NCT03497767

A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases

A Randomised Phase II Trial of Osimertinib With or Without Stereotactic Radiosurgery for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Trans Tasman Radiation Oncology Group · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Non Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Osimertinib	All participants will receive a dose of Osimertinib 80mg once daily
RADIATION	Stereotactic Radiosurgery (SRS)	Dose and fractionation depend on lesion size. All SRS must be completed within 21 days of randomisation and all lesions are to be treated within 7 days.

Timeline

• Start date: 2019-08-15
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2018-04-13
• Last updated: 2024-05-31

Locations

13 sites across 2 countries: Australia, Singapore