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.
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
None
Single group
Olomorasib
DrugOlomorasib 100 mg tb, twice a day
Pembrolizumab
Drug200 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
Progression free survival (PFS)
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.
Overall Survival(OS)
OS will be defined as the time from first dose of study drug to death from any cause.
Adverse events (AEs) will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE)
Adverse events (AEs) will be assessed using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0, from the start of treatment until unacceptable toxicity leading to treatment discontinuation, treatment stopping, or completion of 2 years of treatment, whichever occurs first. The CTCAE provides a grading scale for AE severity: Grade 1 (mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention indicated), Grade 2 (moderate; minimal, local, or noninvasive intervention indicated; limiting instrumental activities of daily living), Grade 3 (severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living), Grade 4 (life-threatening consequences; urgent intervention required), and Grade 5 (death related to adverse event).
Overall response rate
Overall response rate (ORR) is defined as the proportion of response-evaluable patients who achieve a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. CR is defined as the disappearance of all target lesions, and PR as at least a 30% decrease in the sum of the longest diameters of target lesions. RECIST 1.1 defines stable disease (SD) as neither sufficient shrinkage for PR nor sufficient increase for progressive disease (PD), and PD as at least a 20% increase in the sum of the longest diameters of target lesions, unequivocal progression of non-target lesions, or the appearance of new lesions
Duration of Response (DoR)
Duration of Response (DoR) defined as the time from a Complete Response (CR), or Partial Response (PR) to disease progression, death, or end of study. 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.
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