Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study Comparing Patritumab Deruxtecan and Platinum-based Chemotherapy for Patients with Advanced EGFR-mutated Non-small Cell Lung Cancer After EGFR Therapy Failure

Verified siteRegistered 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 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 Epidermal Growth Factor Receptor (EGFR) gene. The study is comparing the effects of a new treatment called Patritumab Deruxtecan (also known by its code name U3-1402 or HER3-DXd) with standard chemotherapy treatments that use platinum-based drugs. These standard treatments include medications like Pemetrexed, Carboplatin, and Cisplatin. The purpose of the study is to see how well these treatments work in patients whose cancer has spread to other parts of the body or is locally advanced and has not responded to previous treatments targeting the EGFR gene.

Participants in the study will receive either the new treatment or one of the standard chemotherapy options. The new treatment, Patritumab Deruxtecan, is given as an infusion, which means it is administered directly into the bloodstream through a vein. The study will last for a period of up to 36 months, during which the effects of the treatments will be monitored. The main goal is to determine how long the cancer can be controlled without getting worse, which is known as progression-free survival. Other aspects, such as overall survival and the response of the cancer to the treatment, will also be evaluated.

This study is important for understanding how effective Patritumab Deruxtecan is compared to existing chemotherapy options for patients with EGFR-mutated NSCLC. By participating in this study, researchers hope to gather valuable information that could lead to better treatment options for this type of lung cancer in the future.

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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive patritumab deruxtecan, and the other group will receive platinum-based chemotherapy.

    You will be informed about which treatment you will receive, as this is an open-label study.

  2. Step 2

    Treatment with patritumab deruxtecan

    If you are assigned to the patritumab deruxtecan group, you will receive this medication through an intravenous infusion. This means the medication will be given directly into your vein.

    The dosage and frequency of administration will be determined by the study protocol and your healthcare provider.

  3. Step 3

    Treatment with platinum-based chemotherapy

    If you are assigned to the platinum-based chemotherapy group, you will receive one of the following medications: pemetrexed, carboplatin, or cisplatin. These medications will also be administered through an intravenous infusion.

    The specific medication, dosage, and frequency will be determined by the study protocol and your healthcare provider.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests to assess the progress of your treatment.

    You will be asked to report any side effects or changes in your health to your healthcare provider.

  5. Step 5

    End of treatment

    At the end of the treatment period, you will have a final assessment to evaluate the effects of the treatment.

    You may be asked to continue follow-up visits to monitor your health and gather additional information for the study.

Who can join the trial?

16 criteria

  • Sign and date the main informed consent form before starting any study-specific procedures.
  • Be willing to provide a sufficient amount and quality of tumor tissue.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1. This is a scale used to assess how a disease affects a patient's daily living abilities, where 0 means fully active and 1 means restricted in physically strenuous activity but able to carry out light work.
  • Have adequate bone marrow reserve and organ function based on recent laboratory tests.
  • If female and capable of having children, must have a negative pregnancy test and agree to use highly effective birth control during the study and for 7 months after the last dose of the study drug.
  • Female participants must not donate or retrieve eggs for personal use during the study and for at least 7 months after the last dose of the study drug.
  • If male, must be surgically sterile or agree to use highly effective birth control during the study and for at least 4 months after the last dose of the study drug.
  • Male participants must not freeze or donate sperm during the study and for at least 4 months after the last dose of the study drug.
  • Be at least 18 years old.
  • Have a confirmed diagnosis of metastatic or locally advanced nonsquamous non-small cell lung cancer (NSCLC) that cannot be treated with surgery or radiation.
  • Have a documented EGFR-activating mutation in the tumor, which is a specific change in the cancer cells that can be detected from a tumor sample or blood test.
  • Have received 1 or 2 prior treatments with approved EGFR TKI drugs, which are targeted therapies for this type of cancer, including a third-generation EGFR TKI like osimertinib.
  • May have received previous treatments before the cancer spread, as long as the cancer progressed at least 12 months after the last dose of such therapy and after receiving a third-generation EGFR TKI for metastatic or locally advanced disease.
  • Have not received any other prior systemic therapies (like chemotherapy or immunotherapy) for metastatic or locally advanced cancer.
  • Have documented disease progression while receiving or after a third-generation EGFR TKI for metastatic or locally advanced disease.
  • Have at least one measurable lesion, which is a tumor that can be accurately measured in size.

Who cannot join the trial?

6 criteria

  • Patients who have a different type of cancer than the one being studied cannot participate.
  • Patients who have not been diagnosed with **EGFR-mutated Non-small Cell Lung Cancer (NSCLC)** cannot participate. **EGFR** stands for **Epidermal Growth Factor Receptor**, which is a protein that can affect the growth of cancer cells.
  • Patients who have not experienced a specific change in their **EGFR** gene, known as an **exon 19 deletion** or **L858R mutation**, cannot participate. These are specific genetic changes that can affect how cancer grows.
  • Patients who have not been diagnosed with **metastatic** or **locally advanced** cancer 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 to distant parts.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which may include those unable to give consent or those with certain health conditions, cannot 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.

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.

Not 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

  • Patritumab Deruxtecan

    is a medication being studied for its potential to treat a type of lung cancer known as non-small cell lung cancer (NSCLC) that has specific genetic changes called EGFR mutations. This medication is designed to target and attach to cancer cells, delivering a powerful drug directly to them to help stop their growth and spread. It is being compared to standard chemotherapy treatments to see if it can help patients live longer without their cancer getting worse.

  • Platinum-based Chemotherapy

    is a common treatment for various types of cancer, including lung cancer. It uses drugs that contain the metal platinum to damage the DNA of cancer cells, which can stop them from growing and dividing. In this study, platinum-based chemotherapy is used as a comparison to see how well the new medication, Patritumab Deruxtecan, works in treating lung cancer with EGFR mutations.

What is already known about the treatment

Patritumab Deruxtecan – This medication is administered through an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating a specific type of lung cancer known as metastatic or locally advanced non-small cell lung cancer (NSCLC) that has mutations in the epidermal growth factor receptor (EGFR). The drug works by targeting and binding to the EGFR on cancer cells, delivering a toxic payload that helps to kill these cells. It is classified as an antibody-drug conjugate, which combines an antibody with a chemotherapy drug to specifically target cancer cells while minimizing damage to normal cells.

Investigated diseases

Metastatic or Locally Advanced Epidermal Growth Factor Receptor-mutated Non-small Cell Lung Cancer – This type of lung cancer is characterized by mutations in the epidermal growth factor receptor (EGFR) gene, which leads to uncontrolled cell growth. It primarily affects the non-squamous cells in the lungs. The disease can either be metastatic, meaning it has spread to other parts of the body, or locally advanced, indicating it has spread extensively within the lungs and nearby areas. The progression involves the continuous growth and spread of cancerous cells, often leading to the formation of tumors. As the disease advances, it can cause symptoms such as persistent cough, shortness of breath, and chest pain. The presence of EGFR mutations often influences the behavior and progression of the cancer.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507964-38-00Protocol codeU31402-A-U301Estimated enrolment586 patientsSponsorDaiichi Sankyo Inc.

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.