The investigators performed a multi-centered, randomized, double blinded, placebo-controlled, prospective clinical trial on the effect of Yiqi-yangyin-jiedu decoction (YYJD), a chinese herbal medicine (CHM) formula combined with gefitinib to prolong the progression free survival (PFS) of advanced pulmonary adenocarcinoma patients with activating EGFR mutation (exon19del or exon21L858R). The investigators plan to enroll 198 cases in 3 years (99 cases for gefitinib, 99 cases for gefitinib plus YYJD), expecting that combination therapy has a better efficacy on prolonging PFS, overall survival, improving quality of life(QOL).
Name: gefitinib
Name: Yiqi-yangyin-jiedu decoction
Name: placebo
Description: Time from start of the study treatment to date of objective tumour progression (excluding clinical deterioration without evidence of objective progression).
Measure: Progression-free survival (PFS) Time: 2 monthsDescription: interval time from the first date of randomization to that of death for any reason, the end of the study, or loss of follow-up
Measure: Overall survival (OS) Time: 2 monthsDescription: The ORR (complete response (CR) plus partial response (PR)) was determined by the Response Evaluation Criteria In Solid Tumors (RECIST) (Eisenhauer et al, 2009) version 1.1.in Solid Tumors (RECIST1.1).
Measure: Objective response rate (ORR) Time: 2 monthsDescription: QOL is assessed using Functional Assessment of Cancer therapy-lung (FACT-L) questionnaire .
Measure: Quality of life (QOL) Time: 2 monthsDescription: Safety assessment is evaluated according to Common Toxicity Criteria (CTC 3.0).
Measure: Safety assessment evaluated according to Common Toxicity Criteria Time: 2 monthsAllocation: Randomized
Parallel Assignment
There are 2 SNPs
Although AZD9291 (AstraZeneca), a third-generation EGFR-TKI is reported with a response rate of 61% in NSCLC patients with EGFR T790M and a mPFS of 9.6 months, resistance to third-generation inhibitors mediated by EGFR C797S mutation is inevitable. --- T790M --- --- C797S ---
In approximately 60% of patients, the mechanism of acquired resistance is the development of an additional EGFR mutation, EGFR T790M. --- T790M ---
Although AZD9291 (AstraZeneca), a third-generation EGFR-TKI is reported with a response rate of 61% in NSCLC patients with EGFR T790M and a mPFS of 9.6 months, resistance to third-generation inhibitors mediated by EGFR C797S mutation is inevitable. --- T790M ---