2023 World Conference on Lung Cancer (Posters)-P1.25. TARGET: A Phase II Study of 5-year Adjuvant Osimertinib in Completely Resected EGFR-mutated Stage II-IIIB NSCLC

P1.25. TARGET: A Phase II Study of 5-year Adjuvant Osimertinib in Completely Resected EGFR-mutated Stage II-IIIB NSCLC - PDF(Abstract)

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This document describes a study called TARGET, which is a Phase II multinational study evaluating the efficacy and safety of adjuvant osimertinib in patients with completely resected EGFR-mutated stage II-IIIB non-small cell lung cancer (NSCLC). Osimertinib is a third-generation, irreversible, epidermal growth factor receptor (EGFR)-tyrosine kinase inhibitor (TKI) that has demonstrated efficacy in EGFR-mutated NSCLC. The study aims to assess the efficacy of 5 years of adjuvant osimertinib in these patients.<br /><br />The primary endpoint of the study is investigator-assessed disease-free survival (DFS) at 5 years in the common EGFR-mutated cohort. Secondary endpoints include investigator-assessed DFS at 3 and 4 years, overall survival at 3, 4, and 5 years in the common EGFR-mutated cohort, and DFS at 3, 4, and 5 years in the uncommon EGFR-mutated cohort. Safety and tolerability, sites of recurrence, CNS metastases, plasma resistance markers, minimal residual disease, emerging resistance mutations, and incidental pulmonary nodules are also being evaluated as exploratory endpoints.<br /><br />The study is currently recruiting patients, and interim analyses of secondary efficacy endpoints are expected in 2027 and 2028, with final completion in 2029. The results of this study will provide valuable information on the use of adjuvant osimertinib in patients with resected EGFR-mutated NSCLC and may help inform treatment decisions in this patient population.<br /><br />Overall, this study aims to further advance the understanding of the role of adjuvant osimertinib in early-stage NSCLC and potentially improve outcomes for patients with EGFR mutations.

Asset Subtitle

Ross Soo

Meta Tag

Speaker Ross Soo

Topic Early-Stage NSCLC: Changing Paradigms & Outcomes

Keywords

TARGET

Phase II

multinational study

efficacy

safety

adjuvant osimertinib

EGFR-mutated

non-small cell lung cancer

investigator-assessed disease-free survival

overall survival