Study on Pembrolizumab Plus MK-1084 for Non-Small Cell Lung Cancer with KRAS G12C Mutations

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07252739

This clinical trial is exploring whether a new treatment, MK-1084, can help treat non-small cell lung cancer (NSCLC) in patients with a specific gene mutation called KRAS G12C. The study aims to assess the safety of MK-1084 and see how well it works in shrinking or eliminating the cancer.

Patient Parameters

Program Overview

Researchers are conducting a study to find out if a new treatment called MK-1084 can help treat non-small cell lung cancer (NSCLC) in patients who have a specific gene mutation known as KRAS G12C. MK-1084 is a targeted therapy designed to attack cancer cells with this mutation. The main goals of the study are to determine the safety of MK-1084 and to see how many patients experience a reduction or disappearance of their cancer during the treatment.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
  • Have a tumor or blood test showing the presence of the KRAS G12C mutation.
  • Be able to provide a sample of tumor tissue, either from a previous biopsy or a new one.
  • Have recovered from side effects of previous cancer treatments to a mild level or baseline, except for certain nerve or hormone-related side effects that are well-managed.
  • If HIV-positive, have well-controlled HIV on antiretroviral therapy.
  • If hepatitis B positive, have an undetectable viral load and have been on antiviral therapy for at least 4 weeks.
  • If hepatitis C positive, have an undetectable viral load.

Exclusion Criteria

  • Have small cell lung cancer or a mixed tumor with small cell elements.
  • Have HIV with a history of certain related diseases like Kaposi's sarcoma.
  • Have active inflammatory bowel disease requiring medication or a clear history of it.
  • Have uncontrolled heart or blood vessel diseases, such as severe heart failure or recent heart attack.
  • Have received previous systemic cancer treatment for advanced or metastatic NSCLC.
  • Have had prior immunotherapy that was stopped due to severe side effects, except for hormone-related issues that are managed with replacement therapy.
  • Have had previous treatment targeting KRAS.
  • Have had recent cancer treatment and not fully recovered from its side effects.
  • Have had significant radiation therapy to the lung recently.
  • Have a diagnosis of immune deficiency or are on high-dose steroids or other immune-suppressing treatments.
  • Have another active cancer that is progressing or needed treatment in the last 3 years.
  • Have active cancer spread to the brain or spinal cord.
  • Have an active autoimmune disease needing treatment in the last 2 years, except for replacement therapies.
  • Have a history of lung inflammation needing steroids or current lung inflammation.
  • Have had a stem cell or organ transplant.
  • Have not fully recovered from major surgery or have ongoing surgical issues.

Locations

FACILITYZIPCITYSTATE
Clermont Oncology Center ( Site 0041)34711ClermontFlorida

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