Study of Osimertinib + SRS vs Osimertinib Alone for Brain Metastases in EGFR Positive Patients With NSCLC

Phase 2 Active not recruiting 40 enrolled British Columbia Cancer Agency AstraZeneca · collab Princess Margaret Hospital, Canada · collab Sunnybrook Health Sciences Centre · collab

RandomizedParallel-groupOpen-labelTreatment

Summary

This open-label, multicenter, randomized phase II study will evaluate the usage of osimertinib alone for brain metastases compared to SRS and osimertinib in patients with newly diagnosed, treatment naiive EGFR positive lung cancer.

Timeline

Start: 2019-03-19
Primary completion: 2025-04
Completion: 2025-04

Outcome

Missed primary endpoint

paper 12-month ic-PFS was not significantly different between SRS plus osimertinib (n = 39) than osimertinib monotherapy (n = 40) (11%, 95% CI: -10% to 32%, p = 0.31; PMID 41534788 ↗

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

Evaluation	Drug	Modality	Dose	Route
Subject	Osimertinib	Small molecule	80 mg	Oral