A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases
Status:
Recruiting
Trial end date:
2024-03-01
Target enrollment:
Participant gender:
Summary
20-40% of patients with NSCLC will develop brain metastases at some point during their course
of disease. Osimertinib has demonstrated intracranial activity in EFGR mutated NSCLC with
leptomeningeal disease in the phase 1 BLOOM study. Stereotactic radiosurgery (SRS) is one of
the standard local treatment for patients with limited number of brain metastases. Currently,
it is unclear whether adding SRS to Osimertinib will result in superior intracranial disease
control in patients with EGFR mutated NSCLC with brain metastases diagnosed de novo or
developed while on first line EGFR tyrosine kinase inhibitors (TKIs) such as Erlotinib and
Gefinitib.
The aim of this study is to compare the effects of Osimertinib alone versus SRS plus
Osimertinib on intra-cranial disease control in EGFR mutated NSCLC with brain metastases
diagnosed or developed while on first line EGFR tyrosine kinase inhibitors.
Phase:
Phase 2
Details
Lead Sponsor:
Trans Tasman Radiation Oncology Group Trans-Tasman Radiation Oncology Group (TROG)