A Study to Evaluate the Efficacy and Safety of Divarasib Compared With Investigator's Choice of Immunotherapy or Observation in Participants With Resected Stage II-III KRAS G12C-Positive Non-Small Cell Lung Cancer (NSCLC)

Study acronym: KRASCENDO 3
StatusRecruiting
PhasePhase 3
Started

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Record History

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  1. Trial sites expanded: 19 → 46 locations
    • Start date changed from estimate of Sep 30, 2026 to Oct 6, 2026
    • Eligibility criteria expanded, about 13 words
  2. Trial sites expanded: 1 → 19 locations
    • Start date: Sep 1, 2026 to Sep 30, 2026
    v6
  3. Recruitment opened
    • Study sites: 0 to 1
    v5
  4. Re-verified, no change to tracked fieldsv4
  5. Study Status, Contacts/Locations, Referencesv3
  6. Re-verified, no change to tracked fieldsv2
  7. Study First Submitted
  • 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 main purpose of this study is to evaluate the efficacy of divarasib compared with investigator's choice of immunotherapy (pembrolizumab or nivolumab) or observation in participants with resected Kirsten rat sarcoma viral oncogene homolog glycine 12 to cysteine (KRAS G12C)-positive Stage II-IIIB NSCLC, regardless of tumor programmed death-ligand 1 (PD-L1) status, who have not achieved pathologic complete response (pCR) following neoadjuvant chemoimmunotherapy.
Trial Details
NCT Number NCT07541170
Lead Sponsor Hoffmann-La Roche
Conditions
(from sponsor)		 Non-small Cell Lung Cancer
Related terms Carcinoma, Non-Small-Cell Lung
Enrollment 400 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov