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

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ClinicalTrials.gov Identifier: NCT03700333
Recruitment Status : Unknown
Verified May 2018 by The First Affiliated Hospital with Nanjing Medical University.
Recruitment status was:  Not yet recruiting
First Posted : October 9, 2018
Last Update Posted : October 9, 2018
Sponsor:
Information provided by (Responsible Party):
The First Affiliated Hospital with Nanjing Medical University

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small-Cell Lung Drug: S-1 therapy Drug: Pemetrexed therapy Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer
Estimated Study Start Date : October 20, 2018
Estimated Primary Completion Date : October 20, 2019
Estimated Study Completion Date : October 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: S-1 Group
Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Tegafur,Gimeracil and Oteracil Potassium Capsules (S-1)
Drug: S-1 therapy
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).

Active Comparator: Pemetrexed Group
Stage IIIB or IV non-small-cell lung cancer (NSCLC) population treated by Pemetrexed
Drug: Pemetrexed therapy
accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(>21 days).




Primary Outcome Measures :
  1. progress free survival [ Time Frame: 1 year ]
    From date of randomization until the date of first documented progression.


Secondary Outcome Measures :
  1. overall survival [ Time Frame: 3 mouths, 6 mouths, 9 mouths, 1 year ]
    every subjects needs to be recorded the data of death.From date of randomization until the date of death from any cause.

  2. objective response rate [ Time Frame: 3 mouths, 6 mouths, 9 mouths, 1 year ]
    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.

  3. duration of response [ Time Frame: 6 weeks, 3 mouths, 18 weeks, 6 mouths, 9 mouths, 1 year ]
    From the date of first documented CR (complete response) or PR (partial response) until the date of first documented progression or recurrence.



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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03700333


Contacts
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Contact: Renhua Guo, MD 025-68136360 rhguo@njmu.edu.cn

Sponsors and Collaborators
The First Affiliated Hospital with Nanjing Medical University
Investigators
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Study Director: Yongqian Shu, MD The First Affiliated Hospital with Nanjing Medical University
Principal Investigator: Renhua Guo, MD The First Affiliated Hospital with Nanjing Medical University
Publications of Results:
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Responsible Party: The First Affiliated Hospital with Nanjing Medical University
ClinicalTrials.gov Identifier: NCT03700333    
Other Study ID Numbers: NHP-18-01
First Posted: October 9, 2018    Key Record Dates
Last Update Posted: October 9, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by The First Affiliated Hospital with Nanjing Medical University:
Carcinoma, Non-Small-Cell Lung
S-1
Pemetrexed
maintenance therapy
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Pemetrexed
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Folic Acid Antagonists
Nucleic Acid Synthesis Inhibitors