<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/NCT02967133</url>
  </required_header>
  <id_info>
    <org_study_id>AFT-31</org_study_id>
    <nct_id>NCT02967133</nct_id>
  </id_info>
  <brief_title>A Study of Nivolumab +/- Nab-paclitaxel in Non-small Cell Lung Cancer</brief_title>
  <official_title>Nivolumab With or Without Nab-Paclitaxel in Previously Treated, Advanced Stage, Non-small Cell Lung Cancer: A Randomized Phase II Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alliance Foundation Trials, LLC.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Celgene Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Alliance Foundation Trials, LLC.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The optimal prioritization of second-line chemotherapy and immune therapy based on&#xD;
      demographic or biomarker data is an area of ongoing investigation. The hypothesis of this&#xD;
      study is that there may be an additive or synergistic antitumor effect of combined&#xD;
      chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to&#xD;
      test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need&#xD;
      despite recent clinical research progress. Early progression for a subset of NSCLC patients&#xD;
      receiving nivolumab is a specific area of clinical need.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nab-paclitaxel will be added to standard nivolumab therapy in previously treated advanced&#xD;
      stage non-small cell lung cancer to help prevent early progression and to improve progression&#xD;
      free survival. The primary endpoint will be to determine if the addition of nab-paclitaxel to&#xD;
      nivolumab improves progression free survival compared to nivolumab alone. Retrospective&#xD;
      studies will be conducted to analyze blood based immune biomarkers, and tumor biomarkers to&#xD;
      better understand the effect that nivolumab combined with chemotherapy has on the immune&#xD;
      system in NSCLC. Patients with advanced stage non-small cell lung cancer who have progression&#xD;
      of cancer after receiving platinum doublet chemotherapy will be randomized to receive&#xD;
      nivolumab with or without nab-paclitaxel. Patients on both arms will receive a maximum of one&#xD;
      year of therapy with the option to retreat at progression.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Lack of enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel 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>13 months</time_frame>
    <description>This study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone. A progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">7</enrollment>
  <condition>Non-Small-Cell Lung Cancer Metastatic</condition>
  <condition>Non-Small Cell Carcinoma of Lung, TNM Stage 4</condition>
  <condition>Nonsmall Cell Lung Cancer</condition>
  <condition>Non Small Cell Lung Cancer Recurrent</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nivolumab q 14 days until disease progression/toxicity</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nivolumab every 21 days until disease progression&#xD;
Nab-paclitaxel every 21 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nivolumab</intervention_name>
    <description>Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.&#xD;
Arm B: Nivolumab 360 mg via intravenous infusion (IV) over 30 minutes day 1 of every 21 day treatment cycle until progression or not tolerated.</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>Opdivo</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>nab-paclitaxel</intervention_name>
    <description>Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.</description>
    <arm_group_label>Arm B</arm_group_label>
    <other_name>abraxane</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Histologically or cytologically confirmed, Stage IV non-small cell lung cancer (per&#xD;
             the Union Internationale contre le Cancer/American Join Committee on Cancer staging&#xD;
             system, 7th edition) or recurrent incurable non-small cell lung cancer that has&#xD;
             progressed after first-line chemotherapy.&#xD;
&#xD;
          2. Prior Therapy: Platinum doublet chemotherapy for current diagnosis of advanced lung&#xD;
             cancer. Only one prior line of chemotherapy for advanced lung cancer allowed. Adjuvant&#xD;
             chemotherapy, neoadjuvant chemotherapy, or chemoradiotherapy given for early stage&#xD;
             lung cancer at least 6 months prior to diagnosis of recurrent/metastatic disease is&#xD;
             not counted as a line of therapy for advanced lung cancer. Patients who received&#xD;
             platinum doublet therapy with or without radiotherapy as part of treatment for early&#xD;
             stage non-small cell lung cancer less than 6 months after developing stage 4 or&#xD;
             recurrent incurable disease will be considered study eligible by the criterion of&#xD;
             having received one line of chemotherapy for non-small cell lung cancer.&#xD;
&#xD;
          3. EGFR, ALK and ROS biomarker positive tumors are eligible as long as the patient has&#xD;
             received at least one standard oral, molecular inhibitor therapy in addition to&#xD;
             standard platinum doublet chemotherapy. More than one molecular inhibitor is allowed&#xD;
             such as a first generation EGFR inhibitor followed by a next generation EGFR inhibitor&#xD;
             when T790 mutation develops. Prior molecular therapy for biomarker positive tumors&#xD;
             such as (but not limited to) MET, RET and BRAF allowed but not required.&#xD;
&#xD;
          4. Prior chemotherapy must have been completed 21 days prior to initiation of protocol&#xD;
             therapy and all toxicities must &lt; grade 2.&#xD;
&#xD;
          5. Patients must have &lt; Grade 2 or pre-existing neuropathy (per CTCAE).&#xD;
&#xD;
          6. Palliative radiation must have been completed 2 weeks prior to the initiation of study&#xD;
             therapy.&#xD;
&#xD;
          7. All patients must have measurable disease. Measurable disease is defined as at least&#xD;
             one lesion that can be accurately measured in at least one dimension (longest diameter&#xD;
             to be recorded) as ≥ 20mm with conventional techniques or as ≥10mm with spiral CT&#xD;
             scan.&#xD;
&#xD;
          8. ECOG Performance Status: 0-1&#xD;
&#xD;
          9. Second malignancy: No &quot;currently active&quot; second malignancy other than non-melanoma&#xD;
             skin cancers.&#xD;
&#xD;
         10. Brain metastases: brain metastases must have been treated at least 2 weeks prior to&#xD;
             enrollment, be asymptomatic from brain metastases, stable on brain imaging, and not be&#xD;
             receiving a supra-physiologic dose of steroids (&gt; 10 mg prednisone daily or&#xD;
             equivalent).&#xD;
&#xD;
         11. Non-pregnant and non-nursing. The effect of nab-paclitaxel and nivolumab on the fetus&#xD;
             is unknown.&#xD;
&#xD;
         12. Women of childbearing potential (WOCBP) must be willing to use 2 methods of birth&#xD;
             control or be surgically sterile, or abstain from heterosexual activity for the course&#xD;
             of the study through 6 months after the last dose of study medication. Patients of&#xD;
             childbearing potential are those who have not been surgically sterilized or have not&#xD;
             been free of menses &gt; 1 year.&#xD;
&#xD;
         13. Male patients must agree to use an adequate method of contraception starting with the&#xD;
             first dose of study therapy through 7 months after the last dose of study therapy.&#xD;
&#xD;
         14. Age ≥18 years.&#xD;
&#xD;
         15. Required Initial Laboratory Values:&#xD;
&#xD;
             Leukocytes ≥2000/ µl Hemoglobin &gt;9.0 g/dL Platelets ≥100,000/ µl ANC ≥1,500/mcL&#xD;
&#xD;
             Serum 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&#xD;
             mg/dL&#xD;
&#xD;
             Male CrCl = (140 - age in years) x weight in kg x 1.00&#xD;
&#xD;
             Total Bilirubin &lt;1.5 mg/dl (except for subjects with Gilbert Syndrome, who can have&#xD;
             total bilirubin &lt; 3.0 mg/dl) SGOT (AST) &lt;2.5 x ULN ALP &lt;2.5 x ULN in absence of liver&#xD;
             metastases (&lt;5 x ULN if liver metastases present PTT &lt;1.5 x ULN&#xD;
&#xD;
         16. An archival tumor sample from either a prior core needle biopsy or surgical specimen&#xD;
             must be available to be submitted for correlative studies as an eligibility&#xD;
             requirement prior to registration. The sample must be shipped within 6 weeks of&#xD;
             enrollment. Participants without an available archival tumor sample are considered&#xD;
             ineligible.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Prior nab-paclitaxel chemotherapy excluded.&#xD;
&#xD;
          2. Prior immune therapy for NSCLC excluded. Patients should be excluded if they have had&#xD;
             prior treatment with an anti-PD-1, anti-PD-L1, anti PD-L2, anti-CTLA-4 antibody, or&#xD;
             any other antibody or drug specifically targeting T-cell costimulation or immune&#xD;
             checkpoint pathways.&#xD;
&#xD;
          3. Patients will be excluded if they have an active, known or suspected autoimmune&#xD;
             disease. Subjects are permitted to enroll if they have vitiligo, type I diabetes&#xD;
             mellitus, 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;
          4. Patients will be excluded if they have a condition requiring systemic treatment with&#xD;
             either corticosteroids (&gt;10mg/day prednisone equivalents) or other immunosuppressive&#xD;
             medications within 14 days of study drug administration. Inhaled or topical steroids&#xD;
             and adrenal replacement doses &gt;10 mg daily prednisone equivalents are permitted in the&#xD;
             absence or active autoimmune disease.&#xD;
&#xD;
          5. Patients should be excluded if they test positive for hepatitis B virus surface&#xD;
             antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating&#xD;
             acute or chronic infection.&#xD;
&#xD;
          6. Patients should be excluded if they have known history of testing positive for human&#xD;
             immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).&#xD;
&#xD;
          7. Allergies and Adverse Drug Reaction: History of allergy to study drug components&#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>Monica Bertagnolli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alliance Foundation Trials, LLC.</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neal Ready, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Alliance Foundation Trials, LLC.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St. Elizabeth's Healthcare</name>
      <address>
        <city>Edgewood</city>
        <state>Kentucky</state>
        <zip>41017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Metro Minnesota community oncology research consortium</name>
      <address>
        <city>Saint Louis Park</city>
        <state>Minnesota</state>
        <zip>55416</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>Nebraska Methodist Hospital</name>
      <address>
        <city>Omaha</city>
        <state>Nebraska</state>
        <zip>68114</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://meetinglibrary.asco.org/content/125962-144</url>
    <description>General Poster Session, Lung Cancer - Non-Small Cell Metastati</description>
  </link>
  <reference>
    <citation>Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.</citation>
    <PMID>26028407</PMID>
  </reference>
  <reference>
    <citation>Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.</citation>
    <PMID>26412456</PMID>
  </reference>
  <reference>
    <citation>Socinski MA, Bondarenko I, Karaseva NA, Makhson AM, Vynnychenko I, Okamoto I, Hon JK, Hirsh V, Bhar P, Zhang H, Iglesias JL, Renschler MF. Weekly nab-paclitaxel in combination with carboplatin versus solvent-based paclitaxel plus carboplatin as first-line therapy in patients with advanced non-small-cell lung cancer: final results of a phase III trial. J Clin Oncol. 2012 Jun 10;30(17):2055-62. doi: 10.1200/JCO.2011.39.5848. Epub 2012 Apr 30.</citation>
    <PMID>22547591</PMID>
  </reference>
  <reference>
    <citation>Liu Z, Wei Z, Hu Y, Gao F, Hao L, Fang P, Sun S, Li J, Jiao S. A phase II open-label clinical study of comparing nab-paclitaxel with pemetrexed as second-line chemotherapy for patients with stage IIIB/IV non-small-cell lung cancer. Med Oncol. 2015 Aug;32(8):216. doi: 10.1007/s12032-015-0660-5. Epub 2015 Jul 14.</citation>
    <PMID>26168982</PMID>
  </reference>
  <reference>
    <citation>Camidge R. et al. ORAL02.05 Safety and Efficacy of First-Line Nivolumab (NIVO; Anti-Programmed Death-1 [PD-1]) and Ipilimumab in Non-Small Cell Lung Cancer (NSCLC) World Lung Cancer Meeting, Denver, CO September 2015.</citation>
  </reference>
  <reference>
    <citation>Adams S, et al. OT1-01-06 A phase III randomized trial of atezolizumab in combination with nab-paclitaxel as first line therapy for patients with metastatic triple-negative breast cancer (mTNBC) San Antonio Breast Cancer Meeting, San Antonio, TX December 2015.</citation>
  </reference>
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    <citation>Eisenhauer EA, Therasse P, Bogaerts J, Schwartz LH, Sargent D, Ford R, Dancey J, Arbuck S, Gwyther S, Mooney M, Rubinstein L, Shankar L, Dodd L, Kaplan R, Lacombe D, Verweij J. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1.1). Eur J Cancer. 2009 Jan;45(2):228-47. doi: 10.1016/j.ejca.2008.10.026.</citation>
    <PMID>19097774</PMID>
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  <reference>
    <citation>O'Brien PC, Fleming TR. A multiple testing procedure for clinical trials. Biometrics. 1979 Sep;35(3):549-56.</citation>
    <PMID>497341</PMID>
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    <citation>Freidlin B, Korn EL, George SL. Data monitoring committees and interim monitoring guidelines. Control Clin Trials. 1999 Oct;20(5):395-407. doi: 10.1016/s0197-2456(99)00017-3.</citation>
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    <citation>Kaplan, E.L., Meier, P., Nonparametric estimation from incomplete observations. J Am Stat Assoc, 1958. 53(282): p. 457-481.</citation>
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    <citation>Mantel N. Evaluation of survival data and two new rank order statistics arising in its consideration. Cancer Chemother Rep. 1966 Mar;50(3):163-70. No abstract available.</citation>
    <PMID>5910392</PMID>
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  <reference>
    <citation>Cox, D.R. Regression models and life-tables. J R Stat Soc 1972 34: p.187-220.</citation>
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    <citation>Fine, J., Gray R., A proportional hazards model for the sub distribution of a competing risk. J Am Stat Assoc, 1999. 94: p. 496-509.</citation>
  </reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>November 8, 2016</study_first_submitted>
  <study_first_submitted_qc>November 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <results_first_submitted>July 12, 2022</results_first_submitted>
  <results_first_submitted_qc>August 16, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">September 8, 2022</results_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Carcinoma, Non-Small-Cell Lung</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Paclitaxel</mesh_term>
    <mesh_term>Nivolumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Anonymized (de-identified) data generated from biospecimens used for future correlative research, including somatic and constitutional (germline) genomic data, may be shared with other researchers or deposited in a publicly accessible or controlled-access data repositories. Correlative study results and data will never be returned to individual patients.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/33/NCT02967133/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Arm A (Nivolumab Alone)</title>
          <description>Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.</description>
        </group>
        <group group_id="P2">
          <title>Arm B (Nivolumab + Nab-Paclitaxel)</title>
          <description>Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="4"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Arm A (Nivolumab Alone)</title>
          <description>Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.</description>
        </group>
        <group group_id="B2">
          <title>Arm B (Nivolumab + Nab-Paclitaxel)</title>
          <description>Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="3"/>
            <count group_id="B2" value="4"/>
            <count group_id="B3" value="7"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66" lower_limit="54" upper_limit="71"/>
                    <measurement group_id="B2" value="70.5" lower_limit="68" upper_limit="82"/>
                    <measurement group_id="B3" value="69" lower_limit="54" upper_limit="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Progression-Free Survival</title>
        <description>This study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone. A progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.</description>
        <time_frame>13 months</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Arm A (Nivolumab Alone)</title>
            <description>Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.</description>
          </group>
          <group group_id="O2">
            <title>Arm B (Nivolumab + Nab-Paclitaxel)</title>
            <description>Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.</description>
          </group>
        </group_list>
        <measure>
          <title>Progression-Free Survival</title>
          <description>This study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone. A progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.</description>
          <units>Months</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="3"/>
                <count group_id="O2" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.3" lower_limit="1.0" upper_limit="NA">Insufficient number of participants with events</measurement>
                    <measurement group_id="O2" value="5.3" lower_limit="1.3" upper_limit="NA">Insufficient number of participants with events</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.5186</p_value>
            <method>Log Rank</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>13 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Arm A (Nivolumab Alone)</title>
          <description>Nivolumab q 14 days until disease progression/toxicity Nivolumab: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.</description>
        </group>
        <group group_id="E2">
          <title>Arm B (Nivolumab + Nab-Paclitaxel)</title>
          <description>Nivolumab every 21 days until disease progression Nab-paclitaxel every 21 days nab-paclitaxel: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 12</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death NOS</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Hypoxia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 12</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="3" subjects_at_risk="3"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Pericardial effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Diarrhea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dry mouth</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gastroesophageal reflux disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gastrointestinal disorders - Oth spec</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Mucositis oral</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="3" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vomiting</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fatigue</sub_title>
                <counts group_id="E1" events="5" subjects_affected="2" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Gen disord and admin site conds-Oth spec</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Creatinine increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Investigations - Other, specify</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="5" subjects_affected="2" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Weight gain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Anorexia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dehydration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hypernatremia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hypocalcemia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hypomagnesemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dysgeusia</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Peripheral sensory neuropathy</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Acute kidney injury</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Hoarseness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Pleural effusion</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Productive cough</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Resp, thoracic, mediastinal - Oth spec</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Rash acneiform</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Rash maculo-papular</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="3"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="4"/>
              </event>
              <event>
                <sub_title>Vasculitis</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="3"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="4"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Neal Ready MD PhD</name_or_title>
      <organization>Duke University Medical Center</organization>
      <phone>(919) 681-6932</phone>
      <email>neal.ready@duke.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02967133
org study id: AFT-31
nct id: NCT02967133
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The optimal prioritization of second-line chemotherapy and immune therapy based on
      demographic or biomarker data is an area of ongoing investigation. The hypothesis of this
      study is that there may be an additive or synergistic antitumor effect of combined
      chemotherapy and nivolumab in the second-line treatment of NSCLC as an important concept to
      test in a clinical trial. Previously treated NSCLC remains a setting of unmet clinical need
      despite recent clinical research progress. Early progression for a subset of NSCLC patients
      receiving nivolumab is a specific area of clinical need.
Nab-paclitaxel will be added to standard nivolumab therapy in previously treated advanced
      stage non-small cell lung cancer to help prevent early progression and to improve progression
      free survival. The primary endpoint will be to determine if the addition of nab-paclitaxel to
      nivolumab improves progression free survival compared to nivolumab alone. Retrospective
      studies will be conducted to analyze blood based immune biomarkers, and tumor biomarkers to
      better understand the effect that nivolumab combined with chemotherapy has on the immune
      system in NSCLC. Patients with advanced stage non-small cell lung cancer who have progression
      of cancer after receiving platinum doublet chemotherapy will be randomized to receive
      nivolumab with or without nab-paclitaxel. Patients on both arms will receive a maximum of one
      year of therapy with the option to retreat at progression.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Progression-Free Survival
time frame: 13 months
description: This study will compare the progression-free survival of patients with advanced stage non-small cell lung cancer whose cancer has progressed after standard first-line platinum based doublet chemotherapy is improved with nivolumab plus nab-paclitaxel compared to nivolumab alone. A progression is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progressions). Appearance of one or more new lesions and/or unequivocal progression of existing non-target lesions. Unequivocal progression should not normally trump target lesion status. It must be representative of overall disease status change, not a single lesion increase.
arm group label: Arm A
arm group type: Active Comparator
description: Nivolumab q 14 days until disease progression/toxicity
arm group label: Arm B
arm group type: Active Comparator
description: Nivolumab every 21 days until disease progression
Nab-paclitaxel every 21 days
intervention type: Drug
intervention name: Nivolumab
description: Arm A: Nivolumab 240 mg via intravenous infusion (IV) over 30 minutes day 1 of each 14 day cycle until disease progression or not tolerated.
Arm B: Nivolumab 360 mg via intravenous infusion (IV) over 30 minutes day 1 of every 21 day treatment cycle until progression or not tolerated.
arm group label: Arm A
arm group label: Arm B
other name: Opdivo
intervention type: Drug
intervention name: nab-paclitaxel
description: Patients in arm B receive nab-paclitaxel at a dose of 100 mg/m2 over intravenous infusion on Days 1 and 8 of each 21 day cycle.
arm group label: Arm B
other name: abraxane
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Monica Bertagnolli, MD
role: Principal Investigator
affiliation: Alliance Foundation Trials, LLC.
last name: Neal Ready, MD, PhD
role: Study Chair
affiliation: Alliance Foundation Trials, LLC.
facility: 
facility: 
facility: 
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country: United States
url: http://meetinglibrary.asco.org/content/125962-144
description: General Poster Session, Lung Cancer - Non-Small Cell Metastati
citation: Brahmer J, Reckamp KL, Baas P, Crino L, Eberhardt WE, Poddubskaya E, Antonia S, Pluzanski A, Vokes EE, Holgado E, Waterhouse D, Ready N, Gainor J, Aren Frontera O, Havel L, Steins M, Garassino MC, Aerts JG, Domine M, Paz-Ares L, Reck M, Baudelet C, Harbison CT, Lestini B, Spigel DR. Nivolumab versus Docetaxel in Advanced Squamous-Cell Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Jul 9;373(2):123-35. doi: 10.1056/NEJMoa1504627. Epub 2015 May 31.
PMID: 26028407
citation: Borghaei H, Paz-Ares L, Horn L, Spigel DR, Steins M, Ready NE, Chow LQ, Vokes EE, Felip E, Holgado E, Barlesi F, Kohlhaufl M, Arrieta O, Burgio MA, Fayette J, Lena H, Poddubskaya E, Gerber DE, Gettinger SN, Rudin CM, Rizvi N, Crino L, Blumenschein GR Jr, Antonia SJ, Dorange C, Harbison CT, Graf Finckenstein F, Brahmer JR. Nivolumab versus Docetaxel in Advanced Nonsquamous Non-Small-Cell Lung Cancer. N Engl J Med. 2015 Oct 22;373(17):1627-39. doi: 10.1056/NEJMoa1507643. Epub 2015 Sep 27.
PMID: 26412456
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PMID: 22547591
citation: Liu Z, Wei Z, Hu Y, Gao F, Hao L, Fang P, Sun S, Li J, Jiao S. A phase II open-label clinical study of comparing nab-paclitaxel with pemetrexed as second-line chemotherapy for patients with stage IIIB/IV non-small-cell lung cancer. Med Oncol. 2015 Aug;32(8):216. doi: 10.1007/s12032-015-0660-5. Epub 2015 Jul 14.
PMID: 26168982
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citation: Adams S, et al. OT1-01-06 A phase III randomized trial of atezolizumab in combination with nab-paclitaxel as first line therapy for patients with metastatic triple-negative breast cancer (mTNBC) San Antonio Breast Cancer Meeting, San Antonio, TX December 2015.
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responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Carcinoma, Non-Small-Cell Lung
mesh term: Paclitaxel
mesh term: Nivolumab
sharing ipd: Undecided
ipd description: Anonymized (de-identified) data generated from biospecimens used for future correlative research, including somatic and constitutional (germline) genomic data, may be shared with other researchers or deposited in a publicly accessible or controlled-access data repositories. Correlative study results and data will never be returned to individual patients.
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