NCT03700333

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

Clinical Research of S-1 Versus Pemetrexed in the Maintenance Treatment of Advanced Non-squamous Non-small Cell Lung Cancer

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: The First Affiliated Hospital with Nanjing Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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

Interventions

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

Timeline

• Start date: 2018-10-20
• Primary completion: 2019-10-20
• Completion: 2019-10-20
• First posted: 2018-10-09
• Last updated: 2018-10-09