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

Sponsor
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
Study ID
NCT06018688
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    Osimertinib 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.
  • Aspirin — DRUG
    Aspirin, also known as acetylsalicylic acid (ASA), is a verysafe medication used to treat pain,fever, or inflammation.

Study Details

This is a single-center, prospective, single-arm, phase II study of Osimertinib combined with Aspirin neoadjuvant therapy for resectable, EGFR mutated non-small cell lung cancer (NSCLC). It is mainly aimed at the population of patients with primary IIA- IIIA EGFR sensitive mutations that are intended to be treated with Osimertinib neoadjuvant therapy.

Key Dates

Start date
Sep 15, 2023
Status verified
Sep 2023
Primary completion
Mar 1, 2026
Completion
Sep 1, 2026

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: osimertinib and aspirin
    Osimertinib and Aspirin starting at a dose of 80 mg and 100mg once a day, orally with meals.The participants will undergo a two-month combination therapy, unless there is tumor progression (worsening) or intolerable toxic reactions that necessitate early termination of the drug treatment. Aspirin will be discontinued one week prior to the surgery.

Primary Outcome Measure

Major pathologic response [ Time Frame: Within 1 month after surgery ]

Central Contacts

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