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Study of Patritumab Deruxtecan for Patients with Previously Treated Metastatic or Locally Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Verified siteInvestigationalNo 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 Non-Small Cell Lung Cancer (NSCLC) that has specific changes in the EGFR gene. These changes, or mutations, can make the cancer more difficult to treat. The study is testing a new treatment called Patritumab Deruxtecan, also known by its code name U3-1402 or HER3-DXd. This treatment is given as a solution through an infusion, which means it is delivered directly into the bloodstream through a vein.

The purpose of the study is to explore how well Patritumab Deruxtecan works in patients whose cancer has spread to other parts of the body or is locally advanced, meaning it has grown but not spread far. Participants in the study will receive the treatment and be monitored over time to see how their cancer responds. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the new treatment.

Throughout the study, doctors will check the size of the tumors and how long the treatment keeps the cancer from getting worse. They will also look at how long patients live after starting the treatment and any side effects they might experience. The study aims to provide more information about the potential benefits and safety of Patritumab Deruxtecan for treating this specific type of 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 screening

    The initial screening involves confirming eligibility for the study. This includes verifying age, medical history, and previous treatments for non-small cell lung cancer (NSCLC).

    A negative pregnancy test is required for females of childbearing potential. Both male and female participants must agree to use effective birth control during the study and for a specified period after the last dose of the study drug.

  2. Step 2

    Baseline assessments

    Baseline assessments are conducted to gather initial health data. This includes physical examinations, blood tests, and imaging studies to measure the extent of the cancer.

    Participants must provide a tumor tissue sample, either from a recent biopsy or an archival sample, to confirm the presence of specific genetic mutations.

  3. Step 3

    Treatment administration

    The treatment involves receiving patritumab deruxtecan, a solution for infusion administered intravenously. The dosage and frequency are determined by the study protocol.

    Participants will receive the treatment in cycles, with each cycle lasting a specified number of weeks. The exact duration and number of cycles depend on individual response and tolerance.

  4. Step 4

    Ongoing monitoring

    Regular monitoring is conducted throughout the study to assess the treatment's effectiveness and safety. This includes repeated imaging studies, blood tests, and physical examinations.

    Participants are monitored for any side effects or changes in health status. Adjustments to the treatment plan may be made based on these findings.

  5. Step 5

    End of treatment

    At the end of the treatment period, final assessments are conducted to evaluate the overall response to the study drug.

    Participants may be asked to continue follow-up visits to monitor long-term effects and overall survival.

Who can join the trial?

12 criteria

  • Sign and date the necessary consent forms before starting any study-specific procedures.
  • Be at least 18 years old. If the legal age of consent is higher, follow local requirements.
  • Have a confirmed diagnosis of **locally advanced or metastatic NSCLC** (a type of lung cancer) that cannot be treated with surgery or radiation to cure it.
  • Show evidence of disease progression after the most recent treatment for advanced cancer. Must have had prior treatment with **osimertinib** (a cancer medication) and at least one **platinum-based chemotherapy** regimen.
  • Have a confirmed **EGFR-activating mutation** (a specific change in the cancer cells) from a tumor or blood sample, specifically exon 19 deletion or L858R.
  • Have at least one measurable lesion (an area of cancer that can be measured) confirmed by a specific review process.
  • Agree to provide a required tumor sample that meets specific criteria, either from a new biopsy or a recent one taken within 3 months.
  • Have an **ECOG performance status** of 0 or 1, which means being fully active or having some symptoms but being able to carry out light work.
  • Have adequate bone marrow and organ function based on recent laboratory tests.
  • If female and able to have children, must have a negative pregnancy test and agree to use effective birth control during the study and for 7 months after the last dose. Must not donate or retrieve eggs during this time.
  • If male, must be surgically sterile or agree to use effective birth control during the study and for 4 months after the last dose. Must not freeze or donate sperm during this time.
  • Be willing and able to attend scheduled visits, follow the drug administration plan, undergo laboratory tests, and comply with other study procedures and restrictions.

Who cannot join the trial?

6 criteria

  • Patients who do not have **metastatic** or **locally advanced** **EGFR mutated Non-Small Cell Lung Cancer (NSCLC)** cannot participate. **Metastatic** means the cancer has spread to other parts of the body, and **locally advanced** means the cancer has grown but not spread far.
  • Patients without an **activating EGFR mutation** cannot participate. This refers to specific changes in the **EGFR gene** that can affect cancer growth.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are not part of the specified clinical trial groups cannot participate.
  • Patients who are not male or female cannot participate, as the study includes both genders.
  • Patients who are not considered part of a **vulnerable population** cannot participate. **Vulnerable population** refers to groups that may need special protection or consideration.
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Investigated drugs

Patritumab Deruxtecan (U3-1402) is a medication being studied for its ability to fight cancer in patients with a specific type of lung cancer known as non-small cell lung cancer (NSCLC) that has certain genetic changes. This medication is designed to target and deliver cancer-fighting agents directly to the cancer cells, potentially helping to shrink tumors or slow their growth. It is being tested in patients whose cancer has already been treated with other therapies but has continued to progress.

What is already known about the treatment

Patritumab Deruxtecan – This medication is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness in treating metastatic or locally advanced non-small cell lung cancer (NSCLC) that has specific mutations in the EGFR gene. The main therapeutic use of Patritumab Deruxtecan is to target and destroy cancer cells in patients who have already received other treatments. At the molecular level, it works by binding to a protein on the surface of cancer cells and delivering a toxic substance that kills these cells. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target cancer cells.

Investigated diseases

Non-Small Cell Lung Cancer (NSCLC) – This is a type of lung cancer that includes several subtypes, such as adenocarcinoma and squamous cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is known for its slower growth compared to small cell lung cancer. When it is described as metastatic, it means the cancer has spread from the lungs to other parts of the body. If it is locally advanced, the cancer has spread to nearby tissues or lymph nodes but not to distant organs. The presence of an EGFR mutation, such as exon 19 deletion or L858R, can influence the behavior and progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512238-13-00Protocol codeU31402-A-U201Estimated enrolment316 patientsSponsorDaiichi Sankyo Inc.

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