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Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced NSNSCLC

Primary Purpose

Carcinoma, Non-Small-Cell Lung

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
S-1 therapy
Pemetrexed therapy
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 Carcinoma, Non-Small-Cell Lung focused on measuring Carcinoma, Non-Small-Cell Lung, S-1, Pemetrexed, maintenance therapy

Eligibility Criteria

18 Years - 74 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Written informed consent
  2. Histological or cytological documented
  3. NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.1.
  4. Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD.
  5. Candidates's expected survival time should be greater than or equal to 3 months with ECOG performance status 0-1, adequate haematological and Hepatic- renal function, and cardiac function.
  6. At least one measurable tumor lesion (maximum diameter has to be greater than 10mm scan by CT or MRI) or malignant lymph node (15mm in short axis), and must not be accepted radiotherapy.
  7. No any other following malignancy or any serious complication caused by metastatic encephaloma.
  8. No any gastrointestinal diseases that could reduce the drug absorption.
  9. Female: Candidates who have any chance to be pregnant must accept pregnancy tests 72 hours before therapy, and take medical allowed contraceptives during therapy or in 3 mouths after therapy. Pregnancy tests results must be negative.Lactation female are not included.
  10. Male: Be sterilized or take contraceptives during therapy or in 3 mouths after therapy.

Exclusion Criteria:

  1. Any unstable systemic disease
  2. Patients with exposure to any recent anticancer therapy outside of this trial.
  3. Pregnant or breast-feeding women

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    S-1 Group

    Pemetrexed Group

    Arm Description

    Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1)

    Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed

    Outcomes

    Primary Outcome Measures

    progress free survival
    From date of randomization until the date of first documented progression.

    Secondary Outcome Measures

    overall survival
    every subjects needs to be recorded the data of death.From date of randomization until the date of death from any cause.
    objective response rate
    ORR(objective response rate) is equal to the sum of cases of CR (complete response) and PR (partial response) divided by the total number of evaluable cases.From date of randomization until the date of first documented progression.
    duration of response
    From the date of first documented CR (complete response) or PR (partial response) until the date of first documented progression or recurrence.

    Full Information

    First Posted
    September 9, 2018
    Last Updated
    October 7, 2018
    Sponsor
    The First Affiliated Hospital with Nanjing Medical University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03700333
    Brief Title
    Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced NSNSCLC
    Official Title
    Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 20, 2018 (Anticipated)
    Primary Completion Date
    October 20, 2019 (Anticipated)
    Study Completion Date
    October 20, 2019 (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
    The purpose of this study is to compare the curative effect of oral S-1 with Pemetrexed in the maintenance treatment of advanced non-squamous non-small cell lung cancer (NSCLC), and initial to explore a new treatment strategy for advanced non-squamous NSCLC.
    Detailed Description
    S-1 consists of Tegafur,Gimeracil and Oteracil Potassium. Tegafur is metabolize to Gimeracil，and slows down the metabolism of 5-FU in high DPD enzyme expression tumor cell, so that 5-FU could bring the antimetabolic fiction more efficiently. Plenty of studies support that S-1 shows a desirable effect on advanced non-squamous NSCLC, and S-1 is more convenient compare with Pemetrexed. The curative effect of Pemetrexed in the maintenance treatment of advanced non-squamous NSCLC has been proved to be valid. The purpose of our study is to explore whether S-1 could replace Pemetrexed in the maintenance treatment of advanced non-squamous 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
    Keywords
    Carcinoma, Non-Small-Cell Lung, S-1, Pemetrexed, maintenance therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    S-1 Group
    Arm Type
    Experimental
    Arm Description
    Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1)
    Arm Title
    Pemetrexed Group
    Arm Type
    Active Comparator
    Arm Description
    Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed
    Intervention Type
    Drug
    Intervention Name(s)
    S-1 therapy
    Intervention Description
    accept S-1(50mg, twice a day, morning and night, if<1.5m2; 75mg, twice a day, morning and night,if >1.5m2 )chemotherapy after finishing first-line therapy(>21 days).
    Intervention Type
    Drug
    Intervention Name(s)
    Pemetrexed therapy
    Intervention Description
    accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(>21 days).
    Primary Outcome Measure Information:
    Title
    progress free survival
    Description
    From date of randomization until the date of first documented progression.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    overall survival
    Description
    every subjects needs to be recorded the data of death.From date of randomization until the date of death from any cause.
    Time Frame
    3 mouths, 6 mouths, 9 mouths, 1 year
    Title
    objective response rate
    Description
    ORR(objective response rate) is equal to the sum of cases of CR (complete response) and PR (partial response) divided by the total number of evaluable cases.From date of randomization until the date of first documented progression.
    Time Frame
    3 mouths, 6 mouths, 9 mouths, 1 year
    Title
    duration of response
    Description
    From the date of first documented CR (complete response) or PR (partial response) until the date of first documented progression or recurrence.
    Time Frame
    6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    74 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Written informed consent Histological or cytological documented NSCLC of stage IIIB (surgery is unacceptable) or IV confirmed by mediastinoscopy or PET based on RECIST1.1. Candidates have been accepted 4-6 cycles of gemcitabine/carboplatin Naive chemotherapy, and evaluated as CR,PR or SD. Candidates's expected survival time should be greater than or equal to 3 months with ECOG performance status 0-1, adequate haematological and Hepatic- renal function, and cardiac function. At least one measurable tumor lesion (maximum diameter has to be greater than 10mm scan by CT or MRI) or malignant lymph node (15mm in short axis), and must not be accepted radiotherapy. No any other following malignancy or any serious complication caused by metastatic encephaloma. No any gastrointestinal diseases that could reduce the drug absorption. Female: Candidates who have any chance to be pregnant must accept pregnancy tests 72 hours before therapy, and take medical allowed contraceptives during therapy or in 3 mouths after therapy. Pregnancy tests results must be negative.Lactation female are not included. Male: Be sterilized or take contraceptives during therapy or in 3 mouths after therapy. Exclusion Criteria: Any unstable systemic disease Patients with exposure to any recent anticancer therapy outside of this trial. Pregnant or breast-feeding women
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Renhua Guo, MD
    Phone
    025-68136360
    Email
    rhguo@njmu.edu.cn
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Yongqian Shu, MD
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Study Director
    First Name & Middle Initial & Last Name & Degree
    Renhua Guo, MD
    Organizational Affiliation
    The First Affiliated Hospital with Nanjing Medical University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    19052037
    Citation
    Shirasaka T. Development history and concept of an oral anticancer agent S-1 (TS-1): its clinical usefulness and future vistas. Jpn J Clin Oncol. 2009 Jan;39(1):2-15. doi: 10.1093/jjco/hyn127. Epub 2008 Dec 3.
    Results Reference
    result
    PubMed Identifier
    20150827
    Citation
    Kubota K, Sakai H, Yamamoto N, Kunitoh H, Nakagawa K, Takeda K, Ichinose Y, Saijo N, Ariyoshi Y, Fukuoka M. A multi-institution phase I/II trial of triweekly regimen with S-1 plus cisplatin in patients with advanced non-small cell lung cancer. J Thorac Oncol. 2010 May;5(5):702-6. doi: 10.1097/JTO.0b013e3181ce3e22.
    Results Reference
    result
    PubMed Identifier
    26131116
    Citation
    Li XN, Qiu D, Pan X, Hou XX. Mutation of the epidermal growth factor receptor gene and its impact on the efficacy of gefitinib in advanced non-small cell lung cance. Int J Clin Exp Med. 2015 Apr 15;8(4):5397-405. eCollection 2015.
    Results Reference
    result

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    Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced NSNSCLC

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