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Clinical Trials | A Global Pivotal Placebo-Controlled Study of LY3537982 in Combination with Pembrolizumab and LY3537982 in Combination with Pembrolizumab, Pemetrexed and Platinum for the First-line Treatment of Participants with KRAS G12C-Mutant Advanced Non-Small Cell Lung Cancer

SUNRAY-01, A Global Pivotal Study in Participants with KRAS G12C-Mutant, Locally Advanced or Metastatic Non-Small Cell Lung Cancer Comparing First- Line Treatment of LY3537982 and Pembrolizumab vs Placebo and Pembrolizumab in those with PD-L1 expression =50% or LY3537982 and Pembrolizumab, Pemetrexed, Platinum vs Placebo and Pembrolizumab, Pemetrexed, Platinum regardless of PD-L1 Expression

The University of Virginia Comprehensive Cancer Center seeks participants ages 18 and over with histologically or cytologically confirmed Stage IIIB-IIIC or Stage IV NSCLC. The purpose of this study is to assess if adding olomrasib (LY3537982) in combination with standard of care anti-cancer drugs is more effective than standard of care in participants with untreated advanced NSCLC. NSCLC must have a change in a gene called KRAS G12C.” There are now 2 parts to the study, Part A and Part B. Your study doctor will determine which part you will benefit most by participating in. All participants in Part A will receive the standard of care medication, pembrolizumab. There are two groups of participants within Part A which you could be enrolled to: pembrolizumab and olomorasib or pembrolizumab and Placebo. Part B will explore whether adding study drug (olomorasib) by mouth to standard of care medications (pembrolizumab, pemetrexed, carboplatin, or cisplatin) received through your veins (intravenous-IV) helps control your cancer for a longer period of time. The study drug will continue as long as you are benefitting from the medication. After you stop the study treatment you will be asked to return for a follow-up visit. You will have a short-term follow-up visit approximately 30 days after last dose of study drug. You will then move on to long term follow visits which may be conducted by phone approximately every 90 days. You may or may not benefit as a result of your participation in this study. However, this study may also help doctors learn things that can help other people in the future. Additional information found here: https://www.clinicaltrials.gov/study/NCT06119581?titles=SUNRAY-01&rank=1 For questions, contact: [email protected]