iowa</state>
        <zip>50801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center - Des Moines</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mission Cancer and Blood - Laurel</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Trinity Cancer Center</name>
      <address>
        <city>Fort Dodge</city>
        <state>Iowa</state>
        <zip>50501</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Jefferson</name>
      <address>
        <city>Jefferson</city>
        <state>Iowa</state>
        <zip>50129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>McFarland Clinic - Marshalltown</name>
      <address>
        <city>Marshalltown</city>
        <state>Iowa</state>
        <zip>50158</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Medical Center-West Lakes</name>
      <address>
        <city>West Des Moines</city>
        <state>Iowa</state>
        <zip>50266</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lawrence Memorial Hospital</name>
      <address>
        <city>Lawrence</city>
        <state>Kansas</state>
        <zip>66044</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas-Wichita Medical Arts Tower</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascension Via Christi Hospitals Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Center of Kansas - Wichita</name>
      <address>
        <city>Wichita</city>
        <state>Kansas</state>
        <zip>67214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Flaget Memorial Hospital</name>
      <address>
        <city>Bardstown</city>
        <state>Kentucky</state>
        <zip>40004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Commonwealth Cancer Center-Corbin</name>
      <address>
        <city>Corbin</city>
        <state>Kentucky</state>
        <zip>40701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Radiation Oncology Resource Center</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Hospital East</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph London</name>
      <address>
        <city>London</city>
        <state>Kentucky</state>
        <zip>40741</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saints Mary and Elizabeth Hospital</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UofL Health Medical Center Northeast</name>
      <address>
        <city>Louisville</city>
        <state>Kentucky</state>
        <zip>40245</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jewish Hospital Medical Center South</name>
      <address>
        <city>Shepherdsville</city>
        <state>Kentucky</state>
        <zip>40165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ochsner Medical Center Jefferson</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Cancer Institute-Downriver</name>
      <address>
        <city>Brownstown</city>
        <state>Michigan</state>
        <zip>48183</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Macomb Hospital-Clinton Township</name>
      <address>
        <city>Clinton Township</city>
        <state>Michigan</state>
        <zip>48038</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Hospital</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Allegiance Health</name>
      <address>
        <city>Jackson</city>
        <state>Michigan</state>
        <zip>49201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Macomb Health Center - Shelby Township</name>
      <address>
        <city>Shelby</city>
        <state>Michigan</state>
        <zip>48315</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford West Bloomfield Hospital</name>
      <address>
        <city>West Bloomfield</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Parkland Health Center-Bonne Terre</name>
      <address>
        <city>Bonne Terre</city>
        <state>Missouri</state>
        <zip>63628</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Medical Center</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Southeast Cancer Center</name>
      <address>
        <city>Cape Girardeau</city>
        <state>Missouri</state>
        <zip>63703</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Region Southwest Campus</name>
      <address>
        <city>Jefferson City</city>
        <state>Missouri</state>
        <zip>65109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sainte Genevieve County Memorial Hospital</name>
      <address>
        <city>Sainte Genevieve</city>
        <state>Missouri</state>
        <zip>63670</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Sullivan Hospital</name>
      <address>
        <city>Sullivan</city>
        <state>Missouri</state>
        <zip>63080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Missouri Baptist Outpatient Center-Sunset Hills</name>
      <address>
        <city>Sunset Hills</city>
        <state>Missouri</state>
        <zip>63127</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Hospital of Anaconda</name>
      <address>
        <city>Anaconda</city>
        <state>Montana</state>
        <zip>59711</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic Cancer Center</name>
      <address>
        <city>Billings</city>
        <state>Montana</state>
        <zip>59101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bozeman Deaconess Hospital</name>
      <address>
        <city>Bozeman</city>
        <state>Montana</state>
        <zip>59715</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Benefis Healthcare- Sletten Cancer Institute</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Great Falls Clinic</name>
      <address>
        <city>Great Falls</city>
        <state>Montana</state>
        <zip>59405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Peter's Community Hospital</name>
      <address>
        <city>Helena</city>
        <state>Montana</state>
        <zip>59601</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kalispell Regional Medical Center</name>
      <address>
        <city>Kalispell</city>
        <state>Montana</state>
        <zip>59901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Community Medical Hospital</name>
      <address>
        <city>Missoula</city>
        <state>Montana</state>
        <zip>59804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Health Saint Francis</name>
      <address>
        <city>Grand Island</city>
        <state>Nebraska</state>
        <zip>68803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heartland Hematology and Oncology</name>
      <address>
        <city>Kearney</city>
        <state>Nebraska</state>
        <zip>68845</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Health Good Samaritan</name>
      <address>
        <city>Kearney</city>
        <state>Nebraska</state>
        <zip>68847</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Regional Medical Center</name>
      <address>
        <city>Lincoln</city>
        <state>Nebraska</state>
        <zip>68510</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Immanuel Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hematology and Oncology Consultants PC</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Bergan Mercy Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alegent Health Lakeside Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Creighton University Medical Center</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68131</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Midlands Community Hospital</name>
      <address>
        <city>Papillion</city>
        <state>Nebraska</state>
        <zip>68046</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Henderson</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at Seven Hills</name>
      <address>
        <city>Henderson</city>
        <state>Nevada</state>
        <zip>89052</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at Charleston</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centers of Nevada Central</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89106</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GenesisCare USA - Las Vegas</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Centers of Nevada Southeast</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Northwest</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at MountainView</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89128</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alliance for Childhood Diseases/Cure 4 the Kids Foundation</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89135</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada-Summerlin</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89144</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>OptumCare Cancer Care at Fort Apache</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89148</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Comprehensive Cancer Centers of Nevada - Central Valley</name>
      <address>
        <city>Las Vegas</city>
        <state>Nevada</state>
        <zip>89169</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Renown Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Mary's Regional Medical Center</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Radiation Oncology Associates</name>
      <address>
        <city>Reno</city>
        <state>Nevada</state>
        <zip>89509</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Good Samaritan Hospital - Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45220</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bethesda North Hospital</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriHealth Cancer Institute-Westside</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45247</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>TriHealth Cancer Institute-Anderson</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45255</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cancer Centers of Southwest Oklahoma Research</name>
      <address>
        <city>Lawton</city>
        <state>Oklahoma</state>
        <zip>73505</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Oklahoma Health Sciences Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Pittsburgh Cancer Institute (UPCI)</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University of South Carolina</name>
      <address>
        <city>Charleston</city>
        <state>South Carolina</state>
        <zip>29425</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital</name>
      <address>
        <city>Chattanooga</city>
        <state>Tennessee</state>
        <zip>37404</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary Medicine Center of Chattanooga-Hixson</name>
      <address>
        <city>Hixson</city>
        <state>Tennessee</state>
        <zip>37343</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial GYN Plus</name>
      <address>
        <city>Ooltewah</city>
        <state>Tennessee</state>
        <zip>37363</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Joseph Regional Cancer Center</name>
      <address>
        <city>Bryan</city>
        <state>Texas</state>
        <zip>77802</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson in The Woodlands</name>
      <address>
        <city>Conroe</city>
        <state>Texas</state>
        <zip>77384</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern/Simmons Cancer Center-Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lyndon Baines Johnson General Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77026-1967</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>M D Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson West Houston</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77079</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson League City</name>
      <address>
        <city>League City</city>
        <state>Texas</state>
        <zip>77573</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UT Southwestern Clinical Center at Richardson/Plano</name>
      <address>
        <city>Richardson</city>
        <state>Texas</state>
        <zip>75080</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson in Sugar Land</name>
      <address>
        <city>Sugar Land</city>
        <state>Texas</state>
        <zip>77478</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Virginia Cancer Center</name>
      <address>
        <city>Charlottesville</city>
        <state>Virginia</state>
        <zip>22908</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Overlake Medical Center</name>
      <address>
        <city>Bellevue</city>
        <state>Washington</state>
        <zip>98004</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison HealthPartners Hematology and Oncology-Bremerton</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison Medical Center</name>
      <address>
        <city>Bremerton</city>
        <state>Washington</state>
        <zip>98310</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Highline Medical Center-Main Campus</name>
      <address>
        <city>Burien</city>
        <state>Washington</state>
        <zip>98166</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Elizabeth Hospital</name>
      <address>
        <city>Enumclaw</city>
        <state>Washington</state>
        <zip>98022</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Francis Hospital</name>
      <address>
        <city>Federal Way</city>
        <state>Washington</state>
        <zip>98003</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Clare Hospital</name>
      <address>
        <city>Lakewood</city>
        <state>Washington</state>
        <zip>98499</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Harrison HealthPartners Hematology and Oncology-Poulsbo</name>
      <address>
        <city>Poulsbo</city>
        <state>Washington</state>
        <zip>98370</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Valley Medical Center</name>
      <address>
        <city>Renton</city>
        <state>Washington</state>
        <zip>98055</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FHCC South Lake Union</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fred Hutchinson Cancer Research Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Washington Medical Center - Montlake</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Franciscan Research Center-Northwest Medical Plaza</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northwest Medical Specialties PLLC</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Billings Clinic-Cody</name>
      <address>
        <city>Cody</city>
        <state>Wyoming</state>
        <zip>82414</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Welch Cancer Center</name>
      <address>
        <city>Sheridan</city>
        <state>Wyoming</state>
        <zip>82801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>July 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>August 8, 2023</last_update_submitted>
  <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2023</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>Mesothelioma</mesh_term>
    <mesh_term>Mesothelioma, Malignant</mesh_term>
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cisplatin</mesh_term>
    <mesh_term>Pemetrexed</mesh_term>
    <mesh_term>Atezolizumab</mesh_term>
    <mesh_term>Antibodies, Monoclonal</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/NCT03228537
org study id: NCI-2017-01230
secondary id: NCI-2017-01230
secondary id: S1619
secondary id: S1619
secondary id: U10CA180888
nct id: NCT03228537
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This phase I pilot trial studies how well atezolizumab, pemetrexed disodium, cisplatin, and
      surgery with or without radiation therapy works in treating patients with stage I-III pleural
      malignant mesothelioma. Immunotherapy with monoclonal antibodies, such as atezolizumab, may
      help the body's immune system attack the cancer, and may interfere with the ability of tumor
      cells to grow and spread. Pemetrexed disodium may stop the growth of tumor cells by blocking
      some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as cisplatin,
      work in different ways to stop the growth of tumor cells, either by killing the cells, by
      stopping them from dividing, or by stopping them from spreading. Giving atezolizumab,
      pemetrexed disodium, and cisplatin before surgery may make the tumor smaller and reduce the
      amount of normal tissue that needs to be removed. Giving atezolizumab after surgery may kill
      any remaining tumor cells.
PRIMARY OBJECTIVE:

      I. To evaluate if the regimen of neoadjuvant cisplatin-pemetrexed disodium
      (pemetrexed)-atezolizumab, surgery +/- radiation, then maintenance atezolizumab is feasible
      and safe for patients with resectable malignant pleural mesothelioma.

      SECONDARY OBJECTIVES:

      I. To evaluate progression free survival (both by Response Evaluation Criteria in Solid
      Tumors [RECIST] 1.1 and also using a modified RECIST for pleural tumors) in patients with
      resectable malignant pleural mesothelioma treated with a regimen of neoadjuvant
      cisplatin-pemetrexed-atezolizumab, surgery +/- radiation, followed by one year of maintenance
      atezolizumab.

      II. To evaluate overall survival in patients with resectable malignant pleural mesothelioma
      treated with a regimen of neoadjuvant cisplatin-pemetrexed-atezolizumab, surgery +/-
      radiation, followed by one year of maintenance atezolizumab.

      III. To evaluate response rate (confirmed and unconfirmed, complete and partial, both by
      RECIST 1.1 and also using a modified RECIST for pleural tumors) in the subset of this patient
      population with measurable disease.

      TRANSLATIONAL MEDICINE OBJECTIVES:

      I. To evaluate the association between immunohistochemical (IHC) expression of PD-L1 in
      tumors and clinical outcomes in mesothelioma patients treated with trimodality/bimodality
      therapy including atezolizumab (anti-PD-L1).

      II. To evaluate the association between expression of immune-related genes identified by
      Immune Nanostring (depending on ribonucleic acid [RNA] availability) and clinical outcomes in
      mesothelioma patients treated with trimodality/bimodality therapy including atezolizumab.

      III. To evaluate the association between multiplex immunofluorescence (IF) of up to 10 immune
      markers in two panels and clinical outcomes in mesothelioma patients treated with
      trimodality/bimodality therapy including atezolizumab.

      OUTLINE:

      NEOADJUVANT: Patients receive atezolizumab intravenously (IV) over 30-60 minutes, pemetrexed
      disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21
      days for 4 cycles in the absence of disease progression or unexpected toxicity.

      SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo
      extrapleural pneumonectomy (EPP) or pleurectomy/decortication (PD). Patients who undergo EPP
      will then undergo radiation therapy (RT).

      MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients
      receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1
      year in the absence of disease progression or unexpected toxicity.

      After completion of study treatment, patients are followed up for up to 3 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression free survival
time frame: From date of registration to step 1 to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years
description: Will be assessed by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Will be evaluated using the method of Kaplan-Meier. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.
measure: Overall survival
time frame: From date of initial registration to date of death due to any cause, assessed up to 3 years
description: Will be evaluated using the method of Kaplan-Meier. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.
measure: Modified Response Evaluation Criteria in Solid Tumors (RECIST) progression free survival
time frame: From date of registration to step 1 to date of first documentation of progression, symptomatic deterioration, or death due to any cause, assessed up to 3 years
description: Will be assessed by modified RECIST 1.1. Will be evaluated using the method of Kaplan-Meier. Confidence intervals around the median will be calculated using the Brookmeyer-Crowley method, confidence intervals around landmark time points will use the Greenwood formula for standard errors.
arm group label: Treatment (chemotherapy, surgery, RT)
arm group type: Experimental
description: NEOADJUVANT: Patients receive atezolizumab IV over 30-60 minutes, pemetrexed disodium IV over 10 minutes, and cisplatin IV over 2 hours on day 1. Cycles repeats every 21 days for 4 cycles in the absence of disease progression or unexpected toxicity.
SURGERY: Within 21-90 days after completion of neoadjuvant therapy, patients undergo EPP or PD. Patients who undergo EPP will then undergo RT.
MAINTENANCE: Within 90 days after completion of either PD or radiation (post-EPP), patients receive atezolizumab IV over 60 minutes on day 1. Treatment repeats every 21 days for up to 1 year in the absence of disease progression or unexpected toxicity.
intervention type: Drug
intervention name: Atezolizumab
description: Given IV
arm group label: Treatment (chemotherapy, surgery, RT)
other name: MPDL 3280A
other name: MPDL 328OA
other name: MPDL-3280A
other name: MPDL3280A
other name: MPDL328OA
other name: RG7446
other name: RO5541267
other name: Tecentriq
intervention type: Drug
intervention name: Cisplatin
description: Given IV
arm group label: Treatment (chemotherapy, surgery, RT)
other name: Abiplatin
other name: Blastolem
other name: Briplatin
other name: CDDP
other name: Cis-diammine-dichloroplatinum
other name: Cis-diamminedichloridoplatinum
other name: Cis-diamminedichloro Platinum (II)
other name: Cis-diamminedichloroplatinum
other name: Cis-dichloroammine Platinum (II)
other name: Cis-platinous Diamine Dichloride
other name: Cis-platinum
other name: Cis-platinum II
other name: Cis-platinum II Diamine Dichloride
other name: Cismaplat
other name: Cisplatina
other name: Cisplatinum
other name: Cisplatyl
other name: Citoplatino
other name: Citosin
other name: Cysplatyna
other name: DDP
other name: Lederplatin
other name: Metaplatin
other name: Neoplatin
other name: Peyrone's Chloride
other name: Peyrone's Salt
other name: Placis
other name: Plastistil
other name: Platamine
other name: Platiblastin
other name: Platiblastin-S
other name: Platinex
other name: Platinol
other name: Platinol- AQ
other name: Platinol-AQ
other name: Platinol-AQ VHA Plus
other name: Platinoxan
other name: Platinum
other name: Platinum Diamminodichloride
other name: Platiran
other name: Platistin
other name: Platosin
intervention type: Procedure
intervention name: Extrapleural Pneumonectomy
description: Undergo EPP
arm group label: Treatment (chemotherapy, surgery, RT)
intervention type: Drug
intervention name: Pemetrexed Disodium
description: Given IV
arm group label: Treatment (chemotherapy, surgery, RT)
other name: Alimta
other name: Almita
other name: LY231514
other name: N-[4-[2-(2-Amino-4,7-dihydro-4-oxo-1H-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-L-glutamic Acid Disodium Salt
intervention type: Procedure
intervention name: Pleurectomy
description: Undergo PD
arm group label: Treatment (chemotherapy, surgery, RT)
other name: Excision of Pleura
intervention type: Radiation
intervention name: Radiation Therapy
description: Undergo RT
arm group label: Treatment (chemotherapy, surgery, RT)
other name: Cancer Radiotherapy
other name: Energy Type
other name: ENERGY_TYPE
other name: Irradiate
other name: Irradiated
other name: Irradiation
other name: Radiation
other name: Radiation Therapy, NOS
other name: Radiotherapeutics
other name: Radiotherapy
other name: RT
other name: Therapy, Radiation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anne S Tsao
role: Principal Investigator
affiliation: SWOG Cancer Research Network
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country: United States
responsible party type: Sponsor
mesh term: Mesothelioma
mesh term: Mesothelioma, Malignant
mesh term: Lung Neoplasms
mesh term: Cisplatin
mesh term: Pemetrexed
mesh term: Atezolizumab
mesh term: Antibodies, Monoclonal