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(Slides)

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A study titled "Efficacy and safety of osimertinib therapy in high-risk stage I EGFRm NSCLC after R0 resection (OSTAR)" aims to evaluate the effectiveness and safety of osimertinib therapy in stage I non-small cell lung cancer (NSCLC) patients who have undergone complete resection. These patients have high-risk factors such as solid and/or micropapillary components or spread through air space (STAS), which are not defined as high-risk recurrent factors by the NCCN guidelines. Currently, these patients have limited benefit from adjuvant chemotherapy, which is highly toxic.<br /><br />The study is a prospective, open, single-center, single-arm phase II clinical study. A total of 65 eligible patients with EGFR mutation-positive nsq-NSCLC and high-risk factors will be enrolled to receive chemo-free treatment with osimertinib 80 mg once daily for up to 3 years. By July 2023, 31 patients have been enrolled in the study. The primary endpoint of the study is to determine the efficacy and applicability of adjuvant osimertinib in these patients.<br /><br />The findings from this study will provide valuable insights into the efficacy and applicability of adjuvant osimertinib therapy in stage I NSCLC patients with high-risk factors. Osimertinib, a potent third-generation EGFR-TKI, has shown promising results in the adjuvant setting for these patients, potentially leading to improved survival outcomes without the need for chemotherapy. This study will contribute to the understanding of the optimal treatment modalities for this specific patient population.

Asset Subtitle

Dongsheng Yue

Meta Tag

Speaker Dongsheng Yue

Topic Early-Stage NSCLC: Pushing the Boundaries

Keywords

Efficacy

Safety

Osimertinib therapy

High-risk stage I EGFRm NSCLC

R0 resection

OSTAR

Non-small cell lung cancer

Adjuvant chemotherapy

Prospective study

EGFR mutation-positive nsq-NSCLC