Study on MK-1084 with Other Treatments for Advanced Non-Small Cell Lung Cancer

Sponsor: Merck Sharp & Dohme LLC

Sponsor score: 40

ClinicalTrials ID:NCT07286149

Provider View

This clinical trial is testing a new targeted therapy, MK-1084, to see if it can help treat advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). The study aims to find out if MK-1084 is safe and effective when used with other treatments.

Patient Parameters

Program Overview

Researchers are conducting a study to determine if MK-1084, a targeted therapy, can effectively treat advanced or metastatic non-squamous non-small cell lung cancer (NSCLC). Targeted therapies work by controlling how specific cancer cells grow and spread. The study's main goals are to assess the safety of MK-1084 and how well patients tolerate it when combined with other treatments, as well as to see how many patients experience a reduction or disappearance of their cancer.

Description

This study is part of a larger research project called the KEYMAKER-U01 protocol. It focuses on testing the safety and effectiveness of MK-1084, a targeted therapy, in combination with other treatments for patients with advanced non-squamous non-small cell lung cancer (NSCLC). The study will evaluate how well patients tolerate the treatment and whether it can help shrink or eliminate tumors.

Eligibility Criteria

Inclusion Criteria

  • Have a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer (NSCLC).
  • Have a tumor with a specific KRAS mutation (G12C).
  • Have experienced disease progression after 1-2 previous treatments, including PD-1/PD-L1 therapy and platinum-based chemotherapy.
  • Provide a tumor tissue sample from a lesion that has not been treated with radiation.
  • Provide a new biopsy sample from a tumor lesion that has not been irradiated before starting treatment.
  • If living with HIV, have well-controlled HIV on antiretroviral therapy.

Exclusion Criteria

  • Have small cell lung cancer or tumors with small cell elements.
  • Have severe lung problems due to other lung illnesses.
  • Have active cancer spread to the brain or spinal cord.
  • Have active inflammatory bowel disease requiring immunosuppressive medication.
  • Have leptomeningeal disease (cancer spread to the membranes around the brain and spinal cord).
  • Have uncontrolled heart or blood vessel disease.
  • Have serious eye conditions like severe dry eye or corneal disease.
  • Have HIV with a history of Kaposi's sarcoma or Multicentric Castleman's Disease.
  • Have previously been treated with a KRAS-targeting agent.
  • Have received a live vaccine within 30 days before starting the study treatment.
  • Have an immune deficiency or are on long-term steroid or immunosuppressive therapy.
  • Have another progressing cancer or one that needed treatment in the last 3 years.
  • Have a history of lung inflammation that required steroids or currently have lung inflammation.
  • Have an active infection needing treatment.
  • Have not fully recovered from major surgery or have ongoing surgical complications.

Locations

FACILITYZIPCITYSTATE
Clermont Oncology Center ( Site 0041)34711ClermontFlorida
University of Illinois Hospital & Health Sciences System ( Site 0044)60612ChicagoIllinois

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