Klin Onkol 2026; 39(5): 325-330. DOI: 10.48095/ccko2026325.
Background: Activating mutations in epidermal growth factor receptor (EGFR) represent one of the most important therapeutically targetable alterations in advanced non-small cell lung cancer (NSCLC). Osimertinib has become a first-line standard of care due to its efficacy, favorable safety profile, and activity in the central nervous system. Nevertheless, most patients eventually experience disease progression during treatment, and searching for strategies that further prolong disease control and delay the emergence of resistance remains an important clinical need. The FLAURA2 study evaluated the combination of osimertinib with platinum-based chemotherapy and pemetrexed in previously untreated patients with locally advanced or metastatic EGFR-mutated non-squamous NSCLC. Compared with osimertinib monotherapy, combination treatment demonstrated a significant prolongation of progression-free survival, and in the final analysis, also a statistically significant improvement in overall survival, with a median of 47.5 months vs. 37.6 months (HR for death 0.77; 95% CI 0.61–0.96; P = 0.02). Aim: The aim of this review article is to summarize the FLAURA2 study and its main clinically relevant results in patients with advanced EGFR-mutated NSCLC treated in the first-line setting. The text describes the study design, characteristics of the study population, and treatment arms, focusing on the efficacy outcomes of osimertinib combined with platinum-pemetrexed chemotherapy compared with osimertinib monotherapy, particularly in terms of progression--free survival, overall survival, and intracranial efficacy. The review also includes a summary of the safety profile of the combination treatment and the main conclusions of the published analyses of the study.