This is a nationwide, multicenter and prospective cohort study. The purpose of this study is to evaluate the synergistic effect and safety of Elemene plus TKIs in EGFR-mutated advanced non-small cell lung cancer.
Name: Elemene plus First-generation EGFR-TKIs
Name: First-generation EGFR-TKIs
Description: PFS was defined as the interval from the date of randomization to the date of the first evidence of disease progression or death, whichever occurs first. Disease progression was defined according to RECIST 1.1.
Measure: PFS Time: Start of treatment until 1-year follow-upDescription: ORR was defined as the percentage of participants with the best overall response (BOR) of complete response (CR) or partial response (PR) based on RECIST 1.1.
Measure: ORR Time: Start of treatment until 1-year follow-upDescription: Disease Control Rate (DCR) = Complete Response (CR) + Partial Response (PR) + Stable Disease (SD) as defined by RECIST 1.1.
Measure: DCR Time: Start of treatment until 1-year follow-upDescription: Overall survival (OS) was defined as the interval from the date of randomization to date of death from any cause, or the date of last known follow-up alive.
Measure: OS Time: Start of treatment until 1-year follow-upDescription: Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect
Measure: Incidence and severity of AE or SAE Time: Start of treatment until 30 days after the last treatmentDescription: All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. A SADR is a serious ADR according to the above criteria of SAE.
Measure: Incidence and severity of ADR or SADR Time: Start of treatment until 30 days after the last treatmentDescription: Quality of Life (QOL) was measured using the European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30 + LC 13).
Measure: Quality of life (QOL) Time: Start of treatment until 1-year follow-upDescription: KPS: Performance status were measured using Karnofsky Performance Scale (KPS)
Measure: Karnofsky Performance Scale (KPS) Time: Start of treatment until 1-year follow-upDescription: TCM symptom score: Traditional Chinese Medical symptoms were measured from these eight aspects: chest pain, oppression in the chest, blood stasis, shortness of breath, weakness, palpitations, dry mouth, vexation. Particular attention should be paid to chest pain and weakness.
Measure: Traditional Chinese Medical(TCM) symptoms score Time: Start of treatment until 1-year follow-upDescription: Including but not limited to drug-resistant genes and circulating tumor cells. Such as PD-L1、MSI-H/dMMR、TMB、HLA、POLE、POLD1、DDR、TP53、KRAS、BRCA2、PBRM1、MDM2/4、EGFR、ALK、PTEN、JAK1/2、DNMT3A、STK11.
Measure: Molecular biomarkers Time: Start of treatment until 1-year follow-upAllocation: Randomized
Parallel Assignment
There is one SNP
3. Patients with EGFR mutations (deletions in exon 19 and L858R in exon 21 of the EGFR gene), plan to receive First-generation EGFR-TKIs (Gefitinib, Erlotinib, Icotinib) monotherapy for the first time. --- L858R ---