All studies
Active not recruitingPHASE3INTERVENTIONAL

A Study to Investigate the Efficacy and Safety of Trastuzumab Deruxtecan as the First Treatment Option for Unresectable, Locally Advanced/Metastatic Non-Small Cell Lung Cancer With HER2 Mutations

This study, called DESTINY-Lung04, is for people with advanced non-small cell lung cancer that has a specific gene change called a HER2 mutation. It's the first treatment option for this type of cancer. Researchers want to see if a new drug, trastuzumab deruxtecan, is more effective and safer than the usual treatments doctors give. "Effective" means helping people live longer or stopping the cancer from getting worse. They will also look at how these treatments affect a person's quality of life. This is a Phase 3 study, which means it involves a larger group of people and compares the new treatment to existing ones.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
454
Start
28 Oct 2021
Estimated completion
30 Jul 2027

What is this study about?

This study is particularly looking at a type of lung cancer called non-small cell lung cancer (NSCLC). Specifically, it's for people whose cancer has spread or cannot be removed by surgery, and who have a special genetic change called a HER2 mutation (exons 19 or 20). This mutation means the cancer cells have too many HER2 proteins, which can make them grow more.

The main goal is to find out if a new drug, trastuzumab deruxtecan, works better than the standard treatments usually given as the first treatment for this kind of advanced lung cancer. The standard treatments typically involve a combination of chemotherapy drugs (like cisplatin or carboplatin) and other medicines (pembrolizumab, pemetrexed). Researchers want to see if the new drug can help people live longer without their cancer growing, or simply live longer overall. They will also pay close attention to the safety of the new drug and how it affects people's side effects and general well-being.

Taking part in this study means you would receive either the new drug or one of the standard treatment combinations. Your doctors would carefully monitor your health and your cancer throughout the study. By comparing the new drug to standard care, the study hopes to find improved treatment options for people with this specific type of lung cancer.

Key takeaways

  • This study is for a specific type of advanced non-small cell lung cancer with a HER2 mutation.
  • It compares a new drug (trastuzumab deruxtecan) to standard, usual treatments.
  • The main aim is to see if the new drug helps people live longer or without their cancer worsening.
  • Researchers will also check for safety, side effects, and quality of life.
  • It's a Phase 3 study, meaning it’s a big study comparing new vs. current options.
  • Participation means receiving one of the study treatments and having regular check-ups.

Who may be eligible?

This study is looking for adults aged 18 or older who have advanced non-small cell lung cancer that can't be removed by surgery or has spread. Your cancer must also have a specific gene change called a HER2 mutation (exons 19 or 20), which will be checked with a special test. You should not have received any previous treatment for your advanced lung cancer aimed at easing symptoms.

There are also some important health checks. Your heart should be working well, and vital organs like your kidneys and liver need to be healthy enough. Doctors will also check your overall health and how well you can go about your daily activities. There are some specific conditions that would mean you couldn't join, such as having certain other gene changes in your cancer, untreated brain tumours, or some other serious health problems like heart attacks recently or severe lung conditions in the past.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Are you 18 years old or older?
  2. Do you have advanced lung cancer that cannot be removed by surgery or has spread?
  3. Has your doctor confirmed your lung cancer has a HER2 gene change (Exon 19 or 20)?
  4. Have you not yet received any treatment for your advanced lung cancer?
  5. Do you have generally good health, including normal heart function?
  6. Do you not have untreated brain tumours or other specific serious health conditions listed by the researchers?
Answer every question to see your result.

What does participation involve?

If you choose to take part, you would be assigned to receive either the new drug (trastuzumab deruxtecan) or a combination of standard treatments. You would have regular visits to the clinic for treatments, check-ups, and tests to see how you are doing and how the treatment is affecting your cancer. These tests might include blood tests, scans, and possibly heart function tests. The doctors will also ask you about your general health and any side effects you might be experiencing. The study will continue as long as the treatment is helping you and you are tolerating it well. The total duration for each person can vary, but there will be ongoing follow-up to monitor your health.

Potential risks and benefits

Potential benefits of joining include receiving a new experimental treatment that might be more effective than current options for your cancer. You would also have very close medical monitoring. However, like all medicines, the study treatments can have side effects, and some may be serious. The new drug's full effects are not yet known. Both the new drug and standard treatments may not work for everyone, or they may cause side effects that are uncomfortable or harmful. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (130)

  • Research Site
    Verified postcode
    Anchorage, United States
  • Research Site
    Verified postcode
    Los Alamitos, United States
  • Research Site
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    Los Angeles, United States
  • Research Site
    Verified postcode
    Orange, United States
  • Research Site
    Verified postcode
    San Francisco, United States
  • Research Site
    Verified postcode
    Santa Monica, United States
  • Research Site
    Verified postcode
    Silver Spring, United States
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    Ann Arbor, United States
  • Research Site
    Verified postcode
    Basking Ridge, United States
  • Research Site
    Verified postcode
    Middletown, United States
  • Research Site
    Verified postcode
    Montvale, United States

Common questions

What is a HER2 mutation?

A HER2 mutation is a specific change in the genes of your cancer cells. It can make the cancer grow more quickly. This study is only for people with this particular change.

What does 'Phase 3' mean for a clinical trial?

Phase 3 means this is a large study comparing a new treatment to existing standard treatments. It's often the last step before a new drug could potentially be approved for wider use.

Will I know if I'm getting the new drug or standard treatment?

Usually, in studies like this, you won't know which treatment you are receiving. This helps researchers get unbiased results. Your study doctor can give you more details about this.

What does 'unresectable' or 'metastatic' mean?

'Unresectable' means the cancer can't be completely removed by surgery. 'Metastatic' means the cancer has spread from where it started to other parts of your body.

What if I decide I don't want to be in the study anymore?

You are free to leave the study at any time, for any reason, without needing to explain why. This will not affect your medical care in the future.

How to find out more

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

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