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EventsOncology Pipeline
Loxo@Lilly aims to create medicines that make life better for all those affected by cancer around the world. Bringing together the focus and spirit of a biotech with the scale, resources, and heritage of Lilly, our team is focused on rapidly delivering impactful new medicines for people with cancer. Our approach centers on creating oncology medicines that unequivocally show early signs of clinical activity and will matter to patients.
SUNRAY-01; NCT06119581
Lung Cancer or NSCLC
KRAS G12C Inhibitor
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*
Key Inclusion Criteria
- Histologically or cytologically confirmed non-small cell lung cancer (NSCLC) with stage IIIB-IIIC or stage IV disease, not suitable for curative intent radical surgery or radiation therapy
- Part B and safety lead-in part B: the histology of the tumor must be predominantly non-squamous (in line with pemetrexed label)
- Disease with evidence of KRAS G12C mutation
- Known programmed death-ligand 1 (PD-L1) expression
- Part A: ≥50%
- Part B: 0%-100%
- Measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy ≥12 weeks
- Ability to swallow capsules
- Adequate laboratory parameters
- Contraceptive use should be consistent with local regulations for those participating in clinical studies
- Women of childbearing potential must:
- Have a negative pregnancy test
- Not be breastfeeding during treatment and after study intervention for at least 180 days
Key Exclusion Criteria
- A documented additional validated targetable oncogenic driver mutation or alteration in genes such as epidermal growth factor receptor (EGFR), anaplastic lymphoma kinase (ALK), BRAF (V600E), human epidermal growth factor receptor 2 (HER2), MET (exon 14), ROS1, rearranged during transfection (RET), or neurotrophic tyrosine receptor kinase (NTRK)1/2/3
- Had any of the following prior to randomization:
- Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC
- One cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated
- Central nervous system (CNS) metastases and/or carcinomatous meningitis
- For participants receiving pemetrexed and platinum (part B and safety lead-in part B):
- Squamous cell and/or mixed small cell/non-small cell histology is not permitted
- Is unable to interrupt aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
- Is unable or unwilling to take folic acid or vitamin B12 supplementation
Contact the Lilly Oncology Clinical Trial Navigation Service
Visit www.clinicaltrials.gov for more information on this trial.
Need additional information or have a question:
The safety and efficacy of the agents under investigation have not been established. There is no guarantee that the agents will receive regulatory approval and become commercially available for the uses being investigated.