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

Sponsor
British Columbia Cancer Agency
Study ID
NCT03769103
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Brain Metastases
  • Lung Cancer Non-small Cell Stage IV

Eligibility Criteria

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

Interventions

  • Osimertinib — DRUG
    Daily oral osimertinib
  • Stereotactic radiotherapy — RADIATION
    1-5 fractions of stereotactic radiotherapy

Study Details

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.

Key Dates

Start date
Mar 19, 2019
Status verified
Oct 2024
Primary completion
Apr 30, 2025
Completion
Apr 30, 2025

Study Design

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

Arms

  • Active Comparator: SRS + Osimertinib
    Stereotactic radiotherapy will be delivered in 1-5 fractions to each brain metastases according to the volume and location of the metastases and clinician discretion. Osimertinib will start 1-7 days post radiotherapy.
  • Experimental: Osimertinib alone
    Osimertinib 80mg PO daily

Primary Outcome Measure

Intracranial progression free survival [ Time Frame: 1 year ]

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