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First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation

Primary Purpose

Non-small Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
icotinib
Chemotherapy
Radiotherapy
Sponsored by
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria:

  • Aged 18 to 75 years
  • Pathologically documented NSCLC
  • Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI
  • Positive EGFR mutation confirmed by ARMS
  • At least 3-month life expectancy
  • KPS ≥ 70
  • Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L
  • Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN
  • Written informed consent before patient registration and any protocol-related procedures

Exclusion Criteria:

  • Previous radiotherapy
  • Received other investigational systemic drugs within 4 weeks prior to study entry
  • Severe or uncontrolled systemic disease
  • Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant
  • Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator
  • Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Active Comparator

    Arm Label

    icotinib plus radiotherapy

    icotinib

    chemotherapy plus radiotherapy

    Arm Description

    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy.

    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib monotherapy.

    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive chemotherapy plus concurrent radiotherapy.

    Outcomes

    Primary Outcome Measures

    Progression-free survival
    Incidence of radiation injure of the lungs
    Measured according to NCI CTCAE v4.0

    Secondary Outcome Measures

    Overall survival
    Tumor response after icotinib induction
    Quality of life
    Measured by FACT-L

    Full Information

    First Posted
    August 8, 2016
    Last Updated
    August 29, 2016
    Sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02883543
    Brief Title
    First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation
    Official Title
    Phase III Study of Icotinib With Concurrent Radiotherapy as First-line Treatment for Unresectable/Oligometastasis NSCLC With EGFR Activating Mutation: a Prospective, Multicentre, Open-label, Randomised Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    June 2018 (Anticipated)
    Study Completion Date
    June 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy.
    Detailed Description
    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy, or chemotherapy plus concurrent radiotherapy, or icotinib monotherapy. The primary endpoint is progression-free survival, and the incidence of radiation-induced lung injury.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    330 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    icotinib plus radiotherapy
    Arm Type
    Experimental
    Arm Description
    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib plus concurrent radiotherapy.
    Arm Title
    icotinib
    Arm Type
    Active Comparator
    Arm Description
    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive icotinib monotherapy.
    Arm Title
    chemotherapy plus radiotherapy
    Arm Type
    Active Comparator
    Arm Description
    Eligible patients are administered with oral icotinib 125mg three times daily for two months, in which responsive patients (partial response and stable disease) are randomized (1: 1: 1) and receive chemotherapy plus concurrent radiotherapy.
    Intervention Type
    Drug
    Intervention Name(s)
    icotinib
    Intervention Description
    Icotinib is orally administered three times per day.
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy
    Intervention Description
    Chemotherapy is given by intravenous administration. Three regimens are available in this study. Regimen 1: etoposide 75mg/m2 d1-5 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 2: docetaxel 75mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2. Regimen 3: pemetrexed 500mg/m2 d1 + cisplatin 75 mg/m2 day1/ day1-2
    Intervention Type
    Radiation
    Intervention Name(s)
    Radiotherapy
    Intervention Description
    5Gy/75.00Gy, 10f/2w for peripheral lung cancer, and 2.4Gy/59.52Gy, 20f/4w for central lung cancer.
    Primary Outcome Measure Information:
    Title
    Progression-free survival
    Time Frame
    2 years
    Title
    Incidence of radiation injure of the lungs
    Description
    Measured according to NCI CTCAE v4.0
    Time Frame
    2 years
    Secondary Outcome Measure Information:
    Title
    Overall survival
    Time Frame
    5 years
    Title
    Tumor response after icotinib induction
    Time Frame
    8 weeks
    Title
    Quality of life
    Description
    Measured by FACT-L
    Time Frame
    2 years

    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: Aged 18 to 75 years Pathologically documented NSCLC Unresectable stage III or oligometastasis (less than three metastasis lesions, brain metastasis is not permitted) stage IV confirmed by CT and/or MRI Positive EGFR mutation confirmed by ARMS At least 3-month life expectancy KPS ≥ 70 Adequate hematological values: hemoglobin ≥ 100 g/L, absolute neutrophils count ≥ 1.5 x 109/L, platelets count ≥ 100 x 109/L Adequate hepatic function: bilirubin ≤ 1.5 x ULN, AST/ALT ≤ 1.5 x ULN Written informed consent before patient registration and any protocol-related procedures Exclusion Criteria: Previous radiotherapy Received other investigational systemic drugs within 4 weeks prior to study entry Severe or uncontrolled systemic disease Active autoimmune disease, or a documented history of autoimmune/acquired immune disease, or a history of organ transplant Pregnant or lactating, women of childbearing potential, unless using effective contraception as determined by the investigator Any other serious underlying medical (e.g. active uncontrolled infection, active gastric ulcer, uncontrolled seizures), psychological and other condition that, in the judgment of the investigator, may interfere with the planned staging, treatment and follow-up, affect patient compliance or place the patient at high risk from treatment-related complications.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Zhenzhou Yang, MD
    Organizational Affiliation
    Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    First-line Icotinib With Concurrent Radiotherapy for NSCLC With EGFR Mutation

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