CompletedPhase 2

Combination of Osimertinib and Aspirin to Treat EGFR Mutation NSCLC Patients

China216 participantsStarted 2019-01-01

Plain-language summary

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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion Criteria: Locally advanced (stage IIIB) or metastatic (stage IV) EGFR-mutant NSCLC. Presence of EGFR-sensitive mutations suitable for treatment with Osimertinib. Intended to receive Osimertinib as first-line therapy, with an expected survival period of more than 3 months. At least one measurable tumor lesion that meets the following criteria: Not previously irradiated. Accurately measurable. Baseline longest diameter ≥10 mm (for non-lymph node lesions) or short axis ≥15 mm (for lymph node lesions). Measurement can be performed via chest CT or PET-CT, provided the method allows reliable repeated measurements. Exclusion Criteria: Currently receiving other anticoagulant treatments. Patients planning to receive anticancer therapies other than Osimertinib. Presence of contraindications to the use of Osimertinib or Aspirin.

What they're measuring

progression-free survival according to resist 1.1

Timeframe: 5 years

Trial details

NCT IDNCT04184921

SponsorDaping Hospital and the Research Institute of Surgery of the Third Military Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-01