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

Phase 3

• Conditions: Carcinoma, Non-Small-Cell Lung
• Interventions: Drug: S-1 therapy; Drug: Pemetrexed therapy

• Registration Number: NCT03700333
• Lead Sponsor: 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.

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-09-09
• Study First Submitted QC: 2018-10-07
• Last Update Submitted: 2018-10-07
• Study First Posted: 2018-10-09
• Last Update Posted: 2018-10-09
• Study Start: 2018-10-20
• Primary Completion: 2019-10-20
• Study Completion: 2019-10-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
progress free survival	1 year	From date of randomization until the date of first documented progression.

Secondary Outcome Measures

Name	Time	Method
overall survival	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.
objective response rate	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.
duration of response	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.