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RecruitingPHASE3INTERVENTIONAL

Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum-based Chemotherapy in First-line HER2 Overexpressing Non-small Cell Lung Cancer

This study is for people with a specific type of lung cancer called non-small cell lung cancer, which has changes in a protein called HER2 and others called PD-L1. It's for cancer that has spread to other parts of the body or can't be removed with an operation. The study aims to see how safe and effective a new combination of treatments is. One group will receive two drugs, trastuzumab deruxtecan and pembrolizumab. The other group will receive standard chemotherapy (pemetrexed and other chemotherapy drugs) along with pembrolizumab. This is for people who haven't had treatment for their advanced lung cancer yet. The goal is to find better ways to treat this condition.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
Daiichi Sankyo
Enrolment target
686
Start
24 Oct 2025
Estimated completion
05 Jul 2032

What is this study about?

This research study is about a type of lung cancer known as non-small cell lung cancer. Specifically, it's for people whose cancer has certain features: high levels of a protein called HER2 and a specific level of another protein called PD-L1. It’s also for cancer that has either spread to other parts of the body (this is called metastatic) or can’t be removed by surgery.

The main aim of this study is to compare two different treatment approaches. One approach involves a newer drug called trastuzumab deruxtecan (you might know it as Enhertu®) given together with pembrolizumab. The other approach uses standard chemotherapy drugs, like pemetrexed, along with pembrolizumab. The researchers want to see if the newer combination is more effective or has fewer side effects than the standard treatment for people in this situation.

This is a 'first-line' treatment study, meaning it's for patients who haven't had any previous treatment for their advanced lung cancer. By comparing these treatments, doctors hope to find better and safer ways to help people with this type of lung cancer.

Key takeaways

  • This study is testing new combinations of drugs for advanced non-small cell lung cancer.
  • It targets cancer with specific HER2 and PD-L1 protein levels.
  • It's for people who haven't had prior treatment for their advanced cancer.
  • The study compares a new drug (trastuzumab deruxtecan) with standard chemotherapy.
  • The goal is to find better and safer treatment options.

Who may be eligible?

To be able to join this study, you must be 18 years or older. You need to have non-small cell lung cancer that has spread or cannot be removed by surgery. Your cancer cells must show certain levels of specific proteins (HER2 and PD-L1) when tested.

It's important that you haven't had any previous specific treatments for your advanced lung cancer. If you had treatments like chemotherapy or immunotherapy in the past for an earlier stage of cancer, you might still be eligible, but there are specific timeframes that need to be met.

The research team will also check for other things, like your general health and how well your body is working, using blood tests and other examinations. They will explain all the details of what they are looking for to make sure the study is a good and safe fit for you.

Quick self-check
  • Are you 18 years old or older?
  • Do you have non-small cell lung cancer that has spread or cannot be removed by surgery?
  • Has your cancer been tested for HER2 and PD-L1 proteins?
  • Have you *not* had previous treatment for your advanced lung cancer?
  • Are you generally well enough to take part in a clinical study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

This section was not provided in the original text, and I cannot generate speculative content. Please provide details on participation if you'd like it included.

Potential risks and benefits

Taking part in a clinical trial offers the chance to access new treatments before they are widely available. While these new treatments might be more effective, they could also have different or unknown side effects compared to standard care. Similarly, standard treatments also have known risks and side effects. The study team will carefully monitor your health and any side effects you experience. You will receive detailed information about potential risks and benefits before deciding to join, and you are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (100)

  • Alaska Oncology & Hematology, LLC
    Anchorage, United States· Recruiting
  • Orange Coast Memorial Medical Center Fountain Valley
    Fountain Valley, United States· Recruiting
  • California Research Institute
    Los Angeles, United States· Recruiting
  • Los Angeles Cancer Network (LACN)
    Los Angeles, United States· Recruiting
  • Providence Medical Foundation
    Santa Rosa, United States· Recruiting
  • Bay Pines VA Healthcare System
    Bay Pines, United States· Recruiting
  • Holy Cross Hospital
    Fort Lauderdale, United States· Recruiting
  • Mid-Florida Hematology & Oncology Centers, P.A.
    Orange City, United States· Recruiting
  • BRCR Global Plantation
    Plantation, United States· Recruiting
  • Hope and Healing Cancer Services
    Hinsdale, United States· Recruiting
  • Logan Health Research
    Kalispell, United States· Recruiting
  • Clinical Research Alliance
    Westbury, United States· Active not recruiting

+88 more sites — see the official record for the full list.

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study focuses on a specific kind that has changes in certain proteins on the cancer cells.

What does 'HER2-overexpressing' mean?

It means your cancer cells have high levels of a specific protein called HER2. This can help doctors choose certain treatments.

What is 'first-line treatment'?

This means it's the very first treatment you receive for your advanced lung cancer, before any other specific therapies.

What is chemotherapy?

Chemotherapy uses strong medicines to kill cancer cells, but it can also affect healthy cells, leading to side effects.

Can I stop participating in the study if I want to?

Yes, absolutely. You have the right to withdraw from the study at any time, for any reason, and it won't affect your ongoing medical care.

How to find out more

Contact for Trial Information

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Study of Trastuzumab Deruxtecan, Pembrolizumab, and Platinum…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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