<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/NCT02259621</url>
  </required_header>
  <id_info>
    <org_study_id>J1414</org_study_id>
    <secondary_id>NA_00092076</secondary_id>
    <nct_id>NCT02259621</nct_id>
  </id_info>
  <brief_title>Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in Resectable NSCLC</brief_title>
  <acronym>NA_00092076</acronym>
  <official_title>Neoadjuvant Nivolumab, or Nivolumab in Combination With Ipilimumab, in 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>Bristol-Myers Squibb</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>
      The proposed study will evaluate the safety and feasibility of preoperative administration&#xD;
      nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a&#xD;
      comprehensive exploratory characterization of the tumor immune milieu and circulating immune&#xD;
      cells and soluble factors in these patients. Data obtained in this study will provide&#xD;
      valuable information for planning further prospective clinical trials of anti-PD-1 and other&#xD;
      immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The proposed study will evaluate the safety and feasibility of preoperative administration&#xD;
      nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a&#xD;
      comprehensive exploratory characterization of the tumor immune milieu and circulating immune&#xD;
      cells and soluble factors in these patients. Data obtained in this study will provide&#xD;
      valuable information for planning further prospective clinical trials of anti-PD-1 and other&#xD;
      immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.&#xD;
      Ultimately, it is highly desirable to discover prospective biomarkers of response and&#xD;
      toxicity to allow patients with NSCLC who are most likely to derive benefit to receive&#xD;
      anti-PD-1 treatment, and conversely to minimize the risk of toxicity and ineffective&#xD;
      treatment for patients who are unlikely to benefit.&#xD;
&#xD;
      In addition, an amendment to this study allows evaluation of the combination of nivolumab and&#xD;
      the anti-CTLA4 antibody, ipilimumab in the neoadjuvant setting for the treatment of&#xD;
      resectable NSCLC. In a large, multicohort, phase 1 trial, the ORR to combination ipilimumab&#xD;
      and nivolumab therapy in patients unselected by PD-L1 status ranged from 39-47%. Incidence of&#xD;
      grade 3-4 toxicity ranged from 33-37% across the combination ipilimumab and nivolumab cohorts&#xD;
      which compares favorably with the rates of toxicity due to platinum doublet chemotherapy in&#xD;
      this disease setting.&#xD;
&#xD;
      The current amendment includes addition of a third arm (Arm C) combining nivolumab and&#xD;
      platinum-doublet chemotherapy in the neoadjuvant setting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">October 2027</completion_date>
  <primary_completion_date type="Actual">October 14, 2022</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>Safety as measured by number of participants with Grade 3 and 4 lab abnormalities, as defined by CTCAE v4.03</measure>
    <time_frame>8 weeks</time_frame>
    <description>Safety will be measured by drawing safety labs. (CBC and a Chemistry Panel will be drawn at 2 week intervals during Nivolumab administration). Grade 3 and 4 lab abnormalities will be recorded from both participating sites.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Safety as assessed by number of Grade 3 and 4 adverse events</measure>
    <time_frame>8 weeks</time_frame>
    <description>Number of Grade 3 and 4 adverse events as defined by CTCAE v4.03 that occur while a subject is participating in the study.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Feasibility as measured by rate of enrollment</measure>
    <time_frame>8 weeks</time_frame>
    <description>Rate of enrollment of subjects at all study sites will be measured as average number of participants enrolled at both sites per day.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pathologic Response</measure>
    <time_frame>6 weeks</time_frame>
    <description>Pathologic response to neoadjuvant nivolumab, nivolumab plus ipilimumab, and nicvolumab, carboplatin, and paclitaxel in resected tumor and lymph nodes. The rate of major pathologic response, defined as &lt;10% residual viable tumor cells in the resection specimen will be compared to historic data with neoadjuvant chemotherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Radiographic Response</measure>
    <time_frame>5 weeks</time_frame>
    <description>Radiographic response to neoadjuvant nivolumab, nivolumab plus ipilimumab, and carboplatin and paclitaxel as defined by RECIST 1.1.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Non-Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Arm B- Nivolumab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab administration:&#xD;
Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm C- Nivolumab, Carboplatin, &amp; Paclitaxel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Anti-PD-1 Therapy</description>
    <arm_group_label>Arm B- Nivolumab</arm_group_label>
    <arm_group_label>Arm C- Nivolumab, Carboplatin, &amp; Paclitaxel</arm_group_label>
    <other_name>BMS-936558 or MDX1106</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Carboplatin</intervention_name>
    <description>Anti-PD-1 Therapy</description>
    <arm_group_label>Arm C- Nivolumab, Carboplatin, &amp; Paclitaxel</arm_group_label>
    <other_name>Paraplatin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paclitaxel</intervention_name>
    <description>Anti-PD-1 Therapy</description>
    <arm_group_label>Arm C- Nivolumab, Carboplatin, &amp; Paclitaxel</arm_group_label>
    <other_name>Taxol</other_name>
    <other_name>Onxal</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histologically proven non-small-cell lung cancer (core biopsy required).&#xD;
&#xD;
               -  Squamous or non-squamous histology&#xD;
&#xD;
               -  Diagnostic core biopsy specimens must be reviewed by a faculty pathologist at&#xD;
                  SKCCC or MSKCC&#xD;
&#xD;
               -  Either a formalin fixed paraffin block or a minimum of fifteen 5-micron tissue&#xD;
                  sections (slides) of tumor biopsy sample must be available for biomarker&#xD;
                  evaluation (study pathologist must review for adequacy of sampling). This can be&#xD;
                  obtained from archived tissues, or from a new biopsy if needed.&#xD;
&#xD;
          -  Stage - High risk NSCLC with resection option for potential cure, as assessed by a&#xD;
             faculty surgeon at SKCCC or MSKCC. This may include clinical stage IB (≥4cm), II and&#xD;
             IIIA(see Appendix A). Subjects with N3 nodal involvement are not included.&#xD;
&#xD;
        ECOG performance status 0-1&#xD;
&#xD;
        -Adequate organ function as follows:&#xD;
&#xD;
          -  Leukocytes ≥ 2,000/mm3&#xD;
&#xD;
          -  Absolute neutrophil count (ANC) ≥ 1000/mm3&#xD;
&#xD;
          -  Platelet count ≥ 100,000/mm3&#xD;
&#xD;
          -  Hemoglobin ≥ 9 g/dL&#xD;
&#xD;
          -  Creatinine ≤ 1.5 x ULN or creatinine clearance (CrCl) ≥40 mL/min (if using the&#xD;
             Cockcroft-Gault formula below):&#xD;
&#xD;
        Female CrCl = (140 - age in years) x weight in kg x 0.85 72 x serum creatinine in mg/dL&#xD;
&#xD;
        Male CrCl = (140 - age in years) x weight in kg x 1.00 72 x serum creatinine in mg/dL&#xD;
&#xD;
          -  Total Bilirubin ≤ 1.5 x ULN (except subjects with Gilbert Syndrome, who can have total&#xD;
             bilirubin &lt; 3.0 mg/dL)&#xD;
&#xD;
          -  AST(SGOT), ALT(SGPT), and alkaline phosphatase ≤ 3 times the upper limit of normal&#xD;
&#xD;
          -  Subjects must have adequate lung function to permit surgical resection determined by&#xD;
             pre-enrollment pulmonary function tests to include DLCO&#xD;
&#xD;
               -  The effects of nivolumab on the developing human fetus are unknown. For this&#xD;
                  reason, women of child-bearing potential (WOCBP) and men must agree to use&#xD;
                  adequate contraception (hormonal or barrier method of birth control; abstinence)&#xD;
                  prior to study entry and for the duration of study participation and for up to 23&#xD;
                  weeks after the last dose of nivolumab. Should a woman become pregnant or suspect&#xD;
                  she is pregnant while she or her partner is participating in this study, she&#xD;
                  should inform her treating physician immediately. Sexually active fertile men&#xD;
                  must use effective barrier birth control if their partners are WOCBP for up to 31&#xD;
                  weeks after the last dose of nivolumab. WOCBP must have a negative serum or urine&#xD;
                  pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within&#xD;
                  two weeks of registration. Women must not be breastfeeding.&#xD;
&#xD;
               -  Patient understands the study regimen, its requirements, risks and discomforts&#xD;
                  and is able and willing to sign the informed consent form. Voluntary signed and&#xD;
                  dated IRB/IEC approved written informed consent form in accordance with&#xD;
                  regulatory and institutional guidelines must be obtained before the performance&#xD;
                  of any protocol related procedures that are not part of normal patient care.&#xD;
                  Subjects must be competent to report AEs, understand the drug dosing schedule and&#xD;
                  use of medications to control AEs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects are excluded if they have an active, known or suspected autoimmune disease.&#xD;
             Subjects are permitted to enroll if they have vitiligo, type I diabetes mellitus,&#xD;
             residual hypothyroidism due to autoimmune condition only requiring hormone&#xD;
             replacement, psoriasis not requiring systemic treatment, or conditions not expected to&#xD;
             recur in the absence of an external trigger.&#xD;
&#xD;
          -  Subjects are excluded if they have a condition requiring systemic treatment with&#xD;
             either corticosteroids (&gt; 10 mg daily prednisone equivalents) or other&#xD;
             immunosuppressive medications within 14 days of study drug administration. Inhaled or&#xD;
             topical steroids and adrenal replacement doses &gt; 10 mg daily prednisone equivalents&#xD;
             are permitted in the absence of active autoimmune disease. As there is potential for&#xD;
             hepatic toxicity with nivolumab or nivolumab/ipilimumab combinations, drugs with a&#xD;
             predisposition to hepatoxicity should be used with caution in patients treated with&#xD;
             nivolumab-containing regimen.&#xD;
&#xD;
          -  Administration of chemotherapy or any other cancer therapy in the pre-operative&#xD;
             period.&#xD;
&#xD;
          -  Subjects with active concurrent malignancies are excluded i.e. cancers other than&#xD;
             NSCLC (except non melanoma skin cancers, in situ bladder, gastric, breast, colon or&#xD;
             cervical cancers/dysplasia).&#xD;
&#xD;
          -  Subjects with brain metastasis are excluded from this study, and all patients should&#xD;
             have brain imaging (either MRI brain or CT brain with contrast) prior to enrollment.&#xD;
&#xD;
          -  Subjects with a history of symptomatic interstitial lung disease.&#xD;
&#xD;
          -  Active systemic infection requiring therapy, positive tests for Hepatitis B surface&#xD;
             antigen or Hepatitis C ribonucleic acid (RNA).&#xD;
&#xD;
          -  Known positive history or positive test for Human Immunodeficiency Virus or Acquired&#xD;
             ImmunoDeficiency Syndrome (AIDS).&#xD;
&#xD;
          -  History of allergy to study drug components.&#xD;
&#xD;
          -  Women who are pregnant or nursing.&#xD;
&#xD;
          -  Men with female partners (WOCBP) that are not willing to use contraception.&#xD;
&#xD;
          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PDL-2, or anti-CTLA-4 antibody (or&#xD;
             any other antibody targeting T cell co-regulatory pathways).&#xD;
&#xD;
          -  Underlying medical conditions that, in the Investigator's opinion, will make the&#xD;
             administration of study drug hazardous or obscure the interpretation of toxicity or&#xD;
             adverse events.&#xD;
&#xD;
          -  Prisoners or subjects who are involuntarily incarcerated or compulsorily detained for&#xD;
             treatment of either a psychiatric or physical (e.g. infectious disease) illness.&#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>Patrick Forde, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins at Bayview Medical Center</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Sloan Kettering</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Cancer Insitute</name>
      <address>
        <city>Edmonds</city>
        <state>Washington</state>
        <zip>98026</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Johnathan Spicer</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
    <country>United States</country>
  </location_countries>
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    <url>http://globocan.iarc.fr</url>
    <description>Ferlay J, Shin HR, Bray F, Forman D, Mathers CD, Parkin D. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10. Lyon, France: International Agency for Research on Cancer; Year 2010</description>
  </link>
  <link>
    <url>http://www.seer.cancer.gov</url>
    <description>Accessed 08/08/2012</description>
  </link>
  <link>
    <url>http://www.clinicaltrials.gov/ct2/show/NCT01274338</url>
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  <verification_date>April 2023</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>October 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>April 19, 2023</last_update_submitted>
  <last_update_submitted_qc>April 19, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 21, 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>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>Paclitaxel</mesh_term>
    <mesh_term>Carboplatin</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02259621
org study id: J1414
secondary id: NA_00092076
nct id: NCT02259621
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The proposed study will evaluate the safety and feasibility of preoperative administration
      nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a
      comprehensive exploratory characterization of the tumor immune milieu and circulating immune
      cells and soluble factors in these patients. Data obtained in this study will provide
      valuable information for planning further prospective clinical trials of anti-PD-1 and other
      immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.
The proposed study will evaluate the safety and feasibility of preoperative administration
      nivolumab +/- ipilimumab in patients with high-risk resectable NSCLC, and will facilitate a
      comprehensive exploratory characterization of the tumor immune milieu and circulating immune
      cells and soluble factors in these patients. Data obtained in this study will provide
      valuable information for planning further prospective clinical trials of anti-PD-1 and other
      immunotherapies in NSCLC, both in the peri-operative and advanced disease setting.
      Ultimately, it is highly desirable to discover prospective biomarkers of response and
      toxicity to allow patients with NSCLC who are most likely to derive benefit to receive
      anti-PD-1 treatment, and conversely to minimize the risk of toxicity and ineffective
      treatment for patients who are unlikely to benefit.

      In addition, an amendment to this study allows evaluation of the combination of nivolumab and
      the anti-CTLA4 antibody, ipilimumab in the neoadjuvant setting for the treatment of
      resectable NSCLC. In a large, multicohort, phase 1 trial, the ORR to combination ipilimumab
      and nivolumab therapy in patients unselected by PD-L1 status ranged from 39-47%. Incidence of
      grade 3-4 toxicity ranged from 33-37% across the combination ipilimumab and nivolumab cohorts
      which compares favorably with the rates of toxicity due to platinum doublet chemotherapy in
      this disease setting.

      The current amendment includes addition of a third arm (Arm C) combining nivolumab and
      platinum-doublet chemotherapy in the neoadjuvant setting.
allocation: Non-Randomized
intervention model: Sequential Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety as measured by number of participants with Grade 3 and 4 lab abnormalities, as defined by CTCAE v4.03
time frame: 8 weeks
description: Safety will be measured by drawing safety labs. (CBC and a Chemistry Panel will be drawn at 2 week intervals during Nivolumab administration). Grade 3 and 4 lab abnormalities will be recorded from both participating sites.
measure: Safety as assessed by number of Grade 3 and 4 adverse events
time frame: 8 weeks
description: Number of Grade 3 and 4 adverse events as defined by CTCAE v4.03 that occur while a subject is participating in the study.
measure: Feasibility as measured by rate of enrollment
time frame: 8 weeks
description: Rate of enrollment of subjects at all study sites will be measured as average number of participants enrolled at both sites per day.
measure: Pathologic Response
time frame: 6 weeks
description: Pathologic response to neoadjuvant nivolumab, nivolumab plus ipilimumab, and nicvolumab, carboplatin, and paclitaxel in resected tumor and lymph nodes. The rate of major pathologic response, defined as <10% residual viable tumor cells in the resection specimen will be compared to historic data with neoadjuvant chemotherapy.
measure: Radiographic Response
time frame: 5 weeks
description: Radiographic response to neoadjuvant nivolumab, nivolumab plus ipilimumab, and carboplatin and paclitaxel as defined by RECIST 1.1.
arm group label: Arm B- Nivolumab
arm group type: Experimental
description: Nivolumab administration:
Three doses of nivolumab will be administered to enrolled patients on Day -42, Day -28, and Day-14 (+/- two days) prior to planned surgery on Day 0 or up to +10 days.
arm group label: Arm C- Nivolumab, Carboplatin, & Paclitaxel
arm group type: Experimental
description: Nivolumab 360 mg IV, Carboplatin AUC 5 or 6 IV, and Paclitaxel 175 or 200 mg/m2 IV every 21 days for 3 cycles prior to planned surgery on Day 0.
intervention type: Drug
intervention name: Nivolumab
description: Anti-PD-1 Therapy
arm group label: Arm B- Nivolumab
arm group label: Arm C- Nivolumab, Carboplatin, & Paclitaxel
other name: BMS-936558 or MDX1106
intervention type: Drug
intervention name: Carboplatin
description: Anti-PD-1 Therapy
arm group label: Arm C- Nivolumab, Carboplatin, & Paclitaxel
other name: Paraplatin
intervention type: Drug
intervention name: Paclitaxel
description: Anti-PD-1 Therapy
arm group label: Arm C- Nivolumab, Carboplatin, & Paclitaxel
other name: Taxol
other name: Onxal
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Patrick Forde, MD
role: Principal Investigator
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
facility: 
facility: 
facility: 
facility: 
facility: 
country: Canada
country: United States
url: http://globocan.iarc.fr
description: Ferlay J, Shin HR, Bray F, Forman D, Mathers CD, Parkin D. GLOBOCAN 2008, Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 10. Lyon, France: International Agency for Research on Cancer; Year 2010
url: http://www.seer.cancer.gov
description: Accessed 08/08/2012
url: http://www.clinicaltrials.gov/ct2/show/NCT01274338
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responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Carboplatin
mesh term: Nivolumab
sharing ipd: No