Clinical trial

A Phase II Study Evaluating Osimertinib Combined With Aspirin Neoadjuvant Therapy for Resectable EGFR Mutated Non-small Cell Lung Cancer (NSCLC)

Name

NEWCOAST

Description

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.

Trial arms

Trial start

2023-09-15

Estimated PCD

2026-03-01

Trial end

2026-09-01

Status

Not yet recruiting

Phase

Early phase I

Treatment

Osimertinib

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.

Arms:

osimertinib and aspirin

Other names:

OSI

Aspirin

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

Arms:

osimertinib and aspirin

Other names:

ASP

Size

Primary endpoint

Major pathologic response

Within 1 month after surgery

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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 44, 'type': 'ESTIMATED'}}

Updated at

2023-09-21

1 organization

2 drugs

2 indications

Organization

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

Drug

Indication

Indication

Drug