2023 World Conference on Lung Cancer (Posters)-EP07.05. Efficacy and Safety of Osimertinib Therapy in High-Risk Stage I EGFRm NSCLC after R0 Resection(OSTAR): A Prospective, Single-Arm Study

EP07.05. Efficacy and Safety of Osimertinib Therapy in High-Risk Stage I EGFRm NSCLC after R0 Resection(OSTAR): A Prospective, Single-Arm Study - PDF(Abstract)

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This document provides a summary of a presentation titled "Efficacy and Safety of Osimertinib Therapy in High-Risk Stage I EGFRm NSCLC after R0 Resection(OSTAR): A Prospective, Single-Arm Study." The study aims to investigate the efficacy and safety of adjuvant therapy with osimertinib in patients with stage I non-small cell lung cancer (NSCLC) who have undergone complete resection.<br /><br />The introduction states that patients with stage I NSCLC who have been completely resected, but present with high-risk factors such as solid and/or micropapillary components or spread through air space (STAS), have a higher likelihood of relapse. However, they have limited benefit from adjuvant chemotherapy. The study references the ADAURA study, which showed that osimertinib significantly reduced the risk of recurrence or death in stage IB subgroup patients. However, the potential benefits of adjuvant therapy with osimertinib in stage I NSCLC patients with high-risk factors are currently unknown.<br /><br />The methods describe the study design, which is a prospective, open, single-center, single-arm phase II clinical study. Eligible patients include those with completely resected stage I EGFR mutation-positive NSCLC with high-risk factors. These patients will receive osimertinib for up to 3 years. The primary endpoint is the 3-year disease-free survival rate, while secondary endpoints include disease-free survival, overall survival, and 3-year and 5-year overall survival rates. Additionally, the study will explore the effects of osimertinib on health-related quality of life and outcomes after relapse. The study aims to enroll 65 patients, with 28 already enrolled as of April 11, 2023.<br /><br />The keywords associated with the presentation are osimertinib, adjuvant therapy, and high-risk factors. The presentation falls under the Early-Stage Non-small Cell Lung Cancer track, and it is categorized as a Clinical Trials in Progress abstract.

Asset Subtitle

Dongsheng Yue

Meta Tag

Speaker Dongsheng Yue

Topic Early-Stage NSCLC: Pushing the Boundaries

Keywords

Osimertinib

adjuvant therapy

high-risk factors

stage I NSCLC

complete resection

EGFR mutation-positive

disease-free survival

overall survival

health-related quality of life

Clinical Trials in Progress