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A Study Evaluating the Efficacy and Safety of Divarasib and Pembrolizumab Versus Pembrolizumab and Pemetrexed and Carboplatin or Cisplatin in Participants With Previously Untreated, KRAS G12C-Mutated, Advanced or Metastatic Non-Squamous Non-Small Cell Lung Cancer

Study acronym: Krascendo 2
StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Minor Trial sites expanded: 280 → 288 locations Eligibility criteria expanded, about 26 words · Secondary endpoints: details revised at 4 of 9 entries Show 2 more changesShow less
    • Eligibility criteria expanded, about 26 words
    • Secondary endpoints: details revised at 4 of 9 entries
  2. Minor Trial sites expanded: 268 → 280 locationsv22
  3. Minor Trial sites expanded: 260 → 268 locationsv21
  4. Minor Trial sites expanded: 251 → 260 locationsv20
  5. Minor Trial sites expanded: 240 → 251 locationsv19
  6. Minor Trial sites expanded: 217 → 240 locationsv18
  7. Minor Trial sites expanded: 195 → 217 locationsv17
  8. Minor Study sites: 180 to 195v16
  9. Minor Study sites: 151 to 180v15
  10. Minor Study sites: 105 to 151v14
  11. Minor Study sites: 63 to 105v13
  12. Minor Study sites: 32 to 63 Start date changed from estimate of Dec 1, 2025 to Oct 24, 2025v12 Show 1 more changeShow less
    • Start date changed from estimate of Dec 1, 2025 to Oct 24, 2025
  13. Minor Study sites: 10 to 32v11
  14. Minor Study sites: 6 to 10v10
  15. Notable Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 6 · Completion date: Oct 1, 2030 to Oct 31, 2030v9 Show 2 more changesShow less
    • Study sites: 0 to 6
    • Completion date: Oct 1, 2030 to Oct 31, 2030
  16. Minor 3 versions Re-verified since Jun 11, 2025, no change to tracked fieldsv6-v8
  17. Notable Primary completion date: Apr 28, 2028 to Nov 30, 2028 Start date: May 1, 2025 to Dec 1, 2025 · Completion date: Feb 9, 2030 to Oct 1, 2030v5 Show 2 more changesShow less
    • Start date: May 1, 2025 to Dec 1, 2025
    • Completion date: Feb 9, 2030 to Oct 1, 2030
  18. Minor 3 versions Re-verified since Feb 20, 2025, no change to tracked fieldsv2-v4
  19. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this study is to evaluate the efficacy and safety of divarasib and pembrolizumab compared with pembrolizumab and pemetrexed and carboplatin or cisplatin, for the first-line treatment of adult participants with KRAS G12C-mutated, advanced or metastatic non squamous non-small cell lung cancer (NSCLC).
Trial Details
NCT Number NCT06793215
Lead Sponsor Hoffmann-La Roche
Collaborators: Chugai Pharmaceutical
Conditions Non-Small Cell Lung Cancer, KRAS G12C Lung Cancer
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov