WCLC 2025 - Posters & ePosters-P3.18.56 EGFR-Mutated Lung Cancer in Randomized Investigator-Initiated Study (ERIS): A National Phase III Trial From the Swedish Lung Cancer Study Group

P3.18.56 EGFR-Mutated Lung Cancer in Randomized Investigator-Initiated Study (ERIS): A National Phase III Trial From the Swedish Lung Cancer Study Group

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The ERIS study is a national Phase III randomized trial conducted by the Swedish Lung Cancer Study Group to compare second- and third-generation EGFR tyrosine kinase inhibitors (TKIs) in advanced EGFR-mutated non-small cell lung cancer (NSCLC). Patients eligible for first-line EGFR-TKI treatment are randomized to receive either a second-generation inhibitor (afatinib or dacomitinib) or the third-generation TKI osimertinib. Randomization is stratified based on the presence of central nervous system metastases and EGFR mutation type. Importantly, patients progressing with T790M-positive resistance during second-generation TKI treatment are recommended to crossover to osimertinib. Subsequent treatment decisions are managed by local investigators.<br /><br />The trial aims to evaluate progression-free survival, total duration of TKI treatment, overall survival, tumor response, adverse effects, and quality of life. In addition, blood and tumor tissue samples are longitudinally collected for exploratory analyses on DNA, RNA, and protein levels to study biomarkers for early treatment prediction and resistance monitoring. This approach may facilitate more personalized therapy strategies.<br /><br />Currently, ERIS is recruiting across 11 Swedish hospitals, with 90 patients randomized so far. The goal is to enroll at least 200 patients over three years, with the study expected to conclude 36 months after the final inclusion.<br /><br />This study addresses a significant gap, as no direct head-to-head trial has previously compared the efficacy and safety of second- versus third-generation EGFR-TKIs in this patient population. With ongoing debates on optimal sequencing of TKIs and resistance mechanisms, ERIS is poised to provide critical evidence to guide treatment decisions in EGFR-mutated advanced NSCLC. The trial is fully academic and funded by Swedish cancer and research foundations.

Asset Subtitle

Maria Planck

Meta Tag

Speaker Maria Planck

Topic Clinical Trials in Progress

Keywords

ERIS study

Phase III randomized trial

EGFR tyrosine kinase inhibitors

second-generation TKI

third-generation TKI

advanced EGFR-mutated NSCLC

progression-free survival

T790M resistance

biomarkers

personalized therapy