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

Nanjing Medical University

Status and phase: Unknown; Phase 3

Conditions: Carcinoma, Non-Small-Cell Lung

Treatments: Drug: Pemetrexed therapy; Drug: S-1 therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03700333

NHP-18-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18 to 74 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

S-1 Group

Experimental group

Description:

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

Treatment:

Drug: S-1 therapy

Pemetrexed Group

Active Comparator group

Description:

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

Treatment:

Drug: Pemetrexed therapy