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Study of trastuzumab deruxtecan with pembrolizumab versus platinum chemotherapy with pembrolizumab for patients with untreated HER2-positive 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 study focuses on treating people with Non-small Cell Lung Cancer that has spread to other parts of the body or cannot be removed by surgery. Specifically, it involves patients whose cancer cells show high levels of a protein called HER2. The study will test a combination of two medications: trastuzumab deruxtecan (also known as DS-8201a) with pembrolizumab, comparing it to standard treatment that combines platinum-based chemotherapy (either cisplatin or carboplatin) with pembrolizumab.

The purpose of this research is to determine if the combination of trastuzumab deruxtecan with pembrolizumab works better than the standard treatment in controlling the disease. The medications will be given through an intravenous infusion, which means they are delivered directly into a vein. Trastuzumab deruxtecan is a type of medication that specifically targets cancer cells with high HER2 levels, while pembrolizumab helps the body's immune system fight cancer cells.

During the study, participants will be randomly assigned to receive either the new combination treatment or the standard treatment. Their cancer will be monitored regularly using imaging scans to check how well the treatment is working. The doctors will continue to check the participants' health and watch for any side effects throughout the study period.

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

    Initial screening and qualification

    Your eligibility for the study will be evaluated if you are an adult (18 years or older) with advanced lung cancer that cannot be removed by surgery.

    A tissue sample from your tumor will be required to test for specific markers called HER2 and PD-L1.

    Your medical history will be reviewed to confirm you have not received previous treatment for advanced lung cancer.

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: You will receive a combination of trastuzumab deruxtecan and pembrolizumab through intravenous infusion.

    Group 2: You will receive platinum-based chemotherapy (either cisplatin or carboplatin) with pemetrexed and pembrolizumab through intravenous infusion.

  3. Step 3

    Treatment period

    Regular treatment sessions will be scheduled for the administration of medications through intravenous infusion.

    Your cancer will be monitored through imaging scans to evaluate how the treatment is working.

    The treatment will continue until either your disease progresses or you are unable to continue with the treatment.

  4. Step 4

    Follow-up period

    After completing or stopping treatment, your health status will continue to be monitored.

    Regular check-ups will be scheduled to track your progress and overall survival.

    The study is planned to continue until June 2032.

Who can join the trial?

9 criteria

  • Must be at least 18 years old at the time of signing the consent form
  • Must be diagnosed with non-squamous non-small cell lung cancer that is either: - Advanced and cannot be surgically removed, or - Has spread to other parts of the body (metastatic)
  • Must have cancer that tests positive for HER2 (a protein that promotes cancer growth) and has specific PD-L1 (an immune system marker) levels
  • Must not have received any previous systemic treatment (treatment that affects the whole body) for advanced or metastatic lung cancer
  • If received previous cancer treatment (such as adjuvant or neoadjuvant therapy), it must have been completed at least 6 months before starting this trial
  • Must have suitable tumor tissue sample available for laboratory testing that has not been previously treated with radiation
  • Must be willing and able to sign and date the required consent forms before any trial procedures begin
  • Must not have any known gene changes (mutations) in the HER2 gene that could be treated with other available therapies
  • For mixed type tumors, the main type must be adenocarcinoma (a type of non-squamous lung cancer)

Who cannot join the trial?

11 criteria

  • Prior treatment with anti-HER2 therapy (therapy targeting a specific protein related to cancer growth)
  • Active brain metastases (cancer that has spread to the brain) or other active cancers requiring treatment
  • History of severe allergic reactions to monoclonal antibodies (a type of targeted therapy)
  • Serious heart conditions including heart failure, uncontrolled high blood pressure, or recent heart attack
  • Active autoimmune disease requiring systemic treatment (conditions where the immune system attacks healthy cells)
  • Current use of immunosuppressive medications (drugs that reduce immune system activity)
  • Active infection requiring treatment, including hepatitis B, hepatitis C, or HIV
  • Pregnant or breastfeeding women
  • Major surgery within 4 weeks before starting the study treatment
  • Participation in another clinical trial within 4 weeks before starting this study
  • Any condition that, in the opinion of the study doctor, would interfere with the safe conduct of the study
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Investigated drugs

  • Trastuzumab Deruxtecan

    is a targeted therapy medication used to treat certain types of cancer. It combines an antibody that targets HER2-positive cancer cells with a chemotherapy drug. This medication is designed to deliver the chemotherapy directly to cancer cells while potentially limiting damage to healthy cells.

  • Pembrolizumab

    is an immunotherapy medication that helps your immune system fight cancer cells. It works by blocking a protein called PD-L1, which can help your immune system recognize and attack cancer cells more effectively.

  • Platinum-based Chemotherapy

    refers to traditional cancer treatment medications that contain platinum. These medications work by damaging the DNA of cancer cells, which prevents them from dividing and growing. This type of chemotherapy is commonly used to treat various types of cancer, including lung cancer.

What is already known about the treatment

  • Trastuzumab Deruxtecan

    An advanced antibody-drug conjugate administered through intravenous infusion, specifically designed for treating HER2-overexpressing cancers including non-small cell lung cancer. This medication works by combining a HER2-targeted antibody with a potent topoisomerase I inhibitor, allowing it to specifically target and destroy cancer cells that overexpress HER2 proteins. It represents a significant advancement in targeted cancer therapy and is currently being studied in combination with other treatments for improved efficacy.

  • Pembrolizumab

    A humanized antibody medication administered via intravenous infusion that belongs to the class of immune checkpoint inhibitors. This medication works by blocking the PD-1 receptor, which helps activate the body's immune system to detect and fight cancer cells more effectively. It is widely used in various types of cancer treatment, including non-small cell lung cancer, and has shown significant success in clinical practice as both a standalone treatment and in combination with other anti-cancer therapies.

Investigated diseases

Non-small Cell Lung Cancer – A type of lung cancer that begins in the large lung cells, including squamous cells, adenocarcinomas, and large-cell carcinomas. It typically grows and spreads more slowly than small cell lung cancer. The disease develops when lung cells begin to grow abnormally and form tumors. In non-squamous variants, the cancer originates specifically in glandular cells. When HER2-overexpressing, the cancer cells have too many HER2 proteins on their surface, which can make the cancer grow more aggressively. The disease can progress to become unresectable (unable to be removed by surgery) or metastatic (spread to other parts of the body).
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515658-26-00Protocol codeDS8201-793Estimated enrolment686 patientsSponsorDaiichi Sankyo Inc.

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