AuthorisedTherapeutic exploratory (Phase II)Interventional

Phase II, clinical trial, to evaluate OS in two cohorts in relapsed stage III non-small-cell lung cancer (NSCLC) pretreated with chemoradiotherapy and durvalumab

This study is for people with a type of lung cancer called non-small cell lung cancer (NSCLC) that has come back after they've already had chemotherapy, radiotherapy, and another drug called durvalumab. The main goal is to see if a drug called IMFINZI can help people live longer. Researchers are also looking at how long people live without their cancer getting worse, how much the cancer shrinks, and whether the treatment is safe and causes side effects. They will also explore if certain markers in the body can predict who might benefit most from IMFINZI. This is a Phase II study, meaning it's a further step to understand how well the treatment works and its safety.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Fondazione Ricerca Traslazionale

Enrolment target

Start

20 Feb 2025

NSCLC non-small cell lung cancer

What is this study about?

This research study is focusing on a type of lung cancer known as non-small cell lung cancer (NSCLC). Specifically, it's for individuals whose cancer has returned after they’ve had a combination of treatments, including chemotherapy, radiotherapy, and a drug called durvalumab. The main aim is to find out if a new treatment, called IMFINZI, can help people with this specific type of advanced lung cancer live longer.

Researchers are also interested in several other important things. They want to see how long people live without their cancer getting worse, and how much the treatment might shrink the cancer. Looking at these aspects helps doctors understand how effective the treatment is. Another key part of the study is to carefully check if the treatment is safe and what side effects people might experience. Understanding both the benefits and risks is crucial for any new medicine.

The study will also explore whether certain biological markers in a person's body can tell us if IMFINZI might work better for them. This means looking at things like specific genes or proteins in the cancer. Finding these clues could help doctors in the future choose the best treatment for each person. This is a Phase II study, which means it’s a detailed step to gather more information about the drug's effectiveness and safety, following earlier research.

Key takeaways

This study is testing a drug called IMFINZI for advanced lung cancer.
It's for people whose non-small cell lung cancer (NSCLC) has returned after specific previous treatments.
The main goal is to see if IMFINZI can help people live longer and is safe.
Researchers are also looking at how the treatment affects cancer growth and if certain body markers predict its success.
You would receive IMFINZI by infusion and have regular check-ups and tests.

Who may be eligible?

This study is looking for adults who are 18 years or older, with no upper age limit. Both men and women can take part in this research.

To be included, you must have non-small cell lung cancer that has unfortunately returned, even after you've already had a combination of treatments. These treatments would have included chemotherapy, radiotherapy, and a specific drug called durvalumab. The study is specifically for people who have received these particular prior treatments.

Your medical team will carefully check your health and your specific cancer details to make sure this study is the right fit for you. They will go through all the criteria to ensure your safety and that you meet the study's requirements.

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 old or older?
Do you have non-small cell lung cancer (NSCLC)?
Has your lung cancer returned after being treated with chemotherapy, radiotherapy, AND durvalumab?
Are you prepared to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you would receive the study drug, IMFINZI, as a solution given directly into your vein (an infusion). The full details of the schedule for these infusions, as well as any hospital visits, will be explained by the study team. You would also have regular check-ups, which include physical exams, blood tests, and scans, to monitor your health and how the treatment is working. These tests help doctors understand the treatment's effects and ensure your safety. The study will continue for a period determined by your health and the treatment's effectiveness, with regular follow-up visits to track your progress. The total duration of your involvement, including treatment and follow-up, will be clearly outlined by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as accessing a new treatment that isn't widely available yet, which might help your cancer. However, there are also potential risks, including side effects from the study drug, which could range from mild to serious. The study team will carefully monitor you for any side effects and provide support. It's important to remember that you have the right to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is non-small cell lung cancer (NSCLC)?

NSCLC is the most common type of lung cancer. This study is specifically for people whose NSCLC has returned after previous treatments.

What is IMFINZI?

IMFINZI is a medicine that will be given into your vein (like a drip) as part of this study. It's being tested to see if it can help people with this type of lung cancer live longer.

What does 'Phase II' mean?

Phase II means this is one of the steps in testing a new treatment. It helps doctors learn more about how well the drug works and its safety in a larger group of people, after initial tests.

Will I know if the treatment is working for me?

The study team will regularly perform tests, like scans, to monitor your cancer and overall health. They will discuss the results with you.

Can I stop participating in the study if I change my mind?

Yes, you are free to withdraw from the study at any time, for any reason. Your decision will not affect your medical care.