A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)

StatusRecruiting
PhasePhase 3
SponsorAmgen
Started

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Record History

Version history last read from ClinicalTrials.gov on Oct 14, 2026. The record was updated there on Oct 23, 2026; versions filed since then are not listed here yet.

The 50 most recent of 92 record versions are listed below. See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 420 → 424 locations
  2. Study sites: 418 to 420
  3. Eligibility criteria expanded, about 9 words
    • Site details revised at 3 of 418 sites
  4. Trial sites expanded: 414 → 418 locationsv89
  5. Site details revised at 1 of 414 sitesv88
  6. Study sites: 412 to 414v87
  7. Trial sites expanded: 407 → 412 locationsv86
  8. Trial sites expanded: 404 → 407 locationsv85
  9. Study sites: 403 to 404v84
  10. Study sites: 401 to 403v83
  11. Trial sites expanded: 383 → 401 locationsv82
  12. Study sites: 382 to 383v81
  13. Study sites: 383 to 382v80
  14. Trial sites expanded: 380 → 383 locationsv79
  15. Site details revised at 4 of 380 sitesv78
  16. Site details revised at 1 of 380 sitesv77
  17. Primary completion pushed from Jun 30, 2026 to Jun 30, 2027
    • Study completion pushed from Jun 30, 2031 to Jun 29, 2032
    • Study sites: 379 to 380
    v76
  18. Study sites revised (379)v75
  19. Study sites: 378 to 379v74
  20. Study sites: 377 to 378v73
  21. Study sites: 378 to 377v72
  22. Study sites revised (378)v71
  23. Study sites: 375 to 378v70
  24. Study sites revised (375)v69
  25. Study sites: 374 to 375v68
  26. Study sites: 373 to 374v67
  27. Site details revised at 3 of 373 sitesv66
  28. Study sites revised (373)v65
  29. Study sites: 372 to 373v64
  30. Study sites revised (372)v63
  31. Study sites revised (372)v62
  32. Site details revised at 1 of 372 sitesv61
  33. Site details revised at 1 of 372 sitesv60
  34. Study sites revised (372)v59
  35. Study sites revised (372)v58
  36. Study sites: 371 to 372v57
  37. Site details revised at 1 of 371 sitesv56
  38. Site details revised at 1 of 371 sitesv55
  39. Study sites: 369 to 371v54
  40. Site details revised at 2 of 369 sitesv53
  41. Study sites revised (369)v52
  42. Study sites: 367 to 369v51
  43. Study sites: 361 to 367v50
  44. Study sites: 360 to 361v49
  45. Re-verified, no change to tracked fieldsv48
  46. Study sites: 354 to 360v47
  47. Study sites: 351 to 354v46
  48. Study sites: 348 to 351v45
  49. Study sites: 344 to 348v44
  50. Study sites: 343 to 344v43
  • 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 primary objectives are to compare progression-free survival (PFS) and overall survival (OS) in participants who receive sotorasib with platinum doublet chemotherapy versus participants who receive pembrolizumab with platinum doublet chemotherapy.
Trial Details
NCT Number NCT05920356
Lead Sponsor Amgen
Conditions
(from sponsor)		 Non-Small Cell Lung Cancer (NSCLC)
Related terms Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Neoplasms
Enrollment 750 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov