A study of MK-1084 and a drug combination for patients with advanced or metastatic non-small cell lung cancer with KRAS G12C mutations.

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What is this study about?

This study focuses on individuals with advanced or metastatic Non-small Cell Lung Cancer, which is a type of lung cancer that has spread to other parts of the body. The research specifically targets patients whose cancer cells contain a KRAS G12C mutation, a specific genetic change that helps the cancer grow. The purpose of the study is to evaluate the safety and how well different combinations of experimental medicines work for this specific condition.

Several different medications are being studied, which may be given alone or in combination with other treatments. These include MK-1084, an oral tablet, as well as patritumab deruxtecan and sacituzumab tirumotecan, which are administered through intravenous infusion, a method where medicine is delivered directly into a vein. Other possible treatments include cetuximab. Some participants may also receive corticosteroids, which are medicines used to reduce inflammation.

During the study, participants will receive different combinations of these medications to see how they affect the cancer. The research will monitor how the body reacts to the treatments and whether the cancer shrinks or stops growing. The course of the study involves regular medical monitoring to track the effects of the drugs and any side effects that may occur.

Who Can Join the Study?

  • You must have a confirmed diagnosis of advanced or metastatic non-squamous non-small cell lung cancer, which means the cancer is an advanced type that has spread to other parts of the body.
  • Your cancer must be confirmed through histology (looking at cells under a microscope) or cytology (looking at individual cells).
  • Your tumor tissue or circulating tumor DNA, which is tiny pieces of genetic material from the cancer found in the blood, must show a specific genetic change called a KRAS G12C mutation.
  • Your cancer must have continued to grow or get worse even after you received one or two previous treatments involving PD-1 or PD-L1 inhibitors (drugs that help the immune system fight cancer) and platinum-based chemotherapy (a type of powerful medicine used to kill cancer cells).
  • You must be able to provide an old sample of your tumor tissue, called an archival sample, from a part of the tumor that has not been treated with radiation.
  • You must be able to provide a new tissue sample through a biopsy, which is a procedure to remove a small piece of tissue for testing, from a part of the tumor that has not been treated with radiation.
  • If you have HIV, your infection must be well-controlled using antiretroviral therapy, which is the daily medication used to manage the virus.
  • The study is open to both males and females within the required age range.

Who Cannot Join the Study?

  • You have been diagnosed with small cell lung cancer, which is a different type of lung cancer, or a mix of cancer types that includes small cell elements.
  • You have received a live vaccine, which is a type of vaccine that uses a weakened version of a germ, within 30 days before your first dose of the study treatment.
  • You have an immunodeficiency, which means your body’s immune system is not working correctly, or you are taking systemic steroids or other immunosuppressive therapy (medicines that lower your body’s ability to fight infection) within 7 days before the first dose.
  • You have another type of malignancy (cancer) that is currently growing or has needed treatment in the last 3 years.
  • You have a history of or currently have pneumonitis (inflammation of lung tissue) or interstitial lung disease (a group of disorders that cause scarring of lung tissue) that required the use of steroids.
  • You have an active infection that requires systemic therapy (medicine that travels through your whole body, such as pills or injections).
  • You have not fully recovered from a major surgery or are experiencing ongoing problems from a recent surgery.
  • You have severe lung problems caused by other sudden illnesses.
  • You have metastases (cancer that has spread) in the central nervous system (the brain and spinal cord) or carcinomatous meningitis (cancer that has spread to the protective layers covering the brain and spinal cord).
  • You have inflammatory bowel disease (a condition causing inflammation in your digestive tract) that is active and requires medicine to lower your immune system, or you have a history of this condition.
  • There is evidence of leptomeningeal disease, which is cancer that has spread to the fluid and membranes surrounding the brain and spinal cord.
  • You have an uncontrolled or serious cardiovascular disorder (heart disease) or cerebrovascular disease (conditions affecting blood flow to the brain, such as a stroke) before being assigned to the study.
  • You have certain eye conditions, such as significant corneal disease (problems with the clear front part of the eye), a history of severe dry eye syndrome, Meibomian gland disease (problems with oil glands in the eyelids), or blepharitis (inflammation of the eyelids).
  • You are living with HIV and have a history of Kaposi’s sarcoma or Multicentric Castleman’s Disease (specific types of rare cancers or immune system disorders).
  • You have previously been treated with a medicine that targets the KRAS gene.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Azienda Ospedaliero Universitaria Careggi Florence Italy
Szpital Wojewodzki Im. Mikolaja Kopernika W Koszalinie Koszalin Poland
Koranyi National Institute For Pulmonology Budapest Hungary

Other Sites

Site Name City Country Status
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Alexandra Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
San Raffaele Scientific Institute Milan Italy
Thoraxklinik Heidelberg gGmbH Heidelberg Germany
Jasz-Nagykun-Szolnok Varmegyei Hetenyi Geza Korhaz-Rendelointezet Szolnok Hungary
Hospital Universitario Virgen Macarena Sevilla Spain
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Isxdnobi Rpufpntzv Pgs Li Snrbfb Der Tprqil Dpgm Axcxqja Iruq Svzlkx Meldola Italy
Udflfvcdbxwkcp Ctlgtzs Khqqxpfhe Gdansk Poland
Ipbsfzus Cztdzg Drducjlbyacuspdye L'hospitalet De Llobregat Spain
Bbqhcbjxngn Vasgkzded Oumzqgfdlrrx Kecskemet Hungary
Ldwax Gcnvlai Hiowjsul Ow Aebybg Athens Greece
Nirgezhd Ipxlrkrv Ovmhnhtqp Ijz Mjcbi Sayynllypciciernaffrirrfqffd Iurcltbq Bzwmnosk Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Germany Germany
Not yet recruiting
22.01.2026
Greece Greece
Recruiting
22.01.2026
Hungary Hungary
Not yet recruiting
22.01.2026
Italy Italy
Recruiting
22.01.2026
Poland Poland
Not yet recruiting
22.01.2026
Spain Spain
Recruiting
22.01.2026

Trial locations

Patritumab deruxtecan is an investigational medicine given through an intravenous infusion to target specific proteins on cancer cells.

MK-1084 is an investigational medicine taken by mouth in tablet form.

Sacituzumab tirumotecan is an investigational medicine given through an intravenous infusion to target specific proteins on cancer cells.

Cetuximab is a medicine given through an intravenous infusion used to target certain growth signals in cancer cells.

Non-small cell lung cancer – This is a type of cancer that begins in the cells of the lungs. It is characterized by the uncontrolled growth of abnormal cells in the lung tissue. The disease can start in the lining of the airways or in the lung tissue itself. As it progresses, the cancer cells may spread from their original location to other parts of the lungs or to different organs in the body. It accounts for the majority of lung cancer cases.

Trial ID:
2024-512248-47-00
Protocol code:
MK-3475-01F
Trial Phase:
Human Pharmacology (Phase I) – Other

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