APPLE trial: Feasibility and activity of AZD9291 (osimertinib) treatment on Positive PLasma T790M in EGFR mutant NSCLC patients. EORTC 1613

APPLE is a randomized, open-label, multicenter, three-arm, phase II study in advanced, EGFR-mutant and EGFR TKI naïve NSCLC patients, to evaluate the best strategy for sequencing gefitinib and osimertinib.Advanced EGFR-mutant NSCLC patients, WHO Performance Status 0-2 who are EGFR tyrosine kinase inhibitors treatment-naïve and eligible to receive first-line treatment with EGFR TKI will be randomized to:• arm A: osimertinib until RECIST 1.1 progression• arm B: gefitinib until emergence of circulating tumour DNA (ctDNA) T790M positive status and then switch to osimertinib until RECIST 1.1 progression• arm C: gefitinib until RECIST 1.1 progression and then switch to osimertinib until second radiologic progressionIn all arms, plasmatic ctDNA T790M test will be performed by central laboratory at the Medical University of Gdansk (Poland) but will be applied as a predictive marker for making treatment decision only in arm B.

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