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A Study to Compare the Efficacy and Safety of Entrectinib and Crizotinib in Participants With Advanced or Metastatic ROS1 Non-small Cell Lung Cancer (NSCLC) With and Without Central Nervous System (CNS) Metastases

StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 13, 2026 (before its estimated September 30, 2026 completion). Its status may not reflect the trial's current state.

Record History

The 50 most recent of 67 record versions are accounted for below. See every version on ClinicalTrials.gov ↗

  1. Primary completion moved earlier from Jun 26, 2028 to Sep 30, 2026 Completion moved earlier from Jun 26, 2028 to Jan 29, 2028 · Enrollment target: estimated 220 to confirmed 217v67 Show 2 more changesShow less
    • Completion moved earlier from Jun 26, 2028 to Jan 29, 2028
    • Enrollment target: estimated 220 to confirmed 217
  2. Study sites: 63 to 61v66
  3. Trial status: Recruiting to Active, Not Recruiting Study sites: 91 to 63v65 Show 1 more changeShow less
    • Study sites: 91 to 63
  4. Study sites revised (91)v64 See this version in full on ClinicalTrials.gov ↗
  5. Re-verified, no change to tracked fieldsv63
Show 45 earlier versionsHide 45 earlier versions
  1. Site details revised at 1 of 91 sitesv62
  2. Re-verified, no change to tracked fieldsv61
  3. Site details revised at 1 of 91 sitesv60
  4. Primary and study completion dates: Dec 1, 2027 to Jun 26, 2028 Site details revised at 2 of 91 sitesv59 Show 1 more changeShow less
    • Site details revised at 2 of 91 sites
  5. Re-verified, no change to tracked fieldsv58
  6. Site details revised at 2 of 91 sitesv57
  7. Site details revised at 1 of 91 sitesv56
  8. 2 versions Re-verified since Apr 11, 2025, no change to tracked fieldsv54-v55
  9. Study sites: 89 to 91v53
  10. Site details revised at 2 of 89 sitesv52
  11. Study sites: 92 to 89v51
  12. 3 versions Re-verified since Oct 25, 2024, no change to tracked fieldsv48-v50
  13. Study sites: 90 to 92v47
  14. Study sites revised (90)v46 See this version in full on ClinicalTrials.gov ↗
  15. Study sites: 88 to 90v45
  16. Study sites: 86 to 88v44
  17. Study sites: 82 to 86v43
  18. Study sites: 80 to 82v42
  19. Study sites: 79 to 80v41
  20. Study sites revised (79)v40 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 77 to 79v39
  22. Study sites: 75 to 77v38
  23. Study sites revised (75)v37 See this version in full on ClinicalTrials.gov ↗
  24. Study sites: 73 to 75v36
  25. Study sites: 72 to 73v35
  26. Site details revised at 6 of 72 sitesv34
  27. Site details revised at 6 of 72 sitesv33
  28. Study sites: 71 to 72v32
  29. Site details revised at 1 of 71 sitesv31
  30. Site details revised at 1 of 71 sitesv30
  31. Site details revised at 2 of 71 sitesv29
  32. Site details revised at 5 of 71 sitesv28
  33. Study sites: 69 to 71v27
  34. Study sites: 67 to 69v26
  35. Study sites: 65 to 67v25
  36. Study sites: 63 to 65v24
  37. Study sites: 61 to 63v23
  38. Study sites: 59 to 61v22
  39. Study sites: 56 to 59v21
  40. Study sites: 55 to 56v20
  41. Study sites: 52 to 55v19
  42. Study sites: 51 to 52v18
  • 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.
The study will compare the efficacy and safety of entrectinib with crizotinib in participants with advanced or metastatic ROS1 non-small cell lung cancer (NSCLC). The participants will self-administer oral entrectinib or crizotinib as described in the protocol and local prescribing information. Treatments will continue until progressive disease, unacceptable toxicity, death, or withdrawal from the study, whichever occurs first.
Trial Details
NCT Number NCT04603807
Lead Sponsor Hoffmann-La Roche
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 217 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov