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Study on Trastuzumab Deruxtecan for Patients with Advanced Non-Small Cell Lung Cancer with HER2 Mutations

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 Non-Small Cell Lung Cancer (NSCLC) that cannot be surgically removed and has specific genetic changes called HER2 exon 19 or 20 mutations. The study is investigating the effectiveness and safety of a treatment called trastuzumab deruxtecan, also known by its code name DS-8201a, as the first treatment option for this type of cancer. Trastuzumab deruxtecan is a special type of medication that combines an antibody with a chemotherapy drug, designed to target and kill cancer cells more effectively.

Participants in the study will receive either trastuzumab deruxtecan or a combination of other medications, including pemetrexed, carboplatin, cisplatin, and pembrolizumab. These 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 compare how well trastuzumab deruxtecan works in stopping the cancer from growing or spreading compared to the other treatment options. The study will also look at the overall survival of participants and monitor any side effects they may experience.

The trial will take place over several years, with regular check-ups and assessments to monitor the participants' health and the progress of their cancer. The study aims to provide valuable information on the best treatment options for patients with this specific type of lung cancer, potentially leading to improved outcomes and quality of life for those affected by the disease.

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, eligibility is confirmed based on specific criteria such as age, disease stage, and health status.

    Participants must have a type of lung cancer with specific genetic mutations and must not have received certain treatments before.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. This process ensures that each participant has an equal chance of receiving any of the treatments being studied.

  3. Step 3

    Treatment administration

    Participants in one group receive trastuzumab deruxtecan (also known as DS-8201a) through an intravenous infusion. The frequency and dosage are determined by the study protocol.

    Participants in the other group receive a combination of platinum-based chemotherapy (either carboplatin or cisplatin), pemetrexed, and pembrolizumab, all administered intravenously. The specific dosage and schedule are outlined in the study protocol.

  4. Step 4

    Monitoring and assessments

    Throughout the study, participants undergo regular assessments to monitor the effectiveness of the treatment and any side effects. This includes imaging tests to evaluate the cancer's response to treatment.

    Participants' health is closely monitored through various tests, including blood tests and heart function tests, to ensure safety and adjust treatment as necessary.

  5. Step 5

    Follow-up

    After completing the treatment phase, participants continue to be monitored for a period to assess long-term outcomes and any delayed side effects.

    The study aims to measure outcomes such as progression-free survival, overall survival, and quality of life.

Who can join the trial?

9 criteria

  • Participants must be **male or female** and at least **18 years old**.
  • The disease must be **locally advanced** (meaning it has spread but not to distant parts of the body) and cannot be treated with surgery to cure it, or it must be **metastatic** (meaning it has spread to other parts of the body).
  • The type of lung cancer must be **non-squamous Non-Small Cell Lung Cancer (NSCLC)** with a specific **HER2 mutation** in parts of the gene called **exons 19 or 20**. This must be confirmed by a test on tissue or blood.
  • Participants should not have received any **systemic therapy** (treatment that affects the whole body) aimed at relieving symptoms for their advanced or metastatic disease.
  • The heart's ability to pump blood, known as **Left Ventricular Ejection Fraction (LVEF)**, must be **50% or higher**.
  • The disease must be **measurable**, meaning it can be assessed by a doctor using specific criteria called **RECIST v1.1**.
  • Participants must have **adequate organ function**, which includes the heart, kidneys, and liver, as defined by the study protocol.
  • The **ECOG performance status** must be **0 or 1**, which means the participant is fully active or has some symptoms but can still carry out light work.
  • There must be **tumor tissue available** for testing by the study team.

Who cannot join the trial?

6 criteria

  • Patients who have a type of lung cancer that is not **Non-Small Cell Lung Cancer** with specific genetic changes called **HER2 exon 19 or 20 mutations** cannot participate.
  • Patients whose cancer can be removed by surgery are not eligible.
  • Patients who do not have cancer that has spread to other parts of the body or is not advanced in the local area cannot join the study.
  • 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 are excluded.
  • Patients who are not considered part of the vulnerable population selected for the study cannot participate.
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Investigated drugs

  • Trastuzumab Deruxtecan

    This medication is being studied as a first-line treatment for patients with a specific type of lung cancer that cannot be removed by surgery or has spread to other parts of the body. It targets cancer cells with certain mutations in the HER2 gene, which are found in some lung cancers. The goal is to see if this medication can help stop the cancer from growing or spreading.

  • Platinum

    This is a type of chemotherapy drug used to treat various cancers, including lung cancer. It works by damaging the DNA of cancer cells, which can stop them from growing and dividing.

  • Pemetrexed

    This is another chemotherapy drug that is often used in combination with other medications to treat lung cancer. It works by interfering with the cancer cells' ability to use folate, a vitamin that is necessary for cell growth.

  • Pembrolizumab

    This medication is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is used to treat several types of cancer, including lung cancer, by blocking a protein that prevents the immune system from attacking cancer cells.

What is already known about the treatment

Trastuzumab Deruxtecan – This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating certain types of lung cancer. It is specifically being tested for use in patients with non-small cell lung cancer that cannot be surgically removed and has specific genetic mutations. The drug works by targeting and binding to the HER2 protein on cancer cells, delivering a chemotherapy agent directly to the cells to kill them. It is classified as an antibody-drug conjugate, combining targeted therapy with chemotherapy.

Investigated diseases

Non-Small Cell Lung Cancer with HER2 exon 19 or 20 mutations – This is a type of lung cancer that is characterized by mutations in the HER2 gene, specifically in exon 19 or 20. It is classified as non-small cell, which is the most common type of lung cancer, accounting for about 85% of cases. The disease can be locally advanced, meaning it has spread to nearby tissues or lymph nodes, or metastatic, indicating it has spread to other parts of the body. The presence of HER2 mutations can influence the behavior of the cancer, potentially affecting its growth and spread. This form of cancer is considered unresectable, meaning it cannot be removed completely through surgery. The progression of the disease is typically monitored through imaging and clinical assessments to evaluate changes in tumor size and spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503674-20-00Protocol codeD967SC00001Estimated enrolment450 patientsSponsorAstraZeneca AB

sourced from the EU Clinical Trials Register and site verification

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