Exploring the Theragnostic Value of Osimertinib in EGFR-mutated Lung Cancer (THEROS)

Summary

This is a single arm, open label, multicentric proof-of-concept, phase II study in patients with EGFR-mutated non-small-cell lung cancer (NSCLC) with acquired TKI resistance who are "unknown" for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a standard plasma genotyping assay. All patients will receive osimertinib as continuous oral treatment for one cycle (28 days). Patients who demonstrate a metabolic response by FDG-PET scanning (to be conducted between day 15 and day 28 of cycle 1) will continue treatment until clinical or radiological progression. Osimertinib treatment will be terminated in patients not experiencing a metabolic response. Primary objective: To study the rate of early metabolic responses to osimertinib in patients with EGFR-mutated NSCLC and acquired TKI resistance who are "unknown" for EGFR T790M status due to non-informative or unfeasible tumor rebiopsy, and a negative finding for EGFR T790M in a standard plasma genotyping assay.

Timeline

Start

2019-06-03

Primary completion

2021-12-31

Completion

2022-09-30

Publications

• Results Schuler M, Hense J, Darwiche K, Michels S, Hautzel H, Kobe C, Lueong S, Metzenmacher M, Herold T, Zaun G, Laue K, Drzezga A, Theegarten D, Nensa F, Wolf J, Herrmann K, Wiesweg M. Early Metabolic Response by PET Predicts Sensitivity to Next-Line Targeted Therapy in EGFR-Mutated Lung Cancer with Unknown Mechanism of Acquired Resistance. J Nucl Med. 2024 Jun 3;65(6):851-855. doi: 10.2967/jnumed.123.266979.

Drugs

Indications