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USZ-STRIKENCT05522660

Immunotherapy or Targeted Therapy With or Without Stereotactic Radiosurgery for Patients With Brain Metastases From Melanoma or Non-small Cell Lung Cancer

StatusRecruiting
PhasePhase 3
Primary completion (estimated)

At risk: Primary completion moved at least 8 months later.

See at-risk trials from ETOP IBCSG Partners Foundation

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Record History

All 20 versions: 19 with changes below, 1 re-verified with no change. See every version on ClinicalTrials.gov ↗

  1. Primary and study completion dates pushed to Jun 2027
    • Eligibility criteria expanded, about 36 words
    • Site details revised at 3 of 15 sites
  2. Primary completion date: Jan 2026 to Sep 2026v19
  3. Site details revised at 1 of 15 sitesv18
  4. Site details revised at 1 of 15 sitesv17
  5. Study sites: 14 to 15v16
Show 13 earlier versionsHide 13 earlier versions
  1. Eligibility criteria shortened, about 84 words
    • Enrollment target: 190 to 180
    v15
  2. Site details revised at 1 of 14 sitesv14
  3. Site details revised at 1 of 14 sitesv13
  4. Site details revised at 1 of 14 sitesv12
  5. Site details revised at 1 of 14 sitesv11
  6. Study sites: 11 to 14v10
  7. Primary completion date: Jan 31, 2026 to Jan 2026
    • Study completion date: Dec 31, 2026 to Dec 2026
    • Site details revised at 1 of 11 sites
    v9
  8. Site details revised at 1 of 11 sitesv8
  9. Site details revised at 1 of 11 sitesv7
  10. Study sites: 10 to 11v6
  11. Site details revised at 2 of 10 sitesv4
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 1 to 10
    • Start date changed from estimate of Jan 15, 2023 to Nov 30, 2022
    v3
  13. Start date: Oct 15, 2022 to Jan 15, 2023
    • Study sites: 0 to 1
    v2
  1. Study First Submitted
  • Notable: the plan changed
  • Minor: routine updates

Endpoints

Primary

CNS-specific PFS, locally assessed as per iRANO criteria
Timeframe: from date of randomization until the date of documented CNS-specific progression, assessed up to 42 months

Arms and interventions

Standard systemic treatment with stereotactic radiosurgery (SRS)Experimental

Arm A

Standard systemic treatment without stereotactic radiosurgeryActive comparator

Arm B

Radiation: Stereotactic radiosurgery

Drugs: Immune checkpoint inhibitor

Sites

15 sites in 5 countries

Italy 6, Spain 3, Switzerland 3, United Kingdom 2, Netherlands 1