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NCT07326566

Study of Silevertinib With Temozolomide for the Treatment of Newly Diagnosed GBM With Unmethylated MGMT and EGFRvIII

StatusRecruiting
PhasePhase 2
Primary completion (estimated)
Track this trial

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Record History

All 30 versions: 29 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 34 → 38 locations
  2. Study sites: 34 to 35
  3. Trial sites expanded: 31 → 34 locations
  4. Study sites: 32 to 33
  5. Study sites: 31 to 32
Show 9 earlier versionsHide 9 earlier versions
  1. Study sites: 30 to 31
  2. Study sites: 29 to 30
    • Eligibility criteria expanded, about 13 words
    • Study description expanded, about 6 words
  3. Study sites: 28 to 29v23
  4. Study sites: 27 to 28v22
  5. Study sites: 25 to 27v21
  6. Study sites: 24 to 25v20
  7. Site contacts updated at 1 of 24 sitesv19
  8. Study sites: 22 to 24v18
  9. Study sites: 21 to 22v17
  1. Trial sites expanded: 18 → 21 locationsv16
  2. Trial sites expanded: 14 → 18 locationsv15
  3. Study sites: 13 to 14v14
  4. Study sites: 12 to 13v13
  5. Study sites: 10 to 12v12
  6. Study sites: 8 to 10v11
  7. Study sites: 7 to 8v10
  8. Study sites: 6 to 7v9
  9. Study sites: 5 to 6v8
  10. Study sites: 4 to 5
    • Start date changed from estimate of Apr 2026 to May 5, 2026
    v7
  11. Study sites: 3 to 4v6
  12. Study sites: 2 to 3v5
  13. Study sites: 1 to 2v4
  14. Trial status: Not Yet Recruiting to Recruitingv3
  15. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

Progression-free survival (PFS) assessed by Blinded Independent Central Review (BICR)
Timeframe: 12 months

Secondary (1)

Overall Survival

Arms and interventions

silevertinib and temozolomideExperimental

silevertinib at dose determined in Part 1 until disease progression in combination with temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles

temozolomideActive comparator

temozolomide 150-200 mg/m2 orally once daily on Days 1 to 5 of each 28-day cycle for maximum of 6 cycles

Drugs: silevertinib in combination with temozolomide, temozolomide (TMZ)

Sites

38 sites in 1 country