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

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 31, 2024 (before its estimated April 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 76 to confirmed 40 · Site details revised at 3 of 3 sitesv7 Show 2 more changesShow less
    • Enrollment target: estimated 76 to confirmed 40
    • Site details revised at 3 of 3 sites
  2. Re-verified, no change to tracked fieldsv6
  3. Primary and study completion dates: Dec 2022 to Apr 2025 Study sites: 1 to 3 · Eligibility criteria revisedv5 Show 2 more changesShow less
    • Study sites: 1 to 3
    • Eligibility criteria revised

    See this version in full on ClinicalTrials.gov ↗

  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Mar 2019 to Mar 19, 2019v4 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Mar 2019 to Mar 19, 2019
  5. Study title expanded, about 2 wordsv3 See this version in full on ClinicalTrials.gov ↗
  6. Start date: Dec 2018 to Mar 2019v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT03769103
Lead Sponsor British Columbia Cancer Agency
Collaborators: AstraZeneca, Princess Margaret Hospital, Canada, Sunnybrook Health Sciences Centre
Conditions Lung Cancer Non-small Cell Stage IV, Brain Metastases
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov