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Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.

Primary Purpose

Non-squamous Non-small-cell Lung Cancer

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Anlotinib + Pemetrexed+Carboplatin
Pemetrexed
Anlotinib + Pemetrexed
Anlotinib
Sponsored by
The First Affiliated Hospital with Nanjing Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

  1. Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months;
  2. Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC;
  3. Signed and dated informed consent;
  4. adequate hematological, liver and renal function

Exclusion Criteria:

  1. prior chemotherapy or treatment with another systemic anti-cancer agent
  2. malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS
  3. evidence of tumor invading major blood vessels
  4. current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes
  5. history of haemoptysis >/=grade 2
  6. clinically significant cardiovascular disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Other

    Experimental

    Experimental

    Experimental

    Arm Label

    First-line Treatment

    Maintenance Treatment A

    Maintenance Treatment B

    Maintenance Treatment C

    Arm Description

    Outcomes

    Primary Outcome Measures

    Progression-Free Survival (PFS)
    PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.

    Secondary Outcome Measures

    Objective Response Rate (ORR)
    Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR).
    Disease control rate (DCR)
    Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
    Overall Survival (OS)
    OS is calculated from diagnosis to death or last follow-up time.
    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

    Full Information

    First Posted
    June 27, 2020
    Last Updated
    June 27, 2020
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04453423
    Brief Title
    Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.
    Official Title
    A Study of the Effect of Anlotinib, Pemetrexed or the Combination As Maintenance Therapy for Patients With Non-Squamous Non-Small Cell Lung Cancer.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    July 1, 2020 (Anticipated)
    Primary Completion Date
    July 1, 2022 (Anticipated)
    Study Completion Date
    July 1, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The First Affiliated Hospital with Nanjing Medical University

    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 study will compare maintenance therapy with anlotinib plus pemetrexed versus pemetrexed or anlotinib alone, in patients with Non-squamous Non-small cell lung cancer who have not progressed during first-line therapy with anlotinib + pemetrexed + carboplatin. The primary endpoint of the study is progression-free survival (PFS); the secondary endpoints are disease control rate (DCR), objective response rate (ORR) and overall survival (OS).

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    90 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    First-line Treatment
    Arm Type
    Other
    Arm Title
    Maintenance Treatment A
    Arm Type
    Experimental
    Arm Title
    Maintenance Treatment B
    Arm Type
    Experimental
    Arm Title
    Maintenance Treatment C
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    Anlotinib + Pemetrexed+Carboplatin
    Intervention Description
    Anlotinib: 12mg, QD, PO, d1-14, 21 days per cycle Carboplatin: AUC 5 on day 1 of 21 days per cycle Pemetrexed: 500mg/m2 iv on day 1 of 21 days per cycle
    Intervention Type
    Drug
    Intervention Name(s)
    Pemetrexed
    Intervention Description
    500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
    Intervention Type
    Drug
    Intervention Name(s)
    Anlotinib + Pemetrexed
    Intervention Description
    Anlotinib:12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase) Pemetrexed:500mg/m2 iv on day 1 of 21 days per cycle(maintenance phase)
    Intervention Type
    Drug
    Intervention Name(s)
    Anlotinib
    Intervention Description
    12mg, QD, PO, d1-14, 21 days per cycle(maintenance phase)
    Primary Outcome Measure Information:
    Title
    Progression-Free Survival (PFS)
    Description
    PFS is defined as the time from the date of treatment to the first date of disease progression or death from any cause.
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Objective Response Rate (ORR)
    Description
    Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1). The percentage of patients who achieved CR and PR was defined as objective response rate (ORR).
    Time Frame
    each 42 days up to intolerance the toxicity or PD (up to 12 months)
    Title
    Disease control rate (DCR)
    Description
    Treatment response are defined as complete response (CR), partial response (PR), stable disease (SD) and progression disease (PD) according to Response Evaluation Criteria in Solid Tumor (RECISIT criteria, version 1.1) and the percentage of patients who achieved CR, PR and SD was defined as disease control rate (DCR).
    Time Frame
    each 42 days up to intolerance the toxicity or PD (up to 12 months)
    Title
    Overall Survival (OS)
    Description
    OS is calculated from diagnosis to death or last follow-up time.
    Time Frame
    12 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

    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: Age ≥ 18 years and ≤ 75, ECOG PS: 0~1, estimated survival duration more than 3 months; Subjects with histologically or cytologically confirmed locally advanced and/or advanced Non-squamous NSCLC; Signed and dated informed consent; adequate hematological, liver and renal function Exclusion Criteria: prior chemotherapy or treatment with another systemic anti-cancer agent malignancies other than NSCLC within 5 years prior to randomization, except for adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer or DCIS evidence of tumor invading major blood vessels current or recent use of aspirin (>325mg/day) or full-dose anticoagulants or thrombolytic agents for therapeutic purposes history of haemoptysis >/=grade 2 clinically significant cardiovascular disease
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Renhua Guo, MD
    Phone
    025-68136360
    Email
    rhguo@njmu.edu.cn

    12. IPD Sharing Statement

    Learn more about this trial

    Combination Chemotherapy With or Without Anlotinib in the Maintenance Treatment of Non-Squamous Non-Small Cell Lung Cancer.

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