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RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Benefit of Adding Durvalumab After Chemotherapy, Durvalumab and Surgery in Patients With Early-stage, Operable, Non-small Cell Lung Cancer.

This research, called ADOPT-lung, is for people in the UK with a type of early-stage lung cancer called non-small cell lung cancer. Participants will first receive chemotherapy along with a drug called durvalumab, followed by surgery. After surgery, if some cancer cells were still present, people will be randomly put into one of two groups. One group will receive extra durvalumab treatment for a year, and the other group will have regular check-ups without further treatment. The main goal is to find out if this extra durvalumab helps prevent the cancer from coming back.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
ETOP IBCSG Partners Foundation
Enrolment target
290
Start
15 Jan 2025
Estimated completion
01 Mar 2030

What is this study about?

This study is called ADOPT-lung and is for people with a type of lung cancer known as non-small cell lung cancer. This particular study focuses on cancer that is considered 'early stage' and can be removed by surgery. The main aim is to see if giving an additional treatment with a drug called durvalumab after initial chemotherapy, durvalumab, and surgery, can help people stay cancer-free for longer.

First, everyone in the study will have a combination of chemotherapy and durvalumab treatment, followed by surgery. After surgery, some people might still have traces of cancer cells. For these individuals, the study will compare two approaches: one group will receive durvalumab for about a year as an extra treatment, while the other group will have regular check-ups without further treatment. This is a common way to compare new treatments fairly.

Doctors want to understand if this extra course of durvalumab can reduce the chance of the cancer returning. This research is important because it could help improve the outlook for people with this type of lung cancer by finding more effective ways to keep the cancer away after surgery.

Key takeaways

  • Tests additional durvalumab after chemotherapy and surgery for certain lung cancers.
  • Aims to reduce the chance of cancer returning.
  • Participants will receive initial treatment, then be randomised to extra durvalumab or observation.
  • Specific health and cancer criteria must be met to join.
  • Participation involves regular hospital visits and monitoring.
  • You can stop participating at any time.

Who may be eligible?

To join this study, you must have been diagnosed with non-small cell lung cancer that is considered 'early stage' (Stage IIB to IIIB) and can be removed by surgery. Your doctors will check if your cancer falls into these categories based on its size and if it has spread to nearby lymph nodes.

You would also need to have certain test results, including having no specific genetic changes (like EGFR or ALK mutations) in your cancer cells. Doctors will perform tests to check your overall health, including your heart, lungs, and liver, to make sure it's safe for you to take part. Your general fitness level must be good, and you need to be at least 18 years old.

There are also specific blood test results needed to confirm your blood cells, kidney, and liver are working well enough. If you are a woman who could become pregnant, you would need to have a negative pregnancy test.

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. Do I have non-small cell lung cancer that is considered early stage?
  2. Is my cancer suitable for surgery?
  3. Have I had tests for specific genetic changes in my cancer?
  4. Am I generally well, and have my blood, kidney, and liver functions been checked?
  5. Am I at least 18 years old?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will first receive chemotherapy combined with durvalumab, followed by surgery. After your surgery, if some cancer cells were found, you will then be randomly assigned to one of two groups. One group will receive durvalumab injections every four weeks for a year, and the other group will be closely monitored without receiving this extra treatment.

You will have regular hospital visits for check-ups, blood tests, and scans to monitor your health and how you are responding to treatment. The exact number and frequency of visits will be explained by the study team, but throughout the entire process, including follow-up, the study could last for several years.

Potential risks and benefits

Taking part in any clinical trial has potential benefits and risks. You might benefit from the additional treatment if it proves effective in preventing the cancer's return. However, there's no guarantee the treatment will work for you, and it may not be better than standard care. You could experience side effects from the treatments, which your doctor will explain in detail. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (42)

  • Chris O'Brien Lifehouse
    Verified postcode
    Camperdown, Australia· Not yet recruiting
  • Nepean Hospital
    Verified postcode
    Penrith, Australia· Recruiting
  • Royal North Shore Hospital
    Verified postcode
    St Leonards, Australia· Recruiting
  • Princess Alexandra Hospital
    Verified postcode
    Woolloongabba, Australia· Not yet recruiting
  • Flinders Medical Centre
    Verified postcode
    Bedford Park, Australia· Not yet recruiting
  • Royal Hobart Hospital
    Verified postcode
    Hobart, Australia· Not yet recruiting
  • Eastern Health
    Verified postcode
    Box Hill, Australia· Recruiting
  • Alfred Hospital
    Verified postcode
    Melbourne, Australia· Recruiting
  • Peter MacCallum Cancer Centre
    Verified postcode
    Parkville, Australia· Recruiting
  • Sir Charles Gairdner Hospital
    Verified postcode
    Nedlands, Australia· Not yet recruiting
  • Wien AKH
    Verified postcode
    Vienna, Austria· Recruiting
  • Institut Jules Bordet - HUB
    Verified postcode
    Anderlecht, Belgium· Recruiting

Common questions

What is durvalumab?

Durvalumab is a type of medicine called immunotherapy, which helps your body's immune system fight cancer cells.

What does 'non-small cell lung cancer' mean?

It's the most common type of lung cancer, and doctors classify it this way based on how the cancer cells look under a microscope.

What does 'randomised' mean?

It means you'll be put into a treatment group by chance, like flipping a coin. This ensures the study is fair.

What is 'disease-free survival'?

This is a measure doctors use to see how long people live without their cancer coming back after treatment.

Will my regular doctors still look after me?

Yes, your usual medical team will continue to be involved in your care throughout the study.

How to find out more

Heidi Roschitzki, PhD

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 "A Study to Evaluate the Benefit of Adding Durvalumab After C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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