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A Study of Telisotuzumab Adizutecan Compared to Standard Treatment in Adults with Advanced Non-Small Cell Lung Cancer After Previous Treatment

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What is this trial about?

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

This study involves Non-Small Cell Lung Cancer that has an EGFR mutation, which is a change in a specific gene that can affect how cancer cells grow. The cancer being studied is the non-squamous type, meaning it does not involve certain flat cells, and it has either spread to other parts of the body or grown in a way that makes surgery difficult. The study is for people whose cancer has continued to grow after treatment with a third-generation EGFR TKI, which is a type of targeted therapy medicine that blocks signals telling cancer cells to grow. The main treatment being tested is telisotuzumab adizutecan, also known as ABBV-400, which is given through a vein. This treatment will be compared to standard care options, which may include combinations of medicines such as carboplatin, cisplatin, pemetrexed, osimertinib, or amivantamab.

The purpose of this study is to find out if telisotuzumab adizutecan is safe and works better than standard treatments for this type of lung cancer. The study will look at whether the treatment can shrink tumors, slow down cancer growth, and help people live longer. It will also measure how the treatment affects quality of life and physical functioning. The study has two parts: the first part will test the safety of the treatment and help determine the best dose to use, while the second part will compare how well the treatment works against standard care options.

During the study, participants will receive either telisotuzumab adizutecan or one of the standard treatment options. The medicine is given through an infusion into a vein over a period of time. Participants will have regular visits where doctors will check their health, take blood samples, and perform scans to see how the cancer is responding to treatment. The study will track how long it takes for the cancer to grow, how long people live, and whether tumors shrink or disappear. Participants may stay in the study for several months or longer, depending on how well the treatment works and whether they experience any problems.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Random assignment to treatment group

    Upon joining the study, you will be randomly assigned to one of the treatment groups. This process is similar to flipping a coin and determines which treatment you will receive.

    The study compares telisotuzumab adizutecan with standard treatment options for lung cancer that has progressed after previous therapy.

  2. Step 2

    Tissue sample submission

    A sample of your tumor tissue will be required for laboratory testing. This can be tissue that was previously collected and stored, or a recently obtained sample.

    The tissue will be tested for a specific protein marker called c-Met using a laboratory technique called immunohistochemistry. This test helps determine characteristics of your cancer cells.

  3. Step 3

    Treatment administration

    Depending on your assigned group, you will receive one of the following treatment options:

    Option 1: Telisotuzumab adizutecan administered through a vein as an infusion.

    Option 2: Standard treatment, which may include one of the following combinations:

    - Osimertinib taken by mouth

    - Pemetrexed given through a vein as an infusion combined with cisplatin given through a vein as an infusion

    - Pemetrexed given through a vein as an infusion combined with carboplatin given through a vein as an infusion

    - Amivantamab given through a vein as an infusion

    The specific doses, frequency, and duration of treatment will be determined by the study protocol and your response to therapy.

  4. Step 4

    Regular monitoring and assessments

    Throughout the study, you will undergo regular medical examinations and tests to monitor your condition and assess how the treatment is working.

    Imaging scans will be performed at scheduled intervals to measure changes in your tumor size. These assessments follow standardized criteria called Response Evaluation Criteria in Solid Tumors, or RECIST version 1.1.

    The imaging results will be reviewed by independent medical experts who do not know which treatment you are receiving. This is called blinded independent central review.

  5. Step 5

    Safety monitoring

    Your health and any side effects you experience will be closely monitored throughout the study.

    You will be asked to report any new symptoms or changes in your condition.

    Regular laboratory tests and physical examinations will be conducted to ensure your safety during treatment.

  6. Step 6

    Quality of life assessments

    You will be asked to complete questionnaires at various points during the study to assess your physical functioning and overall well-being.

    These questionnaires, called EORTC QLQ-C30 and EORTC QLQ-LC13, ask about your daily activities, symptoms related to lung cancer, and your general quality of life.

    Your responses help measure how the treatment affects your day-to-day life and specific lung cancer symptoms.

  7. Step 7

    Continuation of treatment

    Treatment will continue as long as your cancer does not progress and you do not experience unacceptable side effects.

    The study team will regularly evaluate whether continuing treatment remains appropriate for your situation.

  8. Step 8

    Long-term follow-up

    Even after treatment ends, you will continue to be followed to assess your overall survival and long-term outcomes.

    The study is expected to continue until June 2029, though your individual participation duration may vary based on your response to treatment and overall condition.

Who can join the trial?

7 criteria

  • You must have a confirmed diagnosis of non-squamous non-small cell lung cancer, which is a specific type of lung cancer that has spread locally or to other parts of the body, with a specific genetic change called EGFR Exon 19 deletion or Exon21 L858R mutation. This genetic change must be confirmed by an approved laboratory test.
  • You must be able to provide stored or newly collected tumor tissue samples during the screening process for laboratory testing.
  • You must have received one previous treatment with a medication called a third-generation EGFR TKI, which is a type of targeted cancer drug. This treatment could have been given alone or with other medications, and your cancer must have grown or spread while on this treatment or after completing it.
  • You must have an ECOG Performance Status of 0 to 1, which is a scale that measures 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.
  • You must have at least one tumor that can be measured by imaging scans according to specific cancer measurement guidelines, and this tumor must not have been treated with radiation before.
  • If you have cancer that has spread to your central nervous system, which includes your brain and spinal cord, it must either cause no symptoms or be stable after treatment.
  • You must not have current, past, or suspected interstitial lung disease or pneumonitis, which are conditions causing inflammation or scarring in the lungs, if they required treatment with steroid medications.

Who cannot join the trial?

5 criteria

  • The study does not list specific exclusion criteria in the provided information, which means the reasons why patients cannot participate have not been detailed in this document
  • To know if you can take part in this study, you will need to discuss with the research team about any health conditions, previous treatments, or other factors that might prevent you from joining
  • Generally, clinical trials may exclude patients based on factors such as other serious illnesses, certain medications being taken, previous cancer treatments, or test results showing that organs like the liver (the organ that cleans your blood) or kidneys (the organs that filter waste from your blood) are not working well enough
  • Pregnant or breastfeeding women are often excluded from cancer treatment studies to protect the unborn baby or nursing infant
  • People with active infections or weakened immune systems may not be able to participate
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Investigated drugs

  • Telisotuzumab adizutecan

    is an experimental medication being tested in this clinical trial. It is designed to treat a specific type of lung cancer called non-small cell lung cancer that has certain genetic changes (EGFR mutations). This medicine works by targeting cancer cells and delivering a toxic substance directly to them to help destroy the cancer. Patients in this study will receive this medication to see if it is safe and if it works better than other standard treatments available for this type of lung cancer that has continued to grow despite previous treatment.

  • Standard of care

    refers to the usual treatments that doctors currently use to treat this type of lung cancer. These are medications that have already been approved and are regularly prescribed for patients with advanced non-small cell lung cancer with EGFR mutations. In this study, some patients will receive these standard treatments so that researchers can compare how well the new experimental medication works against the treatments that are already being used.

What is already known about the treatment

Telisotuzumab Adizutecan – This is an experimental cancer medication currently being studied in clinical trials for treating a specific type of lung cancer called non-small cell lung cancer that has a particular genetic mutation (EGFR mutation) and has continued to grow despite previous treatments. The drug is given as an infusion into the vein and works by targeting a protein called c-Met on cancer cells, delivering a toxic substance directly to these cells to destroy them while minimizing damage to healthy tissue. It belongs to a class of drugs known as antibody-drug conjugates, which combine the targeting ability of antibodies with the cell-killing power of chemotherapy. Researchers are testing whether this medication is safe and more effective than standard treatments in stopping cancer progression in patients whose disease has worsened after receiving third-generation EGFR inhibitor therapy.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer is a type of cancer that begins in the lungs and is the most common form of lung cancer. The disease starts when cells in the lung begin to grow abnormally and uncontrollably, forming tumors that can interfere with normal lung function. As the cancer progresses, these abnormal cells can spread to nearby tissues and lymph nodes in the chest. In more advanced stages, the cancer may spread to other parts of the body through the bloodstream or lymphatic system, a process called metastasis. The disease typically develops slowly compared to other types of lung cancer, and symptoms may include persistent cough, chest pain, shortness of breath, and fatigue. Non-small cell lung cancer accounts for approximately 80 to 85 percent of all lung cancer cases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2025-521124-29-00Protocol codeM25-713Estimated enrolment224 patientsSponsorAbbVie Deutschland GmbH & Co. KG

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