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Report for Clinical Trial NCT04184921

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Prospective Observational Trial to Evaluate the Efficacy of the Combination of Osimertinib and Aspirin in Patients With Epidermal Growth Factor Receptor(EGFR)-Mutation

The third generation epidermal growth factor receptor-tyrosine Kinase Inhibitor(EGFR-TKI) osimertinib has obvious curative effect for EGFR sensitive mutation and T790M mutation(PMID 27959700), but acquired drug resistance will occur. Previous studies show that apoptosis escape can lead to EGFR-TKI resistance.Osimertinib resistant cells show abnormal activation of PI3K/AKT/BIM activation(PMID 28765329). The classical drug aspirin can effectively decrease AKT phosphorylation and activate of BIM(PMID 28881293).So Investigators speculate that aspirin may decrease the PI3K/AKT/BIM signaling pathways, then promote osimertinib resistant cells apoptosis. The current study aims to evaluate the combination of aspirin and osimertinib in patients with EGFR/T790M mutations.

NCT04184921 Lung Cancer Non-small Cell Stage IV
MeSH:Carcinoma, Non-Small-Cell Lung
HPO:Non-small cell lung carcinoma

2 Interventions

Name: Aspirin 100mg

Description: Aspirin, also known as acetylsalicylic acid (ASA), is a very safe medication used to treat pain, fever, or inflammation.
Type: Drug
Group Labels: 1

osimertinib and aspirin

Name: Osimertinib 80 MG

Description: Osimertinib, also known as azd9291, is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation. It has been approved in clinical applications by the FDA in 2015.
Type: Drug
Group Labels: 2

osimertinib osimertinib and aspirin


Primary Outcomes

Description: To evaluate the response to therapy and progression-free survival rate of the combination of Osimertinib and Aspirin in advanced lung cancer patients who has EGFR-mutation.

Measure: progression-free survival rate according to resist 1.1

Time: 2 years

Secondary Outcomes

Description: To evaluate the overall survival of the combination of Osimertinib and Aspirin in advanced lung cancer patients who has EGFR-mutation.

Measure: overall survival(OS)

Time: 5 years

Description: To evaluate the response to therapy and Objective Response Rate of the combination of Osimertinib and Aspirin in patients who has EGFR-mutation.

Measure: Objective Response Rate(ORR) according to resist 1.1

Time: 2 years

Description: To evaluate the response to therapy and Time to progression of the combination of Osimertinib and Aspirin in patients who has EGFR-mutation.

Measure: Time to progression(TTP) according to resist 1.1

Time: 2 years

Time Perspective: Prospective

Cohort


There are 2 SNPs

SNPs


1 C797S

Previous study showed that one principal mechanism accounting for majority of acquired resistance to Osimertinib in lung cancer is mediated by an exon 20 C797S mutation etc(PMID 29596911). --- C797S ---


2 T790M

Prospective Observational Trial to Evaluate the Efficacy of the Combination of Osimertinib and Aspirin in Patients With Epidermal Growth Factor Receptor(EGFR)-Mutation. Combination of Osimertinib and Aspirin to Treat EGFR Mutation NSCLC Patients The third generation epidermal growth factor receptor-tyrosine Kinase Inhibitor(EGFR-TKI) osimertinib has obvious curative effect for EGFR sensitive mutation and T790M mutation(PMID 27959700), but acquired drug resistance will occur. --- T790M ---

The current study aims to evaluate the combination of aspirin and osimertinib in patients with EGFR/T790M mutations. --- T790M ---

Osimertinib is a 3rd-generation EGFR-TKI used to treat NSCLC patients with resistance to 1st generation EGFR-TKI due to T790M mutation. --- T790M ---



HPO Nodes


HPO: