Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

A study comparing the effectiveness and safety of datopotamab deruxtecan and docetaxel in adults with advanced or metastatic non-squamous non-small cell lung cancer

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This study is being conducted to compare the effectiveness and safety of datopotamab deruxtecan against docetaxel in patients with a specific type of Non-Small Cell Lung Cancer. The cancer being studied is non-squamous non-small cell lung cancer, which is a type of lung cancer that does not grow in the flat, scale-like cells found on the surface of the lungs. The study focuses on patients whose cancer is TROP2-positive, meaning the cancer cells have a specific protein called TROP2 on their surface, and who do not have actionable genomic alterations, which are specific genetic changes in the cancer cells that can be targeted by other existing drugs.

The cancer being investigated is also classified as advanced or metastatic, meaning it has grown beyond the original part of the lung or has spread to other parts of the body. Participants in this trial will receive their treatment through intravenous use, which involves delivering the medication directly into a vein using a liquid solution for infusion. The study will monitor how long the cancer remains stable without growing and the overall length of time patients live during the trial.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    <b>study participation</b>

    After joining the study, assignment to a specific treatment group occurs. this is done through a process called randomization, which is a method used to decide which treatment is received to ensure the results are fair.

    The treatment received is either datopotamab deruxtecan or docetaxel.

  2. Step 2

    <b>treatment administration</b>

    If assigned to the test group, datopotamab deruxtecan is administered as an intravenous infusion. this means the medication is delivered directly into a vein through a tube.

    If assigned to the comparator group, docetaxel is administered as an intravenous infusion through a vein.

  3. Step 3

    <b>monitoring and evaluation</b>

    During the study, the effectiveness of the medication is monitored by measuring progression-free survival, which is the length of time during and after treatment that the disease does not get worse.

    The overall survival, which is the length of time a person remains alive, is also recorded.

    The response rate, which indicates how much the tumor shrinks or disappears, and the duration of response, which is how long that shrinkage lasts, are measured.

    The safety and how well the body tolerates the medication are continuously assessed.

Who can join the trial?

10 criteria

  • You must have a confirmed diagnosis of non-squamous non-small cell lung cancer, which is a specific type of lung cancer that does not involve certain cell shapes, in stage IIIB, IIIC, or IV.
  • Your cancer must be advanced or metastatic, meaning it has spread to other parts of the body.
  • You must test negative for specific genetic changes in your cancer cells, such as EGFR, ALK, ROS1, NTRK, BRAF, RET, MET exon 14 skipping, KRAS G12C, or HER2. These are called actionable genomic alterations, which are specific genetic mutations that can usually be treated with other targeted medicines.
  • Your cancer must test positive for a protein called TROP2 using a specific testing method called NMR (nuclear magnetic resonance) on a specialized device.
  • Your cancer must have shown signs of progression, which means the disease has grown or spread, while you were receiving your most recent treatment or after you finished it.
  • You must have previously received platinum-based chemotherapy (a type of strong medicine used to kill cancer cells) either alone or combined with anti-PD-1/anti-PD-L1 monoclonal antibodies (a type of immunotherapy that helps the immune system fight cancer).
  • You must be able to provide a tumor sample that has been preserved using a method called FFPE (formalin-fixed paraffin-embedded) so that doctors can test for the TROP2 protein.
  • You must have at least one tumor lesion (an area of abnormal tissue) that has not been treated with radiation and is large enough to be clearly measured using a CT scan or MRI.
  • Your ECOG performance status must be 0 or 1, which means you are able to carry out most daily activities and are generally well.
  • Your bone marrow (the part of your body that makes blood cells) and your organ function (how well your organs like the liver or kidneys work) must be healthy and meet specific requirements.

Who cannot join the trial?

12 criteria

  • People with squamous cell carcinoma, mixed non-small cell lung cancer, or small cell lung cancer, which are different types of lung cancer cell shapes.
  • People who have severe pulmonary function compromise, meaning their lungs do not work well enough to breathe normally.
  • People whose lung cancer can be treated with definitive local therapy, which refers to treatments like surgery or radiation that target only one specific area.
  • People who have had another primary malignancy, which is a different type of cancer, unless it was fully treated and has been gone for at least 3 years.
  • People with spinal cord compression, where a tumor presses on the spine, or brain metastases, which are cancer cells that have spread to the brain, unless these conditions are stable and not causing symptoms.
  • People who require corticosteroids (steroid medicines to reduce swelling) or anticonvulsants (medicines to prevent seizures) for the conditions mentioned above.
  • People with clinically significant corneal disease, which means there is a serious problem with the clear front part of the eye.
  • People with an active or uncontrolled hepatitis B or C virus infection, which are viruses that cause inflammation of the liver.
  • People with an HIV infection that is not well controlled.
  • People with an uncontrolled infection that requires medicine given through a vein, such as antibiotics, antivirals, or antifungals.
  • People with a history of non-infectious ILD or pneumonitis, which are conditions involving inflammation or scarring of the lung tissue that is not caused by an infection.
  • People who currently have or are suspected of having ILD or pneumonitis that cannot be ruled out by medical imaging.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

RecruitingNot yet recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Datopotamab deruxtecan

    is a targeted therapy given through a vein that works by delivering medicine directly to certain proteins found on the surface of cancer cells to help fight the disease.

  • Docetaxel

    is a type of chemotherapy drug given through a vein that works by stopping cancer cells from dividing and growing.

What is already known about the treatment

  • Datopotamab deruxtecan

    This medication is administered as a liquid through an intravenous infusion directly into a vein. It is currently being studied in clinical trials as a targeted therapy for patients with certain types of advanced lung cancer. The drug works by attaching itself to a specific protein called TROP2 found on the surface of cancer cells and then releasing a powerful chemotherapy agent directly inside those cells to destroy them. It is classified as an antibody-drug conjugate.

  • Docetaxel

    This medication is given through an intravenous infusion into the bloodstream. It is an established treatment widely used in medical practice to manage various types of advanced cancers. It works by interfering with the internal structure of cancer cells, specifically preventing them from dividing and multiplying correctly, which ultimately leads to cell death. It is classified as a taxane-based chemotherapy drug.

Investigated diseases

Non-squamous non-small cell lung cancer - This is a type of lung cancer that does not originate from squamous cells, which are flat cells found in the lining of the airways. Instead, it develops from other types of cells within the lungs. The disease can start in one area and may eventually spread to other parts of the body. As it progresses, the cancer cells multiply and can interfere with normal lung function. It is characterized by the absence of specific genetic changes that are typically targeted by certain therapies.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520101-39-00Protocol codeD763QC00001Estimated enrolment400 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.