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Study of MCLA-129 with Chemotherapy and Osimertinib for Patients with Advanced Non-Small Cell Lung Cancer and Other Solid Tumors

Verified siteRegistered drugNo 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 the effects of a new treatment called MCLA-129 in patients with advanced forms of cancer, specifically Non-Small Cell Lung Cancer (NSCLC) and other types of solid tumors. The study will explore how well MCLA-129 works on its own and in combination with other cancer treatments, including osimertinib, a medication taken orally, and chemotherapy drugs such as paclitaxel, docetaxel, and carboplatin, which are given through an infusion into a vein.

The purpose of the study is to understand the response of the tumors to the treatment, how safe and tolerable the treatment is for patients, and to gather information on how the body processes MCLA-129. The study will also look at how long patients live without the cancer getting worse and the overall survival rate of the patients. The trial will be conducted in phases, starting with a dose escalation phase to find the best dose of MCLA-129, followed by an expansion phase to further evaluate its effects.

Participants in the study will receive MCLA-129 either alone or in combination with other treatments, and some may receive a placebo. The study will monitor the patients' health and the progression of their cancer over time. This research aims to provide new insights into the treatment of advanced NSCLC and other solid tumors, potentially leading to more effective therapies in the future.

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

    Initial visit

    Upon joining the study, you will have an initial visit where you will receive detailed information about the trial. This includes understanding the purpose, procedures, and potential risks and benefits.

    You will be asked to sign an informed consent form, confirming your willingness to participate and understanding of the study.

  2. Step 2

    Screening

    During the screening phase, your eligibility for the trial will be assessed. This involves checking your medical history, current health status, and specific criteria such as age and performance status.

    Tests may include blood tests, imaging studies, and other assessments to ensure you meet the trial's requirements.

  3. Step 3

    Treatment phase

    If eligible, you will enter the treatment phase. You may receive the investigational drug MCLA-129 alone or in combination with other medications such as osimertinib, paclitaxel, docetaxel, or carboplatin.

    The administration of MCLA-129 is through an intravenous infusion. The frequency and dosage will be determined by the study protocol and your specific treatment plan.

    If you are receiving osimertinib, it will be taken orally as prescribed by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the trial, regular monitoring will occur to assess your response to the treatment and any side effects. This includes physical exams, blood tests, and imaging studies.

    You will have scheduled visits to the clinic for these assessments, and you may be asked to keep a diary of any symptoms or side effects you experience.

  5. Step 5

    End of treatment

    At the end of the treatment phase, a final evaluation will be conducted to assess your overall response to the therapy.

    You will discuss the results with the study team, and they will provide guidance on any further steps or follow-up care needed.

Who can join the trial?

6 criteria

  • Signed informed consent form before starting any study procedures. This means you agree to participate after understanding the study details.
  • Age must be 18 years or older at the time of signing the consent form.
  • Patients with certain types of cancer, such as NSCLC (a type of lung cancer), HNSCC (a type of head and neck cancer), or other solid tumors, with specific mutations as determined by the study doctor.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how well you can perform daily activities. A score of 0 means you are fully active, and 1 means you have some restrictions but can still do light work.
  • Must have adequate heart and organ function, meaning your heart and other organs are working well enough to participate.
  • Life expectancy of at least 12 weeks, as judged by the study doctor.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides solid tumors cannot participate. Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas.
  • Patients who have not recovered from the side effects of previous cancer treatments are excluded.
  • Patients with severe heart problems are not eligible.
  • Patients with uncontrolled infections cannot take part in the study.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cervical cancer, are excluded.
  • Patients with known allergies to the study drugs or similar drugs cannot join the trial.
  • Patients who have received another investigational drug within the last 4 weeks are not eligible.
  • Patients with certain lung conditions that are not well controlled are excluded.
  • Patients with a history of certain autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
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Investigated drugs

  • MCLA-129

    is a special type of treatment called a bispecific antibody. This means it is designed to target two specific proteins in the body, EGFR and c-MET, which are often involved in the growth of cancer cells. By targeting these proteins, MCLA-129 aims to slow down or stop the growth of cancer, particularly in patients with advanced non-small cell lung cancer (NSCLC) and other solid tumors. The study is looking at how well MCLA-129 works on its own and when combined with other treatments.

  • Osimertinib

    is a medication used to treat certain types of lung cancer. It works by blocking the activity of a protein called EGFR, which can help slow down or stop the growth of cancer cells. In this trial, osimertinib is being used in combination with MCLA-129 to see if the two treatments together can be more effective than using MCLA-129 alone.

What is already known about the treatment

MCLA-129 – MCLA-129 is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating advanced non-small cell lung cancer (NSCLC) and other solid tumors. The medication works by targeting two specific proteins, EGFR and c-MET, which are involved in the growth and spread of cancer cells. By blocking these proteins, MCLA-129 aims to slow down or stop the progression of the cancer. It is classified as a bispecific antibody, which means it is designed to bind to two different targets at the same time.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs, muscles, and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially disrupting their normal function. The growth rate and behavior of solid tumors can vary widely depending on their type and location. Over time, they may spread to other parts of the body through a process known as metastasis.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-514461-19-00Protocol codeMCLA-129-CL01Estimated enrolment287 patientsSponsorMerus B.V.

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