Last updated 39 days ago
A Study of First-Line Olomorasib (LY3537982) and Pembrolizumab With or Without Chemotherapy in Patients With Advanced KRAS G12C-Mutant Non-small Cell Lung Cancer
1016 patients around the world
Available in Spain, Brazil, Mexico, United States
Dose Optimization, Part A, and Part B are randomized. Safety Lead-In for Part B is single
arm, non-randomized.
Eli Lilly and Company
28Research sites
1016Patients around the world
This study is for people with
Lung cancer
Non-small cell lung carcinoma
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Histologically or cytologically confirmed 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).Must have disease with evidence of KRAS G12C mutation.Must have known programmed death-ligand 1 (PD-L1) expressionPart A: Greater than or equal to (≥)50 percent (%).Part B: 0% to 100%.Must have measurable disease per RECIST v1.1.Must have an ECOG performance status of 0 or 1.Estimated life expectancy ≥12 weeks.Ability to swallow capsules.Must have adequate laboratory parameters.Contraceptive use should be consistent with local regulations for those participating in clinical studies.Women of childbearing potential mustHave a negative pregnancy test.Not be breastfeeding during treatment and after study intervention for at least 180 days.
- Have 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.Have had any of the following prior to randomization:Prior systemic therapy (chemotherapy, immunotherapy, targeted therapy, or biological therapy) for advanced or metastatic NSCLC.1 cycle of standard-of-care treatment prior to study enrollment will be allowed for cases where immediate treatment is clinically indicated:Have known active central nervous system metastases and/or carcinomatous meningitis.Exclusion Criteria for Participants receiving Pemetrexed and Platinum (Part B and Safety Lead-In Part B)Squamous cell and/or mixed small cell/nonsmall 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.
Sites
Instituto Do Câncer Do Ceará ICC
Hospital Sírio- Libanês Brasilia
Hospital Brasília
Hospital São Domingos
Oncominas
Hospital Do Cancer de Londrina
Liga Norte Riograndense Contra o Câncer-Centro de Pesquisa Clínica
ONCOSITE - Centro de Pesquisa Clinica em Oncologia
Centro Universitário Faculdade de Medicina do ABC (FMABC)
Beneficência Portuguesa de São Paulo
StudySUNRAY-01
SponsorEli Lilly and Company
Conditions
Non-small cell lung carcinoma
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06119581
