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

NCT06018688 | Not Yet Recruiting Phase 2

• 1 other identifier: NEWCOAST
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Non Small Cell Lung Cancer; EGFR Gene Mutation

Keywords

Non-Small Cell Lung Cancer; Aspirin; Osimertinib; EGFR-TKI; neoadjuvant therapy

Outcome Measures

Primary Outcomes (1)

• Major pathologic response

  MPR refers to the percentage of residual viable tumor cells within the tumor bed after neoadjuvant treatment, with a threshold of ≤10%, regardless of the presence of residual viable tumor cells in the lymph nodes.

  Within 1 month after surgery

Secondary Outcomes (4)

• Disease Free Survival

  From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months.

• Objective Response Rate

  1 week before surgery

• Disease Control Rate

  1 week before surgery

• Pathologic complete response

  Within 1 month after surgery

Study Arms (1)

osimertinib and aspirin

EXPERIMENTAL

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.

Drug: Osimertinib; Drug: Aspirin

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.

Also known as: OSI

osimertinib and aspirin

Aspirin DRUG

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

Also known as: ASP

osimertinib and aspirin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with resectable stage IIA-IIIA lung adenocarcinoma.
• Patients with EGFR sensitizing mutations (Ex19del or L858R).
• Intended neoadjuvant therapy with osimertinib, with an anticipated survival expectancy of more than 3 months.
• ECOG PS 0/1.
• Primary lesion diameter of at least 1 cm.
• Patients who have previously taken or are currently taking aspirin therapy are allowed.

You may not qualify if:

• Currently receiving other anticoagulant therapy.
• Previously treated with systemic therapy for NSCLC.
• Other positive driver mutations, including ALK, ROS1, MET14 exon skipping, BRAF, RET, etc.
• Contraindications to the use of osimertinib and aspirin.

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Interventions

osimertinib; Aspirin

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Central Study Contacts

He yong

CONTACT

86-23-68757791; heyong8998@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 31, 2023
• Study Start: September 15, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 21, 2023

Record last verified: 2023-09