Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Thoracic Radiotherapy plus Durvalumab in Elderly and/or frail NSCLC stage III patients unfit for chemotherapy - Employing optimized (hypofractionated) radiotherapy to foster durvalumab efficacy

This research study is for people with a type of lung cancer called non-small-cell lung cancer (NSCLC) that's in an advanced stage (stage III) and can't be removed by surgery. It's specifically for those who might be older or frailer and can't have regular chemotherapy. The study is exploring a new treatment approach that combines a special, shorter course of radiation therapy (thoracic radiotherapy) with a modern immunotherapy drug called durvalumab (also known as Imfinzi). Researchers want to find out how safe this combination is, especially looking at side effects like lung inflammation. They also want to see how well it works at shrinking the cancer. This is an early-stage study (Phase II) to gather more information about this new treatment strategy.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Frankfurter Institut Fuer Klinische Krebsforschung IKF GmbH

Enrolment target

Start

15 Aug 2024

unresectable stage III NSCLC (Non–small-cell lung cancer)

What is this study about?

This study is looking into a new way to treat a specific type of lung cancer called non-small-cell lung cancer (NSCLC). This is the most common type of lung cancer. The study focuses on people whose cancer has spread a bit but can't be removed with an operation (this is called unresectable stage III NSCLC). It's particularly for those who are older or might be a bit frailer and aren't able to have the usual chemotherapy treatment.

The main idea behind this study is to combine two different types of treatment: a specialised form of radiation therapy and a drug called durvalumab, known by its brand name Imfinzi. Radiation therapy uses high-energy rays to kill cancer cells. In this study, they're using a specific, shorter course of radiation. Durvalumab is an immunotherapy drug. Immunotherapy works by helping your body's own immune system fight the cancer. Doctors hope that combining these two treatments will be effective and safe for these patients.

The main things the researchers want to find out are how safe the treatment is and how well it shrinks the cancer. They will be carefully watching for any side effects, especially a type of lung inflammation called pneumonitis. They will also measure how much the tumours shrink. They'll also look at whether the treatment improves the quality of life for patients and how long people live without their cancer getting worse.

Key takeaways

This study is for advanced lung cancer (NSCLC) that can't be surgically removed.
It's designed for older or frailer patients who can't have chemotherapy.
The treatment combines a shorter course of radiation with the drug durvalumab (Imfinzi).
Researchers are mainly checking for safety and how well the treatment shrinks tumours.
It's a Phase II study, gathering early but important information about this new approach.

Who may be eligible?

This study is open to both men and women, aged 18 years and above, with no upper age limit. This means that if you're an older adult who might not be able to have standard chemotherapy, you could potentially be considered.

The study is specifically looking for people who have stage III non-small-cell lung cancer that can't be removed by surgery. A key point is that you must be considered unable to have standard chemotherapy treatment, perhaps due to your age or other health conditions that make you more vulnerable.

Your doctor will discuss all the specific criteria with you, including any other health conditions or medications you might be taking, to make sure this study is the right fit for you. There will be detailed medical checks to ensure your safety if you choose 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.

Do you have non-small-cell lung cancer (NSCLC)?
Has your doctor told you it's Stage III and can't be removed by surgery?
Has your doctor said you're not suitable for standard chemotherapy?
Are you 18 years old or older?
Are you able 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 take part in this study, you would receive the special radiation therapy followed by regular doses of the drug durvalumab (Imfinzi). This drug is given through a drip into your arm (an infusion).

You would have regular visits to the hospital or clinic to receive your treatment and for various health checks. These checks would include blood tests, imaging scans (like CT scans) to see how the tumour is responding, and assessments of any side effects you might be experiencing. They will also ask you about your general well-being and quality of life.

The total length of your participation would depend on how your body responds to the treatment and the study's protocol, but it would involve ongoing treatment and follow-up appointments over a period set by the research team.

Potential risks and benefits

Participating in a study like this might offer the benefit of receiving a new type of treatment that isn't yet widely available, and it could potentially help to control your cancer. However, as with any new treatment, there are potential risks. The researchers will be closely monitoring for side effects, particularly inflammation of the lungs (pneumonitis), which can sometimes be serious. You might also experience other side effects common with cancer treatments, which your doctor will explain in detail. You are free to withdraw from 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
Germany

Common questions

What is 'unresectable stage III NSCLC'?

It means you have a type of lung cancer that has grown too much or spread to nearby areas, so it can't be fully removed by an operation.

What is durvalumab (Imfinzi)?

It's a modern medicine called an immunotherapy. It works by boosting your own body's defence system, your immune system, to find and fight cancer cells.

What does 'hypofractionated radiotherapy' mean?

This is a type of radiation therapy where you receive larger doses of radiation over a shorter period, meaning fewer treatment sessions overall compared to standard radiation.

Why is this study only for people 'unfit for chemotherapy'?

This study is looking for an alternative treatment option for patients who might be too old or too weak to manage the side effects of traditional chemotherapy.

Will I definitely get the study treatment if I join?

Yes, if you're eligible for this specific study, you would receive the combination of the shorter radiation course and durvalumab.