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Evaluation of Datopotamab Deruxtecan in Patients with Non-Squamous Non-Small Cell Lung Cancer and Active Brain Metastases

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What is this trial about?

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

This study is investigating the use of datopotamab deruxtecan (also called Dato-DXd) for people with non-squamous non-small cell lung cancer (NSCLC) who have active brain metastases. Brain metastases occur when cancer cells from the lung spread to the brain. The purpose is to evaluate how effective this medication is at treating cancer that has spread to the brain.

The research is designed as a Phase II trial, which means it is testing both the safety and effectiveness of the treatment. Datopotamab deruxtecan is an antibody-drug conjugate - a type of medication that combines an antibody that targets cancer cells with a drug that kills those cells. During the study, participants will receive this medication and undergo regular assessments including MRI scans (magnetic resonance imaging) of the brain to monitor how the cancer responds to treatment.

The study will measure how well brain tumors respond to the treatment using specialized criteria called RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases). Participants will be monitored for side effects throughout the study, and their quality of life and brain function will also be assessed.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial Screening and Preparation

    Before starting treatment, you will undergo screening tests to confirm your eligibility for the TUXEDO-5 study, which is testing datopotamab deruxtecan for non-small cell lung cancer (NSCLC) with brain metastases.

    You will have tests to check your heart function, blood counts, and liver function. A brain MRI scan will be performed to measure your brain metastases.

    You must have at least one measurable brain lesion (10 mm or larger) visible on an MRI scan.

  2. Step 2

    Treatment Administration

    You will receive datopotamab deruxtecan as an intravenous infusion (through a vein).

    Before each infusion, you may receive premedication which could include dexchlorpheniramine maleate (Polaramine), paracetamol (acetaminophen), or diphenhydramine hydrochloride (Dibondrin) to help prevent infusion reactions.

    The medication will be administered in cycles, with each treatment given on a regular schedule as determined by your doctor.

  3. Step 3

    Regular Monitoring and Assessment

    Throughout the trial, you will have regular brain MRI scans to assess how your brain metastases are responding to treatment using specific criteria called RANO-BM (Response Assessment in Neuro-Oncology Brain Metastases).

    Other body scans will be performed to monitor cancer outside the brain using criteria called RECIST.

    Blood tests will be regularly conducted to monitor your blood counts and organ function.

    Your neurological function will be assessed using a specialized scale to track any changes in your nervous system symptoms.

  4. Step 4

    Side Effect Monitoring

    Throughout treatment, you will be monitored for side effects, which will be graded according to standardized criteria.

    Special attention will be paid to monitoring your corneas (the clear front surface of your eyes) as this medication may affect them.

    You will complete quality of life questionnaires (EORTC QLQ-C30 and EORTC QLQ-BN20) to assess how the treatment is affecting your daily life and brain-specific symptoms.

  5. Step 5

    Continuation of Treatment

    You will continue receiving treatment until one of the following occurs: your disease progresses, you experience unacceptable side effects, or you decide to withdraw from the study.

    If your treatment is effective (showing complete response, partial response, or stable disease), you may continue receiving it for an extended period.

  6. Step 6

    Follow-up Period

    After completing treatment, you will enter a follow-up period to monitor your long-term response and survival.

    Follow-up visits will include imaging scans to check on your cancer status and assessments of any ongoing side effects.

    This follow-up period will continue according to the study protocol, potentially until February 2027 (the study's estimated completion date).

Who can join the trial?

16 criteria

  • You must have non-small cell lung cancer of the non-squamous type (a specific form of lung cancer).
  • You must be at least 18 years old when signing the consent form.
  • You must be able to understand the purpose of the study and sign a written informed consent form.
  • You must have an ECOG performance status of 2 or less (a scale that measures your ability to perform daily activities).
  • You must have a life expectancy of at least 6 weeks at screening.
  • You must have received certain previous treatments for your lung cancer, depending on whether you have specific genetic changes (called actionable genomic alterations or AGA) in your cancer.
  • You must have at least one measurable brain lesion (tumor) of 10 mm or larger on an MRI scan.
  • Your corticosteroid dose (if you take any) must be stable or decreasing for at least 7 days.
  • You must be able to provide a tumor tissue sample (either from previous procedures or a new biopsy).
  • Your heart function must be adequate (with an ejection fraction of at least 50% - this measures how well your heart pumps blood).
  • You must have adequate bone marrow and liver function as measured by blood tests.
  • Any side effects from previous cancer treatments must have resolved to grade 1 or less (except for hair loss or other issues your doctor considers safe).
  • If you're a woman who can become pregnant and are sexually active, you must have a negative pregnancy test and use effective birth control during the study and for 7 months after.
  • If you're a man who is sexually active with a woman who can become pregnant, you must use contraception during the study and for 4 months after.
  • You must not need immediate brain surgery or radiation therapy for your brain metastases (cancer that has spread to the brain).
  • You must be accessible for treatment and follow-up visits.

Who cannot join the trial?

11 criteria

  • Having any other type of lung cancer besides non-small cell lung cancer (NSCLC)
  • Not having brain metastases (cancer that has spread to the brain from the lungs)
  • Previous treatment with an antibody-drug conjugate (a type of targeted therapy that combines an antibody with a cancer-killing drug)
  • Having had surgery, radiation therapy, or other treatments for brain metastases within 2 weeks before starting the study
  • Having leptomeningeal disease (cancer that has spread to the fluid and tissues surrounding the brain and spinal cord)
  • History of interstitial lung disease (a group of disorders that cause scarring of lung tissue) or pneumonitis (inflammation of lung tissue)
  • Significant heart problems, including heart failure or recent heart attack
  • Active infections requiring treatment
  • Uncontrolled high blood pressure
  • Other cancers diagnosed within the past 5 years (except for certain skin cancers or cancer that has been successfully treated)
  • Pregnancy or breastfeeding
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Investigated drugs

Datopotamab deruxtecan (Dato-DXd) is a medication being studied for treating non-squamous non-small cell lung cancer that has spread to the brain (brain metastases). It belongs to a class of drugs called antibody-drug conjugates, which combine an antibody that targets cancer cells with a cell-killing substance. The antibody part helps deliver the medication directly to cancer cells, potentially reducing damage to healthy cells.

What is already known about the treatment

Datopotamab deruxtecan (Dato-DXd) – An antibody-drug conjugate administered intravenously that is currently being investigated in clinical trials for non-small cell lung cancer (NSCLC) with brain metastases. This medication combines a monoclonal antibody targeting TROP2 (a protein often overexpressed in many cancers) with a potent topoisomerase I inhibitor payload, allowing targeted delivery of chemotherapy to cancer cells while potentially reducing systemic side effects. Dato-DXd belongs to the class of targeted cancer therapies and works by binding to cancer cells expressing TROP2, after which the medication is internalized and releases its cytotoxic payload, causing DNA damage and cell death. The TUXEDO-5 study is specifically evaluating its effectiveness against brain metastases in non-squamous NSCLC patients, where treatment options have traditionally been limited.

Investigated diseases

Non-small cell lung cancer (NSCLC) – A type of lung cancer that begins in the cells lining the bronchi and parts of the lung such as the bronchioles or alveoli. It is characterized by abnormal growth of cells that can form tumors and may spread to other parts of the body. NSCLC accounts for about 85% of all lung cancers and includes several subtypes such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. The disease typically progresses slowly compared to small cell lung cancer, though its growth rate can vary. As it advances, NSCLC can spread (metastasize) to nearby lymph nodes and distant organs, including the brain, bones, liver, and adrenal glands.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512369-14-00Protocol codeMEDOPP750Estimated enrolment20 patientsSponsorMedica Scientia Innovation Research S.L.

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