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Study of Zelenectide Pevedotin in Adults with Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer with NECTIN4 Amplification

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What is this trial about?

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

This clinical trial focuses on studying advanced or metastatic non-small cell lung cancer with a specific genetic characteristic called NECTIN4 amplification. The study tests a new medication called zelenectide pevedotin (also known as BT8009) in patients who have already received previous treatments for their cancer. The medication is given through intravenous infusion, which means it is administered directly into a vein.

The main purpose of this study is to determine how well zelenectide pevedotin works in treating patients whose tumors have this specific NECTIN4 amplification. The medication is a type of drug called a bicyclic peptide, which is designed to target specific cancer cells. The study will include patients with two different types of non-small cell lung cancer: squamous and non-squamous forms of the disease.

During the study, participants will receive zelenectide pevedotin through intravenous infusion. The treatment will be given in cycles, with regular medical check-ups to monitor the patient's health and how well the treatment is working. The maximum dose that can be given is 6 milligrams per square meter of body surface area. The study team will track if the tumors shrink, stay the same size, or grow during the treatment period.

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 medical assessment

    Your eligibility will be confirmed through medical tests and examination

    Your cancer must be confirmed as advanced or metastatic non-small cell lung cancer

    A NECTIN4 gene test will be performed to confirm if your tumor has the required genetic characteristics

    Basic health measurements will be taken, including blood tests, liver and kidney function tests

  2. Step 2

    Pre-treatment requirements

    A tumor tissue sample will be collected or previous samples will be used for laboratory testing

    Your oxygen level must be at least 93% when breathing room air

    Pregnancy test is required for women who can become pregnant

    You must agree to use effective birth control methods during the study and for 6.5 months after the last dose

  3. Step 3

    Treatment administration

    Zelenectide pevedotin (BT8009) will be given through an intravenous infusion

    The medication comes as a powder that will be prepared as a solution for infusion

    Regular assessments of your tumor response will be conducted using imaging scans

    Your overall health status will be monitored throughout the treatment

  4. Step 4

    Ongoing monitoring

    Regular blood tests will check your bone marrow function

    Your liver and kidney function will be monitored regularly

    The medical team will track any side effects you may experience

    Imaging scans will be performed to measure how your tumor responds to treatment

  5. Step 5

    Post-treatment follow-up

    You will be monitored for at least 6.5 months after your last treatment dose

    Continue using birth control methods during this period

    Regular check-ups will assess your long-term health status

    Your survival and disease progression will be tracked

Who can join the trial?

19 criteria

  • Must be at least 18 years old
  • Must be able to understand and agree to participate in the study by signing an informed consent form
  • Must have confirmed advanced or metastatic non-small cell lung cancer (cancer that has spread to other parts of the body)
  • Must have a specific genetic feature called NECTIN4 gene amplification confirmed by testing
  • Must not have received more than 3 previous treatments for advanced cancer
  • Must have measurable tumors that can be evaluated using specific criteria (RECIST v1.1)
  • Must provide tumor tissue samples for laboratory testing
  • Must have a life expectancy of at least 12 weeks
  • Must have good physical functioning ability (ECOG score of 0 or 1)
  • Must have adequate oxygen levels (93% or higher) when breathing room air
  • Must have adequate liver, kidney, and blood function based on specific laboratory tests
  • Must have normal blood clotting function, unless on stable anticoagulation therapy
  • Must have adequate bone marrow function showing acceptable levels of:
    • Red blood cells (hemoglobin)
    • White blood cells (neutrophils)
    • Platelets
    • If of childbearing potential, must have a negative pregnancy test
    • Must agree to use effective birth control during the study and for 6.5 months after the last dose
    • Must not donate sperm or eggs during the study and for 6.5 months after the last dose
    • Women must not breastfeed during the study and for 6.5 months after the last dose

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 75 years
  • Prior treatment with zelenectide pevedotin (the study medication)
  • Absence of NECTIN4 amplification in tumor tissue (a specific genetic marker)
  • Current participation in other clinical trials
  • Known allergies to similar medications
  • Presence of brain metastases (cancer spread to the brain) that are not stable or treated
  • Significant heart problems or uncontrolled high blood pressure
  • Active infections requiring treatment
  • Major surgery within 4 weeks before starting the study
  • Pregnancy or breastfeeding
  • Inability to follow study procedures or attend scheduled visits
  • Severe liver or kidney dysfunction
  • History of other cancers within the past 3 years (except for successfully treated non-melanoma skin cancer or cervical cancer in situ)
  • Use of medications that could interfere with the study drug
  • Any condition that, in the opinion of the study doctor, would make participation unsafe
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Investigated drugs

Zelenectide pevedotin is an investigational drug being studied for the treatment of non-small cell lung cancer. It specifically targets tumors that have increased levels of a protein called NECTIN4. This medication belongs to a class of drugs known as antibody-drug conjugates, which combine an antibody that targets specific cancer cells with a drug that can kill those cells. It is designed to work in patients whose cancer has already been treated with other therapies and has either spread to other parts of the body or is at an advanced stage.

What is already known about the treatment

Zelenectide pevedotin - A novel antibody-drug conjugate administered through intravenous infusion, currently being investigated in Phase 2 clinical trials for the treatment of advanced or metastatic non-small cell lung cancer (NSCLC) with NECTIN4 amplification. The medication works by targeting NECTIN4-expressing tumor cells and delivering a potent cytotoxic agent directly to cancer cells, potentially minimizing damage to healthy tissues. This investigational therapy belongs to the class of targeted cancer therapeutics and represents a promising approach for patients who have previously received other treatments for NSCLC, with its effectiveness being evaluated primarily through measuring tumor response rates according to standardized criteria.

Investigated diseases

Non-small Cell Lung Cancer – A type of lung cancer that begins in the large cells outside of the small cells in the lungs. It develops when healthy cells in the lung tissue begin to grow uncontrollably and form masses called tumors. The disease can spread from its original location to other parts of the body through the blood or lymph system, which is known as metastasis. Advanced or metastatic forms indicate that the cancer has spread beyond its initial location in the lungs to other parts of the body. This cancer typically grows and spreads more slowly than small cell lung cancer. Non-small cell lung cancer accounts for the majority of all lung cancer cases.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2025-521115-40-00Protocol codeBT8009-202Estimated enrolment72 patientsSponsorBicycletx Limited

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).