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Study of M9140 for Patients with Advanced Non-Small Cell Lung Cancer

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of lung cancer known as Non-Small Cell Lung Cancer (NSCLC). The treatment being tested is a new medication called M9140, which is a special kind of drug known as an antibody-drug conjugate (ADC). This means it combines an antibody, which is a protein that can attach to specific targets in the body, with a drug that can help fight cancer. In this case, the antibody targets a protein called CEACAM5 that is often found in high amounts on the surface of cancer cells. The drug part of M9140 is designed to kill these cancer cells once the antibody has attached to them.

The purpose of this study is to see how well M9140 works in treating people with advanced NSCLC. Participants in the study will receive M9140 through an intravenous infusion, which means the medication is given directly into a vein. The study will be conducted in two parts, and participants will be monitored to see how their cancer responds to the treatment. Researchers will also keep track of any side effects that occur during the study.

Throughout the study, doctors will use a set of guidelines called RECIST to measure how the cancer is responding to the treatment. They will look at things like whether the cancer has shrunk, stayed the same, or grown. The study will also gather information on how long any positive effects last and how long it takes for the treatment to start working. Additionally, researchers will check the levels of M9140 in the blood and see if the body produces any antibodies against the drug. The study is expected to continue until early 2028.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to sign an informed consent form. This document confirms that you understand the study's purpose and agree to participate.

    You will undergo initial assessments to ensure you meet the study's eligibility criteria. These assessments include checking your overall health status and reviewing your medical history.

  2. Step 2

    Treatment initiation

    The treatment involves receiving the medication M9140, which is an anti-CEACAM5 antibody-drug conjugate. This medication is administered as a powder that is mixed into a solution for infusion.

    The infusion is given intravenously, meaning it is delivered directly into your bloodstream through a vein. This process will occur once every three weeks, referred to as q3w.

  3. Step 3

    Ongoing treatment and monitoring

    Throughout the study, you will continue to receive the M9140 infusions every three weeks. The duration of your participation will depend on your response to the treatment and the study's overall timeline.

    Regular monitoring will be conducted to assess your response to the treatment. This includes measuring any changes in your condition and checking for any side effects.

  4. Step 4

    Assessments and evaluations

    You will undergo periodic assessments to evaluate the effectiveness of the treatment. These assessments will use criteria known as RECIST v1.1 to measure any changes in your condition.

    The study will also monitor for any adverse events, which are any unwanted effects that may occur during the treatment.

  5. Step 5

    Completion of the study

    The study is expected to continue until January 6, 2028. Your participation may end earlier if you complete the treatment or if it is determined that the treatment is not effective for you.

    Upon completion, you will have a final assessment to review your overall health and the outcomes of the treatment.

Who can join the trial?

10 criteria

  • Participants must be able to sign an informed consent form, which means they understand the study and agree to take part.
  • Participants in Part B must have tumors with CEACAM5high and known EGFR mutations, as determined by local clinical practice. EGFR mutations are changes in a gene that can affect cancer growth.
  • Participants must have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1. This is a scale used to assess how a disease affects a patient's daily living abilities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • Participants must have adequate blood, liver, and kidney function, as defined in the study protocol.
  • Participants must have at least one lesion (area of abnormal tissue) that can be measured using RECIST v1.1, which is a set of rules for measuring how tumors respond to treatment.
  • Participants in Part A and Part B must have advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) that is confirmed by a tissue sample. Advanced means the cancer cannot be removed by surgery or cured with radiation, and metastatic means it has spread to other parts of the body.
  • Participants must have been intolerant to, or their cancer must have worsened after, treatments for advanced or metastatic cancer.
  • Participants must have received and their cancer must have worsened after at least one but no more than three lines of therapy for advanced or metastatic disease.
  • Participants who received a treatment containing platinum or a targeted therapy for early-stage disease, and whose cancer returned or spread during or within three months after completing the treatment, are considered to have received a line of treatment for advanced disease.
  • Participants in Part A must have tumors with CEACAM5high expression, including those with any genetic changes other than EGFR mutations.

Who cannot join the trial?

8 criteria

  • Patients with any other type of cancer besides Non-Small Cell Lung Cancer cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not able to follow the study procedures or comply with the study requirements cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with certain medical conditions that might interfere with the study cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have a history of allergic reactions to similar medications cannot participate.
  • Patients who are unable to provide informed consent cannot participate.
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Investigated drugs

M9140 is a special type of treatment called an antibody-drug conjugate. This means it combines an antibody, which is a protein that can find and attach to specific targets in the body, with a drug that can kill cancer cells. In this study, M9140 is being tested to see how well it works in treating people with advanced non-small cell lung cancer. The goal is to see if it can help shrink the cancer or stop it from growing. This treatment is given to patients every three weeks, and researchers are looking to see how the cancer responds to this therapy.

What is already known about the treatment

M9140 – M9140 is administered as an injection every three weeks and is currently being studied in clinical trials for its effectiveness in treating advanced Non-Small Cell Lung Cancer. This medication is an antibody-drug conjugate, which means it combines an antibody with a drug to specifically target and kill cancer cells. It works by binding to a protein called CEACAM5 on the surface of cancer cells, delivering the drug directly to them, and causing cell death. M9140 is classified as an anti-cancer agent and is still under investigation to determine its safety and effectiveness in patients.

Investigated diseases

Non-Small Cell Lung Cancer – Non-Small Cell Lung Cancer (NSCLC) is a group of lung cancers that behave similarly and are the most common type of lung cancer. It typically begins in the epithelial cells lining the lungs. The disease progresses as the cancer cells grow and form a mass, which can invade nearby tissues and spread to other parts of the body. NSCLC is often categorized into subtypes, including adenocarcinoma, squamous cell carcinoma, and large cell carcinoma, based on the type of cells involved. As the disease advances, symptoms such as persistent cough, chest pain, and difficulty breathing may occur. The progression can vary significantly among individuals, influenced by factors like the cancer's genetic mutations and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-517818-15-00Protocol codeMS202329_0010Estimated enrolment78 patientsSponsorMerck Healthcare KGaA

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