To investigate the survival benefit of first-line therapy for patients with EGFR-sensitive mutation-positive advanced non-squamous non-small cell lung cancer treated with S-1plus gefitinib versus gefitinib monotherapy
Name: S-1 plus Gefitinib
Description: S-1: According to the body surface area (BSA) to determine the dose, twice daily, after breakfast and dinner orally Gefitinib: 250mg, 1 day, orally, fasting or with the same serviceType: DrugS-1 plus Gefitinib
Name: Gefitinib
Description: Gefitinib: 250mg, 1 day, orallyType: DrugGefitinib
Description: From start of anti-cancer therapy until progression or death.To evaluate the disease free survival of gefitinib combined with S-1 and gefitinib in patients with Pathological stage IIIc-IV NSCLC harbouring sensitive mutations of EGFR. Progression free survival (PFS)- defined as the time from initial medication to the first documented disease progression or death, whichever occurs first.
Measure: Progression free survival(PFS) Time: 2 yearsDescription: To evaluate the overall survivalof gefitinib combined with S-1 and gefitinib in patients with Pathological stage IIIc-IV NSCLC harbouring sensitive mutations of EGFR in the 3 years since treatment begain
Measure: Overall survival(OS) Time: 3 yearsDescription: To compare disease control rate of the two arms from start of anti-cancer therapy until progression
Measure: Disease control rate Time: 2 yearsDescription: To compare objective response rate of the two arms from start of anti-cancer therapy until progression
Measure: Objective response rate(ORR) Time: 2 yearsDescription: The safety and tolerability profile of gefitinib at a 250 mg daily dose relative to that of radiotherapy.
Measure: Number of Participants with Adverse Events Time: 3 yearsDescription: Quality of Life Questionnaire(such as QLQ-C30 and QLQ-LC13) evaluated since treatment began.At the end of the trial, the differences between the two indicators were compared with Mixed-effects model repeated measures (MMRM), where the baseline was scored as a covariant and the treatment group as a fixed variable. In addition, the baseline values of the two scores, the value of each visit, and the change value of the baseline were statistically described.
Measure: Assessment of Health-related quality of life Time: 3 yearsAllocation: Randomized
Parallel Assignment
There is one SNP
4. exon 19 deletion or exon 21 L858R for EGFR mutation. --- L858R ---