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EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

Primary Purpose

Non-Small-Cell Lung Cancer

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
EGFR-TKI
Chemotherapy(pemetrexed/gemcitabine)
Chemotherapy(carboplatin)
Sponsored by
Shanghai Pulmonary Hospital, Shanghai, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small-Cell Lung Cancer focused on measuring NSCLC, BIM, EGFR mutation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Signed informed consent Age >=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures

Exclusion Criteria:

Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    EGFR-TKI and Chemotherapy

    Arm Description

    NSCLC patients

    Outcomes

    Primary Outcome Measures

    Progress Free Survival

    Secondary Outcome Measures

    Overall Response Rate
    Overall Survival

    Full Information

    First Posted
    July 31, 2016
    Last Updated
    August 6, 2016
    Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02859077
    Brief Title
    EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
    Official Title
    EGFR-TKI With Chemotherapy as First Line Treatment in Stage IIIB/IV NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2016 (undefined)
    Primary Completion Date
    July 2017 (Anticipated)
    Study Completion Date
    July 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai Pulmonary Hospital, Shanghai, China

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    BIM deletion polymorphism might be associated with a poor clinical response to EGFR-TKIs in patients who had NSCLC with EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as first line treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.
    Detailed Description
    BIM deletion polymorphism was a poor clinical response marker to EGFR-TKIs in NSCLC patients who had EGFR mutations. In the study, the investigators want to use EGFR-TKI with chemotherapy as 1 st treatment in stage IIIB/IV NSCLC patients with both EGFR mutation and BIM deletion polymorphism.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Non-Small-Cell Lung Cancer
    Keywords
    NSCLC, BIM, EGFR mutation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    EGFR-TKI and Chemotherapy
    Arm Type
    Experimental
    Arm Description
    NSCLC patients
    Intervention Type
    Drug
    Intervention Name(s)
    EGFR-TKI
    Other Intervention Name(s)
    gefitinib
    Intervention Description
    EGFR-TKI (gefitinib)
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy(pemetrexed/gemcitabine)
    Other Intervention Name(s)
    pemetrexed/gemcitabine
    Intervention Description
    Chemotherapy (pemetrexed/gemcitabine)
    Intervention Type
    Drug
    Intervention Name(s)
    Chemotherapy(carboplatin)
    Other Intervention Name(s)
    carboplatin
    Intervention Description
    Chemotherapy(carboplatin)
    Primary Outcome Measure Information:
    Title
    Progress Free Survival
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Overall Response Rate
    Time Frame
    1 year
    Title
    Overall Survival
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed informed consent Age >=18 years Histologically documented, unresectable, inoperable, locally advanced, recurrent or metastatic Stage IV Non-Small Cell Lung Cancer (NSCLC) A cytologic diagnosis is acceptable (i.e., FNA or pleural fluid cytology) Must have measurable or non-measurable disease Must be able to comply with study and follow-up procedures Exclusion Criteria: Small cell, carcinoid, or mixed small cell lung cancer Malignancies within 3 years except for adequately treated carcinoma in situ of -the cervix or basal or squamous cell skin cancer Symptomatic or untreated brain metastases Prior systemic chemotherapy for NSCLC Unstable systemic disease, including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, or myocardial infarction within 6 months prior to Day 1, or serious cardiac arrhythmia requiring medication (patients with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia, are eligible) History of other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that might affect the interpretation of the results of the study or render the patient at high risk from treatment complications Gastrointestinal tract disease resulting in an inability to take oral medication or a requirement for intravenous (IV) alimentation, or prior surgical procedures affecting absorption Pregnancy or lactation
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Caicun Zhou, MD, PHD
    Phone
    +8613301825532
    Email
    caicunzhoudr@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Yayi He, MD, PHD
    Phone
    +8613818828623
    Email
    doctorjael@qq.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Caicun Zhou, MD, PHD
    Organizational Affiliation
    Shanghai Pulmonary Hospital, Tongji University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    We will share the analysis data.

    Learn more about this trial

    EGFR-TKI With Chemotherapy in NSCLC Patients With Both EGFR Mutation and BIM Deletion Polymorphism

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