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Trial of Two Adagrasib Dosing Regimens in NSCLC With KRAS G12C Mutation (KRYSTAL 21)

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later across 2 updates Jul 30, 2026 → Oct 30, 2026
See other at-risk trials from Mirati Therapeutics Inc.

Record History

  1. Primary completion moved earlier from Nov 30, 2026 to Oct 30, 2026v28
  2. Primary and study completion pushed from Jul 30, 2026 to Nov 30, 2026 Start date: Feb 16, 2024 to Feb 1, 2024v27 Show 1 more changeShow less
    • Start date: Feb 16, 2024 to Feb 1, 2024
  3. Trial status: Recruiting to Active, Not Recruiting Study sites: 120 to 98v26 Show 1 more changeShow less
    • Study sites: 120 to 98
  4. Study sites revised (120)v25 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (120)v24 See this version in full on ClinicalTrials.gov ↗
Show 22 earlier versionsHide 22 earlier versions
  1. Study sites revised (120)v23 See this version in full on ClinicalTrials.gov ↗
  2. Study sites: 115 to 120v22
  3. Study sites: 113 to 115v21
  4. Study sites: 112 to 113v20
  5. Study sites revised (112)v19 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 105 to 112v18
  7. Study sites: 98 to 105v17
  8. Study sites revised (98)v16 See this version in full on ClinicalTrials.gov ↗
  9. Primary and study completion dates: Mar 31, 2025 to Jul 30, 2026v15
  10. Site details revised at 1 of 98 sitesv14
  11. Completion date: Sep 30, 2025 to Mar 31, 2025 Site contacts updated at 1 of 98 sitesv13 Show 1 more changeShow less
    • Site contacts updated at 1 of 98 sites
  12. Start date: Feb 1, 2024 to Feb 16, 2024v12
  13. Study sites revised (98)v11 See this version in full on ClinicalTrials.gov ↗
  14. Study sites: 21 to 98 Primary completion date: Mar 2025 to Mar 31, 2025 · Completion date: Sep 2025 to Sep 30, 2025 · Study description revisedv10 Show 3 more changesShow less
    • Primary completion date: Mar 2025 to Mar 31, 2025
    • Completion date: Sep 2025 to Sep 30, 2025
    • Study description revised

    See this version in full on ClinicalTrials.gov ↗

  15. Study sites: 17 to 21v9
  16. Start date: Apr 5, 2023 to Feb 1, 2024 Study sites: 14 to 17v8 Show 1 more changeShow less
    • Study sites: 14 to 17
  17. Study sites: 11 to 14v7
  18. Study sites: 9 to 11v6
  19. Study sites: 5 to 9v5
  20. Study sites: 2 to 5v4
  21. Study sites: 1 to 2v3
  22. Eligibility criteria expanded, about 17 words Secondary endpoints: 6 to 7v2 Show 1 more changeShow less
    • Secondary endpoints: 6 to 7

    See this version in full on ClinicalTrials.gov ↗

  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.
This study will evaluate the efficacy of two dosing regimens of adagrasib (600 mg BID versus 400 mg BID) in patients with NSCLC with KRAS G12C mutation.
Trial Details
NCT Number NCT05853575
Lead Sponsor Mirati Therapeutics Inc.
Conditions Advanced Cancer, Metastatic Cancer, Malignant Neoplasm of Lung
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov