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NCT07639242

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

Not Yet Recruiting
PHASE2Ages 18+InterventionalTreatment
UNC Lineberger Comprehensive Cancer Center
~60 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:OlomorasibPembrolizumab

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression free survival (PFS)
Measured over Up to 5 years

Conditions

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

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Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Shetal A Patel, MD, PhD · PRINCIPAL_INVESTIGATOR · UNC Lineberger Comprehensive Cancer Center

Who to contact

Rose M Hall
[email protected]
919-984-0000
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Eligibility criteria

Inclusion

Age ≥ 18 years at the time of consent.
Eastern Cooperative Oncology Group performance status (ECOG) of 0-2
Subjects must have previously untreated, Stage IIIB-IIIC or Stage IV Non-Small Cell Lung Cancer (NSCLC) not amenable to curative intent treatment.
Measurable disease according to Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1 within 28 days prior to treatment
Known KRAS G12C mutation identified on tumor tissue or circulating tumor DNA (ctDNA) as determined by molecular testing performed in a CLIA, CAP or other similarly certified laboratory per local guidelines.
Subjects must have a known PD-L1 tumor proportion score (TPS) of 1-49% as determined by an IHC assay in a CLIA, CAP, or other similarly certified laboratory as per local guidelines

What this trial measures

  • Progression free survival (PFS)Up to 5 years

    PFS will be as assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. RECIST indicating if subject experienced a Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), no response or less response than Partial or Progressive; or Progressive Disease (PD), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.