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A Study of Adagrasib Plus Pembrolizumab Plus Chemotherapy vs. Placebo Plus Pembrolizumab Plus Chemotherapy in Participants With Previously Untreated Non-squamous Non-small Cell Lung Cancer With KRAS G12C Mutation (KRYSTAL-4)

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 14 words Secondary endpoints: details revised at 1 of 11 entries · Study sites revised (351) Show 2 more changesShow less
    • Secondary endpoints: details revised at 1 of 11 entries
    • Study sites revised (351)
  2. Study sites revised (351)v35 See this version in full on ClinicalTrials.gov ↗
  3. Study sites revised (351)v34 See this version in full on ClinicalTrials.gov ↗
  4. Study sites: 352 to 351v33
  5. Study sites revised (352)v32 See this version in full on ClinicalTrials.gov ↗
Show 3 earlier versionsHide 3 earlier versions
  1. Study sites: 353 to 352v31
  2. Study sites: 352 to 353v30
  3. Study sites: 351 to 352v29
  1. Trial sites expanded: 346 → 351 locationsv28
  2. Trial sites expanded: 337 → 346 locationsv27
  3. Study sites: 335 to 337v26
  4. Study sites revised (335)v25 See this version in full on ClinicalTrials.gov ↗
  5. Study sites revised (335)v24 See this version in full on ClinicalTrials.gov ↗
  6. Study sites: 323 to 335v23
  7. Site details revised at 1 of 323 sitesv22
  8. Study sites revised (323)v21 See this version in full on ClinicalTrials.gov ↗
  9. Study sites revised (323)v20 See this version in full on ClinicalTrials.gov ↗
  10. Study sites revised (323)v19 See this version in full on ClinicalTrials.gov ↗
  11. Study sites: 329 to 323v18
  12. Study sites revised (329)v17 See this version in full on ClinicalTrials.gov ↗
  13. Study sites revised (329)v16 See this version in full on ClinicalTrials.gov ↗
  14. Study sites revised (329)v15 See this version in full on ClinicalTrials.gov ↗
  15. Study sites revised (329)v14 See this version in full on ClinicalTrials.gov ↗
  16. Study sites revised (329)v13 See this version in full on ClinicalTrials.gov ↗
  17. Study sites revised (329)v12 See this version in full on ClinicalTrials.gov ↗
  18. Study sites: 328 to 329 Eligibility criteria expanded, about 9 wordsv11 Show 1 more changeShow less
    • Eligibility criteria expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  19. Study sites revised (328)v10 See this version in full on ClinicalTrials.gov ↗
  20. Study sites revised (328)v9 See this version in full on ClinicalTrials.gov ↗
  21. Study sites: 327 to 328v8
  22. Study sites revised (327)v7 See this version in full on ClinicalTrials.gov ↗
  23. Study sites: 325 to 327v6
  24. Study sites: 338 to 325v5
  25. Start date changed from estimate of Apr 30, 2025 to Apr 24, 2025 Study sites revised (338)v4 Show 1 more changeShow less
    • Study sites revised (338)

    See this version in full on ClinicalTrials.gov ↗

  26. Study sites: 337 to 338v3
  27. Trial status: Not Yet Recruiting to Recruiting Study sites: 276 to 337v2 Show 1 more changeShow less
    • Study sites: 276 to 337
  28. 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 is a trial to evaluate the efficacy, safety, and tolerability of adagrasib plus pembrolizumab plus platinum-doublet chemotherapy versus placebo plus pembrolizumab plus platinum-doublet chemotherapy in participants with previously untreated, locally advanced or metastatic NSCLC with KRAS G12C mutation
Trial Details
NCT Number NCT06875310
Lead Sponsor Mirati Therapeutics Inc.
Conditions Carcinoma, Non-Small-Cell Lung
Enrollment 630 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov