NCT04184921CompletedPhase 2
Combination of Osimertinib and Aspirin to Treat EGFR Mutation NSCLC Patients
A Multicenter, Prospective, Non-randomized, Open-label Study on the Efficacy and Safety of Osimertinib Combined With Aspirin as First-line Treatment for Patients With Locally Advanced or Metastatic EGFR-positive Non-small Cell Lung Cancer (NSCLC)
Source: ClinicalTrials.gov · Last updated 3 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 216 (actual)
- First submitted
- 29 Nov 2019
- Start date
- 1 Jan 2019
- Primary completion date
- 1 Jun 2023
- Lead sponsor
- Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
- Diseases
- Lung cancer
- NCT number
- NCT04184921
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 216
- From 1 Jan 2019 to the primary completion date, 1 Jun 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Currently receiving other anticoagulant treatments. Patients planning to receive anticancer therapies other than Osimertinib. Presence of contraindications to the use of Osimertinib or Aspirin.
Who the study is looking for
- 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.
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Daping Hospital. Coordinator of this site? Confirm its status | Chongqing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.