Intracranial Activity of AZD9291 (TAGRISSO) in Advanced EGFRm NSCLC Patients With Asymptomatic Brain Metastases

Summary

Patients will receive AZD9291 at a dose of 80 mg once daily. Intracranial response will be assessed with brain MRI scan, systemic evaluation will be done by PET-CT (Positron Emission Tomography-Computed Tomography) scan. In case of isolated CNS progression which may or may not be accompanied by asymptomatic systemic progression, AZD9291 dose will be escalated to 160 mg once daily. For patients whose intracranial disease will progress further, brain radiotherapy (in the form of SRS or WBRT) will be administered; treatment with AZD9291 will be interrupted and re-initiated at a standard dose after the end of radiotherapy course in the absence of symptomatic systemic progression. The treatment will be continued until symptomatic systemic progression, unacceptable toxicity or further intracranial progression following brain radiotherapy administration (whichever occurs first). All patients will be followed until death or 5 years.

Timeline

Start

2016-05

Primary completion

2022-12-31

Completion

2022-12-31

Publications

• Peled N, Kian W, Inbar E, Goldstein IM, Zemel M, Rotem O, Rozenblum AB, Nechushtan H, Dudnik E, Levin D, Zer A, Keren-Rosenberg S, Yust-Katz S, Fuchs V, Remilah AA, Shelef I, Roisman LC. Osimertinib in advanced EGFR-mutant lung adenocarcinoma with asymptomatic brain metastases: an open-label, 3-arm, phase II pilot study. Neurooncol Adv. 2021 Dec 27;4(1):vdab188. doi: 10.1093/noajnl/vdab188. eCollection 2022 Jan-Dec.

Drugs

Indications