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Study Comparing Datopotamab Deruxtecan and Docetaxel for Patients with Advanced or Metastatic 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

This clinical trial is focused on studying a type of lung cancer known as Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC). The study is comparing two treatments: a new medication called Datopotamab deruxtecan (also known by its code name DS-1062a) and an existing chemotherapy drug called Docetaxel. Both medications are given through an intravenous infusion, which means they are delivered directly into the bloodstream through a vein.

The purpose of the study is to see how well DS-1062a works compared to Docetaxel in patients who have already received treatment for their lung cancer. Participants in the study will be randomly assigned to receive either DS-1062a or Docetaxel. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the treatments. The study will last for a period of up to 72 weeks, during which time participants will receive regular infusions and have their health monitored closely by the study team.

Throughout the study, participants will undergo various assessments to track the progress of their cancer and overall health. These assessments may include imaging tests to look at the size and spread of the cancer, as well as regular check-ups to monitor any side effects from the treatments. The goal is to determine which treatment is more effective in controlling the cancer and improving the quality of life for patients with NSCLC.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either datopotamab deruxtecan or docetaxel. Both medications are administered as a solution for infusion, which means they are given directly into the bloodstream through a vein (intravenous).

  2. Step 2

    Treatment administration

    Datopotamab deruxtecan is administered every three weeks. The specific dosage and duration will be determined by the healthcare provider based on the patient's condition and response to treatment.

    Docetaxel is also administered every three weeks. The dosage and duration will be tailored to the patient's needs and response to the medication.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's health and response to the treatment will be closely monitored. This includes regular imaging assessments to measure the disease's progression using a standardized method known as RECIST v1.1.

    The patient's overall health, including liver, kidney, and bone marrow function, will be evaluated regularly to ensure safety and adjust treatment as necessary.

  4. Step 4

    End of treatment

    The treatment will continue until the disease progresses, unacceptable side effects occur, or the patient decides to stop participating in the study.

    The study aims to compare the effectiveness of datopotamab deruxtecan with docetaxel by measuring progression-free survival (PFS) and overall survival (OS).

Who can join the trial?

14 criteria

  • The patient must be able to provide written consent by signing a form before any study procedures begin.
  • The patient must have proper liver function within 7 days before being assigned to a treatment group.
  • The patient must have proper kidney function, even if it's mild or moderate, within 7 days before being assigned to a treatment group.
  • The patient must have a heart function measurement called left ventricular ejection fraction (LVEF) of 50% or higher, checked within 28 days before being assigned to a treatment group. This can be done using an ultrasound of the heart (ECHO) or a special scan (MUGA).
  • The patient must have proper blood clotting function, which is measured by specific blood tests, within 1.5 times the normal limit.
  • The patient must have a break from previous treatments before starting the study, as specified in the study details.
  • The patient must be 18 years or older.
  • The patient must have a life expectancy of at least 3 months, according to the doctor's opinion.
  • The patient must have proof of disease progression, meaning the cancer has gotten worse, while on or after the most recent treatment for advanced or metastatic non-small cell lung cancer (NSCLC).
  • The patient must meet specific previous treatment requirements based on whether they have certain genetic changes in their cancer. This includes having received certain chemotherapy and/or targeted therapy treatments.
  • The patient must undergo a tumor biopsy procedure before treatment, or if available, provide a previous biopsy sample taken within 2 years before signing the consent form.
  • The patient must have measurable disease based on imaging tests, using a standard method called RECIST v1.1.
  • The patient must have a performance status of 0 or 1, which means they are fully active or have some symptoms but can still carry out light work, as assessed by a standard scale called the Eastern Cooperative Oncology Group (ECOG) performance status.
  • The patient must have proper bone marrow function within 7 days before being assigned to a treatment group.

Who cannot join the trial?

8 criteria

  • Patients who have a different type of cancer than the one being studied.
  • Patients who have not been diagnosed with **advanced** or **metastatic** non-small cell lung cancer. **Advanced** means the cancer has spread to other parts of the body, and **metastatic** means it has spread far from where it started.
  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications or their ingredients.
  • Patients who have had certain treatments for cancer recently, which might affect the study results.
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Investigated drugs

  • DS-1062a

    is an investigational medication being studied for its effectiveness in treating advanced or metastatic non-small cell lung cancer (NSCLC). It is being compared to another treatment to see how well it works in patients who have already received other treatments for their cancer.

  • Docetaxel

    is a chemotherapy medication used to treat various types of cancer, including non-small cell lung cancer. In this study, it serves as a comparison to evaluate the effectiveness of the investigational medication DS-1062a.

What is already known about the treatment

  • DS-1062a

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic non-small cell lung cancer (NSCLC). It is not yet widely used in standard medical practice, as it is still under investigation. The main therapeutic indication is for patients with NSCLC, regardless of specific genetic changes in the cancer. DS-1062a works by targeting specific proteins on cancer cells, helping to deliver a toxic substance directly to the tumor, which can inhibit cancer growth. It is classified as an antibody-drug conjugate, a type of targeted cancer therapy.

  • Docetaxel

    This medication is given through an intravenous infusion and is a well-established treatment in the medical field for various types of cancer, including advanced or metastatic non-small cell lung cancer (NSCLC). It is commonly used when other treatments have not been successful. Docetaxel works by interfering with the normal function of microtubules in cells, which are essential for cell division, thereby preventing cancer cells from multiplying. It is classified as a taxane, a type of chemotherapy drug.

Investigated diseases

Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that begins in the cells lining the lungs and is characterized by its non-small cell nature, which refers to the size and appearance of the cancer cells under a microscope. It is considered advanced when it has spread beyond the lungs to other parts of the body, and metastatic when it has spread to distant organs. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with lung function and potentially spread to other areas. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to further complications affecting various bodily systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509865-19-00Protocol codeDS1062-A-U301Estimated enrolment679 patientsSponsorDaiichi Sankyo Inc.

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