Science and Research

SUNRAY-01 trial protocol: an innovative study design of olomorasib and pembrolizumab with or without chemotherapy in KRAS G12C NSCLC

www.clinicaltrials.gov identifier is NCT06119581. EudraCT: 2023-503412-33-00. KRAS is a gene that everyone has that helps our cells grow in a controlled way. When this gene is mutated and active all the time, the cells in the body divide and can grow out of control. This can lead to several cancers, including lung cancer.This ongoing trial is assessing whether adding a new investigational drug, olomorasib, that targets KRAS G12C, in combination with standard-of-care anti-cancer drugs is more effective than standard of care alone in participants with untreated advanced non-small cell lung cancer with a specific change in the KRAS gene, called KRAS G12C.Participants in this trial will receive standard-of-care treatment (pembrolizumab with or without pemetrexed and platinum given as intravenous infusions) in combination with olomorasib or placebo (given orally twice daily).This trial has been intentionally designed to reduce barriers to enrollment by permitting inclusion based on local testing, allowing patients to receive a single cycle of standard-of-care treatment to provide sufficient time for the screening and to provide a treatment option for every patient regardless of their tumor’s PD-L1 (programmed death-ligand 1, a protein that can affect how the immune system fights cancer) expression, allowing patients with small untreated or previously treated brain metastases (areas where cancer has spread), and ensuring that both control and experimental arms receive standard treatment. eng

  • Peters, S.
  • Hochmair, M.
  • Arbour, K. C.
  • Rodriguez, L. P.
  • Reck, M.
  • Leal, T.
  • R. Lindsay C
  • Shun, L.
  • William, W. N.
  • Spira, A. I.
  • Sabari, J. K.
  • Henning Grønberg, B.
  • Nishio, M.
  • Burns, T. F.
  • Girard, N.
  • Capuzzo, F.
  • Merced, A.
  • Fasnacht, N.
  • Visseren-Grul, C.
  • Negrao, M. V.

Keywords

  • Humans
  • *Carcinoma, Non-Small-Cell Lung/drug therapy/genetics/pathology/mortality
  • *Antibodies, Monoclonal, Humanized/administration & dosage/adverse effects
  • *Lung Neoplasms/drug therapy/genetics/mortality/pathology
  • *Antineoplastic Combined Chemotherapy Protocols/therapeutic use/adverse effects
  • *Proto-Oncogene Proteins p21(ras)/genetics
  • Mutation
  • Treatment Outcome
  • Randomized Controlled Trials as Topic
  • Kras
  • Nsclc
  • Study design
  • first-line treatment
  • olomorasib
  • pembrolizumab
  • phase III trial
  • treatment rationale
Publication details
DOI: 10.1080/14796694.2026.2651961
Journal: Future Oncol
Pages: 1073-1082 
Number: 9
Work Type: Original
Location: ARCN
Disease Area: LC
Partner / Member: Ghd
Access-Number: 41940628


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