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Phase 3 Study of MRTX849 (Adagrasib) vs Docetaxel in Patients With Advanced Non-Small Cell Lung Cancer With KRAS G12C Mutation

Study acronym: KRYSTAL-12
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

The 50 most recent of 57 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 343 → 380 locations Completion pushed from Jul 2, 2026 to Oct 30, 2026v57 Show 1 more changeShow less
    • Completion pushed from Jul 2, 2026 to Oct 30, 2026
  2. Results first posted: Jan 22, 2025 Primary endpoint revised · Study sites: 263 to 343 · Completion date: Dec 31, 2024 to Jul 2, 2026 · 2 morev56 Show 5 more changesShow less
    • Primary endpoint revised
    • Study sites: 263 to 343
    • Completion date: Dec 31, 2024 to Jul 2, 2026
    • Start date: Apr 1, 2021 to Feb 23, 2021
    • Secondary endpoints: 8 to 13

    See this version in full on ClinicalTrials.gov ↗

  3. Study sites: 224 to 263 Completion date: Dec 2024 to Dec 31, 2024v55 Show 1 more changeShow less
    • Completion date: Dec 2024 to Dec 31, 2024
  4. Re-verified, no change to tracked fieldsv54
  5. Primary completion date changed from estimate of Mar 2024 to Dec 30, 2023v53
Show 45 earlier versionsHide 45 earlier versions
  1. Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 450 to confirmed 453 · Site details revised at 224 of 224 sitesv52 Show 2 more changesShow less
    • Enrollment target: estimated 450 to confirmed 453
    • Site details revised at 224 of 224 sites
  2. Primary completion date: May 2025 to Mar 2024 Completion date: Nov 2025 to Dec 2024v51 Show 1 more changeShow less
    • Completion date: Nov 2025 to Dec 2024
  3. Study sites: 223 to 224v50
  4. Study sites: 221 to 223v49
  5. Study sites: 217 to 221v48
  6. Study sites: 215 to 217v47
  7. Study sites: 214 to 215v46
  8. Study sites: 187 to 214v45
  9. Study sites: 183 to 187v44
  10. Re-verified, no change to tracked fieldsv43
  11. Study sites: 181 to 183v42
  12. Primary completion date: Aug 2023 to May 2025 Enrollment target: 340 to 450 · Study sites: 178 to 181 · Completion date: Jul 2024 to Nov 2025 · 1 morev41 Show 4 more changesShow less
    • Enrollment target: 340 to 450
    • Study sites: 178 to 181
    • Completion date: Jul 2024 to Nov 2025
    • Secondary endpoints revised (8)

    See this version in full on ClinicalTrials.gov ↗

  13. Study sites: 175 to 178v40
  14. Study sites: 169 to 175v39
  15. Study sites: 165 to 169v38
  16. Study sites: 162 to 165v37
  17. Study sites: 160 to 162v36
  18. Study sites: 156 to 160v35
  19. Study sites: 155 to 156v34
  20. Study sites: 150 to 155v33
  21. Study sites: 148 to 150v32
  22. Study sites: 146 to 148v31
  23. Study sites: 144 to 146v30
  24. Study sites: 140 to 144v29
  25. Study sites: 138 to 140v28
  26. Study sites: 135 to 138v27
  27. Study sites: 132 to 135v26
  28. Study sites: 131 to 132v25
  29. Study sites: 128 to 131v24
  30. Study sites: 126 to 128v23
  31. Study sites: 125 to 126v22
  32. Study sites: 121 to 125 Secondary endpoints: 7 to 8v21 Show 1 more changeShow less
    • Secondary endpoints: 7 to 8

    See this version in full on ClinicalTrials.gov ↗

  33. Study sites: 119 to 121v20
  34. Study sites: 114 to 119v19
  35. Study sites: 112 to 114v18
  36. Start date: Jan 29, 2021 to Apr 1, 2021v17
  37. Study sites: 101 to 112v16
  38. Study sites: 70 to 101v15
  39. Primary completion date: Dec 2022 to Aug 2023 Primary endpoints: 2 to 1 · Enrollment target: 452 to 340 · Study sites: 60 to 70 · 3 morev14 Show 6 more changesShow less
    • Primary endpoints: 2 to 1
    • Enrollment target: 452 to 340
    • Study sites: 60 to 70
    • Completion date: Aug 2023 to Jul 2024
    • Eligibility criteria expanded, about 37 words
    • Secondary endpoints: 5 to 7

    See this version in full on ClinicalTrials.gov ↗

  40. Study sites: 36 to 60v13
  41. Study sites: 28 to 36v12
  42. Study sites: 40 to 28 Study title expanded, about 1 wordv11 Show 1 more changeShow less
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

  43. Study sites: 38 to 40v10
  44. Study sites: 36 to 38v9
  45. Study sites: 34 to 36v8
  • 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 Phase 3 study will evaluate the efficacy of the investigational agent MRTX849 (adagrasib) versus docetaxel in patients who have been previously treated for metastatic NSCLC with a KRAS G12C mutation.
Trial Details
NCT Number NCT04685135
Lead Sponsor Mirati Therapeutics Inc.
Conditions Metastatic Non Small Cell Lung Cancer, Advanced Non Small Cell Lung Cancer
Enrollment 453 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov