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

Sponsor
Trans Tasman Radiation Oncology Group
Study ID
NCT03497767
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Non Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Osimertinib — DRUG
    All participants will receive a dose of Osimertinib 80mg once daily
  • Stereotactic Radiosurgery (SRS) — RADIATION
    Dose and fractionation depend on lesion size. All SRS must be completed within 21 days of randomisation and all lesions are to be treated within 7 days.

Study Details

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.

Key Dates

Start date
Aug 15, 2019
Status verified
May 2024
Primary completion
Apr 30, 2024
Completion
Apr 30, 2024

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Osimertinib
    80mg Osimerinib taken once daily
  • Experimental: Stereotactic Radiosurgery + Osimertinib
    Upfront Stereotactic Radiosurgery (SRS) followed by 80mg Osimerinib taken once daily

Primary Outcome Measure

Intracranial progression free survival at 12 months [ Time Frame: 12 months post randomisation ]

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