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Study of Pembrolizumab (MK-3475) Subcutaneous (SC) Versus Pembrolizumab Intravenous (IV) Administered With Platinum Doublet Chemotherapy in Participants With Metastatic Squamous or Nonsquamous Non-Small Cell Lung Cancer (NSCLC) (MK-3475-A86)

StatusCompleted
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Trial completed · Study completion date changed from estimate of Oct 14, 2026 to Aug 24, 2026 · Eligibility criteria expanded, about 29 words · 2 more Show 5 more changesShow less
    • Trial completed
    • Study completion date changed from estimate of Oct 14, 2026 to Aug 24, 2026
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: details revised at 9 of 12 entries
    • Site details revised at 4 of 126 sites
  2. Re-verified, no change to tracked fieldsv47
  3. Results first posted: May 17, 2024v46
  4. Primary endpoints revised (2) Secondary endpoints revised (12)v45 Show 1 more changeShow less
    • Secondary endpoints revised (12)

    See this version in full on ClinicalTrials.gov ↗

  5. Enrollment target: estimated 512 to confirmed 531v44
Show 42 earlier versionsHide 42 earlier versions
  1. Primary completion date: Feb 10, 2023 to Apr 4, 2023v43
  2. Trial status: Recruiting to Active, Not Recruiting Site details revised at 126 of 126 sitesv42 Show 1 more changeShow less
    • Site details revised at 126 of 126 sites
  3. Study sites: 124 to 126v41
  4. Site details revised at 5 of 124 sitesv40
  5. Study sites: 122 to 124v39
  6. Study sites: 121 to 122v38
  7. Study sites: 117 to 121v37
  8. Study sites: 112 to 117v36
  9. Enrollment target: 450 to 512v35
  10. Study sites: 109 to 112v34
  11. Study sites: 107 to 109v33
  12. Study sites: 106 to 107v32
  13. Study sites: 105 to 106v31
  14. Study sites: 104 to 105v30
  15. Study sites: 101 to 104v29
  16. Primary endpoints revised (2) Study sites: 89 to 101 · Secondary endpoints: 11 to 12 · Eligibility criteria expanded, about 3 wordsv28 Show 3 more changesShow less
    • Study sites: 89 to 101
    • Secondary endpoints: 11 to 12
    • Eligibility criteria expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  17. Study sites: 88 to 89v27
  18. Study sites: 87 to 88v26
  19. Study sites: 86 to 87v25
  20. Study sites: 82 to 86v24
  21. Study sites: 80 to 82v23
  22. Study sites: 77 to 80v22
  23. Study sites: 71 to 77v21
  24. Study sites: 67 to 71v20
  25. Study sites: 63 to 67v19
  26. Study sites: 59 to 63v18
  27. Study sites: 56 to 59v17
  28. Study sites: 52 to 56v16
  29. Study sites: 43 to 52v15
  30. Study sites: 35 to 43v14
  31. Study sites: 31 to 35v13
  32. Study sites: 27 to 31v12
  33. Study sites: 25 to 27v11
  34. Study sites: 22 to 25v10
  35. Study sites: 16 to 22v9
  36. Study sites: 13 to 16v8
  37. Study sites: 10 to 13v7
  38. Study sites: 9 to 10v6
  39. Study sites: 5 to 9v5
  40. Start date changed from estimate of Aug 6, 2021 to Aug 5, 2021v4
  41. Study sites: 3 to 5v3
  42. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 3 · Start date: Jul 20, 2021 to Aug 6, 2021v2 Show 2 more changesShow less
    • Study sites: 0 to 3
    • Start date: Jul 20, 2021 to Aug 6, 2021
  1. Study First Submitted
  • 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 purpose of this study is to evaluate pembrolizumab (MK-3475) subcutaneous (SC) administration as the first-line therapy in the treatment of metastatic squamous and nonsquamous NSCLC by assessing the pharmacokinetics (PK), safety, and efficacy of pembrolizumab SC injection in combination with standard-of-care chemotherapy. The primary hypothesis of the study is Pembrolizumab SC is noninferior to pembrolizumab intravenous (IV) for Cycle 1 Area Under Curve (AUC) and Cycle 6 minimal concentration (Ctrough) at steady state. Participants who discontinue study treatment after receiving the first course of 35 administrations of pembrolizumab (approximately up to 2 years) for reasons other than disease progression or intolerability, may be eligible for a second course of pembrolizumab for up to approximately 1 additional year if they have experienced radiographic disease progression per RECIST 1.1 as assessed by BICR after stopping first course treatment.
Trial Details
NCT Number NCT04956692
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-Small Cell Lung Cancer
Enrollment 531 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov