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Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy (ALTER-L006)

Primary Purpose

Advanced Non-squamous NSCLC

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Anlotinib Hydrochloride
Sponsored by
LanZhou University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Advanced Non-squamous NSCLC focused on measuring Non-squamous NSCLC

Eligibility Criteria

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

Inclusion Criteria:

  • Signed and dated informed consent
  • Age：≥70
  • Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC
  • at least two systematic chemotherapy with upwards of 1-line treatments or cannot suffer
  • The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs
  • Subjects with at least one measurable lesion as defined by RECIST (version 1.1)
  • Expected Survival Time: Over 3 months
  • ECOG PS：0-1
  • main organs function is normal

Exclusion Criteria:

  • 1.Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer)
  • lung squamous carcinoma
  • Other active malignancies requiring treatment
  • History of malignancy
  • Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included
  • Abnormal coagulation (INR>1.5 or PT>ULN+4s or APTT >1.5 ULN); Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation
  • take major surgical treatments or have serious trauma before grouping, or the impact of surgery or trauma has been eliminated for less than 14 days
  • Patients with active or unable to control serious infections
  • Patients with Grade II or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc male ≥ 450 ms, female ≥ 470 ms) ; Patients with grade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% (NYHA Classification)
  • Patients with non-healing wounds or fractures
  • with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus).
  • get arterial/venous thrombosis within 12 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism
  • Patients with cirrhosis, decompensated liver disease, or active hepatitis Have suffered from hemorrhagic disease or coagulation dysfunction
  • diagnosed with disease which will severely endanger the security of patients or influence the completion of this research

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Anlotinib Hydrochloride

    Arm Description

    Anlotinib Hydrochloride p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent

    Outcomes

    Primary Outcome Measures

    PFS
    Progress free survival (PFS)

    Secondary Outcome Measures

    OS
    Overall Survival (OS)
    DCR
    Disease Control Rate (DCR)
    ORR
    Objective Response Rate (ORR)
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    EORTC QLQ-C30
    use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life

    Full Information

    First Posted
    December 15, 2018
    Last Updated
    December 15, 2018
    Sponsor
    LanZhou University
    Collaborators
    General Hospital of Ningxia Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03778853
    Brief Title
    Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy (ALTER-L006)
    Official Title
    An Open, Single-arm, Multi-center Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2019 (Anticipated)
    Primary Completion Date
    December 2019 (Anticipated)
    Study Completion Date
    December 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    LanZhou University
    Collaborators
    General Hospital of Ningxia Medical University

    4. Oversight

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

    5. Study Description

    Brief Summary
    Anlotinib is a multi-target receptor tyrosine kinase inhibitor in domestic research and development. It can inhibit the angiogenesis related kinase, such as VEGFR, FGFR, PDGFR, and tumor celltebiz related kinase -c-Kit kinase. In the phase III study, Patients who failed at least two kinds of systemic chemotherapy (third line or beyond) or drug intolerance were treated with anlotinib (12mg, po. qd. on day 1to14 of a 21-day cycle) or placebo, the anlotinib group PFS and OS were 5.37 months and 9.63 months, the placebo group PFS and OS were 1.4 months and 6.3 months.
    Detailed Description
    It is an open, single-arm, multi-center clinical trial conducted in China, and plan to Recruiting 72 patients in the elderly without systemic chemotherapy. Patents receive 12mg anlotinib orally daily on day 1to 14 of a 21-day cycle until progression of disease, assess safety and efficacy of the drug.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Advanced Non-squamous NSCLC
    Keywords
    Non-squamous NSCLC

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    72 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Anlotinib Hydrochloride
    Arm Type
    Experimental
    Arm Description
    Anlotinib Hydrochloride p.o, qd and it should be continued until disease progress or toxicity cannot be tolerated or patients withdraw consent
    Intervention Type
    Drug
    Intervention Name(s)
    Anlotinib Hydrochloride
    Intervention Description
    Anlotinib Hydrochloride ( 12mg, QD, PO, d1-14, 21 days per cycle), take once when limosis in the morning. If patients cannot suffer from AEs, they can get declined dosage. Other Name: AL3818
    Primary Outcome Measure Information:
    Title
    PFS
    Description
    Progress free survival (PFS)
    Time Frame
    Time Frame: each 42 days up to PD or death(up to 24 months)
    Secondary Outcome Measure Information:
    Title
    OS
    Description
    Overall Survival (OS)
    Time Frame
    From randomization until death (up to 24 months)
    Title
    DCR
    Description
    Disease Control Rate (DCR)
    Time Frame
    each 42 days up to intolerance the toxicity or PD (up to 24 months)
    Title
    ORR
    Description
    Objective Response Rate (ORR)
    Time Frame
    each 42 days up to intolerance the toxicity or PD (up to 24 months)
    Title
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    Description
    Number of Participants with Adverse Events as a Measure of Safety and Tolerability
    Time Frame
    Until 30 day safety follow-up visit
    Title
    EORTC QLQ-C30
    Description
    use EORTC QLQ-C30(version 3) questionnaire to evaluate the quality of life
    Time Frame
    each 42 days up to intolerance the toxicity or PD (up to 24 months)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Signed and dated informed consent Age：≥70 Subjects with histologically or cytologically confirmed locally advanced and/or advanced NSCLC at least two systematic chemotherapy with upwards of 1-line treatments or cannot suffer The negative patients in EGFR&ALK can participate or who positive in EGFR&ALK, have or have not drug tolerance after the treatment with relative targeted drugs Subjects with at least one measurable lesion as defined by RECIST (version 1.1) Expected Survival Time: Over 3 months ECOG PS：0-1 main organs function is normal Exclusion Criteria: 1.Small Cell Lung Cancer (including small cell cancer and other kinds of cancer mixed with non-small cell cancer) lung squamous carcinoma Other active malignancies requiring treatment History of malignancy Have got non remissive toxic reactions derived from previous therapies, which is over level 1 in CTC AE (4.0), alopecia NOT included Abnormal coagulation (INR>1.5 or PT>ULN+4s or APTT >1.5 ULN); Patients with any physical signs of bleeding diathesis or receiving thrombolysis and anticoagulation take major surgical treatments or have serious trauma before grouping, or the impact of surgery or trauma has been eliminated for less than 14 days Patients with active or unable to control serious infections Patients with Grade II or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including QTc male ≥ 450 ms, female ≥ 470 ms) ; Patients with grade III to IV cardiac insufficiency, or left ventricular ejection fraction (LVEF) <50% (NYHA Classification) Patients with non-healing wounds or fractures with kinds of factors which affect oral medicine (e.g. failing to swallow, gastrointestinal tract getting resected, chronic diarrhea and ileus). get arterial/venous thrombosis within 12 months, such as cerebrovascular accidents (including temporary ischemic stoke), deevenous thrombosis, and pulmonary embolism Patients with cirrhosis, decompensated liver disease, or active hepatitis Have suffered from hemorrhagic disease or coagulation dysfunction diagnosed with disease which will severely endanger the security of patients or influence the completion of this research
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    da zhao, professor
    Phone
    0086-13369287188
    Email
    Ydfyzhaohon@163.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    rui chen, doctor
    Phone
    0086-13919899287
    Email
    chrui-001@163.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    xiaoming hou, professor
    Organizational Affiliation
    LanZhou University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

    Learn more about this trial

    Study of Anlotinib in Advanced Non-squamous NSCLC Patients in the Elderly Without Systemic Chemotherapy (ALTER-L006)

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