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Evaluating Datopotamab Deruxtecan with drug combination in adults with TROP2‑positive non‑small cell lung cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

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

The study focuses on adults with Non-small Cell Lung Cancer that tests positive for TROP2 NMR-positive. This type of lung cancer grows in the lungs and is not the small cell form. The investigational medicine is Datopotamab deruxtecan, a drug given by intravenous infusion. In the trial the drug is tested alone or together with the immune‑system medicine durvalumab and the chemotherapy agent carboplatin. The purpose of the study is to learn how well the combination works and how safe it is.

Participants receive the study medication through a vein on a regular schedule, usually every three weeks, and may receive the additional medicines in the same visit. Treatment continues for several cycles, after which patients are followed with clinic visits and imaging scans to watch the cancer. The main outcome measured is progression-free survival, which is the time before the cancer gets worse. Other outcomes include objective response rate, the proportion of patients whose tumors shrink, and duration of response, how long the shrinkage lasts.

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

    Baseline Assessments

    After joining the study, you will undergo a series of baseline examinations, including imaging scans and laboratory tests, to document the status of your lung cancer.

    These assessments help the study team determine eligibility for the treatment phases and establish reference points for later comparisons.

  2. Step 2

    Start of First Treatment Cycle

    You will receive an intravenous infusion of datopotamab deruxtecan. This medication is given through a needle placed in a vein and is administered as a solution for infusion.

    At the same time, you will receive an intravenous dose of durvalumab as a bolus injection or infusion, depending on the study protocol.

    If you are assigned to the combination arm that includes chemotherapy, you will also receive an intravenous infusion of carboplatin during the same visit.

  3. Step 3

    Repeated Treatment Cycles

    The above medications are administered repeatedly according to the study schedule, which is usually every three weeks. The exact dose of each drug is calculated based on your body weight or surface area as specified by the protocol.

    Each cycle includes the same set of infusions (datopotamab deruxtecan, durvalumab, and optionally carboplatin) and may be continued for several months until disease progression, unacceptable side effects, or completion of the planned number of cycles.

  4. Step 4

    Ongoing Monitoring

    During the treatment period, you will have regular clinic visits for safety checks, blood tests, and imaging studies to evaluate how the cancer is responding.

    These assessments are performed at intervals defined by the study, often before each new treatment cycle.

  5. Step 5

    End of Treatment

    Treatment will stop when the study protocol indicates (for example, after a predefined number of cycles) or if the disease progresses or side effects become too severe.

    You will be informed about the reason for ending treatment and what the next steps are.

  6. Step 6

    Follow‑Up Visits

    After treatment ends, you will continue to attend follow‑up visits for a period defined by the study, during which additional scans and laboratory tests may be performed to monitor long‑term outcomes.

    These visits help determine the duration of response and overall benefit of the therapy.

Who can join the trial?

23 criteria

  • Participant must be 18 years of age or older at the time of signing the consent form.
  • Must be able to give signed informed consent, meaning they understand the study and agree to take part.
  • All genders are allowed, but if a person can become pregnant, they must follow birth control requirements:
    • Male participants must use a condom plus another method or avoid sex, and must not donate sperm during the study.
    • Female participants must use one highly effective method of birth control, have a negative pregnancy test, and must not donate eggs during the study.
    • Optional participation in genetic research is allowed; it requires a separate optional consent.
    • Must have a diagnosis of non‑small cell lung cancer (NSCLC) that is:
      • Non‑squamous type (a specific cell pattern),
      • Positive for TROP2 NMR+ (a laboratory marker),
      • Without certain gene changes: no sensitising EGFR mutations, and no ALK or ROS1 rearrangements.
      • Must have cancer that is:
        • Stage IIIB or IIIC that cannot be removed by surgery or definitive chemoradiation, or
        • Stage IV (cancer that has spread to other parts of the body),
        • Performance status must be:
          • ECOG 0‑1 (fully active or able to do light work), or
          • ECOG 2 (up and about more than 50% of waking hours) if blood albumin is at least 2.5 g/dL and there is no large fluid buildup that needs repeated drainage.
          • Must have a known tumor PD‑L1 status (a protein that can affect response to certain medicines).
          • Must have a minimum life expectancy of 12 weeks.
          • Must be able to provide an acceptable FFPE tumor sample (a preserved tissue sample) from a lesion that has not been irradiated.
          • Must have at least one measurable tumor lesion that has not been irradiated and is at least 10 mm in size on a CT or MRI scan (or a lymph node with a short axis of at least 15 mm) so it can be measured over time.
          • Must have adequate blood and organ function, including:
            • Hemoglobin ≥ 9.0 g/dL,
            • Absolute neutrophil count ≥ 1.5 × 10⁹/L,
            • Platelet count ≥ 100 × 10⁹/L,
            • Clotting tests (INR/PT, aPTT) ≤ 1.5 × upper‑limit‑normal,
            • Total bilirubin ≤ 1.5 × ULN (or ≤ 3 × ULN if Gilbert’s syndrome or liver metastases),
            • Liver enzymes ALT/AST ≤ 2.5 × ULN (or ≤ 5 × ULN with liver metastases),
            • Kidney function (creatinine clearance) ≥ 40 mL/min.

Who cannot join the trial?

31 criteria

  • Severe or uncontrolled systemic illnesses such as active bleeding, ongoing infection, serious lung disease, serious gut problems, psychiatric illness, or major heart conditions, if the doctor believes they make participation unsafe.
  • Active or uncontrolled hepatitis B (HBV) or hepatitis C (HCV) infection, including detectable virus in the blood or abnormal liver tests.
  • Human immunodeficiency virus (HIV) infection that is not well controlled (for example, low CD4 cell count, high viral load, recent opportunistic infections, or unstable antiretroviral therapy).
  • Any current infection that needs systemic antibiotics, antivirals, or antifungal medicines, or use of systemic antibiotics within 14 days before randomisation.
  • Active tuberculosis infection, confirmed by history, physical exam, imaging or testing.
  • A resting heart‑rate corrected QT interval (QTc) longer than 470 milliseconds on an electrocardiogram (ECG).
  • Uncontrolled or serious heart disease, including a heart attack or unstable chest pain within 6 months, heart failure (class II‑IV), very high blood pressure, dangerous heart rhythm problems, or use of medicines that lengthen the QT interval.
  • History of interstitial lung disease (ILD) or pneumonitis (lung inflammation or scarring), or any suspected lung disease that cannot be ruled out by imaging.
  • Significant lung problems such as recent pulmonary embolism, severe asthma, severe chronic obstructive pulmonary disease (COPD), restrictive lung disease, or large fluid around the lungs.
  • Previous exposure to certain cancer drugs, including any topoisomerase I inhibitor, chemotherapy for advanced lung cancer, TROP2‑targeted therapy, or chloroquine/hydroxychloroquine without an adequate wash‑out period.
  • Prior adjuvant, neoadjuvant, or definitive chemoradiation for early‑stage disease only if the cancer has progressed and any previous immunotherapy‑related side effects have fully resolved.
  • History of another primary cancer that is still active or was treated within the past 3 years, except for low‑risk skin cancers (basal cell, squamous cell, lentigo maligna) or in‑situ disease that is fully treated.
  • Use of systemic immunosuppressive medication within 14 days before the first dose, except for limited steroid use (intranasal, inhaled, topical, low‑dose physiologic steroids, or steroids for hypersensitivity or anti‑emesis).
  • Any concurrent anti‑cancer treatment (chemotherapy, targeted therapy, immunotherapy, hormonal therapy for cancer) or curative radiation to the chest during the study.
  • Use of any medication known to cause a dangerous heart rhythm called Torsades de Pointes.
  • Receipt of a live, weakened vaccine within 30 days before the first study dose.
  • Recent radiation therapy to the brain (within 2 weeks) or to the chest (within 4 weeks), or ongoing radiation side effects that require steroids.
  • Major surgery (other than placement of a vascular line) or serious injury within 4 weeks of the first dose, or a planned major surgery during the study period.
  • Participation in another clinical trial with an investigational drug within 4 weeks before randomisation, or concurrent participation in another interventional study.
  • Severe allergic (hypersensitivity) reaction in the past to the study drug, its ingredients (such as polysorbate 80), or other monoclonal antibodies.
  • Being assigned to a study group that has already reached its enrollment limit.
  • Having squamous‑cell lung cancer, mixed small‑cell lung cancer, sarcomatoid NSCLC, or lung neuroendocrine tumors (different cancer types from the required non‑squamous NSCLC).
  • Being a staff member involved in planning or conducting the study (including sponsor or site staff).
  • Doctor’s judgment that the participant is unlikely to follow study procedures, restrictions, or requirements.
  • For women only: being pregnant (confirmed by test), breastfeeding, or planning to become pregnant during the treatment period and for a defined time after the last dose.
  • Having tumor genetic alterations that have approved targeted therapies (such as EGFR, ALK, ROS1, NTRK, BRAF V600E, RET, MET exon 14, or other actionable driver mutations).
  • Persistent side effects from previous cancer therapy that have not improved to mild (grade ≤ 1) level, except for hair loss or skin color loss.
  • Active or prior autoimmune, connective‑tissue, or inflammatory disorders (e.g., inflammatory bowel disease, lupus, rheumatoid arthritis, sarcoidosis, etc.) unless the condition is mild, stable, or well‑controlled (such as vitiligo, alopecia, stable hypothyroidism, controlled skin disease, or diet‑controlled coeliac disease).
  • Spinal cord compression or brain metastases that are symptomatic, require steroids or anticonvulsants, or are not stable for at least 2 weeks after local therapy.
  • History of cancer spread to the lining of the brain and spinal cord (leptomeningeal carcinomatosis or metastasis).
  • Clinically significant corneal (eye surface) disease.
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Investigated drugs

  • Mycophenolate mofetil

    is an oral medication that suppresses the immune system. In this study it is given as part of the standard background treatment to help control any immune‑related side effects that might occur during the trial.

  • Datopotamab deruxtecan

    is a targeted therapy given by intravenous infusion. It is designed to find and attach to a specific protein (TROP2) on cancer cells and deliver a chemotherapy‑like payload directly to those cells, helping to stop tumor growth. This drug is the main experimental treatment being tested in the trial.

  • Infliximab

    is an intravenous medication that blocks a molecule called tumor necrosis factor‑alpha (TNF‑α), which can cause inflammation. In the trial it is used as a background therapy to manage inflammatory reactions that may arise from the other study drugs.

  • Carboplatin

    is a chemotherapy drug administered through an IV infusion. It works by damaging the DNA of rapidly dividing cells, including cancer cells. In this study it is combined with the experimental drug and durvalumab to see if adding chemotherapy improves outcomes.

  • Durvalumab

    (sold as Imfinzi) is given by IV infusion as a type of immunotherapy called a checkpoint inhibitor. It helps the body’s own immune system recognize and attack cancer cells. In the trial it is tested together with datopotamab deruxtecan, with or without carboplatin, to evaluate how well the combination works against lung cancer.

What is already known about the treatment

  • Mycophenolate mofetil

    This medication is taken by mouth and works as an immunosuppressant. It is widely used and well documented in medical practice, especially to prevent organ rejection after transplantation. It blocks an enzyme needed for making DNA in certain immune cells, reducing their activity. It belongs to the class of antimetabolite immunosuppressants.

  • Datopotamab deruxtecan

    Given as an intravenous infusion in a solution, this drug is an antibody‑drug conjugate that targets the TROP2 protein on cancer cells. It is currently being studied in clinical trials for certain lung cancers and is not yet fully approved. After binding to TROP2, it delivers a chemotherapy payload that kills the cancer cell. It is classified as a TROP2‑targeted antibody‑drug conjugate.

  • Infliximab

    Administered by intravenous infusion, infliximab is a monoclonal antibody that blocks the inflammatory molecule TNF‑alpha. It is an approved and well‑known treatment for autoimmune conditions such as rheumatoid arthritis and Crohn’s disease. By stopping TNF‑alpha signaling, it reduces inflammation and immune‑mediated damage. It belongs to the class of anti‑TNF biologic agents.

  • Carboplatin

    This medication is given as an intravenous infusion and is a standard chemotherapy drug for many cancers, including lung cancer. It is an approved and widely used treatment in oncology. Carboplatin works by attaching to DNA in dividing cells, causing damage that stops the cells from multiplying. It is classified as a platinum‑based alkylating agent.

  • Durvalumab

    Delivered by an intravenous bolus or short infusion, durvalumab is a monoclonal antibody that blocks the PD‑L1 protein on tumor cells. It is approved for use in certain types of lung cancer and is also being tested in combination therapies. By blocking PD‑L1, it helps the body’s immune system see and attack cancer cells. It is part of the immune checkpoint inhibitor class.

Investigated diseases

TROP2‑positive non‑squamous advanced/metastatic non‑small cell lung cancer - It is a type of lung cancer that arises from the cells lining the airways and does not have the squamous cell appearance. The tumor cells express the protein TROP2, which can be detected by laboratory tests. This disease typically grows within the lung and can spread to nearby lymph nodes and distant organs such as the brain, bones, or liver. As the cancer progresses, patients may experience worsening cough, shortness of breath, and chest pain. The disease course is marked by continual increase in tumor size or new metastatic sites unless intervened.
Trial detailsLast updated 12 Nov 2026
Age18+ yearsPhasePhase IITrial ID2025-524836-21-00Protocol codeD9260C00007Estimated enrolment164 patientsSponsorAstraZeneca AB

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