Olomorasib + Pembrolizumab KRAS G12C Mutant, PD-L1 TPS 1-49% Locally Advanced or Metastatic NSCLC

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT07639242
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Locally Advanced NSCLC
  • Lung Cancer
  • Lung Cancer (NSCLC)
  • Metastatic NSCLC - Non-Small Cell Lung Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Olomorasib — DRUG
    Olomorasib 100 mg tb, twice a day
  • Pembrolizumab — DRUG
    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

Study Details

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.

Key Dates

Start date
Jun 30, 2026
Status verified
Jun 2026
Primary completion
Jun 21, 2030
Completion
Jun 21, 2030

Study Design

Enrollment
60 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Lung Cancer

Primary Outcome Measure

Progression free survival (PFS) [ Time Frame: Up to 5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Rose M Hall
[email protected]
919-984-0000
Rebecca Rambharose
[email protected]
Shetal A Patel, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Lung cancer
By specialty
OncologyLung oncologyLung disease
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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