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Study on the Safety and Effectiveness of Telisotuzumab Vedotin for Patients with Previously Treated c-Met Positive Non-Small Cell Lung Cancer

Verified siteInvestigationalNo 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 study is specifically looking at cases where the cancer has a certain characteristic called c-Met+. The treatment being tested in this trial is a medication called Telisotuzumab Vedotin, which is also known by its code name ABBV-399. This medication is given as a solution for injection directly into the bloodstream, a method known as intravenous administration.

The purpose of the study is to evaluate how well Telisotuzumab Vedotin works in treating patients with c-Met+ NSCLC who have already received other treatments. The study will also look at the safety and tolerability of the medication when given at a specific dose. Participants in the study will receive the medication every two weeks, and the study will monitor their response to the treatment over time.

Throughout the study, researchers will assess how the cancer responds to the treatment, including how long any positive effects last and whether the cancer stops growing. The study will also track the overall survival of participants and how long they live without the cancer getting worse. This information will help determine the effectiveness of Telisotuzumab Vedotin in treating this specific type of lung cancer.

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, the patient is confirmed to have non-small cell lung cancer (NSCLC) with specific characteristics, such as c-Met+ status and non-squamous epidermal growth factor receptor (EGFR) wild type.

    The patient must have progressed on previous treatments or be ineligible for certain therapies. A performance status assessment is conducted to ensure eligibility.

  2. Step 2

    Pre-screening and tumor assessment

    The patient submits tumor material for assessment of c-Met levels. This can be archival or fresh tumor material from the primary or metastatic sites.

    If archival tissue is negative for c-Met overexpression, a fresh biopsy may be required for reassessment.

  3. Step 3

    Treatment initiation

    The patient begins treatment with telisotuzumab vedotin, administered as a solution for injection through intravenous administration.

    The dosage is 1.6 mg per kilogram of body weight, given every two weeks (Q2W).

  4. Step 4

    Monitoring and evaluation

    Throughout the study, the patient's response to the treatment is monitored. The primary focus is on the overall response rate (ORR) to the medication.

    Secondary evaluations include the duration of response (DoR), disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).

  5. Step 5

    Completion of the study

    The study is estimated to conclude by January 6, 2025. The patient's participation continues until the study's end or until specific criteria for discontinuation are met.

Who can join the trial?

11 criteria

  • Must have a confirmed diagnosis of Non-Small Cell Lung Cancer (NSCLC), which is a type of lung cancer, with a specific status of a protein called EGFR (wild type).
  • Must not have an active SARS-CoV-2 infection, which is the virus that causes COVID-19. If previously infected, at least 10 days must have passed since the first positive test or recovery.
  • Must have locally advanced or metastatic NSCLC, meaning the cancer has spread beyond the lungs.
  • Must have a specific protein called c-Met present in the cancer cells, confirmed by a special test. Tumor samples may be needed for this test.
  • If eligible based on previous tumor samples, fresh samples may be needed before starting the study drug, unless not appropriate.
  • Must have tried and not responded to certain cancer treatments, including chemotherapy and immune checkpoint inhibitors. These are treatments that use drugs to kill cancer cells or help the immune system fight cancer.
  • Must have had no more than 2 previous treatments for advanced or metastatic cancer, including no more than 1 chemotherapy treatment.
  • Must not have received previous treatments targeting the c-Met protein.
  • Must have an ECOG Performance Status of 0 to 1, which means being fully active or having some symptoms but still able to carry out light work.
  • Must have a negative test for SARS-CoV-2 if showing symptoms, confirmed by specific tests.
  • Both male and female participants are eligible.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer other than Non-Small Cell Lung Cancer (NSCLC) cannot participate. NSCLC is a type of lung cancer.
  • Patients who are not within the specified age range for the study cannot participate. The study has specific age requirements.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have other serious health conditions that might interfere with the study cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have participated in another clinical trial recently may not be eligible.
  • Patients who have allergies or reactions to the study medication or similar medications cannot participate.
  • Patients who have certain infections or diseases that could affect the study results cannot participate.
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Investigated drugs

Telisotuzumab Vedotin (ABBV-399) is a medication being studied for its effectiveness and safety in treating patients with a specific type of lung cancer known as c-Met positive non-small cell lung cancer (NSCLC). This medication is designed to target and bind to cancer cells that express the c-Met protein, which is often associated with tumor growth and spread. By delivering a potent anti-cancer agent directly to these cells, telisotuzumab vedotin aims to reduce the size of tumors and slow the progression of the disease. The study focuses on understanding how well patients respond to this treatment and how safe it is for them to use.

What is already known about the treatment

Telisotuzumab Vedotin – This medication is administered intravenously and is currently being studied in clinical trials for its safety and effectiveness in treating non-small cell lung cancer (NSCLC) that expresses the c-Met protein. It is in the phase 2 stage of clinical trials, focusing on patients who have previously received treatment. The main therapeutic indication is for c-Met positive NSCLC. Telisotuzumab Vedotin works by targeting and binding to the c-Met protein on cancer cells, delivering a cytotoxic agent directly to the tumor, which helps to inhibit cancer cell growth. It is classified as an antibody-drug conjugate, combining a monoclonal antibody with a chemotherapy drug to enhance its cancer-fighting capabilities.

Investigated diseases

Non-Small Cell Lung Cancer – This is the most common type of lung cancer, accounting for about 85% of cases. It typically begins in the epithelial cells lining the lungs and can spread to other parts of the body. The disease progresses through stages, starting from localized tumors in the lungs to more advanced stages where it may spread to lymph nodes and other organs. Symptoms often include a persistent cough, chest pain, and difficulty breathing. As the disease advances, it may lead to more severe respiratory issues and systemic symptoms like weight loss and fatigue. Early detection is crucial for managing the disease effectively.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-507902-15-00Protocol codeM14-239Estimated enrolment270 patientsSponsorAbbVie Deutschland GmbH & Co. KG

sourced from the EU Clinical Trials Register and site verification

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