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Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

Primary Purpose

Anlotinib, Durvalumab, Small Cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anlotinib In Combination With Durvalumab
Sponsored by
Wuhan Union Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anlotinib

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

- The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; Patients between 18-75 years old; Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide [complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard]; The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks; The life expectancy shall be at least 3 months; ECoG score: 0-1

Exclusion Criteria:

- Small cell lung cancer patients with other pathological types of tumor species; Patients with pathological fracture in bone metastasis of small cell lung cancer; Patients with central nervous system metastasis; Patients who have received chest radiotherapy before; Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Anlotinib In Combination With Durvalumab

    Arm Description

    Outcomes

    Primary Outcome Measures

    progress free survival(PFS)
    the period from the beginning of treatment to the observation of disease progress or death for any reason

    Secondary Outcome Measures

    Overall survival(OS)
    Time from randomization to death for any reason. The last follow-up time is usually calculated as the time of death for the subjects who have lost the visit before death

    Full Information

    First Posted
    March 17, 2020
    Last Updated
    March 17, 2020
    Sponsor
    Wuhan Union Hospital, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04314297
    Brief Title
    Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
    Official Title
    Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2020 (Anticipated)
    Primary Completion Date
    February 2021 (Anticipated)
    Study Completion Date
    February 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Wuhan Union Hospital, China

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Anlotinib, Durvalumab, Small Cell Lung Cancer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    33 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anlotinib In Combination With Durvalumab
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Anlotinib In Combination With Durvalumab
    Intervention Description
    At the end of chest radiotherapy (c2d1), the simultaneous administration of androtinib hydrochloride capsule and PD-1 / L1 inhibitor was started. L Arotinib hydrochloride capsule, 12 mg, Po, QD, was taken orally for two weeks, one week, three weeks as a cycle, completed in the first 14 days until the disease progress; Durvalumab injection, 1500mg, IV, once every three weeks, completed on the first day until the disease progresses. Tetraprizumab injection, 240mg, IV, once every three weeks, completed on the first day until the disease progresses. The choice of durvalumab / trepril mAb was at the discretion of the researchers.
    Primary Outcome Measure Information:
    Title
    progress free survival(PFS)
    Description
    the period from the beginning of treatment to the observation of disease progress or death for any reason
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Overall survival(OS)
    Description
    Time from randomization to death for any reason. The last follow-up time is usually calculated as the time of death for the subjects who have lost the visit before death
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: - The subjects volunteered to join the study and signed the informed consent form. They had good compliance and cooperated with the follow-up; Patients between 18-75 years old; Extensive small cell lung cancer confirmed by histopathology (according to Veterans Administration lung study group, Valg stage) and did not progress after 4-6 cycles (21 days as a cycle) of first-line standard chemotherapy platinum combined with etoposide [complete remission (CR), partial remission (PR) or stable (SD) according to recist1.1 standard]; The time interval between the first TRT and the end of the last chemotherapy should be less than or equal to 6 weeks; The life expectancy shall be at least 3 months; ECoG score: 0-1 Exclusion Criteria: - Small cell lung cancer patients with other pathological types of tumor species; Patients with pathological fracture in bone metastasis of small cell lung cancer; Patients with central nervous system metastasis; Patients who have received chest radiotherapy before; Patients who have used vasotargeted drugs (such as bevacizumab, sunitinib, etc.) including enrotinib and immunosuppressive agents before; Imaging (CT or MRI) showed that the distance between the tumor focus and the large blood vessel was less than or equal to 5 mm, or there was a central tumor invading the local large blood vessel, or there was an obvious cavitary or necrotic tumor in the lung;

    12. IPD Sharing Statement

    Learn more about this trial

    Anlotinib In Combination With Durvalumab As Sequential Therapy of Thoracic Radiotherapy After Induction Chemotherapy For Extensive-Stage Small Cell Lung Cancer:A Single Arm Study

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