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Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Durvalumab
the first line chemotherapy for metastatic NSCLC
stereotactic body radiotherapy (SBRT)
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carcinoma, Non-Small-Cell Lung

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically confirmed non-small cell lung cancer
  • ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node
  • metastasis一group lymph node region will be classified as one metastatic lesion）
  • Tissue biopsy prior to treatment
  • ECOG performance score 0-1

Exclusion Criteria:

  • EGFR mutation or ALK positive.
  • Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia.
  • Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus.
  • Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Durvalumab therapy

    Arm Description

    Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks [q3w] intravenously [iv] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met.

    Outcomes

    Primary Outcome Measures

    PFS
    Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC

    Secondary Outcome Measures

    Safety (AESI, AEs/SAEs)
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    To assess the treat failure patterns
    Treat failure patterns including local failure and distant metastasis
    Objective response rate(ORR)
    ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
    and OS Overall Survival(OS)
    OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.

    Full Information

    First Posted
    January 29, 2020
    Last Updated
    February 2, 2020
    Sponsor
    Zhejiang Cancer Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04255836
    Brief Title
    Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
    Official Title
    A Pilot Study of Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 30, 2020 (Anticipated)
    Primary Completion Date
    September 30, 2022 (Anticipated)
    Study Completion Date
    July 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Zhejiang Cancer Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    This is a Phase II, multi-center pilot study assessing the efficacy and safety of durvalumab combined with chemotherapy and stereotactic body radiotherapy (SBRT) in patients with oligo-metastatic non-small cell lung cancer (NSCLC).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carcinoma, Non-Small-Cell Lung

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Durvalumab therapy
    Arm Type
    Experimental
    Arm Description
    Chemo+Durvalumab (PD-L1 monoclonal antibody)1500 mg every 3 weeks [q3w] intravenously [iv] for 4 cycles, then SBRT 50-60 Gy/≤10f + Durvalumab 1500 mg q4w, then Durvalumab 1500 mg q4w for up to 24 months or until progression or other discontinuation criteria are met.
    Intervention Type
    Drug
    Intervention Name(s)
    Durvalumab
    Other Intervention Name(s)
    IMFINZI
    Intervention Description
    Durvalumab 1500mg q3w combined with chemotherapy for 4 cycles, then 1500mg q4w combined with SBRT, then 1500mg q4w for PD or up to 24 months
    Intervention Type
    Drug
    Intervention Name(s)
    the first line chemotherapy for metastatic NSCLC
    Intervention Description
    paclitaxel+carboplatin or pemetrexed+cisplatin
    Intervention Type
    Radiation
    Intervention Name(s)
    stereotactic body radiotherapy (SBRT)
    Intervention Description
    SBRT total doses of 50-60Gy/≤10F
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    Progression-Free Survival (PFS) assessed according to RECIST 1.1 in subpopulation of patients with oligometastatic NSCLC
    Time Frame
    up to 2 years
    Secondary Outcome Measure Information:
    Title
    Safety (AESI, AEs/SAEs)
    Description
    Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
    Time Frame
    up to 2 years
    Title
    To assess the treat failure patterns
    Description
    Treat failure patterns including local failure and distant metastasis
    Time Frame
    up to 2 years
    Title
    Objective response rate(ORR)
    Description
    ORR was defined as the proportion of participants with partial response (PR) or complete response (CR) to treatment as defined by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.
    Time Frame
    up to 2 years
    Title
    and OS Overall Survival(OS)
    Description
    OS was defined as the time from the date of enrollment until death by any cause. Participants still alive at the time of data analysis were censored at the date of last follow-up.
    Time Frame
    up to 2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Histologically confirmed non-small cell lung cancer ≤3 metastatic organs and ≤5 metastatic lesions (supraclavicular and mediastinal lymph nodes are not classified as distant metastasis; other lymph node metastasis一group lymph node region will be classified as one metastatic lesion） Tissue biopsy prior to treatment ECOG performance score 0-1 Exclusion Criteria: EGFR mutation or ALK positive. Evidence on pulmonary interstitial disease or symptoms of active non-infectious pneumonia. Active infection including tuberculosis, hepatitis B, hepatitis C, or human immunodeficiency virus. Previous treatment with antibody against pd -1, pd - L1, pd - L2, CD137 or CTLA-4 (including ipilimumab or any antibody or drug against T cell co-stimulation or checkpoint pathway).

    12. IPD Sharing Statement

    Learn more about this trial

    Durvalumab Combined With Chemotherapy and Stereotactic Body Radiotherapy (SBRT) in Patients With Oligometastatic Non-small Cell Lung Cancer (NSCLC)

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