xml: <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/NCT06028633</url>
    </required_header>
    <id_info>
      <org_study_id>MISP61001</org_study_id>
      <nct_id>NCT06028633</nct_id>
    </id_info>
    <brief_title>Efficacy and Safety of Nab-paclitaxel-Lenvatinib-Pembrolizumab as Second-line Treatment in Advanced NSCLC Patients</brief_title>
    <official_title>Efficacy and Safety of Albumin-bound Paclitaxel-Lenvatinib-Pembrolizumab in Advanced Nonsquamous NSCLC Patients After Progression to First-line Anti-PD-1/L1 Inhibitor With Platinum-doublet Chemotherapy</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University First Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Merck Sharp &amp; Dohme LLC</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
    </sponsors>
    <source>Peking University First Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to evaluate the efficacy and safety of albumin-bound&#xD;
        paclitaxel-lenvatinib-pembrolizumab in advanced nonsquamous NSCLC patients after progression&#xD;
        to first-line anti-PD-1/L1 inhibitor with platinum-doublet chemotherapy. All participants&#xD;
        will be given with albumin-bound paclitaxel, lenvatinib and pembrolizumab.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 2026</completion_date>
    <primary_completion_date type="Anticipated">October 2024</primary_completion_date>
    <phase>Phase 2</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>Objective response rate</measure>
      <time_frame>About 18 months</time_frame>
      <description>Objective response rate (ORR) assessed per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>About 36 months</time_frame>
      <description>Overall survival (OS)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Progression-free survival</measure>
      <time_frame>About 24 months</time_frame>
      <description>Progression-free survival (PFS) assessed per RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of response</measure>
      <time_frame>About 24 months</time_frame>
      <description>Duration of response (DoR) assessed per RECIST v1.1</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment-related adverse events</measure>
      <time_frame>About 24 months</time_frame>
      <description>Treatment-related adverse events (TRAEs) assessed by CTCAE v5.0</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Single cell sequencing of tumor specimens</measure>
      <time_frame>About 36 months</time_frame>
      <description>Tumor specimens were collected before and after treatment for single cell assays to assess changes in the tumor immune microenvironment</description>
    </other_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">28</enrollment>
    <condition>Advanced Non-squamous Non-small-cell Lung Cancer</condition>
    <condition>Recurrent Non-Squamous Non-Small Cell Lung Cancer</condition>
    <condition>Metastatic Non-squamous Non Small Cell Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Arm I</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Participants will receive pembrolizumab IV 200 mg D1 every 3 weeks, lenvatinib 8 mg orally every day, albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks,until disease progression, intolerable toxicity, investigator decision, or completion of 35 cycles(for pembrolizumab) and 4-6 cycles(for albumin-bound paclitaxel).</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>pembrolizumab</intervention_name>
      <description>pembrolizumab 200mg IV on day 1 for every 3 weeks</description>
      <arm_group_label>Arm I</arm_group_label>
      <other_name>Keytruda</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>lenvatinib</intervention_name>
      <description>lenvatinib 8mg taken orally every day</description>
      <arm_group_label>Arm I</arm_group_label>
      <other_name>Lenvima</other_name>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>albumin-bound paclitaxel</intervention_name>
      <description>albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks</description>
      <arm_group_label>Arm I</arm_group_label>
      <other_name>nab-paclitaxel</other_name>
      <other_name>paclitaxel for injection(albumin bound)</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion criteria&#xD;
  &#xD;
            1. Male/female participants who are at least 18 years of age on the day of signing&#xD;
               informed consent (ICF) with histologically confirmed diagnosis of metastatic&#xD;
               nonsquamous NSCLC (AJCC Staging Manual, Version 8) will be enrolled in this study.&#xD;
  &#xD;
            2. Contraceptive use by men and women should be consistent with local regulations&#xD;
               regarding the methods of contraception for those participating in clinical studies.&#xD;
  &#xD;
            3. Male participants are eligible to participate the study if they agree to the following&#xD;
               during the intervention period and for at least 180 days after the last dose of study&#xD;
               intervention:&#xD;
  &#xD;
               Be abstinent from heterosexual intercourse as their preferred and usual lifestyle&#xD;
               (abstinent on a long-term and persistent basis) and agree to remain abstinent OR must&#xD;
               agree to use contraception unless confirmed to be azoospermia (vasectomized or&#xD;
               secondary to medical cause) as:&#xD;
  &#xD;
               A. Agree to use a male condom plus partner use of an additional contraceptive method&#xD;
               when having penile-vaginal intercourse with a woman of childbearing potential (WOCBP)&#xD;
               who is not currently pregnant. Note: Men with a pregnant or breastfeeding partner must&#xD;
               agree to remain abstinent from penile-vaginal intercourse or use a male condom during&#xD;
               each episode of penile-vaginal penetration.&#xD;
  &#xD;
               B. Contraceptive use by men should be consistent with local regulations regarding the&#xD;
               methods of contraception for those participating in clinical studies. If the&#xD;
               contraception requirements in the local label for any of the study interventions is&#xD;
               more stringent than the requirements above, the local label requirements are to be&#xD;
               followed.&#xD;
  &#xD;
               C. Please note that 7 days after lenvatinib is stopped, if the participant is on&#xD;
               pembrolizumab only, no male contraception measures are needed D. Refrain from donating&#xD;
               sperm for at least 120 days after the last dose of Lenvatinib.&#xD;
  &#xD;
            4. Female participant is eligible to participate if she is not pregnant or not&#xD;
               breastfeeding, and at least one of the following conditions applies:&#xD;
  &#xD;
               A. Not a woman of childbearing potential (WOCBP).&#xD;
  &#xD;
               B. A WOCBP who agrees to follow the contraceptive method that is highly effective&#xD;
               (with a failure rate of &lt;1% per year), with low user dependency, or be abstinent from&#xD;
               heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long&#xD;
               term and persistent basis), during the treatment period and for at least 120 days&#xD;
               after the last dose of pembrolizumab or 30 days after the last dose of lenvatinib,&#xD;
               study treatment, and agrees not to donate eggs (ova, oocytes) to others or&#xD;
               freeze/store these for her own use for the purpose of reproduction during this period.&#xD;
               The investigator should evaluate the potential for contraceptive method failure (i.e.,&#xD;
               noncompliance, recently initiated) in relationship to the first dose of study&#xD;
               intervention.&#xD;
  &#xD;
               C. A WOCBP must have negative highly sensitive pregnancy test (urine or serum as&#xD;
               required by local regulations) within 24 hours before the first dose of study&#xD;
               intervention.&#xD;
  &#xD;
               D. If a urine test cannot be confirmed as negative (i.e., an ambiguous result), a&#xD;
               serum pregnancy test is required. In such cases, the participant must be excluded from&#xD;
               participation if the serum pregnancy result is positive.&#xD;
  &#xD;
               E. The investigator is responsible for review of medical history, menstrual history,&#xD;
               and recent sexual activity to decrease the risk for inclusion of a woman with an early&#xD;
               undetected pregnancy.&#xD;
  &#xD;
            5. Participants must have progressed on treatment with an anti-PD-1/L1 mAb administered&#xD;
               in combination with platinum doublet chemotherapy concomitantly as first line&#xD;
               treatment. Participants who have received Anti-PD-1/PD-L1(either as monotherapy or in&#xD;
               combination with chemotherapy) as initial treatment at early-stage or locally advanced&#xD;
               NSCLC should NOT be enrolled in this study. Anti-PD-1/PD-L1 treatment progression is&#xD;
               defined by meeting all of the following criteria:&#xD;
  &#xD;
               A. Has received at least 2 doses of an approved anti-PD-1/L1 mAb&#xD;
  &#xD;
               B. Has demonstrated disease progression after anti-PD-1/L1 as defined by RECIST v1.1.&#xD;
               The initial evidence of PD is to be confirmed by a second assessment no less than 4&#xD;
               weeks from the date of the first documented disease progression, in the absence of&#xD;
               rapid clinical progression. Eligible participants should have at least 2 pre-study&#xD;
               images as confirmed evidence of PD (assessed by investigator) on treatment of&#xD;
               anti-PD-1/L1 mAb before the study intervention.&#xD;
  &#xD;
               C. Progressive disease has been documented within 12 weeks from the last dose of&#xD;
               anti-PD-1/L1 mAb,&#xD;
  &#xD;
            6. Have confirmation that EGFR-, ALK-, or ROS1-directed therapy is not indicated as&#xD;
               primary therapy. Subjects who have failed directed therapy are not eligible for the&#xD;
               study.&#xD;
  &#xD;
            7. The participant (or legally acceptable representative if applicable) provides written&#xD;
               informed consent for the trial.&#xD;
  &#xD;
            8. Have measurable disease (at least 1 measurable lesion by CT or MRI) based on RECIST&#xD;
               1.1. Lesions situated in a previously irradiated area are considered measurable if&#xD;
               progression has been demonstrated in such lesions.&#xD;
  &#xD;
            9. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.&#xD;
               Evaluation of ECOG is to be performed within 7 days prior to the first dose of study&#xD;
               intervention.&#xD;
  &#xD;
           10. Have a life expectancy of at least 3 months and adequate organ function as defined in&#xD;
               the following table.&#xD;
  &#xD;
           11. Have adequately controlled blood pressure (BP) with or without antihypertensive&#xD;
               medications, defined as BP≤150/90mmHg and no change in antihypertensive medications&#xD;
               within 1 week before treatment initiation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. A WOCBP who has a positive urine pregnancy test within 72 hours prior to treatment&#xD;
               initiation. If the urine test is positive or cannot be confirmed as negative, a serum&#xD;
               pregnancy test will be required.&#xD;
  &#xD;
            2. Has received prior therapy at any stage of disease with any anti-VEGF-TKIs (i.e.&#xD;
               Bevacizumab, Lenvatinib, Anlotinib, Apatinib, etc.) as monotherapy or in combination&#xD;
               with an anti-PD-1/L1 inhibitor.&#xD;
  &#xD;
            3. Has received prior Paclitaxel, Docetaxel or Albumin-paclitaxel as monotherapy or in&#xD;
               combination with other therapies at any stage of disease.&#xD;
  &#xD;
            4. Has received prior radiotherapy within 2 weeks of start of study intervention or has&#xD;
               received lung radiation therapy &gt;30 Gy within 6 months before the first dose of study&#xD;
               intervention. Participants must have recovered from all radiation-related toxicities,&#xD;
               not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout&#xD;
               is permitted for palliative radiation (≤2 weeks of radiotherapy) to non-CNS disease.&#xD;
  &#xD;
            5. Has had major surgery within 3 weeks prior to first dose of study interventions.&#xD;
  &#xD;
               Note: Adequate wound healing after major surgery must be assessed clinically,&#xD;
               independent of time elapsed for eligibility.&#xD;
  &#xD;
            6. Active hemoptysis (bright red blood of at least 0.5 teaspoon) within 3 weeks prior to&#xD;
               the first dose of study drug.&#xD;
  &#xD;
            7. Has radiographic evidence of major blood vessel invasion/infiltration. In the chest,&#xD;
               major blood vessels include the main pulmonary artery, the left and right pulmonary&#xD;
               arteries, the 4 major pulmonary veins, the superior or inferior vena cava, and the&#xD;
               aorta.&#xD;
  &#xD;
               Note: The degree of proximity to major blood vessels should be considered because of&#xD;
               the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis&#xD;
               following lenvatinib therapy.&#xD;
  &#xD;
            8. Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.&#xD;
  &#xD;
            9. Has urine protein ≥1 g/24 hours. Note: Participants with proteinuria ≥2+ (≥100 mg/dL)&#xD;
               on urine dipstick testing or urinalysis will undergo 24-hour urine collection for&#xD;
               quantitative assessment of proteinuria.&#xD;
  &#xD;
           10. Has a LVEF below the institutional (or local laboratory) normal range, as determined&#xD;
               by echocardiogram (ECHO). OR has Prolongation of QTcF interval to &gt;480 ms according to&#xD;
               ECG.&#xD;
  &#xD;
           11. Gastrointestinal malabsorption or any other condition that might affect the absorption&#xD;
               of lenvatinib&#xD;
  &#xD;
           12. Has received a live vaccine or live-attenuated vaccine within 30 days before the first&#xD;
               dose of study intervention. Administration of killed vaccines is allowed.&#xD;
  &#xD;
           13. Is currently participating in or has participated in a study of an investigational&#xD;
               agent or has used an investigational device within 4 weeks prior to the first dose of&#xD;
               study intervention.&#xD;
  &#xD;
           14. Has clinically significant cardiovascular disease within 12 months from first dose of&#xD;
               study intervention, including New York Heart Association Class III or IV congestive&#xD;
               heart failure, unstable angina, myocardial infarction, cerebral vascular accident, or&#xD;
               cardiac arrhythmia associated with hemodynamic instability.&#xD;
  &#xD;
               Note: Medically controlled arrhythmia would be permitted.&#xD;
  &#xD;
           15. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy&#xD;
               (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of&#xD;
               immunosuppressive therapy within 7 days prior to the first dose of study drug.&#xD;
  &#xD;
           16. Has a known history of an additional malignancy, except if the participant has&#xD;
               undergone potentially curative therapy with no evidence of disease recurrence for 3&#xD;
               years since initiation of that therapy. Note: The requirement for no evidence of&#xD;
               disease for 3 years does not apply to the NSCLC for which a participant is enrolled in&#xD;
               the study. This time requirement also does not apply to participants who underwent&#xD;
               successful definitive resection of basal cell carcinoma of the skin, superficial&#xD;
               bladder cancer, squamous cell carcinoma of the skin, in situ cervical cancer, or other&#xD;
               in situ cancers.&#xD;
  &#xD;
           17. Has known active CNS metastases and/or carcinomatous meningitis. Participants with&#xD;
               previously treated brain metastases may participate provided they are radiologically&#xD;
               stable, i.e., without evidence of progression for at least 4 weeks by repeat imaging&#xD;
               (note that the repeat imaging should be performed during study screening), clinically&#xD;
               stable and without requirement of steroid treatment for at least 14 days prior to&#xD;
               first dose of study intervention.&#xD;
  &#xD;
           18. Has active autoimmune disease that has required systemic treatment in the past 2 years&#xD;
               (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive&#xD;
               drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid&#xD;
               replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a&#xD;
               form of systemic treatment and is allowed.&#xD;
  &#xD;
           19. Has a history of (non-infectious) pneumonitis/interstitial lung disease that required&#xD;
               steroids or has current pneumonitis/interstitial lung disease.&#xD;
  &#xD;
           20. Has an active infection requiring systemic therapy.&#xD;
  &#xD;
           21. Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients.&#xD;
  &#xD;
           22. Has a sensitivity to any of the excipients contained in Albumin-paclitaxel and/or&#xD;
               Lenvatinib.&#xD;
  &#xD;
           23. Has a known history of Human Immunodeficiency Virus (HIV) infection.&#xD;
  &#xD;
           24. Has active Hepatitis B (defined as HBsAg positive and/or detectable HBV DNA) or&#xD;
               Hepatitis C virus (defined as anti-HCV Ab positive and detectable HCV RNA) infection.&#xD;
  &#xD;
               Note: Hepatitis B and C screening tests are not required unless:&#xD;
  &#xD;
                 -  Known history of HBV and HCV infection&#xD;
  &#xD;
                 -  As mandated by local health authority&#xD;
  &#xD;
           25. Has a history or current evidence of any condition, therapy, or laboratory abnormality&#xD;
               or other circumstance that might confound the results of the study, interfere with the&#xD;
               participant's participation for the full duration of the study, such that it is not in&#xD;
               the best interest of the participant to participate, in the opinion of the treating&#xD;
               investigator.&#xD;
  &#xD;
           26. Has known psychiatric or substance abuse disorders that would interfere with&#xD;
               cooperation with the requirements of the trial.&#xD;
  &#xD;
           27. Is pregnant or breastfeeding or expecting to conceive or father children within the&#xD;
               projected duration of the study, starting with the screening visit through 120 days&#xD;
               after the last dose of trial treatment.&#xD;
  &#xD;
           28. Has had an allogenic tissue/solid organ transplant.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shikai Wu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Univerisity First Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Shikai Wu</last_name>
      <phone>(86)18910715326</phone>
      <email>skywu4329@sina.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yan Zhu</last_name>
      <phone>(86)13901083721</phone>
      <email>zhuyan0302@126.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University First Hospital Ethics Committee</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100034</zip>
          <country>China</country>
        </address>
      </facility>
      <contact>
        <last_name>Rui Huang</last_name>
        <phone>010-55119025</phone>
        <email>416982188@qq.com</email>
      </contact>
      <investigator>
        <last_name>Shikai Wu</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 22, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 8, 2023</study_first_posted>
    <last_update_submitted>September 10, 2023</last_update_submitted>
    <last_update_submitted_qc>September 10, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking University First Hospital</investigator_affiliation>
      <investigator_full_name>Shikai Wu</investigator_full_name>
      <investigator_title>professor</investigator_title>
    </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>Albumin-Bound Paclitaxel</mesh_term>
      <mesh_term>Pembrolizumab</mesh_term>
      <mesh_term>Lenvatinib</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06028633
  org study id: MISP61001
  nct id: NCT06028633
  lead sponsor: 
  collaborator: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The goal of this clinical trial is to evaluate the efficacy and safety of albumin-bound
        paclitaxel-lenvatinib-pembrolizumab in advanced nonsquamous NSCLC patients after progression
        to first-line anti-PD-1/L1 inhibitor with platinum-doublet chemotherapy. All participants
        will be given with albumin-bound paclitaxel, lenvatinib and pembrolizumab.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Objective response rate
  time frame: About 18 months
  description: Objective response rate (ORR) assessed per the Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1)
  measure: Overall survival
  time frame: About 36 months
  description: Overall survival (OS)
  measure: Progression-free survival
  time frame: About 24 months
  description: Progression-free survival (PFS) assessed per RECIST v1.1
  measure: Duration of response
  time frame: About 24 months
  description: Duration of response (DoR) assessed per RECIST v1.1
  measure: Treatment-related adverse events
  time frame: About 24 months
  description: Treatment-related adverse events (TRAEs) assessed by CTCAE v5.0
  measure: Single cell sequencing of tumor specimens
  time frame: About 36 months
  description: Tumor specimens were collected before and after treatment for single cell assays to assess changes in the tumor immune microenvironment
  arm group label: Arm I
  arm group type: Experimental
  description: Participants will receive pembrolizumab IV 200 mg D1 every 3 weeks, lenvatinib 8 mg orally every day, albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks,until disease progression, intolerable toxicity, investigator decision, or completion of 35 cycles(for pembrolizumab) and 4-6 cycles(for albumin-bound paclitaxel).
  intervention type: Drug
  intervention name: pembrolizumab
  description: pembrolizumab 200mg IV on day 1 for every 3 weeks
  arm group label: Arm I
  other name: Keytruda
  intervention type: Drug
  intervention name: lenvatinib
  description: lenvatinib 8mg taken orally every day
  arm group label: Arm I
  other name: Lenvima
  intervention type: Drug
  intervention name: albumin-bound paclitaxel
  description: albumin-bound paclitaxel IV 100mg/m2 D1, 8 every 3 weeks
  arm group label: Arm I
  other name: nab-paclitaxel
  other name: paclitaxel for injection(albumin bound)
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 75 Years
  healthy volunteers: No
  last name: Shikai Wu
  role: Principal Investigator
  affiliation: Peking Univerisity First Hospital
  last name: Shikai Wu
  phone: (86)18910715326
  email: skywu4329@sina.com
  last name: Yan Zhu
  phone: (86)13901083721
  email: zhuyan0302@126.com
  facility: 
  contact: 
  investigator: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Peking University First Hospital
  investigator full name: Shikai Wu
  investigator title: professor
  mesh term: Lung Neoplasms
  mesh term: Carcinoma, Non-Small-Cell Lung
  mesh term: Paclitaxel
  mesh term: Albumin-Bound Paclitaxel
  mesh term: Pembrolizumab
  mesh term: Lenvatinib
  sharing ipd: No