Study of MK-1084 and Pembrolizumab for Treating KRAS G12C Mutant, Metastatic Non-small Cell Lung Cancer with High PD-L1 Levels

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40
Inactive

ClinicalTrials ID:NCT06345729

Provider View

This clinical trial is testing a new treatment combination of MK-1084 and pembrolizumab for patients with advanced non-small cell lung cancer (NSCLC) that has a specific genetic mutation (KRAS G12C) and high levels of PD-L1. The study aims to see if this combination can improve survival and slow cancer progression compared to standard treatment.

Patient Parameters

Program Overview

The purpose of this study is to evaluate the effectiveness and safety of combining MK-1084 with pembrolizumab as a first treatment option for patients with metastatic non-small cell lung cancer (NSCLC) that has a KRAS G12C mutation and high PD-L1 levels. Researchers are testing if this combination can help patients live longer and delay cancer growth better than the current standard treatment.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with non-small cell lung cancer (NSCLC).
  • Cancer is at Stage IV, meaning it has spread to other parts of the body.
  • Cancer can be measured using standard criteria.
  • Tumor shows PD-L1 expression in 50% or more of the cells.
  • Tumor has the KRAS G12C mutation.
  • Expected to live at least 3 more months.
  • In good general health, with a performance status of 0 or 1.
  • Men must agree to use contraception during the study and for 10 days after the last dose.
  • Women must agree to use contraception during the study and for 10 days after the last dose of oral treatment and 120 days after the last dose of pembrolizumab.
  • Women must not breastfeed during the study and for 120 days after.
  • HIV-positive participants must have well-controlled HIV.
  • Hepatitis B positive participants must have undetectable viral load after treatment.

Exclusion Criteria

  • Diagnosed with small cell lung cancer.
  • Have active inflammatory bowel disease needing medication.
  • Have a history of certain neurological conditions related to cancer.
  • Have an active infection needing treatment.
  • Have serious heart or blood vessel problems.
  • Have uncontrolled medical conditions or diseases.
  • Have certain eye conditions like glaucoma.
  • Cannot swallow pills or have digestive issues affecting absorption.
  • Have had previous treatment for metastatic NSCLC.
  • Have had certain cancer treatments within the last year.
  • Have had radiation therapy within 2 weeks of starting the study.
  • Have had a live vaccine within 30 days before starting the study.
  • Have used an investigational drug or device recently.
  • Have active cancer spread to the brain or spinal cord.
  • Have an immune deficiency or are on high-dose steroids.
  • Have an active autoimmune disease needing treatment in the last 2 years.
  • Have a history of lung inflammation needing steroids.
  • Have HIV with a history of certain cancers.
  • Have had a tissue or organ transplant.
  • Have not fully recovered from major surgery.

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