Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2026

Olomorasib and immunotherapy in stage II-III KRAS G12C-mutant NSCLC after definitive therapy: SUNRAY-02 study rationale (145699)

Jamie Chaft 1 , Marina Garassino 2 , Jhanelle Gray 3 , Jay Lee 4 , Se-Hoon Lee 5 , Julien Mazieres 6 , Ernest Nadal 7 , Joel Neal 8 , Marcelo Negrao 9 , Sanjay Popat 10 , Suresh Senan 11 , Michael Thomas 12 , Masahiro Tsuboi 13 , Martin Benes 14 , Hui Liu 14 , Jian Liu 14 , Qinli Lily Ma 14 , Grace Segall 14 , Tarun Puri 14 , Yi-Long Wu 15 , Aarohan Pruthi 16
  1. MSKCC - Memorial Sloan Kettering Cancer Center, New York, NY, USA
  2. Department of Medicine, University of Chicago , Chicago, USA
  3. Department of Thoracic Oncology, Moffitt Cancer Center, Tampa, FL, USA
  4. Department of Thoracic Surgery, UCLA - David Geffen School of Medicine, Los Angeles, USA
  5. Department of Medical Oncology, Samsung Medical Center (SMC), Seoul, Republic of Korea
  6. Thoracic Oncology Department , Centre Hospitalier Universitaire de Toulouse - Hopital Larrey, Toulouse, France
  7. Medical Oncology Department, ICO - Institut Català d'Oncologia l'Hospitalet (Hospital Duran i Reynals), L'Hospitalet De Llobregat, Spain
  8. Oncology, Stanford University School of Medicine, Stanford, USA
  9. Thoracic/Head & Neck Medical Oncology Dept, The University of Texas MD Anderson Cancer Center - Main Building, Houston, TX, USA
  10. Department of Medicine, The Royal Marsden Hospital - NHS Foundation Trust, London, United Kingdom
  11. Radiation Oncology Department PK-1, 150, Amsterdam UMC - Vrije University Medical Centre (VUmc), Amsterdam, Netherlands
  12. Thoracic Oncology department, Thoraxklinik Heidelberg gGmbH, Heidelberg, Germany
  13. Thoracic Surgery and Oncology Dept, National Cancer Center Hospital East, Kashiwa, Japan
  14. Eli Lilly and Company, Indianapolis, IN, USA
  15. Lung Cancer Institute, Guangdong Province People's Hospital, Guangzhou, China
  16. Eli Lilly, Sydney, NSW, Australia

Aims

Up to half of patients (pts) with early-stage NSCLC die from recurrent/metastatic disease after curative-intent therapy. Despite the relative frequency of KRAS G12C alterations, no KRAS G12Ci are approved for this population, representing a significant treatment gap.

Trial Design

Olomorasib is a potent and highly selective next-generation KRAS G12Ci which has demonstrated promising antitumor and intracranial activity and a manageable safety profile in KRAS G12C-mutant metastatic NSCLC.

The rationale for combining olomorasib and immunotherapy (IO) is supported by the therapeutically synergistic or additive effect of KRAS G12Ci+PD-(L)1 inhibitors in xenograft models, along with promising clinical data combining olomorasib+pembrolizumab in 1L NSCLC.

SUNRAY-02 is a 2-part global, placebo (PBO)-controlled phase 3 study recruiting pts with stage II-III KRAS G12C-mutant NSCLC. Part A pts with resected NSCLC receive olomorasib or PBO, plus pembrolizumab, while Part B pts with unresectable (UR) NSCLC receive olomorasib or PBO, plus durvalumab. Combination treatment is administered for approximately 1 year, followed by olomorasib/PBO monotherapy to complete up to 3 years of treatment.

Part A allows for inclusion of pts with resected NSCLC who have completed neoadjuvant (NA) chemoimmunotherapy (CT+IO) and surgery. Real-world data (RWD) show that adjuvant IO is used in approximately 47% of KRAS G12C-mutant NSCLC after NA CT+IO. SUNRAY-02 will provide evidence of the potential benefit of adjuvant pembrolizumab+olomorasib for pts not achieving pathologic complete response to NA CT+IO. RWD also show that approximately 60% pts with UR NSCLC receive concurrent chemoradiotherapy followed by durvalumab. Olomorasib+IO may provide additional clinical benefit for these pts.