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RecruitingPHASE2INTERVENTIONAL

Neoadjuvant and Adjuvant Treatment in Resectable Non-small Cell Lung Cancer

This study is for people with early-stage non-small cell lung cancer that can be removed by surgery. It's testing different combinations of new drugs, like Durvalumab, Oleclumab, Monalizumab, Dato-DXd, AZD0171, Volrustomig, or Rilvegostomig, alongside traditional chemotherapy. Some drugs are given before surgery to shrink the tumour, and then continued after surgery to help prevent the cancer from coming back. Researchers want to find out if these new combinations are safe and more effective than current treatments. This is a Phase 2 study, meaning it's exploring how well the treatments work and looking closely at side effects.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
630
Start
14 Apr 2022
Estimated completion
28 May 2030

What is this study about?

This study is looking into new ways to treat non-small cell lung cancer, specifically in people whose cancer is found early and can be removed with an operation. The main idea is to try different combinations of medications, both before and after surgery, to give the best chance of successful treatment.

Think of it like this: current treatments often involve surgery, sometimes followed by chemotherapy. This study is testing brand new drugs, often called immunotherapies or targeted therapies, to see if adding them to chemotherapy, or using them in new combinations, can make the treatment even better. The drugs are given *before* surgery (this is called neoadjuvant treatment) to try and shrink the tumour, making the surgery potentially easier or more effective. Then, drugs are also given *after* surgery (this is called adjuvant treatment) to help destroy any remaining cancer cells and reduce the risk of the cancer coming back.

The study involves several different groups, each receiving a specific combination of these new drugs with or without chemotherapy. By doing this, the researchers hope to identify which combinations are safest and most effective at treating lung cancer in its earlier stages. This is an important step towards finding better treatments for the future.

Key takeaways

  • New drug combinations are being tested alongside chemotherapy for early-stage lung cancer.
  • Treatments are given both before and after surgery to improve outcomes.
  • The study aims to find safer and more effective ways to treat non-small cell lung cancer.
  • Participation involves regular hospital visits, tests, and taking study medications.
  • You will be assigned to a treatment group randomly, you can't choose.
  • You can stop participating at any time if you change your mind.

Who may be eligible?

To join this study, you would generally need to have been recently diagnosed with a specific type of non-small cell lung cancer (stages IIA to IIIB) that your doctors believe can be fully removed by surgery. You would also need to be in generally good health, able to perform daily activities without too much difficulty, and have healthy organs and bone marrow.

There are also some reasons why you might not be able to join. For example, if your cancer has certain genetic changes (like specific EGFR mutations or ALK translocations), or if you have a history of serious autoimmune conditions, severe heart problems, or other serious uncontrolled illnesses. Also, if you already have certain lung conditions, like active interstitial lung disease, or if your doctors plan to remove only a small piece of your lung rather than the whole lobe or larger section, you might not be able to take part. Your medical team will carefully check all your health details to see if this study is right for you.

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. Have you been diagnosed with non-small cell lung cancer (stages IIA, IIB, or IIIB)?
  2. Does your doctor believe your cancer can be removed by surgery?
  3. Are you generally well and active in your daily life?
  4. Do you have healthy organ function, including your heart and lungs?
  5. Do you have any serious, uncontrolled health problems like severe heart disease or certain autoimmune conditions?
Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of several treatment groups at random, like flipping a coin. You won't get to choose your specific treatment combination. You will receive medication through injections, infusions (drips), or tablets for a period before your surgery, and then likely continue with some of these medications after your surgery for a longer time, possibly up to a year or more. You'll have regular hospital visits for medical checks, blood tests, scans (like CT scans), and to talk to the study doctors and nurses. These visits will check how you're responding to the treatment and look for any side effects. The total time you're involved in the study, including follow-up appointments after your treatment ends, could be several years.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments before they are widely available, which might be more effective in treating your cancer. However, as these are new combinations, there might be side effects that are not fully known or understood yet. All medications carry risks, including chemotherapy and the newer drugs being tested. You could experience side effects like tiredness, nausea, or more serious reactions. Your medical team will monitor you closely for any problems. It's very important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (97)

  • Research Site
    Verified postcode
    Little Rock, United States· Recruiting
  • Research Site
    Verified postcode
    Los Angeles, United States· Recruiting
  • Research Site
    Verified postcode
    Oakland, United States· Withdrawn
  • Research Site
    Verified postcode
    New Haven, United States· Recruiting
  • Research Site
    Verified postcode
    Stuart, United States· Completed
  • Research Site
    Verified postcode
    Gainesville, United States· Completed
  • Research Site
    Verified postcode
    Chicago, United States· Recruiting
  • Research Site
    Verified postcode
    Baltimore, United States· Withdrawn
  • Research Site
    Verified postcode
    Baltimore, United States· Recruiting
  • Research Site
    Verified postcode
    Boston, United States· Recruiting
  • Research Site
    Verified postcode
    Saint Louis Park, United States· Completed
  • Research Site
    Verified postcode
    Omaha, United States· Recruiting

Common questions

What is 'neoadjuvant' and 'adjuvant' treatment?

Neoadjuvant treatment is given before surgery to shrink the cancer, while adjuvant treatment is given after surgery to help stop it from coming back.

What kind of cancer is this study for?

It's for non-small cell lung cancer that is in its early stages (IIA to IIIB) and can be removed with an operation.

Will I get chosen for a specific drug combination?

No, you will be randomly assigned to one of the treatment groups, like drawing lots, so you won't get to pick.

How long will I be in the study?

The treatment phase could last over a year, and you'll have follow-up appointments for several years to check on your health.

Can I leave the study if I want to?

Yes, absolutely. You can withdraw from the study at any time without having to give a reason, and it won't affect your future medical care.

How to find out more

AstraZeneca Clinical Study Information Center

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 "Neoadjuvant and Adjuvant Treatment in Resectable Non-small C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

Discussion

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