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

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.

Timeline

Start

2019-08-15

Primary completion

2024-04-30

Completion

2024-04-30

Publications

• Lee CK, Lefresne S, Soon YY, Robledo K, Nichol A, Sahgal A, Pinkham MB, Melosky B, Huang Y, McDermott R, Tham IWK, Parmar A, Tey JCS, Liu M, Solomon BJ, Sacher A, Leong CN, Laskin J, Koh WY, Menjak IB, Ang Y, Shultz DB, Low JL, Doherty M, Yong C, Lim MC, Tan AP, Soo RA, Hegi-Johnson F, Ho C. Osimertinib and Stereotactic Radiosurgery for Brain Metastases in EGFR-Mutated Lung Cancer: The STARLET Joint Analysis of OUTRUN and LUOSICNS Randomized Trials. J Thorac Oncol. 2026 May;21(5):103549. doi: 10.1016/j.jtho.2026.01.001. Epub 2026 Jan 12.

Drugs

Indications