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

NCT ID: NCT03700333

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-20
• Study Completion Date: 2019-10-20

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.

Conditions

Carcinoma, Non-Small-Cell Lung

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

S-1 Group

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

Group Type: EXPERIMENTAL

S-1 therapy

Intervention Type: DRUG

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).

Pemetrexed Group

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

Group Type: ACTIVE_COMPARATOR

Pemetrexed therapy

Intervention Type: DRUG

accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(\>21 days).

Interventions

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).

Intervention Type: DRUG

Pemetrexed therapy

accept Pemetrexed (500mg/m2,d1)chemotherapy after finishing first-line therapy(\>21 days).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongqian Shu, MD

Role: STUDY_DIRECTOR

The First Affiliated Hospital with Nanjing Medical University

Renhua Guo, MD

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital with Nanjing Medical University

Central Contacts

Renhua Guo, MD

Role: CONTACT

rhguo@njmu.edu.cn

025-68136360

References

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.

Reference Type: RESULT

PMID: 19052037 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20150827 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26131116 (View on PubMed)

Other Identifiers

NHP-18-01

Identifier Type: -

Identifier Source: org_study_id