Who is sponsoring NCT03497767?

NCT03497767 is sponsored by Trans Tasman Radiation Oncology Group.

What drugs are being tested in NCT03497767?

Interventions in NCT03497767: Osimertinib, Stereotactic Radiosurgery (SRS).

What condition does NCT03497767 study?

NCT03497767 studies Metastatic Non Small Cell Lung Cancer.

Is NCT03497767 still recruiting?

NCT03497767 is currently completed. Last updated 31 May 2024.

Last reviewed 2024-05-31 · How we verify

NCT03497767: OUTRUN

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 2 Last updated 31 May 2024

What this trial tests

Phase 2 trial testing Osimertinib in Metastatic Non Small Cell Lung Cancer in 40 participants. Completed in 30 April 2024.

Timeline

15 August 2019

Primary endpoint
30 April 2024

30 April 2024

Quick facts

Lead sponsor	Trans Tasman Radiation Oncology Group
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	15 August 2019
Primary completion	30 April 2024
Estimated completion	30 April 2024
Sites	13 locations across Singapore, Australia

Drugs / interventions tested

Osimertinib (osimertinib) — full drug profile →
Stereotactic Radiosurgery (SRS)

Conditions studied

Metastatic Non Small Cell Lung Cancer — all drugs for Metastatic Non Small Cell Lung Cancer →

Sponsor

Trans Tasman Radiation Oncology Group — full company profile →

Who can join

18 and older, any sex, with Metastatic Non Small Cell Lung Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Third-generation epidermal growth factor receptor tyrosine kinase inhibitors for the treatment of non-small cell lung cancer.
Andrews Wright NM, Goss GD. · · 2019 · cited 66× · PMID 31857949 · DOI 10.21037/tlcr.2019.06.01
Emerging therapeutics and evolving assessment criteria for intracranial metastases in patients with oncogene-driven non-small-cell lung cancer.
Pan K, Concannon K, Li J, Zhang J, et al · · 2023 · cited 40× · PMID 37592034 · DOI 10.1038/s41571-023-00808-4
Brain metastases: An update on the multi-disciplinary approach of clinical management.
Mitchell DK, Kwon HJ, Kubica PA, Huff WX, et al · · 2022 · cited 39× · PMID 33864773 · DOI 10.1016/j.neuchi.2021.04.001
Modern Radiation Therapy for the Management of Brain Metastases From Non-Small Cell Lung Cancer: Current Approaches and Future Directions.
Mantovani C, Gastino A, Cerrato M, Badellino S, et al · · 2021 · cited 37× · PMID 34796118 · DOI 10.3389/fonc.2021.772789
Management of brain metastases in lung cancer: evolving roles for radiation and systemic treatment in the era of targeted and immune therapies.
Myall NJ, Yu H, Soltys SG, Wakelee HA, et al · · 2021 · cited 36× · PMID 34859233 · DOI 10.1093/noajnl/vdab106
Integration of Systemic Therapy and Stereotactic Radiosurgery for Brain Metastases.
Tonse R, Tom MC, Mehta MP, Ahluwalia MS, et al · · 2021 · cited 30× · PMID 34359583 · DOI 10.3390/cancers13153682
Drug resistance of targeted therapy for advanced non-small cell lung cancer harbored EGFR mutation: from mechanism analysis to clinical strategy.
Zhao Y, Wang H, He C. · · 2021 · cited 26× · PMID 34661758 · DOI 10.1007/s00432-021-03828-8
Combination therapy of brain radiotherapy and EGFR-TKIs is more effective than TKIs alone for EGFR-mutant lung adenocarcinoma patients with asymptomatic brain metastasis.
Chen Y, Wei J, Cai J, Liu A. · · 2019 · cited 26× · PMID 31399067 · DOI 10.1186/s12885-019-6005-6

Verify or expand the search:

Other trials of Osimertinib

Trials testing the same drug.

NCT07295821 — Osimertinib Induction and Maintenance for Chemo-ineligible Stage III Unresectable EGFR+ NSCLC: Single-arm Study · Phase 2 · recruiting
NCT07376382 — A Phase Ⅲ Clinical Study of SYS6010 in Combination With Osimertinib in Patients With Locally Advanced or Metastatic NSCL · Phase 3 · not yet recruiting
NCT07323641 — Telisotuzumab Vedotin and Osimertinib for the Treatment of Progressive, Incurable, Non Small Cell Lung Cancer · Phase 2 · not yet recruiting
NCT07329322 — Phase II Study of Sacituzumab Tirumotecan in Combination With Osimertinib or Sacituzumab Tirumotecan for Neoadjuvant Tre · Phase 2 · not yet recruiting
NCT07375316 — A ctDNA-guided Phase II Trial of Osimertinib in Combination With Sacituzumab Tirumotecan in EGFR-mutated Advanced NSCLC · Phase 2 · recruiting

Other recruiting trials for Metastatic Non Small Cell Lung Cancer

Currently open trials in the same condition.

NCT07222566 — Symbiotic-Lung-01 : A Study to Learn About the Study Medicine Called PF-08634404 in Combination With Chemotherapy in Adu · Phase 3 · recruiting
NCT06066138 — A Study of Therapeutic Drug Monitoring-Based Atezolizumab Dosing · Phase 1 · recruiting
NCT07008742 — Feasibility Study of Tissue and Blood Collection in Oncogene-addicted and Neoadjuvantly Treated Non Small Cell Lung Canc · recruiting
NCT06863233 — A Study of CD8+ T Cell Imaging During Treatment in People With Non-Small Cell Lung Cancer · Phase 1 · recruiting
NCT06731413 — Reduced CT + Anti-PD-1 as First Line Tx in Vulnerable Older Adults w/Adv <50% PD-L1 Non-Small Cell Lung Cancer (NSCLC) · Phase 2 · recruiting

Other Trans Tasman Radiation Oncology Group trials

Trials by the same sponsor.

NCT07135882 — Primary Radiotherapy In MEtastatic Lung Cancer · Phase 3 · not yet recruiting
NCT05796089 — Chemotherapy and Immunotherapy in Extensive-Stage Small-Cell Lung Cancer With Thoracic Radiotherapy · Phase 2 · active not recruiting
NCT02898727 — A Study of Local Therapy for the Treatment of Brain Metastases From HER2 Positive Breast Cancer · NA · completed
NCT01965223 — A Randomized Phase II Study of Stereotactic Ablative Body Radiotherapy for Metastases to the Lung (TROG 13.01 SAFRON II) · NA · completed
NCT01855451 — Weekly Cetuximab/RT Versus Weekly Cisplatin/RT in HPV-Associated Oropharyngeal Squamous Cell Carcinoma · Phase 3 · unknown

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03497767 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Trans Tasman Radiation Oncology Group
Last refreshed: 31 May 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03497767.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing