<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/NCT04400188</url>
  </required_header>
  <id_info>
    <org_study_id>SHR-3162-Ib-115</org_study_id>
    <nct_id>NCT04400188</nct_id>
  </id_info>
  <brief_title>A Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer</brief_title>
  <official_title>A Phase Ⅰb/Ⅱ Study of Fluzoparib (SHR-3162) and Temozolomide With or Without SHR-1316 in Treating Patients With Replapsed Small Cell Lung Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jiangsu HengRui Medicine Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Jiangsu HengRui Medicine Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of&#xD;
      the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small&#xD;
      cell lung cancer&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 11, 2020</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Actual">January 15, 2022</primary_completion_date>
  <phase>Phase 1/Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.</measure>
    <time_frame>At the end of Cycle1 (each cycle is 21 days )</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.</measure>
    <time_frame>Up to approximately 2 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase Ⅱ: Progression Free Survival (PFS) at four months.</measure>
    <time_frame>Up to approximately 2 Years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.</measure>
    <time_frame>Up to approximately 2 Years</time_frame>
    <description>Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Objective Response Rate</measure>
    <time_frame>up to approximately 2 Years</time_frame>
    <description>Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Response</measure>
    <time_frame>Up to approximately 2 Years</time_frame>
    <description>Duration of Response, determined using RECIST v1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Control Rate</measure>
    <time_frame>Up to approximately 2 Years</time_frame>
    <description>Disease Control Rate, determined using RECIST v1.1 criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Response</measure>
    <time_frame>Up to approximately 2 Years</time_frame>
    <description>Time to Response, defined as the time from randomization to PR or CR.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall survival and overall survival at 6 months, 9months and 12 months</measure>
    <time_frame>Up to approximately 1 Year</time_frame>
    <description>Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">25</enrollment>
  <condition>Small Cell Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Experimental A (part 1) : Fluzoparib + temozolomide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fluzoparib</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Experimental A (part 1) : Fluzoparib + temozolomide</arm_group_label>
    <arm_group_label>Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>temozolomide</intervention_name>
    <description>Given PO</description>
    <arm_group_label>Experimental A (part 1) : Fluzoparib + temozolomide</arm_group_label>
    <arm_group_label>Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SHR-1316</intervention_name>
    <description>Given injection</description>
    <arm_group_label>Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects who have recurrent small cell lung cancer confirmed by histology or cytology.&#xD;
&#xD;
          2. Failed one prior line of platinum-based chemotherapy.&#xD;
&#xD;
          3. Subjects must have measurable disease, at least one lesion, by Computed Tomography&#xD;
             (CT) or Magnetic Resonance Imaging (MRI) per RECIST 1.1 criteria (within 28 days prior&#xD;
             to administration of study treatment) ;&#xD;
&#xD;
          4. Freshly acquired samples or archived specimens within 12 months before randomization&#xD;
             must be provided.&#xD;
&#xD;
          5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.&#xD;
&#xD;
          6. Participant must have a life expectancy ≥ 12 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Active or untreated central nervous system (CNS) metastases.&#xD;
&#xD;
          2. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent&#xD;
             drainage procedures.&#xD;
&#xD;
          3. History of autoimmune disease.&#xD;
&#xD;
          4. Positive test result for human immunodeficiency virus (HIV).&#xD;
&#xD;
          5. Active hepatitis B or hepatitis C.&#xD;
&#xD;
          6. Severe infections.&#xD;
&#xD;
          7. Subjects with a condition requiring systemic treatment with either corticosteroids&#xD;
             (&gt;10 mg daily prednisone equivalent) or other immunosuppressive medications within 14&#xD;
             days of first administration of study treatment.&#xD;
&#xD;
          8. Significant cardiovascular disease.&#xD;
&#xD;
          9. History or current evidence of any condition, therapy, or laboratory abnormality that&#xD;
             might confound the results of the study, interfere with the subject's participation&#xD;
             for the full duration of the study, or is not in the best interest of the subject to&#xD;
             participate, in the opinion of the treating investigator.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>You Lu, MD</last_name>
    <role>Study Chair</role>
    <affiliation>West China Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>West China Hospital of Sichuan University</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610015</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 7, 2020</study_first_submitted>
  <study_first_submitted_qc>May 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 22, 2020</study_first_posted>
  <last_update_submitted>February 9, 2023</last_update_submitted>
  <last_update_submitted_qc>February 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
    <mesh_term>Small Cell Lung Carcinoma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Temozolomide</mesh_term>
    <mesh_term>Fluzoparib</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04400188
org study id: SHR-3162-Ib-115
nct id: NCT04400188
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This research study is a multicentre phase Ⅰb/Ⅱ Study to evaluate the efficacy and safety of
      the combination of Fluzoparib (SHR-3162) and temozolomide with or without SHR-1316 in small
      cell lung cancer
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: Fluzoparib (SHR-3162) combined with temozolomide or Fluzoparib (SHR-3162) and temozolomide with SHR-1316
primary purpose: Treatment
masking: None (Open Label)
measure: Phase Ⅰb: Number of Subjects Experienced Any Dose-Limiting Toxicity (DLT) over the DLT period.
time frame: At the end of Cycle1 (each cycle is 21 days )
measure: Phase Ⅰb: Determination of Recommended Phase II dose (RP2D) of Escalating Dose of Fluzoparib and temozolomide with or without SHR-1316.
time frame: Up to approximately 2 Years
measure: Phase Ⅱ: Progression Free Survival (PFS) at four months.
time frame: Up to approximately 2 Years
measure: Phase Ⅱ: Progression Free Survival (PFS) as Assessed by the Investigator according to RECIST v1.1.
time frame: Up to approximately 2 Years
description: Progression Free Survival, defined as the time from randomization to first assessment of disease progression or death, whichever is earlier.
measure: Objective Response Rate
time frame: up to approximately 2 Years
description: Objective Response Rate, determined using RECIST v1.1 criteria, defined as best overall response (complete or partial response) across all assessment time points.
measure: Duration of Response
time frame: Up to approximately 2 Years
description: Duration of Response, determined using RECIST v1.1 criteria.
measure: Disease Control Rate
time frame: Up to approximately 2 Years
description: Disease Control Rate, determined using RECIST v1.1 criteria.
measure: Time to Response
time frame: Up to approximately 2 Years
description: Time to Response, defined as the time from randomization to PR or CR.
measure: Overall survival and overall survival at 6 months, 9months and 12 months
time frame: Up to approximately 1 Year
description: Overall survival is the time interval from the date of randomization to death due to any reason or lost of follow-up.
arm group label: Experimental A (part 1) : Fluzoparib + temozolomide
arm group type: Experimental
arm group label: Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316
arm group type: Experimental
intervention type: Drug
intervention name: Fluzoparib
description: Given PO
arm group label: Experimental A (part 1) : Fluzoparib + temozolomide
arm group label: Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316
intervention type: Drug
intervention name: temozolomide
description: Given PO
arm group label: Experimental A (part 1) : Fluzoparib + temozolomide
arm group label: Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316
intervention type: Biological
intervention name: SHR-1316
description: Given injection
arm group label: Experimental B (part 2) : Fluzoparib + temozolomide + SHR-1316
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: You Lu, MD
role: Study Chair
affiliation: West China Hospital
facility: 
country: China
responsible party type: Sponsor
mesh term: Lung Neoplasms
mesh term: Small Cell Lung Carcinoma
mesh term: Temozolomide
mesh term: Fluzoparib