Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2026
Osimertinib and Stereotactic Radiosurgery for Brain Metastases in EGFR-Mutated Lung Cancer: The STARLET Joint Analysis of OUTRUN and LUOSICNS Randomized Trials.
Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 8 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomised Phase II Trial of Osimertinib With or Without Stereotactic Radiosurgery for EGFR Mutated Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases
Open Label, Multicenter, Phase II Study of Patients With Treatment Naïve Metastatic Epidermal Growth Factor Receptor (EGFR) Mutation-Positive Non-Small Cell Lung Cancer (NSCLC) With Brain Metastases Randomized to Stereotactic Radiosurgery (SRS) and Osimertinib or Osimertinib Alone
Who cites it
8 citing papers in PubMed, 1 synthesis or guideline pooled it.
- A systematic review and network meta-analysis of first-line EGFR-TKI-based combination strategies for EGFR-mutant non-small cell lung cancer with brain metastases.Scientific reports · 2026Pooled it
- Optimal timing of stereotactic radiosurgery with first-line osimertinib in EGFR-mutant non-small cell lung cancer brain metastases: Immediate, early-consolidation and salvage strategies.Oncology letters · 2026Article
- Predictive modeling of lung cancer subtype with integration of clinical and thoracic imaging features to guide early brain metastasis management.Journal of neuro-oncology · 2026Article
- Deferring or delivering stereotactic radiosurgery in EGFR-mutated non-small cell lung cancer: lessons from the STARLET randomized analysis.Translational lung cancer research · 2026Article
- Targeting ClassicalCancers · 2026Review
- Association Between Treatment Sequencing and Overall Survival in Stage IV NSCLC With Brain Metastases: A National Cancer Database Study.Thoracic cancer · 2026Article
- Management of brain metastases in older adults with non-small cell lung cancer.Frontiers in oncology · 2026Review
- Third-generation EGFR-TKI plus pemetrexed-platinum chemotherapyFrontiers in pharmacology · 2026Article
Corrections and comments
- Commented on by
Authors and funding
30 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionClinical guidelines recommend upfront osimertinib monotherapy for asymptomatic brain metastases (BM) in EGFR-mutant NSCLC, despite a lack of randomized trial evidence. We conducted two randomized phase II trials, OUTRUN and LUOSICNS, to evaluate the efficacy and safety of upfront stereotactic radiosurgery (SRS) plus osimertinib versus osimertinib in this patient population.
methodsParticipants with up to ten BM amenable to SRS were randomized 1:1 to SRS followed by osimertinib (80 mg daily) or osimertinib monotherapy. SRS was delivered as a single or multi-fraction regimen. The primary end point was 12-month intracranial progression-free survival (ic-PFS). Key secondary end points include overall survival (OS), patterns of intracranial progression, and safety. Data from both trials were prospectively pooled for a joint analysis.
resultsOverall, 79 participants were randomized. At a median follow-up of 39.0 months, 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; median ic-PFS 21.9 mo versus 17.2 mo). Median OS was 46.1 versus 29.1 months. Among those with intracranial progression, 35% in the SRS plus osimertinib group and 57% in the osimertinib monotherapy group underwent SRS at progression. Grade 3/4 radionecrosis occurred in 5% of participants treated with SRS plus osimertinib.
conclusionsAdding upfront SRS to osimertinib did not significantly improve 12-month ic-PFS in EGFR-mutant NSCLC with BM. This represents the first randomized evidence supporting the use of osimertinib monotherapy as upfront therapy in minimally symptomatic patients with low-burden BM. CLINICALTRIALS: GOV IDENTIFIER: OUTRUN: NCT03497767; LUOSICNS: NCT03769103.
Indexed as
Identifiers
41534788What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.