A Global Study to Assess the Effects of Durvalumab With Oleclumab or Durvalumab With Monalizumab Following Concurrent Chemoradiation in Patients With Stage III Unresectable Non-Small Cell Lung Cancer
This research study is looking at new treatments for a specific type of lung cancer called Stage III Non-Small Cell Lung Cancer, which can't be removed with surgery. After patients have had standard treatment (chemotherapy and radiation together), this study tests if adding extra medication can help. Patients will either receive a combination of Durvalumab and Oleclumab, or Durvalumab and Monalizumab, or a placebo (dummy drug). The main goal is to see how well these new treatments work at keeping the cancer under control and to understand if they are safe. This is a large, international study where information from many hospitals will be collected to ensure reliable results.
At a glance
What is this study about?
This study is for adults who have a type of lung cancer called Stage III Non-Small Cell Lung Cancer. This means the cancer has grown in the lung, possibly into nearby areas, but can't be completely removed by an operation. Before joining this study, participants would have already completed a standard treatment which involves both chemotherapy and radiation given at the same time. This initial treatment is designed to shrink or control the cancer.
The purpose of this study is to see if giving additional medication after this standard treatment can help further. We want to know if these new combinations of drugs can stop the cancer from growing or spreading, and if they are safe to use. You would be randomly assigned (like drawing names from a hat) to one of two groups getting the new drug combinations, or a third group getting a placebo (a treatment that looks like the study drug but contains no active medicine). This is a common way to test new treatments fairly.
The drugs being tested are called Durvalumab (which you might know as MEDI4736), Oleclumab (MEDI9447), and Monalizumab (IPH2201). These are designed to work with your body's immune system to fight the cancer. By comparing the results from people receiving the active drugs to those receiving the placebo, doctors can learn if these new treatments are truly effective and if their benefits outweigh any potential side effects.
Key takeaways
- This study is for people with Stage III non-operable lung cancer who have finished initial chemotherapy and radiation.
- It tests new drug combinations (Durvalumab with Oleclumab, or Durvalumab with Monalizumab) vs. placebo.
- The goal is to see if these new drugs can stop cancer from growing and if they are safe.
- You will receive infusions (drips) of the study drugs or placebo regularly.
- Your health will be closely monitored with tests and scans.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be at least 18 years old and have a confirmed diagnosis of Stage III Non-Small Cell Lung Cancer that doctors have said cannot be removed by surgery. You must have already completed a combined treatment of chemotherapy and radiation, and your cancer should not have grown or spread since then. We would also need a tissue sample from your cancer before your chemotherapy and radiation treatment.
There are also some health requirements, such as having good general health and your major organs working properly. Your medical team will check details about your specific type of lung cancer, including certain genetic markers, to make sure this study is right for you. They will also need to ensure that any side effects from your previous chemotherapy or radiation treatment have mostly cleared up, especially lung inflammation (pneumonitis).
You wouldn't be able to join if you have cancer that's mixed with another type called small cell lung cancer, or if you've recently had another type of cancer that hasn't been completely cured. If your cancer grew worse during or immediately after your chemotherapy and radiation, or if you have certain lung conditions like severe scarring, you also wouldn't be able to participate.
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.
- Are you 18 years or older?
- Do you have Stage III Non-Small Cell Lung Cancer that cannot be surgically removed?
- Have you recently completed combined chemotherapy and radiation for your lung cancer, and it hasn't progressed?
- Do you have a tissue sample from your cancer before your most recent treatment?
- Are you in good general health, and your organs are working well?
- Have any side effects from your previous chemotherapy or radiation mostly cleared up?
What does participation involve?
If you decide to take part, you'll be assigned by chance to one of three treatment groups. This is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving – Durvalumab with Oleclumab, Durvalumab with Monalizumab, or Durvalumab with a placebo. You would come to the clinic for regular visits where you'd receive your study medications, which are given as infusions (into a vein).
During these visits, you'll have various tests and assessments, including blood tests, scans (like CT scans) to check your cancer, and physical examinations. These are to monitor your health, check for side effects, and see how the treatment is working. The study involves regular treatment for an extended period, and you'll have follow-up visits even after you stop taking the study medication to keep track of your health long-term. Your study team will explain the exact schedule of visits and procedures in detail, and you'll always have the right to ask questions.
Potential risks and benefits
Locations (202)
- Research SiteVerified postcodeSan Diego, United States
- Research SiteVerified postcodeNew Haven, United States
- Research SiteVerified postcodeStuart, United States
- Research SiteVerified postcodeUrbana, United States
- Research SiteVerified postcodeNew Albany, United States
- Research SiteVerified postcodeLexington, United States
- Research SiteVerified postcodeLouisville, United States
- Research SiteVerified postcodeAnnapolis, United States
- Research SiteVerified postcodeBaltimore, United States
- Research SiteVerified postcodeBaltimore, United States
- Research SiteVerified postcodeBethesda, United States
- Research SiteVerified postcodeGrand Rapids, United States
Common questions
What is Stage III Non-Small Cell Lung Cancer?
This is a type of lung cancer that has grown in the lung and possibly to nearby lymph nodes or structures, but hasn't spread to distant parts of the body and can't be entirely removed by surgery.
What is a 'placebo'?
A placebo is a substance or treatment that looks exactly like the study drug but contains no active medicine. It's used in studies to help doctors compare how well the new drug works against not receiving it.
Will I know if I'm getting the actual study drug or a placebo?
No, this is a 'double-blind' study, meaning neither you nor your study doctor will know which treatment you are receiving until the study is complete, unless it's medically necessary to know for your care.
Why do I need to have a previous tissue sample?
The study needs to analyse your original cancer tissue to understand its characteristics, which can help researchers learn more about how the new treatments work for different types of cancer.
How long will I be in the study?
The main treatment phase will last for a period, and then you'll have follow-up visits to monitor your health. The exact duration will be fully explained by the study team.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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