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/NCT06032052</url>
    </required_header>
    <id_info>
      <org_study_id>Unicorn</org_study_id>
      <nct_id>NCT06032052</nct_id>
    </id_info>
    <brief_title>Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients</brief_title>
    <official_title>Prospective, Single-arm Phase II Clinical Study of Single-drug Chemotherapy Plus Immunotherapy in Metastatic Non-small Cell Lung Cancer Elderly Patients</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hubei Cancer Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hubei Cancer Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Lung cancer is the cancer with the highest morbidity and mortality among men in the world.&#xD;
        The proportion of elderly lung cancer patients in the global lung cancer population is&#xD;
        steadily increasing, at the same time, it is also the age group with the highest lung cancer&#xD;
        mortality, but there is little evidence for treatment of elderly lung cancer patients. In&#xD;
        this study, the investigators set the definition of the elderly to 65 years and older.&#xD;
  &#xD;
        The progression-free survival (PFS) and overall survival (OS) of immunotherapy plus&#xD;
        chemotherapy were higher than those of chemotherapy alone, which established the dominant&#xD;
        position of dual-drug chemotherapy combined with immunotherapy. Studies showed that elderly&#xD;
        patients benefit from immunotherapy.&#xD;
  &#xD;
        It is controversial whether elderly advanced non-small-cell-lung-cancer (NSCLC) patients&#xD;
        should receive single-drug chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4&#xD;
        studies show that in the advanced NSCLC elderly patients, combined with cisplatin on the&#xD;
        basis of single drug chemotherapy can not significantly prolong OS, and can not improve the&#xD;
        overall health status of patients. Based on the results of this study, single drug&#xD;
        chemotherapy is still the preferred first-line regimen. Another study showed that carboplatin&#xD;
        combined with paclitaxel had longer OS than gemcitabine or vinorelbine alone in elderly&#xD;
        patients with advanced NSCLC with a performance status (PS) score of less than 2. In the era&#xD;
        of immunotherapy, it is not clear whether single-drug chemotherapy combined with&#xD;
        immunotherapy can achieve the same therapeutic effect as dual-drug chemotherapy combined with&#xD;
        immunotherapy. Therefore, the purpose of this study is to investigate the efficacy and safety&#xD;
        of single-drug chemotherapy plus immunotherapy in elderly metastatic NSCLC patients.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lung cancer is the cancer with the highest morbidity and mortality among men in the world.&#xD;
        The age range in which lung cancer is most commonly diagnosed is 65-74 years old. The&#xD;
        proportion of elderly lung cancer patients in the global lung cancer population is steadily&#xD;
        increasing, at the same time, it is also the age group with the highest lung cancer&#xD;
        mortality, but there is little evidence for treatment of elderly lung cancer patients. The&#xD;
        investigators pay special attention to elderly patients because they are a unique group.&#xD;
  &#xD;
        With regard to the definition of &quot;elderly&quot;, considering that more than half of cancer&#xD;
        patients are aged 65 or above. Therefore, we set the definition of the elderly in this phase&#xD;
        II clinical study to 65 years and older.&#xD;
  &#xD;
        The results of Keynote-042 study, Keynote-189 study and Keynote-407 study all showed that the&#xD;
        progression-free survival (PFS) and overall survival (OS) of immunotherapy plus chemotherapy&#xD;
        were higher than those of chemotherapy alone, which established the dominant position of&#xD;
        dual-drug chemotherapy combined with immunotherapy. Meta analysis showed that in patients&#xD;
        with advanced NSCLC, immunotherapy prolonged OS and PFS compared with chemotherapy, and the&#xD;
        prolongation of PFS was not related to age, while OS also benefited in patients aged 65 to 75&#xD;
        years. To sum up, elderly patients benefit from immunotherapy.&#xD;
  &#xD;
        It is controversial whether elderly advanced NSCLC patients should receive single-drug&#xD;
        chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4 studies show that in the advanced&#xD;
        NSCLC elderly patients, combined with cisplatin on the basis of single drug chemotherapy can&#xD;
        not significantly prolong OS, and can not improve the overall health status of patients.&#xD;
        Based on the results of this study, single drug chemotherapy is still the preferred&#xD;
        first-line regimen. Another study showed that carboplatin combined with paclitaxel had longer&#xD;
        OS than gemcitabine or vinorelbine alone in elderly patients with advanced NSCLC with a PS&#xD;
        score of less than 2. In the era of immunotherapy, it is not clear whether single-drug&#xD;
        chemotherapy combined with immunotherapy can achieve the same therapeutic effect as dual-drug&#xD;
        chemotherapy combined with immunotherapy. Therefore, the purpose of this study is to&#xD;
        investigate the efficacy and safety of single-drug chemotherapy plus immunotherapy in elderly&#xD;
        metastatic NSCLC patients, in order to reduce the adverse reactions without reducing the&#xD;
        curative effect and improve their quality of life.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2027</completion_date>
    <primary_completion_date type="Anticipated">September 2026</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>Progression-free Survival</measure>
      <time_frame>up to 12 months</time_frame>
    </primary_outcome>
    <primary_outcome>
      <measure>Objective response rate</measure>
      <time_frame>up to 6 months</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Overall survival</measure>
      <time_frame>up to 18 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Disease control rate</measure>
      <time_frame>up to 6 months</time_frame>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">49</enrollment>
    <condition>Elderly Patients</condition>
    <condition>Metastatic Lung Cancer</condition>
    <arm_group>
      <arm_group_label>Metastatic NSCLC patients over 65 years old</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In metastatic NSCLC patients over 65 years old, we employed gemcitabine or paclitaxel or vinorelbine plus immunotherapy for squamous cell carcinoma. Paclitaxel or pemetrexed plus immunotherapy are available for non-squamous and non-small cell lung cancer.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Single drug chemotherapy plus immunotherapy</intervention_name>
      <description>The choice of chemotherapy plus immunotherapy for squamous cell carcinoma is gemcitabine or paclitaxel or vinorelbine. Paclitaxel or pemetrexed are available for monotherapy for non-squamous and non-small cell lung cancer. Immunotherapy drugs can be Pembrolizumab /Penpulimab/ Camrelizumab/ Tislelizumab / Sintilimab/ sulgarizumab and so on</description>
      <arm_group_label>Metastatic NSCLC patients over 65 years old</arm_group_label>
      <other_name>monochemotherapy plus immunotherapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Regardless of sex, age ≥ 65, PS 0-2.&#xD;
  &#xD;
            2. metastatic NSCLC of American Joint Committee on Cancer (AJCC) 8th edition confirmed by&#xD;
               histology or cytology.&#xD;
  &#xD;
            3. No mutation or fusion of common driving genes, such as epidermal growth factor&#xD;
               receptor (EGFR), anaplastic lymphoma kinase (ALK), ROS proto-oncogene 1 (ROS-1).&#xD;
  &#xD;
               (adenocarcinoma requires genetic testing).&#xD;
  &#xD;
            4. Positive expression of Programmed cell death 1 ligand 1（PD-L1） (TPS ≥ 1%).&#xD;
  &#xD;
            5. First-line treatment (stable brain or bone metastasis, or stable symptoms after local&#xD;
               treatment).&#xD;
  &#xD;
            6. Before treatment, there were perfect enhanced CT images of chest and supraclavicular&#xD;
               area, and measurable tumor lesions.&#xD;
  &#xD;
            7. The estimated survival time is not less than 6 months.&#xD;
  &#xD;
            8. The clinical laboratory criteria within 2 weeks before treatment are as follows:&#xD;
               hemoglobin ≥ 110g / L, leukocytes ≥ 4x109 / L, platelet ≥ 100x109 / L, liver and&#xD;
               kidney function indexes (such as glutamic pyruvic transaminase, glutamic oxaloacetic&#xD;
               transaminase, urea nitrogen, creatinine) were all within 1.25 times of the upper limit&#xD;
               of the normal value.&#xD;
  &#xD;
            9. Informed understanding and voluntary participation in this study, and informed consent&#xD;
               has been signed.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Mutation or fusion of common driving genes (EGFR,ALK or ROS1).&#xD;
  &#xD;
            2. Have received systemic treatment before.&#xD;
  &#xD;
            3. Previous suffering from other malignant tumors (except stage I non-melanotic skin&#xD;
               cancer or cervical carcinoma in situ) or other malignant tumors at the same time.&#xD;
  &#xD;
            4. Other drugs are being tested.&#xD;
  &#xD;
            5. Patients with positive HIV and are receiving antiviral therapy .&#xD;
  &#xD;
            6. Active pulmonary tuberculosis.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>65 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Guang Han</last_name>
      <role>Principal Investigator</role>
      <affiliation>Hubei Cancer Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Guang Han</last_name>
      <phone>13886048178</phone>
      <email>hg7913@hotmail.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lulu Shi</last_name>
      <phone>027-87670318</phone>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Hubei Cancer Hospital</name>
        <address>
          <city>Wuhan</city>
          <state>Hubei</state>
          <zip>430079</zip>
          <country>China</country>
        </address>
      </facility>
    </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 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 15, 2023</last_update_submitted>
    <last_update_submitted_qc>September 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Hubei Cancer Hospital</investigator_affiliation>
      <investigator_full_name>HAN GUANG</investigator_full_name>
      <investigator_title>Chief physician</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lung Neoplasms</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Immunomodulating Agents</mesh_term>
      <mesh_term>Immunologic Factors</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</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/NCT06032052
  org study id: Unicorn
  nct id: NCT06032052
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Lung cancer is the cancer with the highest morbidity and mortality among men in the world.
        The proportion of elderly lung cancer patients in the global lung cancer population is
        steadily increasing, at the same time, it is also the age group with the highest lung cancer
        mortality, but there is little evidence for treatment of elderly lung cancer patients. In
        this study, the investigators set the definition of the elderly to 65 years and older.
  
        The progression-free survival (PFS) and overall survival (OS) of immunotherapy plus
        chemotherapy were higher than those of chemotherapy alone, which established the dominant
        position of dual-drug chemotherapy combined with immunotherapy. Studies showed that elderly
        patients benefit from immunotherapy.
  
        It is controversial whether elderly advanced non-small-cell-lung-cancer (NSCLC) patients
        should receive single-drug chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4
        studies show that in the advanced NSCLC elderly patients, combined with cisplatin on the
        basis of single drug chemotherapy can not significantly prolong OS, and can not improve the
        overall health status of patients. Based on the results of this study, single drug
        chemotherapy is still the preferred first-line regimen. Another study showed that carboplatin
        combined with paclitaxel had longer OS than gemcitabine or vinorelbine alone in elderly
        patients with advanced NSCLC with a performance status (PS) score of less than 2. In the era
        of immunotherapy, it is not clear whether single-drug chemotherapy combined with
        immunotherapy can achieve the same therapeutic effect as dual-drug chemotherapy combined with
        immunotherapy. Therefore, the purpose of this study is to investigate the efficacy and safety
        of single-drug chemotherapy plus immunotherapy in elderly metastatic NSCLC patients.
  Lung cancer is the cancer with the highest morbidity and mortality among men in the world.
        The age range in which lung cancer is most commonly diagnosed is 65-74 years old. The
        proportion of elderly lung cancer patients in the global lung cancer population is steadily
        increasing, at the same time, it is also the age group with the highest lung cancer
        mortality, but there is little evidence for treatment of elderly lung cancer patients. The
        investigators pay special attention to elderly patients because they are a unique group.
  
        With regard to the definition of "elderly", considering that more than half of cancer
        patients are aged 65 or above. Therefore, we set the definition of the elderly in this phase
        II clinical study to 65 years and older.
  
        The results of Keynote-042 study, Keynote-189 study and Keynote-407 study all showed that the
        progression-free survival (PFS) and overall survival (OS) of immunotherapy plus chemotherapy
        were higher than those of chemotherapy alone, which established the dominant position of
        dual-drug chemotherapy combined with immunotherapy. Meta analysis showed that in patients
        with advanced NSCLC, immunotherapy prolonged OS and PFS compared with chemotherapy, and the
        prolongation of PFS was not related to age, while OS also benefited in patients aged 65 to 75
        years. To sum up, elderly patients benefit from immunotherapy.
  
        It is controversial whether elderly advanced NSCLC patients should receive single-drug
        chemotherapy or dual-drug chemotherapy. MILES-3 and MILES-4 studies show that in the advanced
        NSCLC elderly patients, combined with cisplatin on the basis of single drug chemotherapy can
        not significantly prolong OS, and can not improve the overall health status of patients.
        Based on the results of this study, single drug chemotherapy is still the preferred
        first-line regimen. Another study showed that carboplatin combined with paclitaxel had longer
        OS than gemcitabine or vinorelbine alone in elderly patients with advanced NSCLC with a PS
        score of less than 2. In the era of immunotherapy, it is not clear whether single-drug
        chemotherapy combined with immunotherapy can achieve the same therapeutic effect as dual-drug
        chemotherapy combined with immunotherapy. Therefore, the purpose of this study is to
        investigate the efficacy and safety of single-drug chemotherapy plus immunotherapy in elderly
        metastatic NSCLC patients, in order to reduce the adverse reactions without reducing the
        curative effect and improve their quality of life.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Progression-free Survival
  time frame: up to 12 months
  measure: Objective response rate
  time frame: up to 6 months
  measure: Overall survival
  time frame: up to 18 months
  measure: Disease control rate
  time frame: up to 6 months
  arm group label: Metastatic NSCLC patients over 65 years old
  arm group type: Experimental
  description: In metastatic NSCLC patients over 65 years old, we employed gemcitabine or paclitaxel or vinorelbine plus immunotherapy for squamous cell carcinoma. Paclitaxel or pemetrexed plus immunotherapy are available for non-squamous and non-small cell lung cancer.
  intervention type: Drug
  intervention name: Single drug chemotherapy plus immunotherapy
  description: The choice of chemotherapy plus immunotherapy for squamous cell carcinoma is gemcitabine or paclitaxel or vinorelbine. Paclitaxel or pemetrexed are available for monotherapy for non-squamous and non-small cell lung cancer. Immunotherapy drugs can be Pembrolizumab /Penpulimab/ Camrelizumab/ Tislelizumab / Sintilimab/ sulgarizumab and so on
  arm group label: Metastatic NSCLC patients over 65 years old
  other name: monochemotherapy plus immunotherapy
  criteria: 
  gender: All
  minimum age: 65 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Guang Han
  role: Principal Investigator
  affiliation: Hubei Cancer Hospital
  last name: Guang Han
  phone: 13886048178
  email: hg7913@hotmail.com
  last name: Lulu Shi
  phone: 027-87670318
  facility: 
  country: China
  responsible party type: Principal Investigator
  investigator affiliation: Hubei Cancer Hospital
  investigator full name: HAN GUANG
  investigator title: Chief physician
  mesh term: Lung Neoplasms
  mesh term: Immunomodulating Agents
  mesh term: Immunologic Factors
  sharing ipd: Yes