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Active not recruitingPHASE2INTERVENTIONAL

Study to Assess Neoadjuvant Durvalumab (D) and Platinum-Based Chemotherapy (CT), Followed by Either Surgery and Adjuvant D or CRT and Consolidation D, in Resectable or Borderline Resectable Stage IIB-IIIB NSCLC (MDT-BRIDGE)

This study is looking into a new way to treat certain types of non-small cell lung cancer (Stages IIB-IIIB). It involves giving a drug called durvalumab alongside standard chemotherapy before surgery (if possible). For those who can have surgery, they'll then receive more durvalumab. If surgery isn't possible, they'll receive chemotherapy and radiation, followed by durvalumab. Researchers want to understand if this combination of treatments is effective and safe. They'll be carefully checking how patients respond and any side effects. This combination therapy is being explored to improve outcomes for patients with these specific types of lung cancer.

At a glance

Status
Active not recruiting
Phase
PHASE2
Sponsor
AstraZeneca
Enrolment target
142
Start
22 Feb 2024
Estimated completion
27 Aug 2027

What is this study about?

This study is for people in the UK who have a type of lung cancer called non-small cell lung cancer, specifically at stages IIB-IIIB. These stages mean the cancer has grown into nearby tissues or lymph nodes, but it hasn't spread to distant parts of the body. The aim of this research is to see if a particular treatment plan can help manage this cancer better.

The study looks at giving a drug called durvalumab together with standard chemotherapy. This combination is given first, before other treatments. Depending on whether surgery is an option after this initial treatment, patients will then either have surgery followed by more durvalumab, or they will have a combination of chemotherapy and radiation therapy, also followed by durvalumab. The main goal is to find out if this approach is both effective in treating the cancer and safe for patients.

Researchers will be carefully monitoring how patients respond to these treatments and if there are any side effects. By studying this new treatment strategy, doctors hope to improve the care and outcomes for people with these specific types of lung cancer. This is a Phase II study, which means it's testing a promising treatment plan on a larger group of patients to gather more information.

Key takeaways

  • This study explores a new treatment combination for certain non-small cell lung cancers.
  • It combines a drug called durvalumab with chemotherapy before surgery or other treatments.
  • The two treatment paths involve either surgery or chemotherapy/radiation, both followed by more durvalumab.
  • Researchers are testing the safety and effectiveness of this new approach.
  • Participation involves regular hospital visits, assessments, and close monitoring.
  • It's a Phase II study, meaning it's still gathering important information about the treatment.

Who may be eligible?

To be part of this study, you would need to have non-small cell lung cancer that is at stage IIB, IIC, or IIIB (specifically where it has spread to certain lymph nodes, called N2). Doctors would need to confirm that your cancer can either be completely removed by surgery, or that it’s on the borderline of being removable, after a discussion by a team of specialists.

It's important that you haven't received any previous treatment for your lung cancer. You must also be well enough to have surgery, with your heart and lung function being good enough. Your doctor will need to check that your cancer doesn't have certain gene changes (specifically EGFR mutations or ALK translocations).

There are also some reasons why someone couldn't join. For example, if your cancer has already spread to distant parts of your body (Stage IIIC), or if you have specific health conditions that make surgery unsafe. Being pregnant or breastfeeding, or having certain infections like HIV or active hepatitis, would also mean you couldn't take part. The research team will do a full health check to make sure the 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. Do I have non-small cell lung cancer at stage IIB, IIC, or IIIB (N2)?
  2. Has my doctor confirmed my cancer could possibly be removed by surgery, or is borderline resectable?
  3. Have I had any previous treatment for my lung cancer?
  4. Am I generally well enough to undergo surgery and other treatments?
  5. Am I over 18 years old?
Answer every question to see your result.

What does participation involve?

If you join this study, your journey will begin with two cycles of treatment, each lasting three weeks. This involves receiving the study drug, durvalumab, along with standard chemotherapy, both given through a drip into your vein. Afterwards, a team of specialists will assess whether surgery to remove your tumour is possible.

If surgery is recommended, you'll have one or two more cycles of the durvalumab and chemotherapy combination, followed by the surgery. After your recovery from surgery, you'll then receive durvalumab alone every four weeks for up to a year, or until your cancer shows signs of progressing. If surgery isn't an option, you will have about six weeks of daily chemotherapy and radiation therapy. After this, you would then receive durvalumab alone every four weeks, also for up to a year or until your cancer progresses. Throughout the study, you'll have regular hospital visits for assessments, scans, and blood tests to monitor your health and how well the treatment is working. The total time you're on treatment and follow-up will vary depending on your individual response and treatment path.

Potential risks and benefits

Potential benefits of taking part include receiving cutting-edge treatment that may be more effective than standard approaches, as well as close medical monitoring and care. While this study may not directly benefit everyone, the information gained could help future patients with similar conditions. As with any medical treatment, there are potential risks, including side effects from the medications. These will be fully explained to you before you decide to participate. You have the right to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (49)

  • Research Site
    Verified postcode
    The Bronx, United States
  • Research Site
    Verified postcode
    Houston, United States
  • Research Site
    Verified postcode
    Charlottesville, United States
  • Research Site
    Verified postcode
    Vienna, Austria
  • Research Site
    Verified postcode
    Vienna, Austria
  • Research Site
    Verified postcode
    Kingston, Canada
  • Research Site
    Verified postcode
    Chicoutimi, Canada
  • Research Site
    Verified postcode
    Montreal, Canada
  • Research Site
    Verified postcode
    Brno, Czechia
  • Research Site
    Verified postcode
    Olomouc, Czechia
  • Research Site
    Verified postcode
    Prague, Czechia
  • Research Site
    Verified postcode
    Prague, Czechia

Common questions

What is non-small cell lung cancer?

It's the most common type of lung cancer. This study is for specific stages where the cancer is more localised, but hasn't spread widely.

What is durvalumab?

Durvalumab is a type of immunotherapy. It helps your body's immune system recognise and fight cancer cells.

What does 'neoadjuvant' mean?

Neoadjuvant treatment means giving medication (like durvalumab and chemotherapy) before the main treatment, such as surgery or radiation. The goal is to shrink the tumour first.

Will I have to have surgery?

Not necessarily. After initial treatment, a team of doctors will decide if surgery is the best option for you. If not, you'll receive a different set of treatments.

How long will I be in the study?

The treatment part of the study could last up to a year, depending on your individual treatment plan and how you respond. There will also be follow-up appointments.

How to find out more

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

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