Osimertinib Treatment on EGFR T790M Plasma Positive NSCLC Patients (APPLE)

Summary

The phase II APPLE trial gives the opportunity to prospectively validate liquid biopsies as a new standard for testing tumor progression compared with conventional radiological procedure in EGFR mutant advanced NSCLC patients. Moreover based on the sequential T790M test during treatment the investigators will assess the predictive value of liquid biopsies. APPLE trial will examine the best strategy for delivering osimertinib (upfront versus sequential treatment after 1st generation EGFR TKI) in EGFR mutant NSCLC patients. Finally, the trial will also explore the mechanisms of acquired resistance to Osimertinib based on the results of an optional biopsy upon progression.

Timeline

Start

2017-10-10

Primary completion

2022-09-20

Completion

2025-08-12

Publications

• Remon J, Besse B, Aix SP, Callejo A, Al-Rabi K, Bernabe R, Greillier L, Majem M, Reguart N, Monnet I, Cousin S, Garrido P, Robinet G, Campelo RG, Madroszyk A, Mazieres J, Curcio H, Wasag B, Pretzenbacher Y, Grillet F, Dingemans AC, Dziadziuszko R. Overall Survival From the EORTC LCG-1613 APPLE Trial of Osimertinib Versus Gefitinib Followed by Osimertinib in Advanced EGFR-Mutant Non-Small-Cell Lung Cancer. J Clin Oncol. 2024 Apr 20;42(12):1350-1356. doi: 10.1200/JCO.23.01521. Epub 2024 Feb 7.

Drugs

Indications