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Pembrolizumab With or Without Maintenance Sacituzumab Tirumotecan (Sac-TMT; MK-2870) in Metastatic Squamous Non-small Cell Lung Cancer (NSCLC) [MK-2870-023]

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 74 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Eligibility criteria expanded, about 35 words · Secondary endpoints: details revised at 8 of 11 entries · Study sites revised (216) Show 3 more changesShow less
    • Eligibility criteria expanded, about 35 words
    • Secondary endpoints: details revised at 8 of 11 entries
    • Study sites revised (216)
  2. Study sites revised (216)v73 See this version in full on ClinicalTrials.gov ↗
  3. Study sites: 215 to 216v72
  4. Completion pushed from Feb 12, 2031 to Aug 15, 2031v71
  5. Site details revised at 1 of 215 sitesv70
  6. Site details revised at 4 of 215 sitesv69
  7. Trial sites expanded: 212 → 215 locationsv68
  8. Site details revised at 8 of 212 sitesv67
  9. Site details revised at 5 of 212 sitesv66
  10. Site details revised at 10 of 212 sitesv65
  11. Site details revised at 3 of 212 sitesv64
  12. Study sites: 210 to 212v63
  13. Study sites: 208 to 210v62
  14. Study sites: 207 to 208v61
  15. Study sites revised (207)v60 See this version in full on ClinicalTrials.gov ↗
  16. Study sites: 205 to 207 Eligibility criteria expanded, about 33 wordsv59 Show 1 more changeShow less
    • Eligibility criteria expanded, about 33 words

    See this version in full on ClinicalTrials.gov ↗

  17. Re-verified, no change to tracked fieldsv58
  18. Study sites: 204 to 205v57
  19. Site details revised at 1 of 204 sitesv56
  20. Site details revised at 3 of 204 sitesv55
  21. Site contacts updated at 2 of 204 sitesv54
  22. Study sites: 203 to 204v53
  23. Site contacts updated at 2 of 203 sitesv52
  24. Study sites: 202 to 203v51
  25. Study sites: 201 to 202 Eligibility criteria shortened, about 4 wordsv50 Show 1 more changeShow less
    • Eligibility criteria shortened, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  26. Site contacts updated at 2 of 201 sitesv49
  27. Site contacts updated at 1 of 201 sitesv48
  28. Study sites: 200 to 201v47
  29. Site details revised at 3 of 200 sitesv46
  30. Study sites: 199 to 200v45
  31. Site details revised at 6 of 199 sitesv44
  32. Site contacts updated at 5 of 199 sitesv43
  33. Site details revised at 1 of 199 sitesv42
  34. Site contacts updated at 2 of 199 sitesv41
  35. Site contacts updated at 1 of 199 sitesv40
  36. Site contacts updated at 3 of 199 sitesv39
  37. Study sites: 194 to 199 Eligibility criteria expanded, about 52 wordsv38 Show 1 more changeShow less
    • Eligibility criteria expanded, about 52 words

    See this version in full on ClinicalTrials.gov ↗

  38. Study sites: 189 to 194v37
  39. Study sites revised (189)v36 See this version in full on ClinicalTrials.gov ↗
  40. Study sites: 187 to 189v35
  41. Study sites: 185 to 187v34
  42. Study sites: 184 to 185v33
  43. Study sites: 183 to 184v32
  44. Study sites revised (183)v31 See this version in full on ClinicalTrials.gov ↗
  45. Study sites: 181 to 183v30
  46. Study sites: 179 to 181v29
  47. Study sites: 176 to 179v28
  48. Study sites: 175 to 176v27
  49. Study sites revised (175)v26 See this version in full on ClinicalTrials.gov ↗
  50. Study sites: 169 to 175v25
  • 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 is a phase 3 study of pembrolizumab in combination with carboplatin/taxane (paclitaxel or nab-paclitaxel) followed by pembrolizumab with or without maintenance sacituzumab tirumotecan (sac-TMT; MK-2870) in first-line treatment of metastatic squamous non-small cell lung cancer. It is hypothesized that pembrolizumab with maintenance sacituzumab tirumotecan is superior to pembrolizumab without sacituzumab tirumotecan maintenance with respect to overall survival (OS).
Trial Details
NCT Number NCT06422143
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer, NSCLC
Enrollment 851 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov