The purpose of this study is to observe the safety and efficacy of Aspirin combined with Trametinib and Dalafenib in the treatment of advanced BRAF V600E mutated non-small cell lung cancer (NSCLC)
Inoperable stage IIIB-IV patients with non-small cell lung cancer;
BRAF V600E mutation;
Dabrafenib and Trametinib are planned for treatment, and the survival period is expected to be more than 3 months;
ECOG PS 0/1;
The patient is currently receiving other anticoagulant therapy;
The patient was previously treated with systemic anti-NSCLC;
The patient had other positive driver mutations, including EGFR, ALK, ROS1, MET14, RET, etc.
The patient had contraindications for dalafenib or trametinib and aspirin use;
This study is aimed at patients with advanced non-small cell lung cancer with BRAF V600E mutation in primary stage IIIB-IV. Dabrafenib and Trametinib are proposed for the treatment of advanced lung cancer
Cohort
Prospective
Combind asprin with Trametinib and Dabrafenib
DrugTreatment drug: Dabrafenib 150 mg BID, Trametinib 2 mg QD, Aspirin 100 mg/tablet, 1 tablet/time, QD
PFS
Progression-free survival (PFS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib
Proportion of patients with fever
Refers to the proportion of patients with fever from the beginning of treatment to the end of follow-up.
OS
3 year Overall Survival (OS) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib
ORR
The Objective Response Rate (ORR) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib. ORR will be analyzed using tests, and logistic regression methods will be used to explore other factors that influence the outcome.
DCR
The Disease Control Rate (DCR) was calculated in 36 patients treated with aspirin combined with Dabrafenib and Trametinib. DCR will be analyzed using tests, and logistic regression methods will be used to explore other factors that influence the outcome.
Risk of coronary events
Risk of coronary events was calculated in 36 patients treated with aspirin combined with Dabrafenib and TrametinibTrametinib
Effectiveness evaluation/efficacy analysis
Univariate analysis of the relationship between lung cancer and treatment regimens: DFS and OS were used to compare whether there was a statistical difference (P-value less than or equal to 0.05) in the overall survival curve between the experimental and control groups by log-rank test; Multifactor analysis: PFS and OS will use a COX-proportional hazard model to estimate the hazards ratio and explore other factors that influence efficacy.
Security assessment
Security analysis data sets will be used for analysis. descriptive statistics, adverse events (AE), laboratory test results (blood biochemistry, liver and kidney function, coagulation and stool routine, etc.) and important vital signs (such as blood pressure) were mainly used to summarize and analyze the list.
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