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RecruitingPHASE3INTERVENTIONAL

A Global Study to Assess the Effects of Durvalumab + Domvanalimab Following Concurrent Chemoradiation in Participants With Stage III Unresectable NSCLC

This study is for people in the UK with a type of lung cancer called Stage III Non-Small Cell Lung Cancer (NSCLC) that cannot be removed by surgery. Participants have already had a combination of chemotherapy and radiation treatment, and their cancer has not grown worse. Researchers want to compare a new combination of two medicines, Durvalumab and Domvanalimab, against Durvalumab combined with a dummy medicine (placebo). The aim is to see if the new combination is effective and safe in preventing the cancer from returning or getting worse after initial treatment. This is a large, international study where patients are randomly assigned to receive one of the treatments without knowing which one it is.

At a glance

Status
Recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
860
Start
18 Feb 2022
Estimated completion
01 Oct 2030

What is this study about?

This study is focused on a specific type of lung cancer known as Stage III Non-Small Cell Lung Cancer (NSCLC). This means the cancer is advanced but hasn't spread to distant parts of the body. For these patients, standard treatment often involves a combination of chemotherapy and radiation given at the same time. The purpose of this study is to explore if certain newer medicines can help after this initial treatment.

The study will compare two different treatment approaches: one group of patients will receive a combination of two drugs, Durvalumab and Domvanalimab. The other group will receive Durvalumab along with a 'placebo', which looks like a medicine but contains no active drug. This allows researchers to understand if adding Domvanalimab to Durvalumab offers extra benefits. Both Durvalumab and Domvanalimab are types of immunotherapy, which work by helping your body's own immune system fight cancer.

By comparing these treatments, doctors hope to find out if the new combination can help prevent the cancer from returning or growing, and if it's safe for patients. This is an important step in developing new ways to manage advanced lung cancer and potentially improve long-term outcomes for patients after their initial chemotherapy and radiation.

Key takeaways

  • This study tests new immunotherapy combinations for advanced lung cancer.
  • It's for people whose cancer hasn't worsened after initial chemotherapy and radiation.
  • Participants will be randomly assigned to receive one of two treatments.
  • All study treatments and clinical monitoring are covered by the trial.
  • You can withdraw from the study at any time without affecting your care.

Who may be eligible?

To be considered for this study, you must be at least 18 years old and have a confirmed diagnosis of Stage III Non-Small Cell Lung Cancer that cannot be surgically removed. You should have already completed a standard course of simultaneous chemotherapy and radiation for your lung cancer, and crucially, your cancer must not have worsened during or after this treatment.

Your medical team would also need to check specific details about your cancer, such as certain genetic markers (EGFR and ALK 'wild-type' status) and a protein called PD-L1, from a tumour sample taken before your chemotherapy and radiation. You also need to be generally well enough to participate, with good levels of health as determined by your doctor and normal function of your organs.

There are also some reasons why you might not be able to join. For example, if you have certain other serious health conditions or other cancers that have required treatment recently, or if you experienced severe side effects like lung inflammation (pneumonitis) from your previous radiation treatment. The study also cannot include patients whose cancer progressed during their initial chemotherapy and radiation, or those who received their radiation and chemotherapy at different times.

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 or older?
  2. Do you have Stage III Non-Small Cell Lung Cancer?
  3. Have you already completed chemotherapy AND radiation given at the same time?
  4. Has your cancer NOT gotten worse during or after that prior treatment?
  5. Are you generally well and fit enough for treatment, as assessed by your doctor?
Answer every question to see your result.

What does participation involve?

If you join the study, you would be randomly assigned to one of two treatment groups, meaning neither you nor your doctor would choose which treatment you receive. You would also not know if you are receiving the combination treatment or the comparison treatment (Durvalumab with a placebo). The study involves regular visits for treatments and assessments, which include blood tests, physical examinations, and scans to monitor your health and how the treatment is working.

The duration of your participation would depend on how your body responds to the treatment. You would continue to receive the study treatment for a set period, or until your cancer worsens, or if you experience unacceptable side effects. Throughout the study, you would have close medical supervision, and there would be follow-up appointments after your treatment period ends to continue monitoring your health.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments before they are widely available and close medical monitoring. However, there are also potential risks; the new treatments might have side effects that are not yet fully known or might not work for everyone. You will be fully informed of all known risks before deciding to participate. It's very important to remember that participating is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (264)

  • Research Site
    Verified postcode
    Chandler, United States· Recruiting
  • Research Site
    Verified postcode
    Phoenix, United States· Suspended
  • Research Site
    Verified postcode
    Fountain Valley, United States· Recruiting
  • Research Site
    Verified postcode
    Santa Rosa, United States· Recruiting
  • Research Site
    Verified postcode
    Washington D.C., United States· Recruiting
  • Research Site
    Verified postcode
    Jacksonville, United States· Suspended
  • Research Site
    Verified postcode
    Orlando, United States· Recruiting
  • Research Site
    Verified postcode
    Saint Augustine, United States· Recruiting
  • Research Site
    Verified postcode
    Macon, United States· Suspended
  • Research Site
    Verified postcode
    Elmhurst, United States· Suspended
  • Research Site
    Verified postcode
    Maywood, United States· Withdrawn
  • Research Site
    Verified postcode
    Naperville, United States· Withdrawn

Common questions

What is Durvalumab and Domvanalimab?

These are immunotherapy drugs that help your body's immune system fight cancer. Durvalumab is already used for some lung cancers, and Domvanalimab is a newer drug being tested.

What is a 'placebo'?

A placebo is a dummy treatment that looks like the real drug but contains no active medicine. It helps researchers fairly compare the effects of the active treatment.

What does 'randomised and double-blind' mean?

It means you are randomly assigned to a treatment group (like flipping a coin), and neither you nor your doctor will know which treatment you are receiving. This ensures the results are as fair and unbiased as possible.

What is Stage III NSCLC?

This refers to Non-Small Cell Lung Cancer that has grown in the lung and possibly spread to nearby lymph nodes, but has not yet spread to distant parts of the body.

Will I have to pay to be in this study?

No, all study-related treatments and assessments are typically provided at no cost to you.

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 "A Global Study to Assess the Effects of Durvalumab + Domvana…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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