Clinical Trial: NCT03497767
A Randomised Phase II Trial of Osimertinib With or Without SRS for EGFR Mutated NSCLC With Brain Metastases
Status:
COMPLETEDPhase:
Phase 2| Lead Sponsor: | Trans Tasman Radiation Oncology Group |
| Information Provided By: | Trans Tasman Radiation Oncology Group |
| Last Update Posted: | 2024-05-31 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Osimertinib
- Radiation: Stereotactic Radiosurgery (SRS)
Other Study ID Numbers
- TROG 17.02
Start Date (Actual)
Primary Completion Date (Actual)
Study Completion Date (Actual)
Enrollment (Actual)
Study Type
Phase
| Lead Sponsor: | Trans Tasman Radiation Oncology Group |
| Information Provided By: | Trans Tasman Radiation Oncology Group |
| Last Update Posted: | 2024-05-31 |
Study Overview
Brief 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.
Official Title
Conditions
Intervention / Treatment
- Drug: Osimertinib
- Radiation: Stereotactic Radiosurgery (SRS)
Other Study ID Numbers
- TROG 17.02