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Olomorasib + Pembrolizumab KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic NSCLC
Sponsor: UNC Lineberger Comprehensive Cancer Center
Summary
This clinical trial evaluates the combination of olomorasib and pembrolizumab as a first-line treatment for patients with advanced or metastatic non-small cell lung cancer (NSCLC) that has a Kirsten Rat Sarcoma Virus (KRAS) G12C mutation and a programmed death-ligand (PD-L1) score between 1% and 49%. The main goal of the study is to determine how long patients live without their cancer worsening after starting treatment, also known as progression-free survival (PFS). Additional goals include evaluating how many patients experience tumor shrinkage or disappearance, how long responses to treatment last, overall survival, and the safety and side effects of the treatment combination. Furthermore, how well the treatment works in patients whose cancer has spread to the brain, outcomes in patients with a lower Eastern Cooperative Oncology Group performance status (ECOG), and whether certain tumor or blood-based biomarkers are associated with treatment response or side effects, if enough patient data is available for analysis.
Official title: Olomorasib Plus Pembrolizumab as First-Line Treatment for KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-06
Completion Date
2030-06-21
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
Olomorasib
Olomorasib 100 mg tb, twice a day
Pembrolizumab
200 mg, 30-minute IV infusion in every 3 weeks for first 12 cycles or 395 mg for first 12 cycles Sub-cutaneous in abdomen or thigh
Locations (1)
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States