Aurora Kinase Inhibitor LY3295668 in Combination With Osimertinib for the Treatment of Advanced or Metastatic EGFR-Mutant Non-squamous Non-small Cell Lung Cancer

StatusCompleted
PhasePhase 1/2
Started

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Record History

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  1. Trial completed Show 4 more changesShow less
    • Primary completion date changed from estimate of Jun 7, 2028 to Sep 15, 2026
    • Eligibility criteria expanded, about 44 words
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description revised
  2. Primary and study completion pushed from Jun 30, 2026 to Jun 7, 2028v20
  3. 3 versions Re-verified since Nov 18, 2025, no change to tracked fieldsv17-v19
  4. Primary and study completion dates: Jun 30, 2025 to Jun 30, 2026v16
  5. 2 versions Re-verified since Feb 26, 2025, no change to tracked fieldsv14-v15
Show 12 earlier versionsHide 12 earlier versions
  1. Study Identification, Study Status, Oversight, Conditionsv13
  2. Study Identification, Study Status, Oversight, Conditionsv12
  3. 2 versions Re-verified since Sep 21, 2023, no change to tracked fieldsv10-v11
  4. Primary and study completion dates: May 25, 2024 to Jun 30, 2025v9
  5. Re-verified, no change to tracked fieldsv8
  6. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 30 to confirmed 32
    • Site details revised
    v7
  7. Re-verified, no change to tracked fieldsv6
  8. Eligibility criteria shortened, about 35 wordsv5
  9. Re-verified, no change to tracked fieldsv4
  10. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 31, 2022 to Feb 17, 2022
    • Site details revised
    v3
  11. Study Status, Referencesv2
  1. Study First Submitted
  • 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 phase Ib/II trial studies the side effects and best dose of aurora A kinase inhibitor LY3295668 when given together with osimertinib in patients with EGFR-mutant non-squamous non-small cell lung cancer that has spread to other places in the body (advanced or metastatic). Aurora A kinase inhibitor LY3295668 and osimertinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving aurora A kinase inhibitor LY3295668 in combination with osimertinib may help control EGFR-mutant non-squamous non-small cell lung cancer.
Trial Details
NCT Number NCT05017025
Lead Sponsor M.D. Anderson Cancer Center
Collaborators: National Cancer Institute (NCI)
Conditions
(from sponsor)		 Advanced Lung Non-Squamous Non-Small Cell Carcinoma, Metastatic Lung Non-Squamous Non-Small Cell Carcinoma, Stage III Lung Cancer AJCC v8, Stage IIIA Lung Cancer AJCC v8, Stage IIIB Lung Cancer AJCC v8, Stage IIIC Lung Cancer AJCC v8, Stage IV Lung Cancer AJCC v8, Stage IVA Lung Cancer AJCC v8 +1 more
Related terms Lung Neoplasms
Enrollment 32 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov