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Phase 2 Trial of Adagrasib Monotherapy and in Combination With Pembrolizumab and a Phase 3 Trial of Adagrasib in Combination in Patients With a KRAS G12C Mutation KRYSTAL-7

StatusRecruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 98 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Eligibility criteria expanded, about 15 words Study sites revised (770) Show 1 more changeShow less
    • Study sites revised (770)
  2. Study sites revised (770)v97 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (770)v96 See this version in full on ClinicalTrials.gov ↗
  4. Primary completion moved earlier from Jun 9, 2032 to Oct 31, 2028 Completion moved earlier from Jun 9, 2032 to Oct 31, 2029 · Study sites revised (770)v95 Show 2 more changesShow less
    • Completion moved earlier from Jun 9, 2032 to Oct 31, 2029
    • Study sites revised (770)

    See this version in full on ClinicalTrials.gov ↗

  5. Trial sites expanded: 767 → 770 locationsv94
  6. Primary completion pushed from Oct 31, 2028 to Jun 9, 2032 Enrollment reduced: 806 → 626 participants · Trial sites expanded: 764 → 767 locations · Completion pushed from Oct 31, 2029 to Jun 9, 2032v93 Show 3 more changesShow less
    • Enrollment reduced: 806 → 626 participants
    • Trial sites expanded: 764 → 767 locations
    • Completion pushed from Oct 31, 2029 to Jun 9, 2032
  7. Study sites: 761 to 764v92
  8. Study sites: 756 to 761v91
  9. Study sites: 755 to 756v90
  10. Study sites revised (755)v89 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 754 to 755v88
  12. Study sites revised (754)v87 See this version in full on ClinicalTrials.gov ↗
  13. Study sites revised (754)v86 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 751 to 754v85
  15. Study sites: 749 to 751v84
  16. Study sites: 742 to 749v83
  17. Study sites: 741 to 742v82
  18. Study sites revised (741)v81 See this version in full on ClinicalTrials.gov ↗
  19. Study sites: 740 to 741v80
  20. Study sites: 738 to 740v79
  21. Study sites: 733 to 738v78
  22. Study sites: 731 to 733v77
  23. Study sites: 729 to 731v76
  24. Study sites: 725 to 729v75
  25. Study sites: 721 to 725v74
  26. Study sites: 718 to 721v73
  27. Study sites: 715 to 718v72
  28. Study sites: 714 to 715v71
  29. Study sites revised (714)v70 See this version in full on ClinicalTrials.gov ↗
  30. Study sites: 713 to 714v69
  31. Study sites: 712 to 713v68
  32. Study sites: 708 to 712v67
  33. Study sites: 700 to 708v66
  34. Study sites: 695 to 700v65
  35. Study sites: 598 to 695v64
  36. Study sites: 537 to 598v63
  37. Study sites: 524 to 537v62
  38. Study sites: 523 to 524v61
  39. Study sites: 500 to 523v60
  40. Study sites: 487 to 500v59
  41. Study sites: 485 to 487v58
  42. Study sites: 484 to 485v57
  43. Study sites: 481 to 484v56
  44. Study sites: 477 to 481v55
  45. Study sites: 472 to 477v54
  46. Study sites: 470 to 472v53
  47. Study sites: 456 to 470v52
  48. Study sites revised (456)v51 See this version in full on ClinicalTrials.gov ↗
  49. Study sites: 335 to 456v50
  50. Study sites: 156 to 335v49
  • 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 Phase 2 portion of this study evaluates the efficacy and safety of MRTX849 monotherapy and in combination with pembrolizumab in cohorts of patients with advanced NSCLC with KRAS G12C mutation and any PD-L1 TPS and who are candidates for first-line treatment. The Phase 3 portion of the study compares the efficacy of adagrasib in combination with pembrolizumab versus pembrolizumab in patients with unresectable, locally advanced or metastatic squamous or nonsquamous NSCLC with KRAS G12C mutation and PD-L1 TPS \>=50% and who are candidates for first line treatment.
Trial Details
NCT Number NCT04613596
Lead Sponsor Mirati Therapeutics Inc.
Conditions Advanced Non-Small Cell Lung Cancer, Metastatic Non-Small Cell Lung Cancer
Enrollment 626 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov