SUNRAY-02: a study of olomorasib combined with immunotherapy in stage II-III KRAS G12C-mutant non-small cell lung cancer after definitive therapy
16 affiliations
- 1Thoracic Oncology, Department of Medicine, MSKCC - Memorial Sloan Kettering Cancer Center, New York, NY, USA
- 2Thoracic Oncology, Department of Medicine, Weill Cornell Medical College, New York, NY, USA
- 3Division of Thoracic Surgery, UCLA - David Geffen School of Medicine, Los Angeles, CA, USA
- 4Department of Radiation Oncology, Cancer Center Amsterdam, Amsterdam University Medical Centre (VUmc), Amsterdam, The Netherlands
- 5Department of Medicine, Division of Oncology, Stanford University School of Medicine, Stanford, CA, USA
- 6Department of Medical Oncology, Institut Català d’Oncologia (ICO), Barcelona, Spain
- 7Department of Thoracic/Head & Neck Medical Oncology, UT MD Anderson Cancer Center, Houston, TX, USA
- 8Lung Unit, The Royal Marsden Hospital - NHS Foundation Trust, London, UK
- 9Department of Medicine, Hematology Oncology Section, Thoracic Oncology Program the University of Chicago, Chicago, IL, USA
- 10Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL, USA
- 11Division of Hematology/Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea
- 12Thoracic Oncology Department, Centre Hospitalier Universitaire - Univ Toulouse, Toulouse, France
- 13Department of Thoracic Oncology, Thoraxklinik, Heidelberg University Hospital and National Center for Tumor Diseases (NCT), NCT Heidelberg, a Partnership Between DKFZ and Heidelberg University Hospital, Heidelberg, Germany
- 14Translational Lung Research Center Heidelberg (TLRC-H), Member of the German Center for Lung Research (DZL), Heidelberg, Germany
- 15Eli Lilly and Company, Indianapolis, IN, USA
- 16Guangdong Lung Cancer Institute, Guangdong Province People’s Hospital, Guangdong Academy of Medical Sciences, Southern Medical University, Guangzhou, China
Abstract
More than half of patients with early-stage non-small cell lung cancer (NSCLC) experience recurrent disease following definitive therapy. Targeted therapies have demonstrated significant and clinically meaningful benefit in EGFR-, ALK-, or RET-driven early-stage NSCLC. There are, however, no approved therapies for early-stage KRAS G12C-mutant NSCLC, presenting a potential therapeutic opportunity. Olomorasib is a potent, highly selective next-generation KRAS G12C inhibitor(i) demonstrating promising antitumor and intracranial activity with a manageable safety profile in KRAS G12C-mutant metastatic NSCLC. Preclinical studies have shown that KRAS G12C inhibition reverses KRAS-mediated immune suppression, creating an inflamed tumor microenvironment responsive to immunotherapy. Combining olomorasib and immune checkpoint inhibitors is supported by synergistic and additive effects in preclinical and clinical setting. SUNRAY-02 is a 2-part global, placebo-controlled phase III study recruiting patients with stage II-III KRAS G12C-mutant NSCLC following definitive therapy. Part A patients with resected NSCLC receive olomorasib or placebo in combination with pembrolizumab, while Part B patients with unresectable NSCLC receive olomorasib or placebo in combination with durvalumab. Combination treatment continues for approximately 1-year, followed by olomorasib or placebo monotherapy, completing up to 3-years of treatment. This trial addresses a critical treatment gap in KRAS G12C-mutant early-stage NSCLC.
Clinical trial registration: NCT06890598 (www.clinicaltrials.gov); EudraCT: 2024-512302-25–00.
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BibTeX
@article{chaft2026sunray02,
title = {{SUNRAY-02: a study of olomorasib combined with immunotherapy in stage II-III KRAS G12C-mutant non-small cell lung cancer after definitive therapy}},
author = {Jamie Chaft and Jay M. Lee and Suresh Senan and Joel W. Neal and Ernest Nadal and Marcelo V. Negrao and Sanjay Popat and Marina C. Garassino and Jhanelle E. Gray and Se-Hoon Lee and Julien Mazieres and Michael Thomas and Martin Benes and Hui Liu and Jian Liu and Qinli Lily Ma and Grace Segall and Tarun Puri and Yi-Long Wu},
journal = {Future Oncology},
year = {2026},
month = oct,
doi = {10.1080/14796694.2026.2736401},
url = {https://doi.org/10.1080/14796694.2026.2736401},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - SUNRAY-02: a study of olomorasib combined with immunotherapy in stage II-III KRAS G12C-mutant non-small cell lung cancer after definitive therapy
AU - Jamie Chaft
AU - Jay M. Lee
AU - Suresh Senan
AU - Joel W. Neal
AU - Ernest Nadal
AU - Marcelo V. Negrao
AU - Sanjay Popat
AU - Marina C. Garassino
AU - Jhanelle E. Gray
AU - Se-Hoon Lee
AU - Julien Mazieres
AU - Michael Thomas
AU - Martin Benes
AU - Hui Liu
AU - Jian Liu
AU - Qinli Lily Ma
AU - Grace Segall
AU - Tarun Puri
AU - Yi-Long Wu
PY - 2026
DA - 2026/10/01
JO - Future Oncology
DO - 10.1080/14796694.2026.2736401
UR - https://doi.org/10.1080/14796694.2026.2736401
AB - More than half of patients with early-stage non-small cell lung cancer (NSCLC) experience recurrent disease following definitive therapy. Targeted therapies have demonstrated significant and clinically meaningful benefit in EGFR-, ALK-, or RET-driven early-stage NSCLC. There are, however, no approved therapies for early-stage KRAS G12C-mutant NSCLC, presenting a potential therapeutic opportunity. Olomorasib is a potent, highly selective next-generation KRAS G12C inhibitor(i) demonstrating promising antitumor and intracranial activity with a manageable safety profile in KRAS G12C-mutant metastatic NSCLC. Preclinical studies have shown that KRAS G12C inhibition reverses KRAS-mediated immune suppression, creating an inflamed tumor microenvironment responsive to immunotherapy. Combining olomorasib and immune checkpoint inhibitors is supported by synergistic and additive effects in preclinical and clinical setting. SUNRAY-02 is a 2-part global, placebo-controlled phase III study recruiting patients with stage II-III KRAS G12C-mutant NSCLC following definitive therapy. Part A patients with resected NSCLC receive olomorasib or placebo in combination with pembrolizumab, while Part B patients with unresectable NSCLC receive olomorasib or placebo in combination with durvalumab. Combination treatment continues for approximately 1-year, followed by olomorasib or placebo monotherapy, completing up to 3-years of treatment. This trial addresses a critical treatment gap in KRAS G12C-mutant early-stage NSCLC. Clinical trial registration: NCT06890598 (www.clinicaltrials.gov); EudraCT: 2024-512302-25–00.
SN - 1479-6694
SN - 1744-8301
ER -