SUNRAY 1
Research type
Research Study
Full title
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 Pembrolizumab and LY3537982 vs Pembrolizumab and Placebo in those with PD-L1 ≥ 50% or Pembrolizumab, Pemetrexed, Platinum Chemotherapy and LY3537982 vs Pembrolizumab, Pemetrexed, Platinum Chemotherapy and Placebo regardless of PD-L1 Expression.
IRAS ID
1008769
Contact name
Lilly Cork
Contact email
Sponsor organisation
Eli Lilly and Company
Research summary
Lung cancer is the second most diagnosed cancer worldwide, with approximately 2.2 million diagnoses in 2020, contributing to about 11.4% of the total cancer cases. Lung cancer is responsible for the highest number of cancer deaths each year worldwide. The most common type of lung cancer is called Non-Small Cell Lung Cancer (NSCLC). Most patients with NSCLC have advanced stage cancer that cannot be removed surgically by the time they are diagnosed. Only 6% of these patients would be expected to live for 5 years. Standard treatment for newly diagnosed NSCLC patients whose cancer does not have one of the common NSCLC genetic mutations include an immune checkpoint inhibitor alone or in combination with chemotherapy.
KRAS G12C mutations are found in approximately 12% of patients with NSCLC and are associated with poorer treatment outcomes. Current approved treatments for first-line NSCLC with KRAS mutations do not target the KRAS mutations specifically.
LY3537982 is an investigational medicine being developed to target KRAS G12C mutations. In early studies LY3537982 has shown a low rate of side effects and a promising efficacy profile on its own and when combined with the immune checkpoint inhibitor pembrolizumab.
SUNRAY-01 is a new clinical research study from Eli Lilly and Company. This study will test how well LY3537982 can treat advanced NSCLC that has the KRAS G12C mutation.
In the SUNRAY-01 study all patients will receive standard-of-care treatment for their cancer (the same they would receive if they were not participating in the trial). In addition to this treatment, half of the study participants will receive the investigational medicine, LY3537982, and half of participants will receive a placebo. The goal of the SUNRAY-01 study is to find out whether adding LY3537982 improves the outcomes of standard-of-care treatment for NSCLC.
SUNRAY-01 will enroll roughly 1100 participants at over 370 centres globally.REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0930
Date of REC Opinion
22 Dec 2023
REC opinion
Further Information Favourable Opinion