Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated NSCLC Patients.

Launched by DAPING HOSPITAL AND THE RESEARCH INSTITUTE OF SURGERY OF THE THIRD MILITARY MEDICAL UNIVERSITY · Aug 27, 2023

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ClinConnect Summary

This clinical trial is studying the combination of two medications, Osimertinib and Aspirin, as a treatment before surgery for patients with a specific type of lung cancer called non-small cell lung cancer (NSCLC) that has certain genetic changes known as EGFR mutations. The goal is to see if this combination can help shrink the cancer before it is removed surgically. The trial is focused on patients who have a stage of cancer that can still be surgically treated and who have specific EGFR mutations that are known to respond to Osimertinib.

To be eligible for this trial, participants need to be between the ages of 65 and 74 with resectable stage IIA or IIIA lung adenocarcinoma, and they must have the EGFR mutations that the study is targeting. They should be in good overall health with a performance status (ECOG PS) of 0 or 1, meaning they are fully active or can carry out light activities. Patients who have previously taken aspirin or those currently on it can participate. However, those on other blood thinners or who have received other treatments for lung cancer will not be eligible. Throughout the trial, participants can expect close monitoring and support as they receive the study medications before their surgery.

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Eligibility criteria

• Inclusion Criteria:
• • 1. Patients with resectable stage IIA-IIIA lung adenocarcinoma.
• • 2. Patients with EGFR sensitizing mutations (Ex19del or L858R).
• • 3. Intended neoadjuvant therapy with osimertinib, with an anticipated survival expectancy of more than 3 months.
• • 4. ECOG PS 0/1.
• • 5. Primary lesion diameter of at least 1 cm.
• • 6. Patients who have previously taken or are currently taking aspirin therapy are allowed.
• Exclusion Criteria:
• • 1. Currently receiving other anticoagulant therapy.
• • 2. Previously treated with systemic therapy for NSCLC.
• • 3. Other positive driver mutations, including ALK, ROS1, MET14 exon skipping, BRAF, RET, etc.
• • 4. Contraindications to the use of osimertinib and aspirin.