BO45885- Divarasib compared with immunotherapy or observation in patients with NSCLC - KRASCENDO 3

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, OPEN-LABEL STUDY EVALUATING THE EFFICACY AND SAFETY OF DIVARASIB COMPARED WITH INVESTIGATOR’S CHOICE OF IMMUNOTHERAPY OR OBSERVATION IN PATIENTS WITH RESECTED STAGE II-III KRAS G12C-POSITIVE NON-SMALL CELL LUNG CANCER

• IRAS ID

  1013804

• Contact name

  N/A N/A

• Contact email

  medinfo.uk@roche.com

• Sponsor organisation

  F. Hoffmann-La Roche AG

• Eudract number

  2025-524263-21

• Research summary

  The purpose of this study is to compare the effects, good or bad, of divarasib versus regular care (pembrolizumab or nivolumab or observation) Participants in this study, will get either divarasib or pembrolizumab, or nivolumab, or observation. To be eligible for this study, potential participants will need to have a particular genetic change (biomarker) called the KRAS G12C mutation.
  This study is testing a drug called divarasib, which targets the KRAS G12C mutation.
  Divarasib is an experimental study drug, which means health authorities have not approved divarasib for the treatment of lung cancer.

  This study will include a screening period of up to 42 days, a study treatment period, and
  follow-up period during which participants will be followed for safety outcomes and longterm
  survival outcomes. KRAS G12C mutation testing for eligibility may be performed
  as part of pre-screening ahead of the screening period.
  Participants in the experimental arm will receive divarasib as follows:
  -Divarasib 400 mg PO QD for up to 52 cycles (21-day cycles; approximately 3 years)
  Participants in the control arm will receive pembrolizumab, nivolumab, or go under
  observation, depending on the treatment received prior to surgery
  -Pembrolizumab: 200 mg IV Q3W or 395 mg SC and 4,800 units berahyaluronidase
  alfa Q3W, for up to 13 cycles (21-day cycles; approximately 9 months)
  - Nivolumab: 480 mg IV Q4W or 1,200 mg SC and 20,000 units hyaluronidase Q4W,
  for up to 13 cycles (28-day cycles; approximately 12 months)
  - Observation: No study treatment given

  Approximately 30 participants will take part in the study in the UK at 8 sites and 400 worldwide.
  
  The study is sponsored by F. Hoffmann- La Roche

  Research Summary; Version 1 dated 3rd February 2026

• REC name

  West of Scotland REC 1

• REC reference

  26/WS/0084

• Date of REC Opinion

  13 Jul 2026

• REC opinion

  Further Information Favourable Opinion