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Study of Datopotamab Deruxtecan and Pembrolizumab for Patients with Advanced or Metastatic Non-small Cell Lung Cancer Without Actionable Genomic Alterations

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 investigating the effectiveness of a new treatment combination involving two medications: Datopotamab deruxtecan (also known by its code name DS-1062a) and Pembrolizumab (commonly known as Keytruda). These medications are given as a solution through a vein, a method known as intravenous infusion. The trial aims to compare the effects of using both medications together versus using Pembrolizumab alone.

The purpose of the study is to see if the combination of Datopotamab deruxtecan and Pembrolizumab can help patients live longer without their cancer getting worse, compared to those who receive only Pembrolizumab. Participants in the study will be randomly assigned to receive either the combination treatment or Pembrolizumab alone. The study will monitor the participants over a period of time to assess the progression of the disease and overall survival.

Throughout the study, participants will have regular visits to receive their treatment and undergo various tests to monitor their health and the status of their cancer. The study will continue for up to 24 months, and participants will be closely observed to ensure their safety and to gather information on how well the treatments are working. This trial is an important step in exploring new treatment options for people with advanced stages of non-small cell lung cancer.

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 treatment phase

    Upon joining the study, the patient will begin the initial treatment phase. This involves receiving medications through an intravenous (IV) infusion.

    The medications administered are datopotamab deruxtecan and pembrolizumab. Both are given as a solution for infusion.

    The frequency and dosage of these medications will be determined by the study protocol and the patient's specific condition.

  2. Step 2

    Treatment monitoring

    Throughout the treatment period, the patient's health and response to the medication will be closely monitored.

    Regular visits will be scheduled to assess the patient's condition, including laboratory tests and imaging studies to evaluate the progression of the disease.

    The patient's overall health, including heart function and any side effects, will be evaluated to ensure safety and effectiveness of the treatment.

  3. Step 3

    Progression-free survival assessment

    The primary goal of the study is to measure progression-free survival (PFS), which is the time from the start of treatment until the disease progresses or the patient passes away from any cause.

    This assessment will be conducted by an independent review to ensure unbiased results.

  4. Step 4

    Overall survival assessment

    Another key objective is to evaluate overall survival (OS), which is the duration from the start of treatment until death from any cause.

    This measure helps determine the long-term effectiveness of the treatment.

  5. Step 5

    End of treatment

    The treatment phase will continue until the study's end date or until the patient experiences significant disease progression or adverse effects that necessitate discontinuation.

    The estimated end date for the trial is April 30, 2028.

Who can join the trial?

17 criteria

  • Sign and date the necessary consent forms before starting any study-specific procedures.
  • Have a life expectancy of at least 3 months.
  • Have adequate bone marrow function as defined in the study protocol.
  • If female and able to have children, must not be pregnant or breastfeeding, and must agree to use effective birth control or avoid heterosexual intercourse during the study and for a specified time after the last dose of study drugs.
  • If male, must be surgically sterile or use a condom along with partner's use of effective birth control if the partner can have children, or avoid heterosexual intercourse during the study and for a specified time after the last dose of study drugs.
  • Male participants must not freeze or donate sperm during the study and for a specified time after the last dose of study drugs. Consider preserving sperm before joining the study.
  • Female participants must not donate or retrieve eggs during the study and for a specified time after the last dose of study drugs. Consider preserving eggs before joining the study.
  • Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and comply with other study procedures and restrictions.
  • Be an adult, at least 18 years old or the legal adult age in your area, at the time of giving consent.
  • Have a specific type of lung cancer called non-squamous non-small cell lung cancer (NSCLC) that meets certain criteria, including being at an advanced stage and not suitable for surgery or certain other treatments.
  • Have negative test results for specific genetic changes in the cancer, such as EGFR, ALK, and ROS1, or be willing to undergo testing for these changes.
  • Provide a tumor tissue sample for testing specific proteins and other markers, unless prohibited by law.
  • Have a tumor with high expression of a protein called PD-L1, as determined by a specific test.
  • Have an adequate period without treatment before starting the study drugs.
  • Have measurable disease based on imaging tests.
  • Have a left ventricular ejection fraction (LVEF) of at least 50%, which is a measure of heart function, determined by specific heart tests.
  • Have an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 or 1, which indicates the level of daily functioning.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer besides Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) cannot participate. This type of cancer affects the lungs and has spread to other parts of the body.
  • Patients who have had previous treatments that might interfere with the study results are not eligible.
  • Patients with serious health conditions that could make it unsafe for them to participate in the study are excluded.
  • Patients who are unable to follow the study procedures or attend the required visits cannot take part.
  • Patients who are pregnant or breastfeeding are not allowed to participate.
  • Patients who have allergies to the study medications or similar drugs are excluded.
  • Patients who are currently participating in another clinical trial are not eligible.
  • Patients with a history of certain heart conditions or diseases that affect the immune system are excluded.
  • Patients who have had a recent major surgery or injury that could affect the study are not eligible.
  • Patients with active infections that require treatment are excluded.
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Investigated drugs

  • Dato-DXd

    is an investigational medication being studied for its potential to treat advanced or metastatic non-small cell lung cancer. It is being tested in combination with another medication to see if it can help slow down the progression of the disease or improve survival rates in patients.

  • Pembrolizumab

    is a medication used to treat certain types of cancer by helping the immune system recognize and attack cancer cells. In this trial, it is being used alone and in combination with Dato-DXd to determine if the combination provides better outcomes for patients with non-small cell lung cancer.

What is already known about the treatment

  • Dato-DXd

    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 being evaluated in combination with pembrolizumab to determine its impact on progression-free survival and overall survival. Dato-DXd works by delivering a cytotoxic agent directly to cancer cells, targeting specific proteins on the cell surface. It is classified as an antibody-drug conjugate, which combines the targeting ability of antibodies with the cancer-killing power of chemotherapy.

  • Pembrolizumab

    This medication is given as an intravenous infusion and is widely used in the treatment of various cancers, including advanced or metastatic non-small cell lung cancer (NSCLC). It is a well-established therapy that works by blocking a specific protein on immune cells, allowing the immune system to better attack cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor, which enhances the body's natural immune response against cancer.

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-squamous histology. It is termed "advanced" or "metastatic" when the cancer has spread beyond the lungs to other parts of the body. The disease progresses as cancer cells grow uncontrollably, forming tumors that can interfere with lung function and spread to other organs. Symptoms may include persistent cough, chest pain, and difficulty breathing. As the disease advances, it can lead to further complications affecting overall health and quality of life.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507933-12-00Protocol codeDS1062-A-U304Estimated enrolment760 patientsSponsorDaiichi Sankyo Inc.

sourced from the EU Clinical Trials Register and site verification

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