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Phase 3 Study of Sitravatinib Plus Nivolumab vs Docetaxel in Patients With Advanced Non-Squamous Non-Small Cell Lung Cancer

Study acronym: SAPPHIRE
StatusTerminated
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 56 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Reclassified as terminated (was completed) Sponsor's reason: Inability to meet protocol objectives
    • Site details revised at 1 of 261 sites
    v56
  2. Secondary endpoints: details revised at 10 of 13 entries
    • Site details revised at 1 of 261 sites
    v55
  3. Trial status: Active, Not Recruiting to Completed
    • Study completion date changed from estimate of Oct 31, 2025 to Sep 30, 2025
    v54
  4. Study completion date: Jun 23, 2025 to Oct 31, 2025v53
  5. Study sites: 246 to 261
    • Study completion date: Dec 31, 2024 to Jun 23, 2025
    v52
Show 45 earlier versionsHide 45 earlier versions
  1. Study sites: 234 to 246v51
  2. Results first posted: Jun 25, 2024
    • Study completion date: Apr 30, 2024 to Dec 31, 2024
    • Secondary endpoints revised (13)
    v50
  3. Enrollment target: estimated 532 to confirmed 577
    • Secondary endpoints: 3 to 13
    v49
  4. Re-verified, no change to tracked fieldsv48
  5. Primary completion date changed from estimate of Sep 2022 to Mar 20, 2023
    • Study completion date: Jul 2023 to Apr 30, 2024
    v47
  6. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 236 to 234
    v46
  7. Study sites: 235 to 236v45
  8. Study sites: 233 to 235v44
  9. Study sites: 228 to 233v43
  10. Study sites: 219 to 228v42
  11. Study sites: 216 to 219v41
  12. Study sites: 208 to 216v40
  13. Study sites: 211 to 208v39
  14. Study sites: 205 to 211v38
  15. Study sites: 195 to 205v37
  16. Study sites: 189 to 195v36
  17. Study sites: 180 to 189v35
  18. Study sites: 164 to 180v34
  19. Study sites: 165 to 164v33
  20. Study sites: 148 to 165v32
  21. Study sites: 133 to 148v31
  22. Study sites: 116 to 133v30
  23. Study sites: 105 to 116
    • Primary completion date: Apr 2022 to Sep 2022
    • Study completion date: Dec 2022 to Jul 2023
    v29
  24. Study sites: 96 to 105v28
  25. Study sites: 91 to 96v27
  26. Study sites: 89 to 91v26
  27. Study sites: 88 to 89v25
  28. Study sites: 85 to 88v24
  29. Study sites: 80 to 85v23
  30. Study sites: 79 to 80v22
  31. Study sites: 78 to 79v21
  32. Re-verified, no change to tracked fieldsv20
  33. Study sites: 74 to 78v19
  34. Re-verified, no change to tracked fieldsv18
  35. Study sites: 66 to 74v17
  36. Enrollment target: 664 to 532
    • Study sites: 64 to 66
    • Eligibility criteria expanded, about 36 words
    • Study title expanded, about 3 words
    v16
  37. Re-verified, no change to tracked fieldsv15
  38. Study sites: 59 to 64v14
  39. Study sites: 50 to 59
    • Secondary endpoints: details revised at 1 of 3 entries
    • Study description expanded, about 13 words
    v13
  40. Study sites: 44 to 50v12
  41. Study sites: 31 to 44v11
  42. Study sites: 22 to 31v10
  43. Study sites: 14 to 22
    • Start date changed from estimate of Jul 2019 to Jul 15, 2019
    v9
  44. Study sites: 5 to 14v8
  45. Study sites: 4 to 5v7
  • 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 study will compare the efficacy of the investigational agent sitravatinib in combination with nivolumab versus docetaxel in patients with advanced non-squamous NSCLC who have previously experienced disease progression on or after platinum-based chemotherapy and checkpoint inhibitor therapy.
Trial Details
NCT Number NCT03906071
Lead Sponsor Mirati Therapeutics Inc.
Collaborators: Bristol-Myers Squibb
Conditions
(from sponsor)		 Metastatic Non-Squamous Non-Small Cell Lung Cancer
Enrollment 577 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov