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A Study of Calderasib (MK-1084) Plus Pembrolizumab (MK-3475) in Participants With KRAS G12C Mutant Non-small Cell Lung Cancer (NSCLC) With Programmed Cell Death Ligand 1 (PD-L1) Tumor Proportion Score (TPS) ≥50% (MK-1084-004/KANDLELIT-004)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint removed 2 → 1 primary endpoints
Enrollment reduced 42% 600 → 348 participants
See other at-risk trials from Merck (MSD)

Record History

The 50 most recent of 78 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Primary endpoint(s) modified Enrollment reduced: 600 → 348 participants · Primary completion moved earlier from Feb 19, 2029 to Jan 24, 2028 · Trial sites expanded: 225 → 240 locations Show 3 more changesShow less
    • Enrollment reduced: 600 → 348 participants
    • Primary completion moved earlier from Feb 19, 2029 to Jan 24, 2028
    • Trial sites expanded: 225 → 240 locations
  2. Lead sponsor: Merck Sharp & Dohme LLC to Merck Sharp & Dohme LLC Enrollment target: 600 to 348 · Primary completion date: Feb 19, 2029 to Jan 24, 2028 · Study sites: 225 to 240 · 1 more Show 4 more changesShow less
    • Enrollment target: 600 to 348
    • Primary completion date: Feb 19, 2029 to Jan 24, 2028
    • Study sites: 225 to 240
    • Eligibility criteria revised
  3. Site details revised at 1 of 225 sitesv76
  4. Site details revised at 2 of 225 sitesv75
  5. Trial sites expanded: 222 → 225 locationsv74
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 220 to 222v73
  2. Site details revised at 2 of 220 sitesv72
  3. Study sites: 219 to 220v71
  1. Trial sites expanded: 216 → 219 locationsv70
  2. Study sites: 215 to 216v69
  3. Study sites: 213 to 215v68
  4. Study sites revised (213)v67 See this version in full on ClinicalTrials.gov ↗
  5. Study sites: 212 to 213v66
  6. Study sites: 209 to 212v65
  7. Study sites: 208 to 209v64
  8. Study sites: 207 to 208v63
  9. Study sites revised (207)v62 See this version in full on ClinicalTrials.gov ↗
  10. Study sites revised (207)v61 See this version in full on ClinicalTrials.gov ↗
  11. Interventions: MK-1084 (Drug), Pembrolizumab (Biological), Placebo (Other) to Calderasib (Drug), Pembrolizumab (Biological), Placebo (Other) Study title expanded, about 1 wordv60 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  12. Study sites: 206 to 207v59
  13. Site details revised at 1 of 206 sitesv58
  14. Study sites: 205 to 206v57
  15. Study sites: 203 to 205v56
  16. Study sites: 202 to 203v55
  17. Study sites: 200 to 202v54
  18. Study sites: 199 to 200v53
  19. Study sites: 198 to 199v52
  20. Study sites: 195 to 198v51
  21. Study sites: 194 to 195v50
  22. Study sites: 192 to 194v49
  23. Re-verified, no change to tracked fieldsv48
  24. Study sites: 191 to 192v47
  25. Study sites: 190 to 191v46
  26. Study sites: 188 to 190v45
  27. Study sites: 185 to 188v44
  28. Study sites: 183 to 185v43
  29. Study sites: 182 to 183v42
  30. Study sites: 179 to 182v41
  31. Study sites: 177 to 179v40
  32. Site contacts updated at 10 of 177 sitesv39
  33. Study sites: 174 to 177v38
  34. Study sites: 172 to 174v37
  35. Study sites: 167 to 172v36
  36. Site contacts updated at 1 of 167 sitesv35
  37. Study sites: 163 to 167v34
  38. Study sites: 159 to 163v33
  39. Study sites: 156 to 159v32
  40. Study sites: 152 to 156v31
  41. Study sites: 144 to 152v30
  42. Study sites: 141 to 144v29
  • 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 study evaluating the efficacy and safety of calderasib with pembrolizumab as first-line treatment in participants with locally advanced or metastatic non-small cell lung cancer (NSCLC) with identified Kirsten rat sarcoma viral oncogene homolog G12C (KRAS G12C) mutation and programmed cell death ligand 1 (PD-L1) tumor proportion score (TPS) ≥50%. There is one primary study hypothesis: Combination of calderasib and pembrolizumab is superior to placebo plus pembrolizumab with respect to progression free survival (PFS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
Trial Details
NCT Number NCT06345729
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Non-small Cell Lung Cancer
Enrollment 348 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov